Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1698838933455.pdf (New Zealand)
Therapeutic Products and Medicines Bill Government Bill Explanatory note General policy statement The Therapeutic Products and Medicines Bill is an omnibus Bill.

It is proposed that it be divided at the conclusion of the committee of the whole House stage of the legislative process into 2 Bills.

Parts 1 to 5 will then be enacted as the Therapeutic Products Act 2006, and Parts 6 and 7 will become the Medicines Act 2006.
This approach is proposed due to the extent of the impact on the Medicines Act 1981 of the changes effected by Parts 1 to 5.

Parts 1 to 5 establish a new joint trans-Tasman regulatory scheme for the regulation of therapeutic products.
The joint regulatory scheme will cover: the regulation of the manufacture, supply, import, ex- port, and promotion of therapeutic products; the setting of stand- ards in relation to the quality, safety, and efficacy or performance of therapeutic products; post-market monitoring of therapeutic prod- ucts; and enforcement of the joint scheme’s requirements.
Respon- sibility for regulating aspects of therapeutic products covered by the joint scheme will be transferred from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), which is part of the Ministry of Health, to the Australia New Zealand Therapeutic Products Authority (the Authority).
The Authority’s role and gov- ernance is defined in the Agreement between the Government of Aus- 103—1 2 Therapeutic Products and Medicines Bill Explanatory note tralia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products (the Agree- ment), signed in December 2003.

It will be established by an Aus- tralian Act that will be the equivalent to Parts 1 to 5.
Parts 6 to 7 repeal and replace the Medicines Act 1981 (and regula- tions made under that Act) with updated legislation for controls on medicines, such as the scheduling of medicines, licensing of pharma- cies, and prescribing rights, that apply after the medicines have been approved for the market and are in the domestic supply and distribu- tion chain.
Government’s objectives The Government is committed to safeguarding the public health and safety of New Zealanders by establishing a new regulatory scheme for therapeutic products.

To achieve this goal, the Government is proposing to set up the Authority as a world-class joint regulatory agency (the Australia New Zealand Therapeutic Products Authority) to administer a joint regulatory scheme with Australia.

The joint scheme and the Authority are being established under the Agreement.
The Agreement sets out the governance and accountabil- ity arrangements for the Authority and how it is to be established.

It also provides a framework for the joint regulatory scheme for ther- apeutic products.

Parts 1 to 5 give effect to the joint scheme an- ticipated by the Agreement.

The scheme cannot commence until all Parts of the Bill are passed by Parliament.
The Agreement will, sim- ilarly, come into effect only once it has been ratified by an exchange of diplomatic notes between New Zealand and Australia.

This ratifi- cation will not occur until after the Bill is passed.
The objectives of the Agreement are to— • safeguard public health and safety in Australia and New Zealand by establishing and maintaining a joint scheme con- sistent with international best practice for the regulation of the quality, safety, and efficacy or performance of therapeutic products, and of their manufacture, supply, import, export, and promotion: establish a world-class regulatory agency to administer the scheme and to be accountable to both parties (the Australian and New Zealand Governments): • Explanatory note Therapeutic Products and Medicines Bill 3 • • establish a Ministerial Council (consisting of one New Zealand and one Australian Minister): avoid unnecessary barriers to trade.
Key concerns to be addressed by the joint scheme New Zealand is facing 2 key problems with its arrangements for regu- lating therapeutic products: outdated legislation, and a regulatory capacity that is not sustainable even in the short to medium term.

Addressing outdated legislation and providing a sustainable future-proofed regulatory regime The joint scheme will provide a means of maintaining an effective and sustainable regulatory capacity for New Zealand and Australia into the future.
While New Zealand faces a capacity problem now, Australia expects to face a similar challenge to its regulatory capacity in the longer term.

The Authority will provide for enhanced capacity in terms of technical expertise to evaluate the risks and benefits of in- creasingly complex therapeutic products.
Neither New Zealand nor Australia alone has the capacity to operate a world-class regulatory scheme for therapeutic products on an ongoing basis; together, the 2 nations can pool resources and ensure that citizens of both coun- tries gain the maximum protection in the area of therapeutic products safety.
New Zealand’s current regulatory framework for therapeutic prod- ucts, under the Medicines Act 1981 and the Medicines Regulations 1984, is outdated and gives rise to some significant safety risks, trade barriers, and costs to Crown and industry.

Updating the legislation is necessary to ensure that New Zealand meets international best prac- tice for the regulation of therapeutic products.
Ensuring the safety of medical devices and complementary medicines Regulation of medical devices and complementary medicines in New Zealand is minimal.

The joint scheme will regulate all therapeu- tic products, consistent with international best practice.

This in- cludes the risk-based regulation of medical devices and complemen- tary medicines.
The scheme will enhance public confidence by sub- jecting medical devices, and complementary medicines to a regula- tory scheme that provides assurance about safety and quality.

4 Therapeutic Products and Medicines Bill Explanatory note The joint scheme will apply the internationally harmonised approach to the regulation of medical devices developed by the Global Harmo- nization Taskforce partnership of the EU, Japan, USA, Canada, and Australia.
For New Zealand, this will mean introducing pre-market approvals, quality requirements, and an enhanced level of post-mar- ket monitoring and surveillance.

Complementary medicines include herbal remedies and medicines, traditional treatments, homeopathic remedies, and most dietary sup- plements.

The joint scheme will, for the first time in New Zealand, introduce risk-based regulation of complementary medicines as a subset of therapeutic products.
It will use an approach that enables product sponsors to gain marked authorisation by self-certification against the Scheme requirements.

Enhancing closer economic relations and facilitating trade The new scheme will be a significant enhancement of closer eco- nomic relations (CER) with Australia and trans-Tasman regulatory co-operation, consistent with the CER agreement of 1983, and the Trans-Tasman Mutual Recognition Arrangement agreed in 1996.
The Authority will be the first example of a true trans-Tasman au- thority that explicitly acknowledges joint co-operation between our 2 independent nations.

The establishment of the Authority will see New Zealand’s profile amongst the international therapeutics community increased.

This will facilitate the export of therapeutic products beyond Australia.
It will also offer more to other key regulators in terms of information sharing and potential for the Authority to develop mutual recogni- tion agreements with other key regulators such as those in the US, Canada, and Europe.

Greater regional and global influence over the development of international regulatory standards and harmonisation initiatives will also be provided.

The Authority will be able to ensure that health and safety object- ives are met without imposing unnecessary trade barriers.
A cred- ible trans-Tasman regulator will impose a quality standard that will be recognised and respected internationally.

This will enable New Zealand firms to prove the quality of their products and make them more attractive in an international market.

Explanatory note Therapeutic Products and Medicines Bill 5 The joint scheme will develop the therapeutic products industry in New Zealand, including research and development.
The new scheme will mean that manufacturers only need to apply for one product ap- proval in order to access both the Australian and New Zealand mar- kets.

It will mean that medicines approved for use in one country would also be approved for use in the other country, helping to limit the licensing and approval costs for the manufacturer and giving New Zealanders and Australians access to the same therapeutic products.
Exporters will also have an assurance that products have a recognised regulatory stamp of approval for safety and quality.

Relationship between the Agreement, the Bill, and Rules and Orders The Agreement between the two countries provides the framework for the joint scheme and the Authority by specifying the scope and framework, and accountability and governance arrangements, of the scheme.
The vehicles for establishment under the Agreement are the Agreement itself, the implementing legislation, and jointly made Rules and Orders.

The Agreement The Agreement sets the scope of the regulatory model, which aims to protect public health and safety, and sets out the corporate govern- ance structure for the Authority.

It is through the governance struc- ture that New Zealand sovereignty is managed.
The Agreement thus lies at the heart of the model, as it provides for symmetry in relation to the control of the Authority through the Ministerial Council and the Board.
The Agreement— • sets the overall objective of regulating the quality, safety, and efficacy or performance of therapeutic products: establishes a Ministerial Council of the Australian and New Zealand Ministers of Health to oversee the Authority and the regulatory scheme: establishes the Board of the Authority responsible to the Ministerial Council for the governance of the Authority.
The Agreement also sets the composition of the Board, its role, and the process for the appointment of the 5 members: • • 6 • • • • • • Therapeutic Products and Medicines Bill Explanatory note provides for the appointment of the Managing Director of the Authority to be responsible for the regulatory decisions about therapeutic products and for the day-to-day management of the Authority: provides for the Authority to be established as a body corpo- rate in Australian law and derive its governance and account- ability mechanisms from the jointly signed Agreement and its joint structures—the Ministerial Council and the Board: describes the high-level accountability provisions for the Au- thority: provides that the Ministerial Council may make Rules for a number of purposes: provides that the Authority may make Orders for a number of purposes to do with the regulation of therapeutic products: provides for therapeutic products approvals, departures from the scheme in exceptional circumstances, reviews of the Au- thority’s decisions, funding arrangements for the Authority, and a number of other matters.
Implementing legislation The Agreement requires both New Zealand and Australia to intro- duce implementing legislation to confer the necessary rights, powers, and privileges on the Authority to enable it to perform its regula- tory functions.

Parts 1 to 5 represent New Zealand’s implementing legislation.

Equivalent implementing legislation will be introduced into the Australian Parliament.

Once the legislation is passed in both countries, the Agreement will be ratified and come into force.
As it does so, it will establish the Ministerial Council and the Board of the Authority.

It will also allow the regulatory details (Rules and Orders) to be formally developed.

Rules and Orders The Rules are central to the arrangements for the Authority and scheme as they provide the joint decision-making vehicle that ensures equality of voice and freedom from unilateral influence.
Rules can be made for a range of purposes as set out in Article 9 of the Agreement, including governance and accountability, fees and charges, and prescribing standards of good regulatory prac- Explanatory note Therapeutic Products and Medicines Bill 7 tice.

Rules are akin to regulations.

Orders issued by the Managing Director of the Authority will provide a further level of regulatory detail.
Rules and Orders are given the force of law in each country and are subject to disallowance by the Parliaments of both countries.

Parts 1 to 5 (to be the Therapeutic Products Act 2006) The key elements of the regulatory framework for therapeutic prod- ucts are— • • • • • The detail of the regulatory scheme will be covered in Rules.
This section of the explanatory note covers the key elements of the scheme that are addressed in Parts 1 to 5. pre-market assessment of product safety, quality, and efficacy: licensing of manufacturers to assure product quality: setting standards to assure product quality and performance: post-market monitoring of product safety and quality: surveillance to check for compliance.
Governance and accountability The Agreement, Parts 1 to 5, and the equivalent Australian legisla- tion ensure that both countries have an equal voice in the governance of the scheme and the Authority, and that neither country may take unilateral action in respect of the scheme and the Authority.

The Aus- tralian and New Zealand implementing legislation have provisions that ensure the same approach across both countries.
Parts 1 to 5— • recognise the Authority established under the Agreement and given legal personality by the Australian implementation le- gislation.

The Authority’s governance and accountability ar- rangements are derived from the Agreement: makes the Authority accountable to Health Ministers and the Parliaments of both New Zealand and Australia, and to Min- isters of Finance, where appropriate: makes the Authority responsible for a joint regulatory scheme that applies in both New Zealand and Australia.
The ability to establish the regulatory scheme comes from the Agreement and the detail of the scheme will be in Rules (made by the Min- • • 8 • Therapeutic Products and Medicines Bill Explanatory note isterial Council) and technical Orders (made by the Managing Director of the Authority); and makes the Authority responsible for delivering common regu- latory outcomes and implementing and enforcing regulatory arrangements in both countries.
• • The model for the Authority has been intentionally designed to retain not just the expected government reporting processes but also im- portant parliamentary and public accountability controls.

In these re- gards, the Authority will have very similar accountabilities to a New Zealand Crown entity and to an Australian Commonwealth Author- ity.
Specifically, the Authority will be— • required to provide an annual report and statement of intent and other accountability documents equivalent to those of a Crown entity, which will be tabled in the New Zealand House of Representatives: subject to scrutiny of its regulatory decisions through a merits review process and judicial review: subject to other legislative requirements in both countries, eg, Official Information/Freedom of Information Acts, Privacy Acts, Ombudsmen Acts, and Auditors-General scrutiny.
In addition, the Bill requires Rules and Orders to be presented to Par- liament.

There is a tailored disallowance scheme based on that in the Regulations (Disallowance) Act 1989, but with differences to reflect the joint nature of the Rules and Orders.

Members of Parliament will have 3 months to give notice of motion to disallow a Rule or Order.

Parliament will have 21 sitting days, from the notice of motion, to disallow the Rule or Order.
Parts 1 to 5 also provide for other governance and accountability matters such as— • • • • seeking information from Australia: providing for audit (joint with Australia): financial matters: controls on subsidiaries.

Explanatory note Therapeutic Products and Medicines Bill 9 Governance The Ministerial Council and its functions are established under the Agreement.

The Ministerial Council comprises the Australian and New Zealand Ministers of Health.

Its primary role is to oversee the joint scheme.


The Agreement also provides for the appointment of a Board of the Authority comprising 5 members.

This includes the Managing Director of the Authority.

The Managing Director is the chief executive of the Authority and is accountable to the Board for fi- nancial and administrative matters.

A range of expert advisory com- mittees will provide advice to the Managing Director in relation to regulatory decisions.
Part 4 places governance duties on Board members (eg, duties to act with honesty and integrity, to comply with Acts and Rules, and to act with care, due diligence, and skill).

The Bill also provides that Board members are subject to criminal and civil sanctions for failing to comply with their duties.
In New Zealand, this means adopting additional measures, consistent with Australia, to ensure a seamless environment under which the Board members are subject to the same duties and sanctions, regardless of their location.

Part 4 also provides for management of conflicts of interest and pro- tection of Board members acting in good faith.
Rules and Orders The Agreement requires the making of Rules by the Ministerial Council and the making of Orders by the Managing Director of the Authority on details of the regulatory scheme.
The regulatory requirements will be set out principally in Rules (eg, medicines, medical devices, administration, advertising, and fees and charges) made by the Ministerial Council, but also, in the case of technical details such as labelling requirements and standards, in Orders issued by the Managing Director of the Authority.

These in- struments, and any changes made to them over time, will be subject to scrutiny by the Parliaments in a similar way to domestic regula- tions.
Part 1 includes a discrete disallowance regime to enable this to occur.

The use of Rules and Orders rather than domestic regulations is a central part of the joint scheme.

There will be only one set of Rules and Orders for both countries.
10 Therapeutic Products and Medicines Bill Explanatory note Compliance Part 2 creates a tiered offence regime that provides for both criminal and civil penalties for breaches of the regulatory regime in relation to the manufacture, import, export, supply, and promotion of thera- peutic products, misrepresentation, product tampering, and making false or misleading statements.
The starting point for the enforce- ment regime was the Australian Therapeutic Goods Act 1989, which is a more comprehensive regime than the one set out in the New Zealand Medicines Act 1981.

Part 2, therefore, provides for an enhanced enforcement regime.

In some cases, this has resulted in higher penalties for significant breaches of the law (eg, counterfeiting medicines).
This is a benefit of the new joint scheme to New Zealand, where enforcement powers and options have previously been seen to be limited.

New Zealand has been fortunate not to experience significant non-compliance problems such as have occurred in Australia and internationally, but New Zealand cannot be complacent.

The offences regime reflects this.


Part 2 introduces a tiered approach for penalties, with fines of up to $550,000 (and/or 5 years’ imprisonment) for an individual, and fines of up to $5,500,000 for a body corporate.

In Parts 1 to 5, monetary penalties are identified by way of penalty units, where one penalty unit equals $110.
The joint nature of the regime requires that there must be no oppor- tunity for regulatory arbitrage; thus the offences and penalties area has been one where there has been particular focus on ensuring the provisions in both countries’ Bills are drafted so as to achieve as near a similar outcome as possible.

However, the Bill recognizes the value of a broad-based approach to addressing non-compliance.
Part 2 pro- vides an opportunity to introduce new enforcement options, short of formal court proceedings, designed to encourage and facilitate early correction of non-compliant activity, such as a non-compliance no- tice regime and the ability of the Authority to accept enforceable undertakings.
Search and seizure Part 2 includes search and seizure provisions allowing an authorised officer of the Authority to monitor compliance with the provisions Explanatory note Therapeutic Products and Medicines Bill 11 of the Bill, Rules, and Orders.

The provisions are similar to current legislation which has search and entry provisions made after the New Zealand Bills of Rights Act 1990 (eg, the Agricultural Compounds and Veterinary Act 1997 and the Animal Products Act 1999).
They allow the officer to enter and search a place (excluding a dwelling house or a marae) without a warrant at any reasonable time to monitor compliance, or if the officer has reasonable grounds to believe that it is necessary in the interest of public health in order to avoid an imminent risk of death, serious illness, or serious injury, and it is not practicable in the circumstances to obtain a search warrant.
In other circumstances the Authority is required to apply for a warrant to enter and search a place.

Merits review and judicial review The Agreement requires that the implementing legislation of both countries provides for the merits review of regulatory decisions by a review tribunal.

The Agreement also permits each country to provide for judicial review of Rules and of decisions and Orders made by the Authority.

Part 3 makes provision for both of these things.


Regulatory decisions of the Authority will be subject to merits review by a New Zealand Review Tribunal, established by the Bill.

The members of the Tribunal for a particular review will be drawn from a merits review panel appointed by the Ministerial Council.

A similar tribunal will operate in Australia.

A merits review involves a reconsideration of the merits of the de- cision.
There are provisions to enable a review to be transferred be- tween the New Zealand and Australian Review Tribunals in certain cases, and to ensure the same decision is not reviewed by more than one tribunal.

There are rights of appeal from the New Zealand Re- view Tribunal to the High Court.

Decisions of the Authority take effect in both countries subject to any orders made by either Review Tribunal or a court on appeal.
Ombudsmen and Privacy Legislation and Information Management The Official Information Act 1982, the Privacy Act 1993, the Pro- tected Disclosures Act 2000, the Public Audit Act 2001, and other relevant accountability legislation will apply to the Authority in the same manner as they do to other agencies in New Zealand.
12 Therapeutic Products and Medicines Bill Explanatory note Part 3 allows for the transfer of complaints between Australian and New Zealand Ombudsmen and Privacy Commissioners, where the complaint more appropriately sits within the other jurisdiction.

The Bill also continues current policy under the Medicines Act 1981, where it is acknowledged that in certain situations, for regulatory rea- sons, information will need to be disclosed and will require protec- tion.
In the event of a public health and safety risk, information will be able to be placed in the public arena.

Consistent with New Zealand’s commitments under the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement that protects the data around innovative medicines, innovators will be given protections that ensure the Au- thority cannot use protected information for a specified period of time in order to approve generic medicines.
While the patent term for therapeutic substances in New Zealand is 20 years, in Australia the patent term for therapeutic products can be extended to 25 years.

The Authority can consider an application to register a generic product prior to the expiry of the patent in New Zealand or Australia.
The Bill confirms that the supplier can market the generic product in New Zealand following the expiry of the New Zealand patent, notwithstanding that the substance may still be pro- tected by an Australian patent in Australia.

Regulations The Agreement provides for regulations to be made regulating any products which are excluded from the joint scheme under Article 12 of the Agreement.

This provides for departures from the scheme in exceptional circumstances.
There are also provisions allowing regu- lations to be made setting fees and charges for any functions per- formed by the Agency that fall outside the scope of the scheme, and to address temporary or transitional measures needed to implement the scheme.

Transitionals Part 5 provides for transitional arrangements for approvals of medicines and medical devices.
Explanatory note Therapeutic Products and Medicines Bill 13 Transfer of employees Part 5 also provides for the transfer of Medsafe employees and assets to the new Authority.

Parts 6 and 7 (to be the Medicines Act 2006) Parts 6 and 7 repeal the existing Medicines Act 1981 and Parts 1 to 5 move controls into the trans-Tasman regulatory scheme.
Controls in the current Medicines Act 1981 that will not be covered by the new trans-Tasman regulatory scheme will be regulated under Parts 6 and 7 and include— • storage, and record-keeping requirements for provisions setting out when, how, and by whom prescription medicines can be prescribed, dispensed, and administered: scheduling of medicines (eg, prescription, pharmacy only): transport, medicines: provisions covering the licensing and ownership of pharma- cies: a licensing regime covering the retail and wholesale supply of scheduled medicines: enforcement provisions for such controls (eg, offences, penal- ties, powers for enforcement officers, etc).
• • • • • The establishment of a new regulatory scheme for therapeutic prod- ucts has provided an opportunity to update the Medicines Act 1981.

Significant changes have not been recommended because the major- ity of provisions in the Medicines Act 1981 are sound.

Changes in- clude minor technical amendments to fix some inconsistencies and new provisions to update old provisions.
Changes are also recom- mended to ensure that there is seamless and effective regulation of therapeutic products under Parts 1 to 5 and Parts 6 and 7.

These Parts, when enacted as separate Acts, need to be compatible to ensure effective regulation and enforcement across the joint scheme and do- mestically.

The end result will be more modern legislation.

Licensing regime and controlled activities Parts 6 and 7 largely carry over the existing licensing regime and controls on medicines activities.
This includes the supply of sched- uled medicines by wholesale, supplying medicines by vending ma- 14 Therapeutic Products and Medicines Bill Explanatory note chine, dispensing medicines, administering and possessing prescrip- tion medicines, and prohibiting and restricting prescribing activities.
The licensing authority (the Director-General of Health) issues li- cences to persons to supply scheduled medicines by wholesale, to supply pharmacy medicines other than by wholesale, to dispense medicines, and to operate pharmacies.

Exceptions to rolling over the current provisions of the Medicines Act 1981 are discussed below.

Appeals in relation to the licensing process Parts 6 and 7 streamline the current appeals process for appeals on licensing decisions.
Applicants currently have a statutory right to ap- peal to the Medicines Review Committee and a subsequent right of appeal on questions of law to the District Court.

The New Zealand Medicines Review Committee has not been convened to consider li- censing issues for many years, and will be disestablished under the joint scheme.
Accordingly, the proposed appeal structure for the new Medicines Act provides for the possibility of 2 appeals from a deci- sion of the Director-General of Health (the licensing authority).

A party may make a first appeal to the District Court.

From there, a further appeal may be made to the High Court, but only on a ques- tion of law and with the leave of the Court.

The decision of the High Court would be final.


Enforcement Parts 6 and 7 update the offence provisions to ensure that they are consistent with the proposed enforcement scheme under Parts 1 to 5.
Parts 6 and 7 contain similar search and seizure provisions to those in Parts 1 to 5, providing the Ministry of Health’s medicines control officers with the right to enter and search any place (excluding a dwelling house or a marae) without a warrant, at any reasonable time, to monitor compliance, or if the officer has reasonable grounds to believe that it is necessary in the interest of public health in order to avoid an imminent risk of death, serious illness, or serious injury, and it is not practicable in the circumstances to obtain a search warrant.
Medicines control officers are required to apply for a warrant to enter and search a place at any other times.

Explanatory note Therapeutic Products and Medicines Bill 15 Penalties and offences Offences from the Medicines Act 1981 that relate to the domestic medicines chain are carried over into Parts 6 and 7.

They cover issues such as security, storage, packaging, labelling, delivering, dis- posing, and prescribing of medicines.
A new continuum of penalties is introduced to reflect the seriousness of each specific offence, and to make penalties comparable with other modern legislation.

Penalties range between— • a fine of $5,000 for an individual or a fine of up to $40,000 for a body corporate, for less serious offending; and a fine of up to $100,000 and up to 12 months’ imprisonment for an individual or a fine of up to $250,000 for a body corporate, for serious offending.
• Parts 6 and 7 also introduce a higher penalty in respect of offending where it can be proved that the conduct was wilful and endangered public health.

The penalty for this conduct, on indictment, is to be a fine of up to $100,000 and up to 12 months’ imprisonment for an individual (or both) and a fine of up to $250,000 for a body corporate.
Parts 6 and 7 also change some offences from strict liability offences to normal offences to require an element of intention for consistency with the New Zealand Bill of Rights Act 1990.

Parts 6 and 7 retain the ability for officers under the Act (and po- lice) to obtain a search warrant in respect of offending against the Medicines Act.

This is regardless of whether the specific offence features a term of imprisonment.
Medicines control officers and po- lice are able to enter, search and seize property, and compel the pro- duction of documents.

Search and seizure is also possible without consent or a warrant, where this is essential to ensure effective en- forcement of the law.
Parts 6 and 7 also include 2 new offences— • to prohibit the prescribing of prescription medicines by indi- viduals who are not prescribers (ie, who are not health practi- tioners with a prescribing right under the legislation) or veter- inarians.

The offence will be punishable by a maximum fine of $10,000: for persons who do not dispose of medicines in the manner prescribed by regulations made under the legislation (eg, en- vironmental requirements for safe disposal).
The proposed of- • 16 Therapeutic Products and Medicines Bill Explanatory note fence carries a maximum fine of $5,000 for an individual and $40,000 for a body corporate.

Pharmacy ownership Parts 6 and 7 incorporate recent reforms to the licensing regime for pharmacies made to the Medicines Act 1981, in September 2004, in conjunction with the passage of the Health Practitioners Competence Assurance Act 2003.
The Bill requires operators of community and hospital pharmacies to be licensed by the Director-General of Health.

Ownership of pharmacies is restricted to pharmacists, who must hold at least a 51% share of a pharmacy.

Companies may also operate a pharmacy as long as a pharmacist or pharmacists own 51% or more of the company’s share capital.

Neither a pharmacist nor a company may hold a majority interest in more than 5 pharmacies.
Pharmacies legally carrying on business when the Bill comes into force will be deemed to have a licence to operate.

Designated prescribers Parts 6 and 7 also incorporate recent reforms made in regulating des- ignated prescribers.

The Bill permits regulations to be made to al- low new groups of health practitioners to be deemed “designated pre- scribers” (eg, nurse practitioners, optometrists etc).
The regulations can impose conditions and restrictions on who may be a designated prescriber, and set out requirements for the qualifications, training, and competencies of designated prescribers.

The relevant registra- tion authority (eg, Nursing Council) must, by notice in the Gazette, specify the prescription medicines that designated prescribers may prescribe, and must keep this list up to date and make this list pub- licly available.
The registration authorities are also responsible for gazetting the competencies and training for designated prescribers.

If the Minister has a concern about the ability of a registration au- thority to fulfil its statutory obligations, he or she is able to audit the registration authority’s functions, and ask the registration authority to respond to any concerns raised by the audit.
If the Minister is dis- satisfied with the registration authority’s response to the audit, he or she may also revoke the registration authority’s Gazette notices and develop regulations setting out new requirements regarding the lists of medicines, competencies and training, and qualifications for des- ignated prescribers.
The Bill includes transitional provisions so that Explanatory note Therapeutic Products and Medicines Bill 17 existing prescribing regulations are carried over until the registration authorities are able to gazette new prescribing notices.

Parts 6 and 7 also allow the Governor-General, on the recommen- dation of the Minister of Health, following consultation with ap- propriate organisations, to make regulations designating a class of health practitioner to be authorised prescribers.
This means that, over time, if designated prescribers demonstrate their competence to pre- scribe safely and appropriately, the regulatory framework covering such health practitioners could be aligned to the framework govern- ing existing prescribers (ie, medical practitioners, dentists, and mid- wives).
Xenotransplantation Parts 6 and 7 carry over provisions from Part 7A of the Medicines Act 1981 relating to xenotransplantation (medical procedures involv- ing the transplanting of live tissues or organs from an animal source into people).

The Bill allows the Minister of Health to authorise persons to conduct xenotransplantation procedures, if the procedure does not impose an unacceptable risk to the health and safety of the public.
The Medicines Bill removes reference to the consideration of ethical, cultural, and spiritual issues, because health and disability ethics committees will consider these issues on a case-by-case basis for each xenotransplantation clinical trial application.

To date, the Minister has not authorised any xenotransplantation.
It is proposed that xenotransplantation be covered by the joint scheme, but until new controls are in place to govern the safety of the practice, regulation needs to be covered by the Medicines Act.

The provisions will expire on 31 December 2008.

This should allow sufficient time for the new controls to be in place under the proposed joint scheme to be administered by the Authority.

The Medicines Bill does, however, provide for this date to be extended by Order in Council, should the need arise.
The Bill also updates the definition of xenotransplantation to bring it in line with the Food and Drug Administration’s definition, which is considered more straightforward.

18 Therapeutic Products and Medicines Bill Explanatory note Good prescribing practice Parts 1 to 5 will give force of law in New Zealand to Rules made under the Agreement.

These Rules, which are currently being drafted and consulted on, will prohibit the export of a therapeutic product without a product licence.
This will stop the export of a medicine (including over-the-counter medicines) from New Zealand by any- body other than the holder of the product licence for the medicine.

In particular, the export of medicine in the course of, or for the pur- pose of, retail sales, following internet sales, will largely be prohib- ited by the requirement that the exporter must hold a valid product licence.
There are, however, current concerns about prescribers in New Zealand issuing prescriptions for overseas clients not in New Zealand, or counter-signing prescriptions issued by doctors who are overseas (eg, via the Internet).

To address this concern, Parts 6 and 7 include a provision that en- sures prescribers are only able to prescribe medicines for patients who are physically present in New Zealand or are permanent New Zealand residents temporarily overseas.
The intention of this is to guard against inappropriate prescribing of medicines to overseas pa- tients (regardless of whether the subsequent export of therapeutic products to the patients is also illegal).

It would also allow for un- usual but legitimate prescribing situations where a patient may not have had a face-to-face consultation with their prescriber (eg, a locum prescribing for someone in a remote area).

Parts 6 and 7 also remove some of the restrictions on prescribing practice.
The current restriction on dentists’ prescribing of prescrip- tion medicines is removed, and replaced with a provision that al- lows dentists to prescribe prescription medicines for up to 3 months.

This is consistent with other prescribers and is appropriate, given the changes to the practice of dentistry and availability of medicines use- ful in dental treatment in recent times.
Parts 6 and 7 also allows for an exception to the requirement that prescribers are not allowed to prescribe prescription medicines for a term exceeding 3 months (or 6 months for oral contraceptives).

The Director-General of Health will be able to waive this requirement in special circumstances (eg, army personnel operating overseas).
Explanatory note Therapeutic Products and Medicines Bill 19 Supply of unscheduled medicines from vending machines Since the Medicines Act came into force in 1981, the sale of unscheduled (general sales) medicines from outlets such as super- markets, dairies, and petrol stations has become commonplace (eg, paracetamol).
Parts 6 and 7 recognise the supply of unscheduled medicines from vending machines, but prohibit the supply of sched- uled medicines (eg, prescription medicines and pharmacy-only medicines) from vending machines unless permitted in accordance with regulations made under the legislation (ie, the sale of unsched- uled medicines from a vending machine would be a controlled activity).
The Bill therefore permits the sale, through vending ma- chines, of the same range of medicines currently able to be sold in supermarkets.

The risk arising from the supply of medicines from vending machines, which are securely sealed units dispensing one unit at a time, is likely to be less than the risk arising in retail outlets where medicines may be stored on low shelves and purchases of multiple packs are easily made.
Issuing of licences to supply medicines by retail, for premises that do not meet the 10 kilometre rule, if it is in the interests of public health Parts 6 and 7 include a new provision for a licence to sell medicines by retail to be issued to an outlet other than a pharmacy, where the Director-General considers this to be in the best interests of public health.
This would be an extension to the current requirement that pharmacy-only medicines may only be sold from a pharmacy, or from a shop that is at least 10 kilometres, by the most practicable route from a pharmacy.

This proposal would still enable licences to be issued in relation to shops in remote areas, but would also enable other outlets to be licensed to sell specific medicines where this was considered appropriate.
Reasons for declining a licence application Parts 6 and 7 clarify the sorts of considerations the Director-General of Health (acting as the licensing authority) must take into account in granting a licence to a person who is “fit and proper”.

This in- cludes whether the person has previous convictions, has an adequate knowledge of the licence requirements, or has the competencies and resources to reliably undertake the licensed activities.
20 Therapeutic Products and Medicines Bill Explanatory note Elevation of some regulations in the Medicines Regulations 1984 to the Medicines Act Parts 6 and 7 take a different approach to the current Medicines Act.

Rather than prohibiting certain prescribed activities, the Bill provides that an activity can be undertaken unless it is prohibited.

There are several provisions set out in the current Medicines Regulations 1984 which are elevated to Parts 6 and 7.
These provisions involve quite invasive powers, which are more appropriately dealt with in primary legislation.
For example, Regulation 31, which permits a Medical Officer of Health to serve a notice on any owner or occupier of a premise prohibiting the use of the premises for, or in connection, with the manufacture, storage, or packing of any medicine or related prod- uct for sale, where there are concerns about the construction or disre- pair of the premises or the use or character of neighbouring premises, is elevated to the Bill.
New definitions and regulation-making powers Parts 6 and 7 add new definitions to clarify current practice in re- lation to compounding, dispensing, and prescribing.

New regula- tion-making powers relating to prescribing, dispensing, record keep- ing, and information requirements have been added to allow regula- tions to be made that take into account advances in technology, such as new developments in electronic transmission and storage of infor- mation.
Clause by clause analysis Clause 1 is the title clause.

The intention is that this Bill will even- tually be enacted as 2 Acts, the Therapeutic Products Act 2006 (re- ferred to in the Bill as Parts 1 to 5) and the Medicines Act 2006 (referred to in the Bill as Parts 6 and 7).

Clause 2 is the commencement clause.

It provides for Parts 1 to 5, and Parts 6 and 7, and for specific provisions of those Parts, to be brought into force by Orders in Council.

Clause 3 states the object of the Act.


Explanatory note Therapeutic Products and Medicines Bill 21 Part 1 Preliminary, and Rules and Orders Subpart 1—Preliminary provisions Clause 4 states the purpose of Parts 1 to 5.

Clause 5 provides an overview of Parts 1 to 5.

Clause 6 defines terms used in Parts 1 to 5.

All defined terms are listed here, but the actual definition of many terms is given in other clauses or the Agreement.
Terms that are used primarily in a par- ticular Part are defined in a clause at the beginning of that Part, with clause 6 merely providing a cross-reference to the clause that sets out the definition.

Clause 7 carries forward the effect of section 32A of the Medicines Act 1981.

That section provides for the Crown to import and supply products without having to comply with the usual regulatory proced- ures under that Act.
Clause 7 authorises the Minister to specify that a product that is identical to another product (being a product that has a product licence granted by the Authority under the Rules) is subject to a Crown exemption.

A product that is subject to a Crown exemp- tion may be imported and supplied in New Zealand as if it had a prod- uct licence.

The Minister must consult with the Australian Minister before specifying a product as being subject to a Crown exemption.
Clause 8 provides that Parts 1 to 5 and the Rules and Orders bind the Crown.

Subpart 2—General provisions about Rules and Orders Rules and Orders having force of law Clause 9 provides that Rules and Orders (as defined in clause 6) have the force of law as if they were regulations made under an Act.
Clause 10 states that the effect of this subpart, in conjunction with the equivalent provision in the Australian Act, is that a Rule or Order cannot be in force as part of the law of one country without it also being in force as part of the law of the other country.

Clause 11 contain requirements relating to the commencement of Rules and Orders.
Rules and Orders cannot come into force before they are published (either on the Authority’s Internet site or in the Gazette) or notice of them has been given in the Gazette.

22 Therapeutic Products and Medicines Bill Explanatory note Clause 12 provides that the Minister must not agree to making Rules relating to the governance or accountability of the Authority without the agreement of the Finance Minister, unless the Finance Minister has waived that requirement.
Subpart 3—Publication, presentation, and disallowance of Rules and Orders Meaning of Rule and Order for publication, presentation, and disallowance purposes Clause 13 provides that, for the purposes of this subpart, an instru- ment containing 2 or more Rules or Orders is taken to be a single Rule or single Order.

Publication of Rules and Orders Clause 14 requires that the Authority must publish and maintain on its Internet site every Rule, Order, and the explanatory statement of every Rule and Order.
It may also publish compilations on its Internet site.

Rules and Orders must be published as soon as practicable after they are made.

The Internet site must include information about when Rules or Orders, or provisions of Rules and Orders, come into force or cease to be in force.

Clause 15 provides for the correction of published Rules, Orders, and compilations.
Clause 16 provides that a Rule or Order published on the Internet site is to be taken as a complete and accurate record of the Rule or Order, and that a compilation is to be taken to be a complete and accurate record of the compiled Rule or Order as amended and in force on the date of compilation.
Clause 17 requires the Authority to retain the original signed copy of every Rule and Order until it is passed to the appropriate archival authority, and to make hard copies of Rules and Orders available to Ministers on request and to any other person on request and payment of the prescribed fee (if any).

Clause 18 states that no copyright exists in Rules or Orders.
Explanatory note Therapeutic Products and Medicines Bill 23 Presentation of Rules and Orders Clause 19 requires the Minister to present a copy of every Rule and Order to the House of Representatives within 6 sitting days after the date on which the Rule or Order is made.

Failure to do so means that the Rule or Order will not come into force or, if it is in force, it ceases to be in force.
It is intended that, following presentation, Rules and Orders should be subject to scrutiny by the Regulations Review Committee.

This cannot be provided for in the Act because it involves a matter of Parliamentary procedure.

An amendment to the Standing Orders of the House of Representatives will therefore be sought once this Bill is enacted in order to give effect to the intention.
Clause 20 provides that the Minister, when presenting a Rule or Order to the House of Representatives, must also present an explana- tory statement of the Rule or Order.

Disallowance of Rules and Orders Clause 21 explains that the purpose of clauses 22 to 26 is to estab- lish a disallowance scheme enabling the New Zealand House of Rep- resentatives to disallow Rules and Orders.
A discrete disallowance scheme is required because Rules and Orders are not regulations for the purposes of the Regulations (Disallowance) Act 1989.

In order to reflect the joint nature of the Scheme, this disallowance scheme needs to be as similar to the equivalent scheme under the Australian Act as possible.

Clause 22 provides that a Rule or Order can only be disallowed as a whole, and not in part.

Individual provisions of Rules and Orders cannot be disallowed.
Clause 23 states that any member of Parliament may give a notice of motion to disallow a Rule or Order.

The member must give the notice within 3 months of the date on which the Rule or Order was presented to the House of Representatives.
Clause 24 provides that a Rule or Order be disallowed if— • a notice of motion to disallow the Rule or Order is given by a member of the Regulation Review Committee and no decision on the motion is made within 21 days of it being given; or 24 Therapeutic Products and Medicines Bill Explanatory note • a notice of motion to disallow the Rule or Order is given by any Member of Parliament and the notice is called on, moved, and agreed to with 21 days of being given.
A Rule or Order that is disallowed ceases to be in force.

Clause 25 sets out the circumstances in which a notice of motion to disallow a Rule or Order lapses.

Clause 26 requires the Minister to give notice in the Gazette if a Rule or Order is disallowed, and requires the Authority to give notice of any disallowances on its Internet site.
Clause 27 states that a Rule or Order is not in force if it is not in force under the Australian Act as a result of a failure to table the Rule or Order as required by the Australian Act, or disallowance by either House of the Parliament of Australia.

Part 2 Enforcement of regulatory scheme Subpart 1—General provisions relating to Part For the joint regulatory scheme to work, the enforcement regime in each country must be as similar as possible.
This is so that the out- come of enforcement action is not dependent upon which country the action was taken in.

The starting point in designing the enforcement regime was the Australian Therapeutic Goods Act 1989.

This is a more comprehensive regime than the one set out in New Zealand’s Medicines Act 1981.
As a result of the need to align the enforcement regime in this Bill with that of the Australian Bill, the provisions of this Part include the following features: • penalties are expressed as penalty units (where 1 penalty unit equals $110) and are high by New Zealand standards.
The penalty levels could not drop below existing Australian levels and must be equivalent to them: some matters normally left to the common law (such as de- fences, and the precise identification of elements of offences) are spelt out in this Part.
This is because the Australian crim- inal law is codified in the Criminal Code Act 1995 and, in order • Explanatory note Therapeutic Products and Medicines Bill 25 • • • • to provide more certainty of outcome, New Zealand’s equiva- lent rules need to be articulated in this Part: the enforcement options include 3 varieties of offences as well as civil penalties, non-compliance notices, and enforceable undertakings.
These are currently available in Australia in the therapeutic goods context and have been provided for in this Part so that the range of enforcement action currently avail- able in Australia is also available in New Zealand: a single kind of proscribed conduct (such as manufacturing a therapeutic product without a manufacturing licence) may therefore attract a range of enforcement responses.

Court-im- posed penalties are set out in up to 4 tiers.
The pattern of tiered responses in many (but not all) cases is as follows: • • civil penalties—for engaging in the proscribed conduct: summary offences—for knowingly or recklessly engag- ing in the proscribed conduct: indictable offences—for knowingly or recklessly en- gaging in the proscribed conduct where the conduct re- sults in harm or a serious risk of harm: strict liability offences—for engaging in the proscribed conduct and the conduct results, or is likely to result, in harm: • • in addition, a non-compliance notice provides for a penalty without judicial involvement.
It can be issued where a person may be liable to a civil penalty or a strict liability offence.

If the recipient pays the amount required under the notice, no further proceedings may be issued: enforceable undertakings are a new enforcement tool in New If a person gives an enforceable undertaking, the Zealand.

Authority may ask the High Court to make a range of orders if the person fails to honour the undertaking.
Definitions and jurisdiction Clause 28 provides definitions of terms primarily used in subparts 1 to 3 of this Part.

These subparts identify the main regulatory of- fences and provide for civil penalties, offences, non-compliance no- tices, and enforceable undertakings.

26 Therapeutic Products and Medicines Bill Explanatory note Clause 29 relates to jurisdiction.
Clause 29(1) provides that a person may be convicted of an offence under this Part if any part of the con- duct constituting the offence occurred in New Zealand or Australia.

It does not matter— • whether some of the conduct occurred outside New Zealand or Australia; or whether the person proceeded against was in New Zealand or Australia at the time of the conduct constituting the offence.
• Clause 29(2) mirrors the provisions in clause 29(1) in relation to a person liable to a civil penalty under this Part.

General provisions about offences Clause 30 provides that prosecutions for summary offences under this Part may be commenced at any time within 6 years after the (The time limit that conduct constituting the offence occurred.

would otherwise apply under the Summary Proceedings Act 1957 is 6 months.)
Clause 31 sets out sentencing guidelines for offences involving harm, or risk of harm, to any person.

Clause 32 sets out matters relating to the prosecution and available defences in respect of the strict liability offences in this Part.

Clause 33 explains how alternative verdicts are dealt with under Aus- tralian and New Zealand legislation.

Clause 34 imposes notice requirements on defendants who wish to raise specific defences to certain indictable offences.
Clause 35 provides that the Managing Director may certify certain matters, and that such a certificate can then be used in evidence in civil or criminal proceedings under this Part.

Proceedings for civil penalties Clause 36 provides for the Authority to apply to the High Court for a civil penalty against a person who is liable under this Part.
Clause 37 provides that the High Court may order a person to pay a civil penalty if the person has contravened a civil penalty provision, or has aided, induced, or conspired (etc) in such a contravention.

The Court must have regard to the criteria set out in subclause (2) when determining the amount of civil penalty that must be paid.

Maximum Explanatory note Therapeutic Products and Medicines Bill 27 amounts of civil penalties are set out in individual civil penalty pro- visions.
Clause 38 provides that applications for a civil penalty must be made within 6 years after the conduct giving rise to the liability occurred, and provides for the standard of proof and procedural matters in civil penalty proceedings.
Relationship between civil penalty and criminal proceedings Clause 39 bars proceedings for a civil penalty under this Part against a person in relation to particular conduct if there are already pro- ceedings underway against that person for a civil penalty under the Australian Act in respect of the same conduct, or if such proceedings have been completed.
Clause 40 bars criminal proceedings under this Part if criminal pro- ceedings relating to the same conduct are underway, or have been completed, in Australia.

Clause 41 allows criminal proceedings for an offence under this Part to commence against a person even if proceedings for a civil penalty, whether in New Zealand or Australia, have commenced against that person in respect of the same conduct.

Clause 42 provides that a person may not be penalised more than once in respect of the same conduct.
Clause 43 describes the effect of the withdrawal or discontinuation of proceedings on any limitation period applying to subsequent pro- ceedings.

Clause 44 provides that evidence given in civil penalty proceedings is not generally admissible in subsequent criminal proceedings relating to the same conduct.

Clause 45 clarifies that nothing in clauses 39 to 44 affects the abuse of process jurisdiction of any court.
Liability of executive officers Clause 46 provides that an executive officer of a body corporate com- mits an offence if— • the body corporate commits an offence under this Part; and 28 • • • Therapeutic Products and Medicines Bill Explanatory note the officer knew that the offence was being or would be com- mitted; and the officer was in a position to influence the conduct of the body corporate in relation to the commission of the offence; and the officer failed to take all reasonable steps to prevent the commission of the offence.
Clause 47 provides for the civil liability of an executive officer of a body corporate.

The grounds of liability mirror those establishing criminal liability under clause 46.

Clause 48 prescribes criteria for establishing whether an executive officer failed to take all reasonable steps to prevent the commission of an offence or the contravention of a civil penalty provision.
Clause 49 applies the notice requirements for adducing evidence, as set out in clause 34, to a defendant charged under clause 46 in relation to specified offences by a body corporate.

Subpart 2—Regulatory offences and civil penalties Subpart 2 sets out the regulatory offences and civil penalties that are the core of the enforcement regime.

Many of these are set out in the tiered approach described above.
Most refer to the Rules (and in some cases to Orders) because the Rules and Orders prescribe the detail of the regulatory regime applying to therapeutic products.

Manufacture, import, export, and supply Clauses 50 to 59 relate to the manufacture, import, export, and supply of therapeutic products.
They specify offences and civil penalties in respect of the following conduct— • manufacturing a therapeutic product without a manufacturing licence or the correct manufacturing licence (clause 50): breaching a condition of a manufacturing licence (clause 51): manufacturing, importing, exporting, or supplying a therapeu- tic product without a product licence or the correct product li- cence (clause 52): breaching a condition of a product licence (clause 53): • • • Explanatory note Therapeutic Products and Medicines Bill 29 • • • • • • breaching a condition of a special purpose approval or an ex- emption (clause 54): importing, exporting, or supplying a product that does not con- form to applicable standards (clause 55): breaching a condition of an authorisation not to conform to applicable standards (clause 56): breaching a condition of a conformity assessment certificate (conformity assessment certificates apply only to medical de- vices) (clause 57): being a manufacturer and supplying or exporting a therapeutic product to which conformity assessment procedures have not been applied (clause 58): being a person other than a manufacturer and supplying or ex- porting a therapeutic product to which conformity assessment procedures have not been applied (clause 59).
Advertising Clause 60 sets out the purpose of the provisions about advertising therapeutic products, with particular reference to the Advertising Code to be established under the Rules.

Clause 61 provides, for the purposes of clauses 62 to 66, a definition of circumstances as it is used in the context of advertisements.

Clause 62 identifies proscribed advertisements and specifies the civil penalties and offences associated with publishing or broadcast- ing proscribed advertisements.
Clause 63 sets out the civil penalties and offences associated with broadcasting or publishing an advertisement without an approval in circumstances in which, under the Rules, an approval is required.

Clause 64 sets out the civil penalties and offences associated with making restricted representations in advertisements.

Restricted rep- resentations are representations identified as such in the Rules or Orders, and that require the Authority’s approval.
Clause 65 sets out the civil penalties and offences associated with failing to comply with a direction, issued under the Rules by the Au- thority, that relates to an advertisement about a therapeutic product.

30 Therapeutic Products and Medicines Bill Explanatory note Clause 66 provides for liability to a civil penalty if a person fails to comply with an information requirement notice given by the Author- ity.
Clause 67 sets out some guidelines for courts on the level of civil penalty or fine to be imposed in relation to a civil penalty or offence relating to advertising.
Misrepresentation Clauses 68 to 72 set out offences and civil penalties relating to the following conduct associated with misrepresentation: dealing with counterfeit products (clause 68): • setting out a false product licence number (clause 70): • falsely representing that a therapeutic product is subject to a • product licence (clause 71): claiming to supply a therapeutic product when the product can- not be lawfully supplied (clause 72).
• Clause 69 provides for relief from liability where a person is, or may be, liable to a civil penalty under clause 68 (dealing with counterfeit products).

Product tampering Clause 73 makes it an offence for certain people to fail to promptly notify the Authority of circumstances that indicate that therapeutic products have been, or are proposed to be, tampered with.
False or misleading information in applications and declarations Clauses 74 and 75 create offences and provide for liability to a civil penalty if a person makes a false or misleading statement in certain kinds of applications and certificates, and in declarations relating to conformity assessment procedures.
Adverse effect information Clause 76 creates an offence and provides for liability to a civil penalty if the holder of a product licence fails to give adverse effect information in relation to a therapeutic product, as required by the Rules.

Explanatory note Therapeutic Products and Medicines Bill 31 Compliance with information requirement notice Clauses 77 to 84 are about the offences and civil penalties associated with failing to comply with information requirement notices.
These are notices given by the Authority under the Rules that require the re- cipient to provide certain information relating to particular therapeu- tic products.

Different offences, civil penalties, and defences apply, depending on who the recipient of the notice is.

Compliance with recovery notice Clause 85 creates offences and provides for liability to a civil penalty in respect of the failure to comply with a recovery notice.
A recovery notice is a notice given by the Authority under the Rules that require the recipient to take specific steps relating to the recovery (which may include the recall) of products.

Clause 86 provides relief from liability where a person is, or may be, liable to a civil penalty under clause 85(2) (failing to comply with a recovery notice).

Clause 87 makes it an offence for a person to intentionally export or supply a therapeutic product that the person knows to be subject to a recovery notice.
Information about sponsors Clause 88 provides that a person who manufactures, imports, ex- ports, or supplies a therapeutic product commits an offence, or is li- able to a civil penalty, if the person— • • claims not to be the sponsor of the therapeutic product; and is required by the Authority to provide information about the identity of the sponsor of the therapeutic product; and fails to provide that information within the time specified by the Authority, or provides false or misleading information.
• 32 Therapeutic Products and Medicines Bill Explanatory note renders the person liable to a civil penalty under this Part; or constitutes a strict liability offence against this Part.
Subpart 3—Non-compliance notices and enforceable undertakings Non-compliance notices Clause 89 authorises the Authority to issue a non-compliance notice to a person who has, within the last 12 months, engaged in conduct that the Authority has reasonable cause to believe— • • A person who is issued with a non-compliance notice may, by pay- ing a specified monetary penalty within a specified time, avoid any further proceedings relating to the conduct.
Clause 90 allows the Authority to withdraw a non-compliance notice at any time before the monetary penalty is paid in full.

Clause 91 specifies the date by which the monetary penalty is to be paid.

Clause 92 specifies the maximum amount of monetary penalty that may be specified in a non-compliance notice.
Clause 93 provides that civil penalty or criminal proceedings may not be commenced against the recipient of a non-compliance notice (in relation to the conduct referred to in the notice) if the person pays the monetary penalty, or the time for paying the penalty has not yet passed.

Clause 94 provides that payment of a monetary penalty must not be construed as an admission of guilt or liability.
Clause 95 provides for regulations prescribing the form of a non- compliance notice and sets out matters that must be set out in the notice.

Enforceable undertakings Clause 96 provides that the Authority may accept a written undertak- ing (an enforceable undertaking) given by a person in connection with a matter in relation to which the Authority has a power or func- tion relating to the regulation of therapeutic products.
Clause 97 enables the Authority to apply to the High Court to enforce an undertaking if the Authority considers that the person who gave the undertaking has breached any of its terms.

Explanatory note Therapeutic Products and Medicines Bill 33 Subpart 4—Search and seizure Authorised officers Clause 98 provides definitions of terms primarily used in subparts 4 and 5 (which relate to search and seizure, information sharing, and customs matters).
Clause 99 authorises the Managing Director to appoint authorised officers for the purposes of Parts 1 to 5.

Clause 100 requires the Managing Director to issue authorised offi- cers with identity cards.

Entry, search, and seizure without warrant Clause 101 authorises an authorised officer to enter, at any reason- able time, a place (other than a dwelling house or marae) in order to monitor compliance with the Rules and Orders.
It sets out the powers of an authorised officer who enters a place under this clause.

Clause 102 provides that an authorised officer or member of the po- lice may enter a place (other than a dwelling house or marae) without consent or warrant in certain circumstances in order to avoid an im- minent risk of death, serious illness, or serious injury, and sets out the powers of the person entering under this clause.
Clause 103 allows the occupier of a place to request that the Author- ity make an inspection of the place.

Search warrants Clause 104 provides for the issue of search warrants, which must be in a form prescribed by regulations.

Clause 105 identifies the powers of an authorised officer or member of the police, and any person called on to assist, who enters a place under a search warrant issued under clause 104.
Conduct of entry, search, and seizure Clause 106 provides that an authorised officer or member of the po- lice may ask any person to assist with a search under this Part.

Clause 107 provides that an authorised officer must show his or her identity card on entering a place, and at any time during the search if requested.
34 Therapeutic Products and Medicines Bill Explanatory note Clause 108 requires that an authorised officer or member of the police must, before entering a place under this Part,— announce that he or she is authorised to enter; and • give any person present an opportunity to consent to the entry.

• Clause 109 requires a person conducting a search under a warrant to provide a copy of the warrant to the occupier whose place is being searched.
Clause 110 provides that an occupier whose place is being searched may observe the search as long as he or she does not impede it.

Clause 111 relates to the use of electronic equipment found at a place during a search.

A person conducting a search must take care not to damage the equipment or corrupt information stored on it, and the Authority may be liable for damages if the person fails to take care.
Clause 112 provides that documents seized from a place must, if prac- ticable, be copied before the original is removed.

A copy of the docu- ment seized must be left at the place.

If it is not practicable to copy a document before it is seized, a copy must be provided as soon as practicable afterwards.

Clause 113 requires that a person who seizes anything during a search must provide the occupier with a receipt for the thing.
What happens to things seized Clause 114 provides for the return of things that have been seized and sets out the circumstances in which they may be retained.

Clause 115 provides that an authorised officer or member of the po- lice who wishes to retain a thing seized for more than 90 days may apply to the District Court for an order to retain the thing.

Clause 116 provides for a court to order therapeutic products relating to a conviction or the imposition of a civil penalty to be forfeited to the Crown.
Testing and analysis of samples Clause 117 imposes requirements on an authorised officer who ob- tains a sample for testing or analysis (other than under a search war- rant).

Clause 118 provides that the analysis and testing of samples must be done in accordance with the Rules and Orders.

Explanatory note Therapeutic Products and Medicines Bill 35 Clause 119 provides for how a certificate of analysis may be admis- sible as evidence.
Clause 120 provides that a person who is convicted of an offence or ordered to pay a civil penalty must pay the fees and expenses of any testing or analysis.

Offences relating to search and seizure Clause 121 creates a range of offences relating to hindering or inter- fering with searches and seizures.
Subpart 5—Miscellaneous Information sharing for law enforcement purposes Clause 122 provides for the sharing between government agencies and the Authority of information relating to compliance with the law and law enforcement.

The information may relate not just to enforce- ment of this Act but also to related enactments, such as the Biosecur- ity Act 1993 and the Customs and Excise Act 1996, identified in the clause.
Customs Clause 123 provides for authorised officers to inspect any therapeutic product, and any documents associated with its import or export, if the therapeutic product is in a customs controlled area.

Clause 124 sets out the powers of an authorised officer to seize and otherwise deal with non-compliant therapeutic products that are im- ported into, or exported from, New Zealand.
A non-compliant thera- peutic product is one that does not comply with the Rules or Orders, or with regulations, or that constitutes a risk to public health.

Clause 125 is about what happens to a consignment at a port when a sample is taken for analysis.

Clause 126 provides for the relationship between Parts 1 to 5 and the Customs and Excise Act 1996.
36 Therapeutic Products and Medicines Bill Explanatory note Patents Clause 127 confirms that the fact that a product is protected by an Australian patent does not in itself prevent it from being marketed in New Zealand.
Part 3 Administrative law matters This Part deals with— • • • the system for reviewing decisions by the Authority: how judicial review applies to decisions by the Authority: how the Ombudsmen in New Zealand and Australia deal with issues relating to the Authority: how the Privacy Commissioners in New Zealand and Australia deal with privacy issues associated with the Authority: how the Authority manages the keeping and disclosure of in- formation, including information relating to the governments of New Zealand and Australia, and highly sensitive commer- cial information, and the application of the New Zealand Pub- lic Records Act 2005.
• • Clause 128 provides definitions of terms used primarily in this Part.

Subpart 1—Merits review General provisions Clause 129 provides an overview of this subpart.

This subpart gives effect to Article 13 of the Agreement, which requires New Zealand to provide for the review by a merits review tribunal of the merits of certain decisions made by the Authority.
Application for review Clause 130 provides that a person whose interests are affected by a reviewable decision may apply to the Review Tribunal (which is the New Zealand Review Tribunal established under clause 135) for a review.
A reviewable decision is any decision of the Authority in relation to— • • an application for an approval; or the amendment, suspension, or revocation of an approval; or Explanatory note Therapeutic Products and Medicines Bill 37 • any other matter specified in the Rules as being open to merits review.

Clause 131 restricts applications for merits review if an internal re- view process is available under the Rules.
Clause 132 describes how reasons for a decision, and other infor- mation, may be withheld if the Australian Commonwealth Attor- ney-General has issued a public interest certificate under the Admin- istrative Appeals Tribunal Act 1975 of the Commonwealth of Aus- tralia.

Clause 133 bars applications for review to the Review Tribunal if an application for review has already been made to the Australian Review Tribunal (which is the tribunal provided for in the Australian Act).
Clause 134 provides that an application to review a decision of the Authority does not affect the operation of the decision unless the ap- plicant has obtained an order to stay the decision under review.

Review Tribunal Clause 135 provides for the establishment and constitution of the (New Zealand) Review Tribunal.
A minimum of 3 members of the Merits Review Panel (the members of whom are appointed under the Agreement by the Ministerial Council) is required to constitute a Review Tribunal for a particular review.

Clause 136 provides protection from personal liability to members of the Review Tribunal for any act or omission done in good faith in the course of their duties.

Clause 137 provides for the remuneration of members of the Review Tribunal.
Conduct of review Clause 138 provides that the parties to proceedings before the Re- view Tribunal are— • • • the applicant; and the Authority; and any person whom the Review Tribunal is satisfied is a person whose interests are affected by the decision.

38 Therapeutic Products and Medicines Bill Explanatory note It also provides that the Attorney-General may appear and be heard in proceedings in which the Attorney-General considers that the interest of the public is or may be involved.
Clause 139 states that the Review Tribunal may regulate its own pro- cedure, subject to the Agreement, the Rules, and Parts 1 to 5.

It also provides that specific procedural provisions applying to the Review Tribunal are set out in Schedule 2.

Clause 140 provides that the decision of the majority of the members of the Review Tribunal is the decision of the Review Tribunal.

If no majority is reached, then the decision of the Review Tribunal is the decision of the chairperson.
Clause 141 specifies the powers of the Review Tribunal when re- viewing a decision of the Authority.

Clause 142 provides that if the Review Tribunal remits a matter to the Authority, the Authority must give effect to any directions of the Review Tribunal, reconsider the matter, and issue a fresh decision.

Clause 143 explains the extent to which new information may be considered by the Review Tribunal.
Transfer of review proceedings Clause 144 enables review proceedings in New Zealand to be trans- ferred to the Australian Review Tribunal if the Review Tribunal is satisfied that it is in the interests of justice to have the review con- ducted by the Australian Review Tribunal.

Review proceedings must be transferred if a public interest certificate has been issued (see the note on clause 132) in respect of information or a matter that is or may be in evidence before the Review Tribunal.
Clause 145 provides for proceedings that are transferred to the Re- view Tribunal from the Australian Review Tribunal.

Effect of decisions Clause 146 provides that a decision by the Authority has effect sub- ject to any order of the Review Tribunal, the Australian Review Tri- bunal, or a decision of a court on appeal from either tribunal.
Explanatory note Therapeutic Products and Medicines Bill 39 Appeals and stating case Clause 147 provides for a party to review proceedings to appeal to the High Court against a decision of the Review Tribunal on a question of law.

Clause 148 provides for the Review Tribunal to state a case for the opinion of the High Court on a question of law arising in any pro- ceedings before the Tribunal.

The Tribunal may state a case on its own initiative or on application by any party.
Subpart 2—Judicial review Clause 149 provides that this subpart applies only to judicial review proceedings relating to decisions of the Authority, and to Rules and Orders.

Clause 150 enables decisions of the Authority, Rules, and Orders to be judicially reviewed under the Judicature Amendment Act 1972.

Clause 151 states the effect of orders made by a court in judicial review proceedings concerning a decision of the Authority, or a Rule or Order.
Clause 152 provides that a court may stay judicial review proceed- ings on its own initiative or on application by a party.

Proceedings may be stayed if the court considers it more appropriate for them to be heard and determined in a court in Australia or if it is satisfied that the matter is the subject of final orders made by an Australian court.

Clause 153 sets out some procedural matters in respect of a court’s determination of whether a judicial review proceeding should be stayed.
Subpart 3—Action by Ombudsmen Clause 154 acknowledges that the Authority is subject to the Om- budsmen Act 1975 and to the Ombudsman Act 1976 of the Com- monwealth of Australia.

Clause 155 provides for co-operation between New Zealand Om- budsmen and the Australian Ombudsman when taking acting con- cerning the Authority.

It requires a New Zealand Ombudsman to ad- vise the Australian Ombudsman of any investigation of the Author- ity under the Ombudsmen Act 1975.
New Zealand Ombudsmen may exercise powers under the Ombudsmen Act 1975 to respond to any 40 Therapeutic Products and Medicines Bill Explanatory note request for assistance by the Australian Ombudsman.

The Australian Ombudsman has reciprocal obligations under the Australian Act to assist and advise New Zealand Ombudsmen.

Clause 156 enables New Zealand Ombudsmen to transfer complaints under the Ombudsmen Act 1975 to the Australian Ombudsman.
Clause 157 provides that a New Zealand Ombudsman may, at the request of the Australian Ombudsman, agree to the transfer of a complaint concerning the Authority from Australia, if satisfied that the matter can be conveniently and effectively dealt with by a New Zealand Ombudsman.

Clause 158 provides that a New Zealand Ombudsman may refuse to deal with— • complaints investigated, or similar to those investigated, by the Australian Ombudsman; or complaints that will be transferred to Australia.
• Clauses 159 and 160 relate to immunities extended to the Australian Ombudsman and others in relation to actions in New Zealand.

Subpart 4—Action by Privacy Commissioners Clause 161 acknowledges that the Authority is subject to the Privacy Act 1993 and to the Privacy Act 1988 of the Commonwealth of Aus- tralia.

Clause 162 modifies the application of privacy principle 11, as set out in section 6 of the Privacy Act 1993, so far as it relates to the Au- thority.
This is necessary for consistency with the Australian Privacy Act 1988.

Clause 163 provides for co-operation between the New Zealand Pri- vacy Commissioner and the Australian Privacy Commissioner in re- spect of any investigation concerning the Authority.

The provisions are similar to those relating to Ombudsmen under clause 155.

Clause 164 provides for the transfer to the Australian Privacy Com- missioner of complaints concerning the Authority that are received by the New Zealand Privacy Commissioner.
Clause 165 provides for the transfer of complaints regarding the Authority from the Australian Privacy Commissioner to the New Zealand Privacy Commissioner.

Explanatory note Therapeutic Products and Medicines Bill 41 Clause 166 provides that the New Zealand Privacy Commissioner may decide to take no action, or no further action, on any complaint that has been dealt with by the Australian Privacy Commissioner or that is being transferred to the Australian Privacy Commissioner.
Clauses 167 and 168 relate to immunities extended to the Australian Privacy Commissioner and others in relation to actions in New Zealand.

Clause 169 extends to the New Zealand Privacy Commissioner the same level of immunity that is given to the Australian Privacy Com- missioner in respect to actions in New Zealand.

Subpart 5—Information management Clause 170 acknowledges that the Official Information Act 1982 gen- erally applies to information held by the Authority.
However, it does not apply to Australian Government information or to information of the Authority that was held by the Australian Therapeutic Goods Agency at the time of the latter’s disestablishment.

Clause 171 acknowledges that the Authority is subject to the Privacy Act 1993 and refers to the earlier provisions about the Privacy Com- missioner.

Clauses 172 to 177 authorise the release of specific types of infor- mation to specific people or organisations in specific circumstances.
Some of these provisions authorise releases that would be possible anyway under the Official Information Act 1982, but are included here for the avoidance of doubt and for symmetry with the Australian Act.

Clause 178 authorises the release to the public of specified informa- tion held by the Authority in limited circumstances.
Clause 179 protects from civil and criminal liability any person who, in good faith, makes information available under any of clauses 170 to 178, clause 183, or under the Medicines Act 1981 (where clause 184 applies).

Protected active ingredient information Clause 180 explains the purpose of clauses 181 to 184.

42 Therapeutic Products and Medicines Bill Explanatory note Clause 181 provides definitions of protected active ingredient infor- mation and active moiety.
Protected active ingredient information is information that— • is about, or relates to, the active moiety of a therapeutic prod- uct; and is submitted in support of an application for a product licence; and is not in the public domain on the date on which the application is received by the Authority.

• • Clause 182 prohibits the Authority from disclosing protected active ingredient information during the 2 periods when the information is protected.
The first period of protection starts from the date the Authority receives the application for the product licence and ends on the earlier of— the date that is 5 years later; or • • the date on which the second period of protection starts.

The second period of protection starts on the date on which the Au- thority decides the application, and ends on the date that is 5 years later.
Clause 183 allows the Authority to release protected active ingredi- ent information during its periods of protection if— • • • Clause 184 preserves the application of sections 23A to 23C of the Medicines Act 1981 to confidential supporting information (as de- fined in those sections) in relation to applications dealt with before the Scheme comes into force.

disclosure is under any of clauses 172 to 178; or the applicant or licence holder agrees; or the information is in the public domain.
Use of information by Authority Clause 185 applies if Rules limit the use that the Authority may make of information.

It bars civil or criminal proceedings against any per- son who, in good faith, uses the information in breach of those Rules.

Archives Clause 186 acknowledges that the Authority is subject to the New Zealand Public Records Act 2005 and the Archives Act 1983 of Explanatory note Therapeutic Products and Medicines Bill 43 the Commonwealth of Australia.
Responsibility for the records will be determined under a memorandum of understanding between the (New Zealand) Chief Archivist and the Director-General of the Na- tional Archives of Australia.

Part 4 Governance and accountability Clause 187 defines terms used primarily in this Part.

Subpart 1—Ministerial Council, Board, and Board members Ministerial Council Clause 188 provides an overview of the role and functions of the Ministerial Council, which is largely provided for in the Agreement.
General provisions relating to Board Clause 189 provides an overview of the Board.

The Board comprises 5 members who are appointed by the Ministerial Council.

The role and functions of the Board are set out in paragraphs 5 and 6 of Article 6 of the Agreement, but more detailed matters relating to the Board will be provided in the Rules.

Clause 190 states Parliament’s expectations of the Board.
These ex- pectations are derived from sections 49 and 50 of the Crown Entities Act 2004, which impose duties on the Boards of statutory entities to (amongst other things) ensure that the entity acts consistently with its functions and that it performs its functions in a manner consistent with the spirit of service to the public.

Clause 191 prohibits the Minister from appointing to the Board, or concurring in appointing to the Board, any person to whom subclause (1) applies.
The restrictions are similar to those that apply to people appointed as members of Crown entities.

Clause 192 provides that the powers, functions, and duties of the Board are not affected by a vacancy in its membership, and that the validity of a Board member’s actions is not affected by flaws in that person’s appointment.

Clause 193 protects the actions of the Board from being challenged on the grounds that it did not comply with Board procedures.
44 Therapeutic Products and Medicines Bill Explanatory note Managing Director Clause 194 provides an overview of the role of the Managing Dir- ector (which is mainly provided for in the Agreement).

Subpart 2—General matters relating to Authority Clause 195 provides an overview of the establishment, functions, and powers of the Authority.
Although the Authority is not a Crown entity, and is not subject to the Crown Entities Act 2004, it is subject to broadly equivalent financial and accountability controls.

the Government’s financial position; or government policies or programmes.

Providing information Clause 196 requires the Authority to promptly inform the Minister of any regulatory decision that affects or is likely to affect— • • The Authority must also provide the Minister with certain informa- tion on request.
Clause 197 requires the Authority to comply with any written request by the Minister of Finance for information about the operations and performance of the Authority or its subsidiaries.

Clause 198 requires the Authority to supply, at the written request of the Secretary to the Treasury, information about the operations and performance of the Authority or its subsidiaries.

The Secretary may only request information under this clause if it is for any of the purposes specified in subclause (2).
Compliance with directions Clause 199 requires the Authority to give effect to any written direc- tion from the Ministerial Council that is about a matter of govern- ment policy.

Review of operations Clause 200 provides for the review of the operations or performance of the Authority or any of its subsidiaries by the Ministerial Council, the Minister, or the Australian Minister.
Explanatory note Therapeutic Products and Medicines Bill 45 Employees and others Clause 201 prohibits a person from disclosing information obtained solely as a result of being— • • an employee of the Authority: a contractor of, or person acting under delegation from, the Authority: a member of a Board Committee, or expert advisory commit- tee.
• Clause 202 makes it an offence for an employee of the Authority to intentionally use his or her position to gain an improper advantage or to cause detriment to the Authority.

Immunities, indemnities, and insurance Clause 203 provides that clauses 204 to 207 apply to former or cur- rent senior officers, members of Board committees, members of ex- pert advisory committees, and employees of the Authority.
A senior manager is a person who makes or participates in making decisions that affect the whole or a substantial part of the operations of the Au- thority, or who has the capacity to significantly affect the Authority’s financial standing.

Clause 204 provides that a person specified in clause 203 is not liable for the liability of the Authority merely because he or she is such a person.
Clause 205 provides a person referred to in clause 203 with immunity from criminal and civil proceedings for any act or omission during the course of the operations of the Authority.

The immunity does not apply to acts or omissions done in bad faith.

Clause 206 allows the Authority to indemnify any person referred to in clause 203.

Clause 207 authorises the Authority to provide insurance for any per- son referred to in clause 203.
Clause 208 bars civil and criminal proceedings against the Author- ity for any act or omission in the course of the exercise or intended exercise of its functions.

The immunity does not apply— • • if the Authority acted without reasonable care or in bad faith: to certain criminal proceedings.
46 Therapeutic Products and Medicines Bill Explanatory note Clause 209 acknowledges that, despite clause 208, the Authority is subject to the Health and Safety in Employment Act 1992, but limits those who can be prosecuted under that Act to Board members resi- dent in New Zealand and others working for the Authority primarily in New Zealand.

Miscellaneous matters Clause 210 contains presumptions about documents on which the seal of the Authority is imprinted.
Clause 211 sets out presumptions about documents purported to be signed by the Managing Director.

Subpart 3—Financial and associated matters Clause 212 provides that the Authority must not borrow or amend the terms of a borrowing except in accordance with the Rules.

Subclause (2) specifies other activities that are subject to the same restrictions.

Clause 213 provides that the Authority must not give a guarantee to, or indemnify, another person except in accordance with the Rules.
(This clause does not apply to an indemnity given under clause 206.)

Clause 214 restricts the Authority’s involvement in derivative trans- actions (as defined in subclause (2)).

Clause 215 contains requirements relating to the Authority’s banking practices.

Clause 216 restricts the circumstances in which the Authority may acquire securities.

Clause 217 restricts the Authority’s involvement in other entities such as companies, partnerships, trusts, and unincorporated joint ventures.
Clause 218 requires the Authority to ensure that none of its sub- sidiaries— • • Clause 219 requires Board members to ensure that the annual ac- counting period of any of the Authority’s subsidiaries is the same as the financial year of the Authority.

does anything that the Authority cannot do; or exercises any of the Managing Director’s powers.
Explanatory note Therapeutic Products and Medicines Bill 47 Clause 220 requires the Authority keep trust money in a separate bank account and to promptly pay into that account any trust money received.

Clause 221 allows the Authority to invest trust money but only in accordance with the Rules.

Clause 222 exempts the income of the Authority from income tax.
Clause 223 describes how goods and services acquired by the Au- thority are to be treated for the purpose of determining the Author- ity’s input tax under the Goods and Services Tax Act 1985.

Subpart 4—Reporting Overview Clause 224 explains the Authority’s reporting obligations under Art- icle 8 of the Agreement and how the Authority is to discharge those obligations in New Zealand and Australia.
Statement of intent Clause 225 requires the Board to prepare a statement of intent for the Authority before the start of each financial year.

Clause 226 explains Parliament’s expectation that the Board will en- sure that the Authority complies with its statement of intent.

This re- flects the duty imposed on members of Crown entities under section 49 of the Crown Entities Act 2004.
Clause 227 provides that the Ministerial Council may, after consult- ing the Board, direct the Board to amend the Authority’s statement of intent.

A direction to amend a statement of intent must be presented to the House of Representatives and be gazetted as soon as practic- able.

Clause 228 requires the Board to amend the statement of intent if cer- tain circumstances apply (for example, if the information contained in it is substantially misleading).
Clause 229 requires that the statement of intent, and every amend- ment made to it, must— • be presented by the Minister to the House of Representatives within the specified time; and be published by the Authority on its Internet site promptly after it has been presented.
• 48 Therapeutic Products and Medicines Bill Explanatory note Annual report Clause 230 acknowledges that, under the Agreement, the Board is required to prepare an annual report for the Authority for each finan- cial year and provide it to the Ministerial Council.
Clause 231 requires that the Authority’s annual report must be pre- sented by the Minister to the House of Representatives within the time specified and be published by the Authority on its Internet site within 10 working days after the annual report is received by the Min- isterial Council.
Audit Clause 232 appoints the Auditor-General as an auditor of the Author- ity and each of its subsidiaries, and acknowledges that the Australian Auditor-General is also appointed (under the Australian Act) as an auditor of the Authority.

Keeping accounting records Clause 233 requires the Authority to maintain and keep proper ac- counting records.
Offences Clause 234 provides that a senior officer commits an offence if he or she intentionally contravenes the requirement to keep proper ac- counting records.
Clause 235 makes it an offence for a person to knowingly— • refuse or fail to produce information as required under this Part or the Rules; or resist or obstruct any person who is carrying out any function under this Part or the Rules; or make false representations about his or her authority under this Part or the Rules; or give false or misleading information in response to a require- ment under this Part or the Rules.
• • • Explanatory note Therapeutic Products and Medicines Bill 49 Subpart 5—Board members and other senior officers Board member conflict of interest Clause 236 describes the obligations of a Board member in a conflict of interest situation.

These reflect the obligations on members of Crown entities.

Clause 237 requires a Board member to disclose any material per- sonal interest and specifies the matters that must be disclosed.
Clause 238 allows the Board to permit any member with a material personal interest to participate in a matter (despite any contravention of clause 236) if the Board is satisfied that it is in the public interest.

Clause 239 requires that the Ministerial Council is notified as soon as practicable of any failure by a Board member to comply with clause 236.

A failure to comply with clause 236 does not affect the validity of the relevant act or matter.
Clause 240 provides for the Authority to avoid an act done in breach of the provisions about conflict of interest in certain circumstances.

Duties of senior officers Clause 241 provides that the duties of senior officers set out in clauses 242 to 246 apply regardless of where the senior officer is located at the time of the act or omission.

Clause 242 requires senior officers to act with honesty and integrity when carrying out their duties as senior officers.
Clause 243 requires senior officers not to contravene, or agree to the Authority contravening, Parts 1 to 5, the Australian Act, or the Rules.

Clause 244 requires senior officers to carry out their duties with care, diligence, and skill.
Clause 245 provides that senior officers must— • exercise their powers and carry out their duties in good faith and for a proper purpose: not pursue their own interests at the expense of the Authority’s interests: not use their position to gain an improper advantage or cause a detriment to the Authority.
• • 50 Therapeutic Products and Medicines Bill Explanatory note Clause 246 provides that senior officers and former senior officers must not misuse any information that they have obtained solely as a result of being, or having been, a senior officer.

Criminal consequences of failing to comply with duties Clause 247 makes it an offence for a senior officer to contravene certain duties referred to in clauses 245 and 246.
Clause 248 provides that the Finance Minister may require a person to give all reasonable assistance in connection with criminal proceed- ings under clause 247.

The criteria in subclause (2) must be satisfied before assistance is required.

Information provided under this clause may not be used in proceedings as evidence against the person who provided assistance.
Civil consequences of failing to comply with duties Clauses 249 to 254 set out a civil penalty regime in relation to a breach of duties by senior officers.

The regime is broadly equivalent to the civil penalty regime provided in Part 2 relating to regulatory matters.

Clause 249 provides that the Minister or the Finance Minister may apply to the High Court for a civil penalty order against a senior officer or former senior officer.
Clause 250 provides that the High Court may order a person to pay a civil penalty if the Court is satisfied that— • the person has breached any of the duties set out in clauses 243 to 246; and the breach is serious or materially prejudices the interests of the Authority or the Authority’s ability to pay its creditors.

• The maximum civil penalty is 2 000 penalty units, and is payable to the Crown.
Clause 251 states how and when an application for a civil penalty may be made, and provides for procedural matters.

Clause 252 states the extent to which the Authority may be involved in proceedings for a civil penalty order.

Explanatory note Therapeutic Products and Medicines Bill 51 Clause 253 provides relief from liability, in certain circumstances, for a person against whom civil penalty proceedings have been com- menced under clause 249.
Clause 254 allows the Finance Minister to require a person to give all reasonable assistance in connection with an application for a civil penalty under this Part.

Disqualification for breach of duty Clause 255 provides that the High Court may make a disqualification order against a senior officer or former senior officer.

It must disqualify a A disqualification order lasts up to 10 years.
person from being a Board member and may do any or all of the following: • disqualify the person from being a promoter or a director of a company in New Zealand: prohibit the person from involvement in the management of a company in New Zealand: disqualify the person from being a member of any Crown en- tity.

• • A breach of a disqualification order is an offence.

Clause 256 provides for a person who is subject to a disqualification order to apply to the Court for the order to be quashed or amended.
Clause 257 provides for the effect of disqualification under equiva- lent provisions of the Australian Act.

Compensation orders Clause 258 provides for an application to be made to the High Court for a compensation order against a senior officer or former senior officer if— • the person has breached any of the duties referred to in clauses 243 to 246; and the Authority suffered damage as a result of the breach.
• Clause 259 provides that an application for compensation must be made no later than 6 years after the alleged breach.

52 Therapeutic Products and Medicines Bill Explanatory note Civil liability of others involved Clause 260 describes the liability of a person who is involved in the breach by a senior officer of any of the duties specified in clauses 245 or 246.
Defence in criminal or civil penalty proceedings Clause 261 provides a defence to a senior officer or former senior officer who is proceeded against for a breach of duty.

The fact that the person relied on information and advice given by employees of the Authority, professional advisers, or other specified persons is a defence only if the person acted in good faith, made proper inquiries as circumstances required, and had no knowledge that the reliance was unwarranted.
General relief from civil liability Clauses 262 provides for when a court may relieve a person from liability in civil proceedings under this Part.

Restriction on use of evidence Clause 263 provides that evidence given by a person in proceedings against that person for a civil penalty may not be used in criminal proceedings against that person.
Relationship between criminal and civil penalty proceedings Clause 264 bars proceedings for a civil penalty under this Part against a person in relation to particular conduct if there are already proceed- ings underway against that person for a declaration of breach or for a pecuniary penalty under the Australian Act in respect of the same conduct.
Clause 265 bars criminal proceedings under this Part against a person in relation to particular conduct if criminal proceedings against the person under the Australian Act in respect of the same conduct are underway or have been completed.
Explanatory note Therapeutic Products and Medicines Bill 53 Clause 266 allows criminal proceedings for an offence under this Part to commence against a person even if— • proceedings in New Zealand for a civil penalty under this Part have commenced against the person in respect of the same conduct; or proceedings in Australia for a declaration of breach or for a pecuniary penalty under the Australian Act have commenced against the person in respect of the same conduct.
• Any civil penalty proceedings that have commenced against a per- son under this Part must be stayed if criminal proceedings are com- menced against the person in respect of the same conduct.

Clause 267 describes the effect of the withdrawal of proceedings on any limitation period applying to subsequent proceedings.

Clause 268 clarifies that nothing in clauses 264 to 267 affects the abuse of process jurisdiction of any court.
This is important where, for example, a person has been acquitted in Australia and charges relating to the same conduct are commenced in New Zealand.

Part 5 Regulations, and transitional and miscellaneous provisions Subpart 1—Regulations Clause 269 is a regulation-making power relating to Article 12 of the Agreement which is about departures from the Scheme.
This Article provides that either party may exclude or modify the application of the Scheme to specified products or classes of products (referred to in this clause as excluded products) having regard to “exceptional public health, safety, third country trade, environmental or cultural factors that affect that Party”.

If a product is an excluded product, it will have to be regulated outside the Scheme by regulations made by the relevant country.
This clause authorises the making of those regulations, and in particular provides for— • aspects of the Scheme to be applied, with or without modifi- cation, to excluded products; and regulations to provide an alternative way of regulating ex- cluded products.

• 54 Therapeutic Products and Medicines Bill Explanatory note Clause 270 authorises the making of regulations requiring the pay- ment of fees and charges for any functions performed by the Author- ity that are outside the scope of the Scheme.
Clause 271 provides for temporary or transitional regulations to be made that are necessary or expedient to fully implement the Scheme in New Zealand.

The main transitional measures are spelt out in subpart 2, but this clause allows regulations to be made to help ensure a smooth transition to the new Scheme.

Clause 272 contains standard provisions providing for the making of regulations that do not fall within any category of regulations already provided for.
Subpart 2—Transitional provisions relating to Scheme Preliminary The way the transitional provisions for the regulatory aspects of the Scheme work is broadly as follows.

Products and activities that were lawful before the Scheme starts will be deemed to have been granted a transitional approval by the Authority on the day the Scheme starts.

The effect of a transitional approval is to largely maintain the legal status quo for the product or activity to which it relates.
This means that if, under the Medicines Act 1981 (the former Act), a product could be lawfully supplied subject to certain conditions, then after the start date the product can lawfully continue to be supplied as long as those conditions are met.

A failure to comply with the condi- tions will be dealt with as it would have been under the former Act.
If an application is pending under the former Act at the start date (a pending application), the Authority must consider the application in accordance with the former Act (unless the application is withdrawn or lapses).

The Authority may then issue a transitional approval.

The transitional approval will operate in the same way as transitional approvals that are deemed to have been granted.

Transitional approvals operate only in New Zealand and only during the transition period.
The transition periods for different types of products and activities will be set by the Rules.

Transitional approvals will be subject to the provisions of the former Act (and any regulations made under it) identified in the Rules, but may also be subject to certain applicable rules.

Holders of transitional Explanatory note Therapeutic Products and Medicines Bill 55 approvals can apply for approvals granted in accordance with the Rules (Scheme approvals) during the transition period.
A Scheme approval will be effective in both New Zealand and Australia, and will be subject to Parts 1 to 5 and the Rules and Orders.

Clause 273 provides an outline of the transitional provisions.

Clause 274 sets out definitions of terms used in subpart 2 of this Part.

Clause 275 provides for the saving of the former Act (and regula- tions made under it) and describes how to apply that Act after the Scheme starts.
For instance, references to the Minister in the former Act must be read as if they were references to the Authority, because the Authority will take over the functions of the Minister when ap- plying that Act during the transition period.

Clause 276 provides that transitional approvals are subject to applic- able fees and charges prescribed by Rules.
Medicines: transitional approvals Clauses 277 and 278 provide for transitional approvals to replace existing consents (ie, consents given under any of sections 20, 23, or 24(3) of the former Act) and existing approvals (ie, given under section 24D of the former Act) relating to medicines.

Related products: transitional approvals Clauses 279 and 280 provide for transitional approvals to replace existing consents for related products.
Medicines and related products: material changes Clauses 281 to 283 provide for transitional approvals to be granted by the Authority in relation to applications under section 24 of the former Act, which is about changed medicines.

Medicines and related products: pending applications Clauses 284 to 288 deal with what happens to a range of different pending applications relating to medicines and related products.
Ap- plications may be withdrawn so that they can be dealt with immedi- ately by the Authority under the Scheme.

Otherwise, they will gener- 56 Therapeutic Products and Medicines Bill Explanatory note ally be dealt with by the Authority in accordance with the former Act.

There are provisions for treating certain applications as lapsed, and provisions about refunding fees when an application is withdrawn.
Medicines: existing exemptions under former Act Clauses 289 and 290 provide for the continuation, for 6 months, of certain exemptions applying to authorised prescribers and medical practitioners.

Medicines: clinical trials approved under former Act Clauses 291 to 294 provide for transitional approvals for clinical trials approved under the former Act.
Medicines: pending application for approval of clinical trial Clauses 295 to 297 provide for the Authority to grant transitional approvals in relation to pending applications for clinical trials.

Medicines: transitional approvals for existing licences Clauses 298 to 300 provide for transitional approvals for existing licences relating to the manufacture and packing of medicines.
Medicines: pending applications for licences Clauses 301 to 304 provide for the Authority to grant transitional ap- provals in relation to pending applications for a licence to manufac- ture or a licence to pack medicines.

Medical devices: transitional approval Clauses 305 to 309 set out a system for providing transitional ap- provals for medical devices.
During the establishment period (which is after the Authority is established but before the Scheme comes into force), if the sponsor of a medical device provides cer- tain declarations and information to the Authority, then on the start Explanatory note Therapeutic Products and Medicines Bill 57 date a transitional approval will be deemed to have been granted in respect of the medical device.
Medical devices: exemptions Clause 310 provides an exemption from the need to obtain a transi- tional approval for certain medical devices.

Dietary supplements: transitional approvals Clauses 311 to 315 set out a system for providing transitional ap- provals for dietary supplements.

Dietary supplements were not regu- lated under the former Act.
During the establishment period, if the sponsor of a dietary supplement that does not have an existing con- sent, existing approval, or existing licence, provides certain declar- ations and information to the Authority, then on the start date a tran- sitional approval will be deemed to have been granted in respect of that dietary supplement.
Newly designated therapeutic products: transitional approvals Clauses 316 to 319 set out a system for providing transitional ap- provals for newly designated therapeutic products, which are those therapeutic products not already dealt with in this subpart, and which, though lawfully supplied before the start date, were not regulated under the former Act.
During the establishment period, if spon- sors of those products provide certain declarations and information to the Authority, then on the start date a transitional approval will be deemed to have been granted in respect of the product.

Notices Clause 320 describes what happens after the start date if a notice is issued before the start date under section 36(1) or (3) of the former Act.
Advertising Clause 321 provides that advertisements that were lawful to publish under the former Act may continue to be lawfully published after the start date, but only for a limited period.

58 Therapeutic Products and Medicines Bill Explanatory note Appeals Clauses 322 and 323 provide for appeals against decisions made either under the former Act, or by the Authority in accordance with the former Act, after the start date.
Offences Clause 324 provides that offences under the former Act or regula- tions, whether committed before or after the start date, must be in- vestigated and prosecuted, and any penalties must be imposed, as if the former Act had not been repealed.

Clause 325 identify the offences and civil penalties under Parts 1 to 5 that do not apply in respect of holders of transitional approvals.
These offences and civil penalties do not apply because the equiva- lent provisions under the Medicines Act 1981 will apply instead.

Proceedings Clauses 326 and 327 provide that proceedings that were barred be- fore the commencement of this subpart remain barred, and that any proceedings commenced before the subpart comes into force may be continued and completed as if the former Act were still in force.
Subpart 3—Transitional provisions relating to employees Clause 328 provides for the transfer of Medsafe employees to the Authority on the transfer date.

Clause 329 provides that the transfer does not break an employee’s continuity of service.

Clause 330 provides that there is no compensation payable for any technical redundancy that may occur as a result of the transfer.
Clause 331 preserves the right of Medsafe employees who were con- tributors under the Government Superannuation Fund Act 1956 to remain in that scheme.

Explanatory note Therapeutic Products and Medicines Bill 59 Subpart 4—Transitional provisions relating to assets Clause 332 provides that the purpose of clauses 333 and 334 is to en- able the assets and liabilities of Medsafe to be transferred to the Au- thority using the mechanisms provided in the Health Sector (Trans- fers) Act 1993.
Clause 333 amends the Health Sector (Transfers) Act 1993 so that Medsafe assets and liabilities will be able to be transferred to the Authority under that Act.

Clause 334 provides that the transfer may not take place unless the Ministerial Council has agreed to the proposal.

Subpart 5—Miscellaneous provisions Clause 335 provides that the enactments in Schedule 3 are amended.

These amendments relate to the establishment of the Authority.
Clause 336 provides that Schedule 8 sets out other consequential amendments that are consequential upon the enactment of Parts 1 to 5.

Schedules 4 to 7 relate only to Parts 5 and 6, but Schedule 8 con- tains amendments that relate to all Parts of this Bill.

Part 6 General provisions Clause 337 explains the purpose of Parts 6 and 7 and notes that those Parts relate to the law relating to medicines at the consumer end of the supply chain.

Clause 338 provides an outline of Parts 6 and 7.


Clause 339 sets out definitions of a large number of terms used in Parts 6 and 7.

Application and administration Clause 340 sets out the application of Parts 6 and 7 and clarifies the relationship between those Parts and Parts 1 to 5.

The requirements, obligations, and restrictions imposed on activities undertaken with medicines by Parts 6 and 7 are in addition to those imposed on ac- tivities undertaken with therapeutic products by Parts 1 to 5.
Clause 341 provides that Parts 6 and 7 bind the Crown.

60 Therapeutic Products and Medicines Bill Explanatory note Clause 342 sets out how certain activities undertaken under Parts 6 and 7 (such as supplying and dispensing medicines) apply in the context of the employee and employer relationship.

Part 7 Substantive provisions relating to medicines Subpart 1—Controlled activities Clause 343 provides an overview of subpart 1, which deals with con- trolled activities.
Controlled activities are defined in clause 339 as activities that are prohibited under subpart 1 of Part 7 unless under- taken by a person otherwise authorised by or under Parts 6 and 7.
In general terms, a person commits an offence if that person under- takes any of the following controlled activities without being author- ised by or under Parts 6 and 7: • • • • • • • • • Clause 343(4) provides that, despite being otherwise authorised to undertake an activity by or under Parts 6 and 7, a person may still be restricted from undertaking that activity under— an instrument referred to in subpart 2; or • the regulations.
• supplying scheduled medicines by wholesale: supplying scheduled medicines other than by wholesale: supplying medicines by auction: supplying medicines by vending machine: dispensing medicines: prescribing prescription medicines: administering prescription medicines: possessing prescription medicines: operating a pharmacy.

Supplying scheduled medicines by wholesale Clauses 344 to 346 relate to the supply of scheduled medicines by wholesale.
Supplying scheduled medicines by wholesale is a con- Explanatory note Therapeutic Products and Medicines Bill 61 trolled activity, and a person must not supply scheduled medicines by wholesale unless the person— • • is authorised to do so by the regulations (clause 345): holds a licence to do so (whether as a fixed or mobile vendor) and is complying with the terms and conditions imposed by or under the licence (clause 346(a) and (c)): is an employee of a person who holds a licence to do so as a fixed vendor and is complying with the terms and conditions of the licence (clause 346(b)): is deemed to hold a licence to supply scheduled medicines by wholesale as a fixed vendor under clause 518(3), being a li- cence that has been issued under the Misuse of Drugs Act 1975 to sell by wholesale a controlled drug that is also a prescrip- tion medicine (clause 346(d)).
• • A person who supplies scheduled medicines by wholesale other than under the authority of clause 345 or 346 commits an offence (clause 344(2)).

Supplying scheduled medicines other than by wholesale Clauses 347 to 357 relate to the supply of medicines other than by wholesale.

Supplying scheduled medicines other than by wholesale is a controlled activity.
Clause 347 makes it an offence to supply a scheduled medicine other than by wholesale without doing so under the authority of any of clauses 348 to 356.
Clause 348 provides that a prescriber (being an authorised prescriber or a designated prescriber) may supply scheduled medicines other than by wholesale to— • a patient under his or her care or a person who has care of his or her patient; or another prescriber at his or her request; or to another prescriber’s patient, or a person who has care of that prescriber’s patient, at the other prescriber’s request.
Clause 349(1) provides that a pharmacist may supply scheduled medicines other than by wholesale— • in a hospital, if that is where the pharmacist is employed; or • • 62 Therapeutic Products and Medicines Bill Explanatory note in a pharmacy.

• Clause 349(2) clarifies that, despite being authorised to supply sched- uled medicines other than by wholesale under subclause (1), there are certain other factors that need to be complied with when supplying prescription medicines or pharmacist-only medicines.
For example, prescription medicines need to be supplied in accordance with a pre- scription or standing order (clause 349(2)(a)).

Clause 350 provides that a veterinarian may supply scheduled medicines other than by wholesale for the treatment of an animal under his or her care or an animal under the care of another veter- inarian.
Clauses 351 to 353 describe the limited circumstances in which an employee working with a prescriber, pharmacist, or veterinarian may supply scheduled medicines other than by wholesale.

Clause 354 provides that a person may supply scheduled medicines other than by wholesale if the person is deemed to hold a licence under clause 518(4) and the person complies with the licence.
Clause 355 sets out the circumstances in which a person may supply pharmacy medicines other than by wholesale under a licence and as an employee of a licence holder of that kind.

Clause 356 provides that a person may supply a scheduled medicine other than by wholesale if authorised to do so by regulations or a standing order.

Clause 357 provides that supply of a scheduled medicine, under clause 456, to a medicines control officer is not supply other than by wholesale for the purposes of clause 347.
Standing orders for supply of scheduled medicines other than by wholesale Clause 358(1) allows an authorised prescriber to issue a standing order authorising a specified class of persons to supply prescription medicines or pharmacist-only medicines other than by wholesale to any specified class of persons, in certain circumstances.

Similar powers are provided to veterinarians under subclause (2).

Supplying medicines by auction Supplying medicines by auction is also a controlled activity.
Clause 359 makes it an offence for a person to supply medicines by auction.

Explanatory note Therapeutic Products and Medicines Bill 63 Supplying medicines by vending machine Clause 360 makes it an offence to undertake the controlled activity of supplying medicines by vending machine unless the person is au- thorised to so by the regulations.
• • Dispensing medicines Clause 361 makes it an offence for a person to undertake the con- trolled activity of dispensing medicines other than under the author- ity of any of clauses 362 to 368.
Clauses 362 to 366 describe the circumstances in which medicine may be dispensed by— • prescribers, who may dispense medicines to the same persons they may supply scheduled medicines to other than by whole- sale (clause 362): pharmacists, who may dispense a medicine in the course of pharmacy practice (clause 363): dispensary technicians, pharmacy graduates, pharmacy students, and pharmacy technicians, who may dispense medicines in a pharmacy, but if the medicine is a prescrip- tion medicine, only when under the direct supervision of a pharmacist (clause 364): veterinarians, who may dispense medicines for the purposes of the treatment of an animal under his or her care or under the care of another veterinarian (clause 365): employees who work with veterinarians, who may dispense medicines in certain limited circumstances (clause 366).
Clause 367 provides that a person may dispense medicines if author- ised to do so by the regulations.

Clause 368 describes the circumstances in which a licence holder and the licence holder’s employees may dispense medicines by using an automated dispensing machine.

• • Prescribing prescription medicines Prescribing prescription medicines is a controlled activity.
Clause 369(1) makes it an offence for a person to prescribe prescription 64 Therapeutic Products and Medicines Bill Explanatory note medicines unless the person is a prescriber or a veterinarian.
Clause 369(2) to (4) provides that— • authorised prescribers may only prescribe prescription medicines under the authority of clause 370; and a designated prescriber may only prescribe prescription medicines under the authority of clause 371; and veterinarians may only prescribe prescription medicines under the authority of clause 372.

• • Clause 370 describes the circumstances in which an authorised pre- scriber may prescribe prescription medicines.
Authorised prescribers are limited to prescribing prescription medicines for the treatment of patients— • under the prescriber’s care or the care of another prescriber at that prescriber’s request; and who are in New Zealand or are usually permanently resident in New Zealand, but are outside New Zealand for a limited period.

• Under clause 371(1), a designated prescriber is subject to the same restrictions as an authorised prescriber.
In addition, a designated pre- scriber may only prescribe prescription medicines that are specified in— • a prescribing notice issued by the prescribing authority with which the designated prescriber is registered; or regulations made under clause 501.

• Clause 372 describes the circumstances in which veterinarians may prescribe prescription medicines.

These are limited to the treatment of an animal under the veterinarian’s care or under the care of another veterinarian, at that veterinarian’s request.
Prescribing notices Clause 373 relates to the requirements for prescribing notices issued by prescribing authorities.
A prescribing authority (being a health au- thority that has designated prescribers registered with it) must, under clause 373(1), issue a prescribing notice in the Gazette, specifying— the prescription medicines that designated prescribers regis- • tered with the authority may prescribe; and Explanatory note Therapeutic Products and Medicines Bill 65 • the circumstances in which those prescription medicines may be prescribed.
Clause 373(2) provides that subclause (1) does not apply to a pre- scribing authority if regulations have been made under clause 501.

Regulations are made under clause 501 on the recommendation of the Minister, in circumstances where he or she is dissatisfied with the outcome of exercising his or her powers under Schedule 4.
Clause 373(3)(a) restricts the types of prescription medicines that may be included in a prescribing notice to prescription medicines that are directly related to the designated prescribers’ scope of practice.

Clause 373(3)(b) provides that the prescribing authority may only in- clude a prescription medicine in a prescribing notice after consider- ing all relevant public health and safety concerns.
Clause 373(4) clar- ifies that a prescribing notice may impose conditions or restrictions on the circumstances in which a designated prescriber may prescribe prescription medicines listed in a prescribing notice.

Clause 373(5) enables a prescribing notice to include a complete prohibition on pre- scribing certain prescription medicines in certain circumstances.

Clause 374 requires a prescribing authority to review a prescribing notice no later than 6 months after it is issued.
A review must con- sider— • whether a prescription medicine that is not specified in a pre- scribing notice should be included; and whether a prescription medicine that is specified in a pre- scribing notice should no longer, because of public health and safety concerns, continue to be included.
Clause 375 requires a prescribing authority to— • make available for inspection a consolidated list of prescrip- tion medicines that designated prescribers registered with the prescribing authority may prescribe; and • ensure that copies of the list may be bought at reasonable cost.

Clause 376 enables the Minister to use the powers set out in Schedule 4 in relation to a prescribing authority’s obligations under clauses 373 to 375.
• Administering prescription medicines Administering prescription medicines is also a controlled activity.

Clause 377 makes it an offence for a person to administer prescription 66 Therapeutic Products and Medicines Bill Explanatory note medicines in the knowledge that he or she is not authorised to do so under any of clauses 378 to 380.

Clauses 378 and 379 describe the circumstances in which prescribers and veterinarians may administer prescription medicines.
Clause 380 permits a person to administer prescription medicine if— directed by the prescriber or veterinarian who prescribed the • medicine; or authorised by the regulations; or authorised under a standing order issued under clause 381.
• • Standing orders authorising administering certain medicines Clause 381 enables authorised prescribers and veterinarians to issue standing orders allowing a specified class of persons to administer, to a specified class of persons in specified circumstances, specified prescription medicines or pharmacist-only medicines.

Possessing prescription medicines Possessing prescription medicines is a controlled activity.
Clause 382 makes it an offence for a person to possess prescription medicines without a reasonable excuse or sufficient authority.

Clause 383(1) describes some of the circumstances in which a per- son has a reasonable excuse for possessing prescription medicines.

Clause 383(2) provides that the fact that a person did not know that a medicine was a prescription medicine is not, in itself, a reasonable excuse.

Operating pharmacy Operating a pharmacy is also a controlled activity.
It is an offence, under clause 384, for a person to operate a pharmacy unless— the person holds a licence to operate the pharmacy; and • the pharmacy is under the immediate supervision and control • of a pharmacist.

Explanatory note Therapeutic Products and Medicines Bill 67 Subpart 2—Instruments prohibiting and restricting activities with medicines Clause 385 provides an outline of subpart 2.
Clause 386 provides that, even if an activity is otherwise authorised under Parts 6 and 7, it may be restricted or prohibited in the limited circumstances provided for by a prohibition notice, restriction notice, or statement relating to dependency issued under this subpart.
Minister may prohibit certain activities Clause 387 enables the Minister, if he or she believes there is a risk to public health and safety, to prohibit— • a specified prescriber or veterinarian from prescribing speci- fied prescription medicines or a class or description of pre- scription medicines: a specified person from undertaking any activity that he or she is otherwise authorised to undertake by or under Parts 6 and 7.
This prohibition may be general or in relation to a specified medicine or class or description of medicine.

• A prohibition notice issued under clause 387 must be notified in the Gazette.

Under clause 387(3) a person who contravenes a prohibition notice commits an offence.
Clause 388 requires that a prohibition notice issued under clause 387 be made on the recommendation of— • • the appropriate health authority in the case of a prescriber; or the Veterinary Council of New Zealand (Veterinary Council) in the case of a veterinarian.

The health authority or the Veterinary Council may conduct an in- quiry in order to determine whether a recommendation should be made.

The organisation conducting the inquiry have the powers set out in Schedule 5.
Restriction notice Clause 389 relates to restriction notices.

A restriction notice may be issued by a Medical Officer of Health who has been authorised to do so by the Director-General under section 510.

A restriction notice re- stricts prescribers and persons supplying medicines from prescribing 68 Therapeutic Products and Medicines Bill Explanatory note or supplying a prescription medicine or pharmacist-only medicine to a named individual (the restricted individual).
Clause 390 makes it an offence for a person to knowingly prescribe or supply prescription medicines or pharmacist-only medicines to a restricted individual.

Clause 391 makes it an offence for a restricted individual to pro- cure or attempt to procure a prescription medicine or pharmacist- only medicine from a person whom the restricted individual knows, or ought to know, is restricted from prescribing or supplying the medicine.
Clause 392 enables a restricted individual to appeal or to seek a re- view of a restriction notice in the manner set out in Schedule 6.

Statement relating to dependency Clause 393 enables a Medical Officer of Health, who has been au- thorised by the Director-General under section 510, to issue a state- ment of dependency in respect of an individual’s dependency on a prescription medicine or pharmacist-only medicine.

Subpart 3—Licences Clause 394 provides an outline of subpart 3.
Subpart 3 contains provisions about the following types of licences: • licences to supply scheduled medicines by wholesale as fixed vendors: licences to supply scheduled medicines by wholesale as mo- bile vendors: licences to supply pharmacy medicines other than by whole- sale: licences to dispense medicines using automated dispensing machines: licences to operate pharmacies.

• • • • Applying for licence Clause 395 sets out who may apply for a licence.
Clause 396 sets out how an application for a licence must be made.

Explanatory note Therapeutic Products and Medicines Bill 69 Contents of application Clause 397 requires an applicant for a licence to supply or dispense medicines to specify in the application the type of medicines for which the licence is sought.

An application for a licence to operate a pharmacy must include the particulars required by clause 421.
Clause 398 requires an application for a licence to contain sufficient information to enable a licensing authority to make a decision under clause 399.

Clause 398(2) provides that the licensing authority may require further information from an applicant.

Granting of licence Clause 399 specifies criteria that the licensing authority must be sat- isfied of before granting a licence.
The criteria include, without limi- tation,— • • that applicant is eligible to apply for a licence; and that the applicant is not disqualified from holding a licence; and that the application contains all requested information; and that the applicant has sufficient knowledge of the obligations of the licence and the hazards associated with the medicines to which it will, if granted relate; and that the premises and equipment the applicant proposes to use are adequate and suitable.
• • • Clause 400 provides additional criteria in respect of which a licens- ing authority must be satisfied before granting a licence to supply pharmacy medicines other than by wholesale.

Refusal of licence Clause 401 requires the licensing authority to give an applicant who is refused a licence— • • a reasonable opportunity to be heard; and the written reasons for refusal, if the applicant so requests.
70 Therapeutic Products and Medicines Bill Explanatory note Authority conferred on licence holder by licence Clauses 402 to 406 describe the authority conferred on the holder of a licence to— • supply scheduled medicines by wholesale as a fixed vendor (clause 402): supply scheduled medicines by wholesale as a mobile vendor (clause 403): supply pharmacy medicines other than by wholesale (clause 404): dispense medicines by using an automated dispensing ma- chine (clause 405): operate a pharmacy (clause 406).
• • • • Conditions of licence Clause 407 relates to conditions imposed on a licence.

Licence hold- ers must, as a condition of every licence issued under Parts 6 and 7, continue to comply with the criteria referred to in clause 399.

Con- ditions on a licence may be imposed by the licensing authority or by the regulations.

Clause 408 requires the licensing authority to provide, at the licence holder’s request, written reasons explaining why a condition is im- posed on a licence.
Clause 409 states that a condition of a licence takes effect from the date it is imposed.

Clause 409(2) also enables the licensing authority to alter or cancel a licence if the licence holder fails to comply with a condition of the licence.

Suspending, cancelling, and disqualifying holding of licence Clause 410 provides that if a licence holder gives materially false or misleading information in an application for a licence, the licence may be suspended and eventually cancelled.
Clause 411 requires the licensing authority to provide, at the request of a licence holder, written reasons for cancelling the licence.

Clause 412 sets out the powers of the court in respect of a licence holder who is charged with, or convicted of, an offence under Parts 6 and 7 or the regulations.

Explanatory note Therapeutic Products and Medicines Bill 71 Clause 413 requires a licence holder, whose licence has been can- celled or endorsed by a court, to produce the licence as the court di- rects.
Under clause 413(2), a person who fails to produce the licence commits an offence.

Duration of licence Clause 414 states the duration of a licence.

A licence remains in force for 1 year from the date on which it is granted, unless— • • Clause 415 provides for the situation where— • it is sooner cancelled; or clause 424 applies.

a new licence is issued before the expiry of a current licence; or a licence expires before an application for a new licence is determined.
• Clause 416 requires a licence holder to surrender a licence if the li- cence holder has ceased to undertake the controlled activity to which the licence relates.

Register of licences and records of licensing authority Clause 417 requires the licensing authority to keep a register of li- cences and any other registers or records required by the regulations.

Subpart 4—Operating pharmacies Clause 418 provides an outline of subpart 4.
The requirements placed on a licence to operate a pharmacy under subpart 4 are in addition to the requirements placed on licences generally under sub- part 3.

Clause 419 defines what it means to hold an interest in a pharmacy for the purposes of subpart 4.

A person holds an interest in a pharmacy if the person has, or acquires, a direct or indirect estate or interest in the pharmacy that affects the ownership, management, or control of the pharmacy practice carried on in the pharmacy.
72 Therapeutic Products and Medicines Bill Explanatory note Additional information for pharmacy licence Clause 420 ensures that a licence to operate a pharmacy is granted only to applicants who meet the additional criteria specified in sub- clause (1), being that the applicant— • • is qualified under any of clauses 422 to 424; and is a person who is able to satisfy the condition set out in clause 425.

The criteria apply for the duration of a licence.


A licence may be cancelled if the licensing authority is satisfied that the licence holder no longer meets those criteria.

Clause 421 enables the licensing authority to require additional in- formation (over and above that referred to in clauses 397 and 398) from an applicant for a licence to operate a pharmacy.

Companies Clause 422 sets out the circumstances in which a company may be granted a licence to operate a pharmacy.
Those circumstances are limited and are the same as the circumstances that exist under the Medicines Act 1981 (as amended by the Medicines Amendment Act 2003).

Majority interest in pharmacy Clause 423 sets out the circumstances in which an individual may be granted a licence to operate a pharmacy or hold a majority interest in a pharmacy.

Those circumstances are limited and are the same as the circumstances that exist under the Medicines Act 1981 (as amended by the Medicines Amendment Act 2003).
Mortgagees in possession Clause 424 provides that a mortgagee in possession of a pharmacy may be granted a licence to operate that pharmacy for a limited period of 3 months or as determined by the licensing authority.

Mandatory condition on pharmacy licence Clause 425 imposes a mandatory condition on every licence to op- erate a pharmacy.
A licence holder must not request or require a pharmacist who is employed or engaged in duties at a pharmacy to Explanatory note Therapeutic Products and Medicines Bill 73 act in a way that is inconsistent with the pharmacist’s professional or ethical standards of pharmacy practice.

Clause 426 enables the licensing authority to impose penalties on a licence holder who fails to comply with a condition imposed on the licence holder’s licence.
Restrictions on operating and holding interests in pharmacies Clause 427 provides that a prescriber must not hold an interest in a pharmacy unless he or she— • • has the consent of the licensing authority; and holds the interest in accordance with any conditions or restric- tions imposed by the licensing authority.

Clause 428 prohibits— • • a company from operating more than 5 pharmacies; and a pharmacist from operating more than 5 pharmacies or hold- ing a majority interest in more than 5 pharmacies.
Fee on prescriptions Clause 429 makes it an offence for a pharmacist, a person licensed to operate a pharmacy, or an operator or a manager of a pharmacy to give, offer, or agree to give to a prescriber or any other person any money or other consideration as a fee on prescriptions.

Subpart 5—Certain requirements, restrictions, and offences associated with medicines Clause 430 provides an outline of subpart 5.
Security, storage, and premises Clause 431 requires that a person who holds a licence to operate a pharmacy must keep prescription medicines and pharmacist-only medicines secure from public access.

A person who contravenes that requirement commits a strict liability offence.
74 Therapeutic Products and Medicines Bill Explanatory note Clause 432 sets out requirements for the storage of scheduled medicines in a person’s possession or charge and makes it a strict liability offence to contravene those requirements.

Clause 433 sets out requirements relating to the storage of scheduled medicines in unattended buildings or vehicles.

Non-compliance with the requirements is an offence.
Clause 434 relates to premises whose condition may cause the de- terioration or contamination of any medicine.

A Medical Officer of Health may prohibit such premises from being used to store medicines.

It is an offence not to comply with a notice issued under this clause.

Containers and packages Clause 435 specifies requirements for containers used for supplying, storing, or transporting medicines.

A person who contravenes those requirements commits a strict liability offence.
Clause 436 requires a person who is in possession of a medicine to ensure it is in a container that complies with the relevant provisions of Parts 6 and 7 and the regulations.

Failure to ensure that the container complies with the relevant requirements is a strict liability offence.

A defence in a prosecution for such an offence is available under clause 436(3).
Packing and preparing medicines Clause 437 prohibits a person from, in the course of business, pack- ing or preparing a medicine for use in a room or on a surface used for food or drink.

A person who contravenes this provision commits a strict liability offence.

Delivering medicines Clause 438 specifies how a person must deliver medicines for the purposes of supply other than by wholesale.

A person who contra- venes this provision commits a strict liability offence.
Disposal of medicines Clause 439 requires a person to dispose of a medicine in the manner prescribed by the regulations (if any).

A person who fails to dispose Explanatory note Therapeutic Products and Medicines Bill 75 of a medicine in the prescribed manner commits a strict liability of- fence.

Record keeping Clause 440 contains requirements about records that must be kept by a person who, in the course of business, supplies medicines.
A person who contravenes the requirements commits a strict liability offence.

Clause 441 provides for circumstances when persons who supply medicines in the course of business must allow the inspection of, and provide when requested, records relating to supply.

Knowingly risking public health Clause 442 provides that it is an indictable offence to knowingly risk public health by failing or refusing to comply with a provision of Parts 6 and 7 or the regulations.
Subpart 6—Enforcement and certain procedural matters Clause 443 provides an outline of subpart 6.

Clause 444 provides definitions of important terms used in subpart 6, including article, evidential material, occupier, and place.

Medicines control officers Clause 445 provides for the appointment of medicines control offi- cers.

Clause 446 requires the Director-General to issue medicines control officers with an identification card.
The card must state the provi- sions of Parts 6 and 7 that a medicines control officer is appointed to enforce and any restrictions on the medicines control officer’s en- forcement powers.

Clause 446(4) requires a medicines control offi- cer to produce his or her identification card for inspection— • • on entering a place; or on request when exercising a power under subpart 6.
76 Therapeutic Products and Medicines Bill Explanatory note Powers of entry, search, and seizure Clause 447 enables a medicines control officer to enter a place (ex- cept a dwellinghouse or marae) at any reasonable time, to determine whether a person is complying with Parts 6 and 7.

Clause 447(2) lists the powers that may be exercised on entry.
Clause 448 enables a medicines control officer or a member of the police to enter a place (other than a dwellinghouse or marae) if he or she has reasonable grounds to believe that— • • • Clause 449 empowers a District Court Judge, Community Magis- trate, Justice of the Peace, or Registrar to issue a search warrant on application, if he or she is satisfied that— • Parts 6 and 7 are not being complied with; and it is necessary in the interests of public health; and it is not practicable to obtain a search warrant.
there are reasonable grounds to believe that there is evidential material at the place to which the warrant relates; or a search is unable to be conducted or completed under clause 447 or 448 for any reason.

• Clause 450(1) lists the powers that may be exercised under a search warrant issued under clause 449 (those powers include the ability to use reasonable force to enter the place or open any thing).
The rest of clause 450 sets out certain matters relating to executing a search warrant, including, for example, the requirement to leave a written inventory of things seized.

Matters associated with search Clause 451 provides that an occupier whose place is being searched may observe the search as long as he or she does not impede it.

Clause 452 relates to the use of electronic equipment found at a place during a search.
Medicines control officers and members of the po- lice must take care not to damage the equipment or corrupt informa- tion stored on it.

Clause 453 provides that documents seized from a place must, if practicable, be copied before the original is removed.

What happens to seized property Clause 454 provides for the disposal of things that have been seized.
Explanatory note Therapeutic Products and Medicines Bill 77 Clause 455 enables a medicines control officer to apply for an order to retain for more than 6 months any thing that has been seized under this subpart.

Analysis of samples Clause 456 sets out how a medicines control officer must obtain a sample for analysis other than under a search warrant.

Clause 457 contains provisions relating to the analysis of a sample and the certificate of the analyst.
Clause 458 provides for how a certificate of analysis may be admis- sible as evidence.

Clause 459 enables a court to order a person who is convicted of an offence (the defendant) to pay the fees and expenses of the testing or analysis.

Wilfully obstructing Clause 460 makes it an offence for a person to willfully obstruct a medicines control officer or member of the police, or person assisting a medicines control officer or member of the police, who is exercising powers under this subpart.
False or misleading statement, declaration, or answer Clause 461 makes it an offence for a person to knowingly— • make a false or misleading declaration, statement, or answer; or create or produce a false of misleading document; or create, produce, or make use of a document that is not genuine.

• • Powers of Director-General and Medical Officer of Health Clause 462 enables the Director-General or a Medical Officer of Health to require, in certain circumstances, the production of any document or record.
Clause 463 makes it an offence to fail or refuse to produce a docu- ment or record required under clause 462.
78 Therapeutic Products and Medicines Bill Explanatory note Disclosure of information Clause 464 provides for certain agencies to be able to disclose to each other information (that they are otherwise unable to disclose under information privacy principles 2 and 11 of the Privacy Act 1993)— in order to ensure the health and well-being of persons using • or dealing with medicines; or for the purposes of maintaining the law, including the preven- tion, investigation, and detection of offences under Parts 6 and 7 and other listed enactments.
• Matters relating to proceedings Clause 465 states when an information may be laid under Parts 6 and 7 or the regulations and provides for matters that must be served with any summons issued.

Clause 466 provides for the service of documents in proceedings under Parts 6 and 7.

Clause 467 states a presumption that in proceedings, unless the con- trary is proved, the contents of a container are the same as the de- scription of its contents on the label.
Clauses 468 and 469 set out presumptions relating to— • the certificate purported to be signed by the licensing author- ity: the authenticity of copies of documents or records.

• Matters arising from conviction Clause 470 provides for the forfeiture of certain articles of a person being convicted of an offence under Parts 6 and 7 or the regulations.
Clause 471 requires the Court to send the particulars of the convic- tion of a health practitioner or veterinarian to the appropriate health authority, in the case of a health practitioner, or the Veterinary Coun- cil, in the case of a veterinarian.

Matters effecting liability Clause 472 specifies which offences under Parts 6 and 7 are strict liability offences and explains key aspects of the prosecution and de- fence in respect of strict liability offences.
Explanatory note Therapeutic Products and Medicines Bill 79 Clause 473 specifies the liability of an employer for the actions of an employee who commits an offence under Parts 6 and 7 or the regulations and sets out the defence available to the employer in such proceedings.

Clause 474 specifies the liability of directors and persons involved in the management of a body corporate where the body corporate contravenes Parts 6 and 7.
Clause 475 provides protection from civil or criminal liability for persons acting under any of the functions conferred by or under Parts 6 and 7.

Subpart 7—Appeals Clause 476 provides an outline of subpart 7.

Appeals against decision of Medical Officer of Health in respect of premises Clause 477 sets out how a person may appeal to a District Court against a decision made under section 434 that prohibits the use of the premises for certain activities.
Licensing appeals Clause 478 enables a person to appeal to the District Court against licensing decisions of the licensing authority.

Clause 479 provides for the status of a decision of the licensing au- thority pending the determination of an appeal.

Clause 480 sets out procedural matters in respect of an appeal to the District Court.

Clause 481 provides for a further appeal to the High Court, but only on a question of law and with the leave of the Court.
Clause 482 provides for the status of the decision of the District Court pending the determination of an appeal against that decision to the High Court.

Clause 483 provides that the appropriate rules of Court apply to the hearing of appeals.

Clause 484 prevents a person from being deprived of his or her right of appeal merely because the person has accepted a licence or com- plied with a condition or requirement of a licence.
80 Therapeutic Products and Medicines Bill Explanatory note Clause 485 requires the licensing authority to implement the decision of the Court on appeal.

biological material; and xenotransplantation.

Subpart 8—Restrictions on xenotransplantation Clause 486 provides a brief outline of the matters dealt with in sub- part 8.

Clause 487 defines— • • Clause 488 makes it an offence to conduct xenotransplantation other than as provided under section 489 or 490.
Clause 489 empowers the Minister to authorise a person or persons to conduct a particular xenotransplantation.

The Minister’s author- isation must be published in the Gazette and presented to the House of Representatives.

Clause 490 provides that xenotransplantation may be authorised by Order in Council on the recommendation of the Minister.

Clause 491 sets out the criteria that must be satisfied before the Min- ister makes a recommendation under clause 490.
If the Minister is not satisfied that the criteria are being met, the Minister may obtain advice from persons whom he or she considers appropriately quali- fied.

Clause 492 sets out options available to the Minister for the purpose of obtaining advice on the applicability of the criteria referred to in clause 491.
Clause 493 allows a person to apply to the Minister requesting— • authorisation to conduct xenotransplantation under clause 489; or the Minister’s recommendation that authorisation be granted under clause 490.

• Clause 494 provides that the Crown is not liable to pay compensation for loss or damage arising from the restrictions imposed by clause 488.

Clause 495 states the enforcement powers that apply in relation to a prosecution for an offence under clause 488.
Explanatory note Therapeutic Products and Medicines Bill 81 Clause 496 applies if the Director-General or a Medical Officer of Health reasonably suspects that a person possesses, in breach of Parts 6 and 7, an article for use in xenotransplantation.

The Director-Gen- eral or Medical Officer of Health may require that person to produce any document or record relating to the prohibited article.
Clause 497 makes an offence for a person to fail or refuse to produce any document or record required under clause 496.

Clause 498 provides for the expiry of subpart 8 on 31 December 2008.

There is a power to extend that date by Order in Council.

Subpart 9—Regulations, Orders in Council, ministerial notices, and other instruments Regulations Clause 499 authorises the making of regulations for the purposes specified in subclause (2).
Clause 499(2) includes a range of purposes associated with activities that are authorised under Parts 6 and 7.

The regulations are made on the advice of the Minister obtained after consulting organisations and bodies likely to be substantially affected by the regulations.

Regulations designating designated prescribers Clause 500 authorises the making of regulations designating certain health practitioners as designated prescribers.
Regulations relating to prescribing notices Clause 501 authorises the making of regulations on the recommen- dation of the Minister, that— • revoke prescribing notices relating to a particular class of des- ignated prescribers: prescribe prescription medicines that designated prescribers are authorised to prescribe, and the circumstances in which those prescription medicines may be prescribed: prescribe conditions or restrictions on the circumstances in which certain prescription medicines may be prescribed: prohibit the prescribing of certain prescription medicines.
• • • 82 Therapeutic Products and Medicines Bill Explanatory note Before recommending the making of regulations under clause 501, the Minister must undertake the steps set out in Schedule 4 and must be satisfied that there is a risk to public health and safety.

Regulations designating authorised prescribers Clause 502 authorises the making of regulations for designating health practitioners (who are already designated prescribers) as au- thorised prescribers.
Regulations relating to qualifications, training, and competence of prescribers and veterinarians when prescribing Clause 503 authorises the making of regulations in respect of quali- fications, training, and competence requirements of prescribers and veterinarians when prescribing prescription medicine.
Regulations relating to pharmacy ownership and operation Clause 504 authorises the making of regulations to provide exemp- tions from, or modifications of, the restrictions on pharmacy owner- ship and operation set out in clause 422(1) (in the case of a company) and clause 423(1) (in the case of a person other than a company).

The regulations are made on the recommendation of the Minister.
The Minister must not recommend the making of the regulations unless he or she considers that the proposed regulations— • • will improve health services or access to those services; and are necessary to meet the needs of the community in the par- ticular location of the pharmacy or proposed pharmacy.

Approval and appointments relating to laboratories and analysts Clause 505 provides that the Minister may approve by notice in the Gazette a laboratory for the purposes of Parts 6 and 7.
Clause 506 provides that the Minister may appoint, by notice in the Gazette, an analyst in charge of an approved laboratory.

Explanatory note Therapeutic Products and Medicines Bill 83 Clause 507 authorises an analyst appointed by the Minister under clause 506 to authorise a person to act as an analyst for the purposes of Parts 6 and 7.
Appointment of advisory and technical committees Clause 508 provides for the appointment of an advisory or technical committee to advise the Minister on matters dealt with in Parts 6 and 7 or the regulations.

Certain powers of Director-General Clause 509 enables the Director-General to publish, for the purpose of protecting the public, statements in relation to any activities under- taken with medicines under Parts 6 and 7.
Clause 510 provides that the Director-General may authorise a Med- ical Officer of Health to issue restriction notices or statements relat- ing to dependency.

Subpart 10—Scheduled medicines and referring to medicines Scheduled medicines Clause 511 defines the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) as the electronic register con- taining the Managing Director’s listings of scheduled medicines and poisons, including any additions to that register.
Clause 512 provides definitions of prescription medicine, pharma- cist-only medicine, and pharmacy medicine.

Each type of medicine requires— a listing in the relevant schedule of the (SUSMP); or • • a declaration by the Minister by notice in the Gazette.

Clause 513 enables the Minister to declare a medicine to be a prescription medicine, pharmacist-only medicine, or pharmacy medicine.

The declaration must be made by notice in the Gazette.
Clause 514 enables the Minister to depart from the listing of a sched- uled medicine in the SUSMP by notice in the Gazette.

84 Therapeutic Products and Medicines Bill Explanatory note Clause 515 requires the Director-General to keep an Internet register of all declarations and departures of scheduled medicines made under clauses 513 and 514.

Clause 516 provides that a certified copy of the SUSMP, or an extract of it, is prime facie evidence of the matters contained in it.
Evidence of a Gazette notice issued under subpart 10 is covered by section 46 of the Evidence Act 1908.

Referring to medicines Clause 517 provides that an individual, person, or body who is re- quired by Parts 6 and 7 to specify medicine may do so by reference to its name or trade name or its pharmacological action.

Subpart 11—Miscellaneous matters Relationship to other enactments Clause 518 describes the relationship between Parts 6 and 7 and the Misuse of Drugs Act 1975.
Except as specified in subclauses (1) to (5) of clause 518, the Misuse of Drugs Act 1975 overrides Parts 6 and 7.

Transitional regime for designated prescribers Clause 519 provides for how designated prescribers appointed under the Medicines Act 1981 (the former Act) may continue to be desig- nated prescribers under Parts 6 and 7.

Transitional regime for standing orders Clause 520 continues the effect of standing orders issued under the former Act.
Transitional regime for licences Clause 521 deals with applications made, but not determined, under the former Act for licences to sell medicines by wholesale.

Clause 522 relates to licences to sell medicines by wholesale that were granted under the former Act.

Clause 523 deals with applications made, but not determined, under the former Act for licences to sell medicines by retail.
Explanatory note Therapeutic Products and Medicines Bill 85 Clause 524 relates to licences to sell medicines by retail that were granted under the former Act.

Clause 525 deals with applications made, but not determined, under the former regulations for a licence to hawk medicines.

Clause 526 relates to licences to hawk medicines that were granted under the former regulations.

Clause 527 provides for applications made, but not determined, under the former Act for a licence to operate a pharmacy.
Clause 528 deals with licences to operate a pharmacy that were granted under the former Act.

Clause 529 relates to other types of licences that were granted under the former Act, and provides that such licences may be deemed to be a licence under Parts 1 to 5.

Clause 530 provides for conditions on licences that are deemed to be licences under Parts 6 and 7.
Transitional regime for proceedings and appeals under former Act Clauses 531 and 532 provide for proceedings and appeals that were commenced under the former Act.

Transitional regime for officers under former Act Clause 533 provides for employees of the Ministry appointed under the former Act.

Clause 534 prevents claims for payment or compensation against the Crown for loss of office or appointment held under the former Act.
Transitional regime for xenotransplantation Clause 535 provides for the transition of any authorisation relating to xenotransplantation issued by the Minister under the former Act.

Transitional regime for approved laboratory and analyst under former Act Clause 536 deems laboratories approved under the former Act as approved laboratories for the purposes of Parts 6 and 7.

Clause 537 provides for analysts authorised under the former Act.
86 Therapeutic Products and Medicines Bill Explanatory note Repeal Clause 538 repeals the Medicines Act 1981.

Clause 539 provides for the ability to make transitional and savings regulations.

Clause 540 provides that clause 539 expires on the date that is 2 years from its commencement.

Revocations Clause 541 revokes the regulations and orders specified in Schedule 7.

Savings Clause 542 preserves the validity of actions done under the former Act or former regulations (listed in Schedule 7).
Clause 543 saves the Medicines (Approved Laboratories and Ana- lysts in Charge) Notice 2000.

Clause 544 saves the Medicines (Standing Order) Regulations 2002.

Clause 545 saves the Medicines (Designated Prescriber: Nurse Prac- titioners) Regulations 2005.

Clause 546 saves the Medicines (Designated Prescriber: Op- tometrists) Regulations 2005.

Clause 547 saves Orders in Council made under section 96D(1) of the former Act that authorise the conduct of 1 or more classes of specified biotechnical procedure.
Consequential amendments Clause 548 provides for consequential amendments to the enact- ments specified in Schedule 8.

Schedules Schedule 1 sets out the full text of the Agreement.

Schedule 2 sets out procedural provisions relating to the Review Tri- bunal established under Part 3.

Schedule 3 contains substantive amendments to other enactments re- lating to the establishment of the Authority.
These include provisions such as the amendment to the Ombudsmen Act 1975 which inserts the Authority into Part 2 of Schedule 1, which has the effect of mak- Explanatory note Therapeutic Products and Medicines Bill 87 ing the Authority subject to both that Act and the Official Informa- tion Act 1982.

Schedule 4 sets out the powers of the Minister (under Part 7) in re- lation to prescribing authorities’ obligations.
Schedule 5 sets out the powers of health authorities or the Veterinary Council (under Part 7) when making an inquiry under clause 388(2).

Schedule 6 sets out the procedures associated with reviews and ap- peals of restriction notices.

Schedule 7 lists regulations and orders revoked as a consequence of the repeal of the Medicines Act 1981.

Schedule 8 sets out consequential amendments relating to the enact- ment of both Parts 1 to 5 and Parts 6 and 7.
Regulatory impact and compliance cost statement for Parts 1 to 5 Problem definition New Zealand’s regulatory framework for therapeutic products is out- dated, unsustainable and in need of reform.

It does not adequately manage the public health risks associated with the use of medical de- vices and medicines.

In addition, while the basic regulatory frame- work for pharmaceuticals is sound, its operation is unsustainable.
Pharmaceuticals Pharmaceuticals (prescription and over-the-counter medicines) have significant health benefits, but can present serious risks, especially if used inappropriately.

Before a pharmaceutical product can be offered for supply in New Zealand, the distributor must obtain the consent of the Minister of Health.
Applications for consent are assessed by Medsafe to ensure that the benefits of use outweigh the risks if the product is used appropriately, and to identify any appropriate special requirements or restrictions on supply.

While the current regulatory approach is consistent with inter- national best practice, the regime is unsustainable for New Zealand.
As pharmaceuticals become increasingly complex and sophisticated, it is becoming increasingly difficult for New Zealand to maintain the expertise necessary to evaluate new products when such expertise is in short supply globally.

Without adequate technical expert- 88 Therapeutic Products and Medicines Bill Explanatory note ise, Medsafe will be unable to meet the regulatory objectives for pharmaceuticals within acceptable time-frames.
Complementary medicines Most complementary medicines contain ingredients with a very low inherent risk.

Most of the risk arises from poor quality in manufac- ture, or from distributors making unsubstantiated and sometimes out- rageous claims about the health benefits of products.
Risks arising from poor quality in manufacture can include— • under or over potency, or complete absence of ingredients stated on the label: poor formulation leading to non-availability of active ingredi- ents: adulteration with undeclared ingredients (including prescrip- tion medicines such as steroids), or substitution of a toxic herbal ingredient for the ingredient stated on the label: inaccurate or incomplete labelling, such as non-disclosure of ingredients, or inadequate dosage instructions and warning statements to enable the product to be used safely: contamination with heavy metals, microbes, radioactivity or other ingredients used by the manufacturer.
• • • • Unsubstantiated claims that a product can prevent or treat a serious disease result in a serious risk to the vulnerable consumer who be- lieves the claim and either stops taking prescribed medication or fails to seek appropriate medical treatment.

In New Zealand, complementary medicines are currently marketed as foods under the Dietary Supplements Regulations 1985 (made under the Food Act 1981).
The concerns with this regime are as follows: • therapeutic claims on dietary supplements are prohibited.

However, in practice only a low level of enforcement has been possible and many are marketed with therapeutic claims, some of which are inaccurate, misleading or potentially dangerous.
There is currently widespread and constant distribution (in leaflets and magazines, and on websites) of advertisements for complementary medicines making unsubstantiated thera- peutic claims including those for the prevention or treatment of serious diseases such as cancer, tuberculosis, diabetes, heart disease and obesity: Explanatory note Therapeutic Products and Medicines Bill 89 • • • manufacturing standards for food are not adequate for comple- mentary medicines presented in pharmaceutical dose forms, where appropriate formulation, quality in the manufacturing process, and accuracy of labelling and dosage are essential to the safety, effectiveness and appropriate use of the product.
It is estimated that up to 10% of the total retail sales value of dietary supplements in New Zealand comes from products manufactured in premises in New Zealand or overseas that do not meet the New Zealand Code of Good Manufacturing Prac- tice for Manufacture and Distribution of Therapeutic Goods (Good Manufacturing Practice) standards.
Consumers pur- chasing products have no way of identifying which products are of high quality and therefore safe to use: there is no requirement for new ingredients used in dietary sup- plements to undergo any pre-market safety assessment, or for products to be registered.
There is therefore no safety check on ingredients being used, and no register of products or dis- tributors to facilitate efficient investigation and product recall when a safety alert arises: because it is illegal to make therapeutic claims for dietary sup- plements, manufacturers and distributors are unable to law- fully provide consumers with the information they need to In many in- choose products wisely and use them safely.
stances consumers are not provided with information about contra-indications, adverse effects or interactions even when these are well recognised and may have a significant influence on whether they can safely use the product.

Medical devices Medical devices include products ranging from very low risk (eg, gauze dressings) to high-risk devices such as heart valves, which, if they fail, could lead to severe harm or death, with all the associated personal and social costs.
In contrast to most developed countries, New Zealand does not re- quire medical devices to be approved before being marketed.

Med- safe’s role is limited to market surveillance and dealing with safety issues as they emerge.

Because there is no register of medical de- vices, this is inefficient and costly.
90 Therapeutic Products and Medicines Bill Explanatory note The vast majority of medical devices are imported, mainly from the US, Europe, Japan, and Australia, where devices are required to be registered.

Most medical devices in use in New Zealand would there- fore meet adequate safety standards, particularly as world standards converge around the Global Harmonization Task Force (GHTF) re- quirements.
However, without similar standards applying in New Zealand, there is a risk that poor quality product that cannot be sold overseas will be dumped on the New Zealand market, with poten- tially serious health risks.

Anecdotal evidence also suggests that the overall risk to consumers from medical devices is increasing.

Magnitude of risk Risk cannot be eliminated.

From society’s point of view, the ob- jective is to achieve an appropriate risk reduction at reasonable cost.
While lack of data makes it difficult to quantify the risk for comple- mentary medicines and medical devices, the risk can be significant, resulting in serious injury and death.

In most developed countries, regulatory arrangements for therapeu- tic products are predicated on the assumption that the costs of harm are likely to be far greater than the costs of policies aimed at reduc- ing risk.
For medical devices and complementary medicines, New Zealand’s regulatory regime is out of step with international practice and World Health Organization recommendations.

Given the rising risk profile as products become more widely used and more sophisti- cated, and the existing evidence of problems and their consequences (discussed above), there is a prima facie case for policy intervention.
Trans-Tasman Mutual Recognition Arrangement (TTMRA) In the context of closer economic relations (CER), the Australian Commonwealth, States and Territories and New Zealand committed to the Trans-Tasman Mutual Recognition Arrangement (TTMRA) in 1998.

One of its objectives is to allow goods and services legally traded in Australia to be also traded without regulatory impediment in New Zealand, and vice versa.

Therapeutic products are 1 of 6 areas where mutual recognition has not yet been achieved.
Australian and New Zealand Health Ministers concluded that mutual recognition in any area of the program would not be acceptable at this time, or in the future, unless there were sig- Explanatory note Therapeutic Products and Medicines Bill 91 nificant changes in the legislative framework that lead to a greater convergence in regulatory arrangements in the two countries.
Public policy objectives Health objectives The primary policy objective is to manage the risks to public health and safety from avoidable harm associated with the use of thera- peutic products.
In particular, to regulate therapeutic products for safety, quality and efficacy to ensure that the benefits of use will out- weigh the risks if the product is used appropriately; to regulate prod- ucts in accordance with international best practice, adopting a glob- ally harmonised approach where possible; and to ensure that health and safety objectives are met while minimising costs to business and Government, and without imposing unnecessary trade barriers.
Wider objectives Policy options can have different impacts on the Government’s ob- jectives for trade and industry development.

In the context of thera- peutic products, secondary policy objectives are— • • • progression of CER: facilitation of trans-Tasman trade in therapeutic products: facilitation of exports of therapeutic products beyond Aus- tralia: development of the therapeutic products industry in New Zealand, including research and development.
• Feasible options Non-regulatory options There are no non-regulatory options that would adequately achieve the health and safety objectives.

In an unregulated but highly competitive market, there would be a lack of incentive for suppliers of therapeutic products to provide balanced information about the benefits and risks of their products.
Consumers would find it extremely difficult or impossible to identify quality product from substandard and potentially harmful product, or to take a case under consumer protection legislation because of the high burden of proof required.
92 Therapeutic Products and Medicines Bill Explanatory note Public education programmes (designed to enable consumers to evaluate the benefits and risks of products, make informed choices and use products safely), would not be effective, since most con- sumers do not have the knowledge or skills required to assess the accuracy or completeness of the available information or to interpret that information appropriately.

Regulatory options Four regulatory options have been identified.
Continuation of the status quo Under this option the main focus would be on evaluating and approv- ing pharmaceuticals and on post-market monitoring functions.

There would be no pre-market requirements for medical devices.

Dietary supplements would remain under food legislation with therapeutic claims prohibited.

The current Medsafe budget is $6.7 million, of which $2.9 million is Crown funding and the remainder comes from fees paid by industry.
Enhancing the regulatory framework, with local evaluation to international standards Under this option, the regulatory framework would be extended to in- corporate pre- and post-market controls for the full range of therapeu- tic products—prescriptions and over-the-counter medicines, comple- mentary medicines and medical devices.
There would be local evalu- ation to international standards, and mutual recognition arrangements with other reputable regulators for some aspects (such as evaluation of medical devices and assessment of good manufacturing practice).

A global shortage of expertise in evaluating increasingly specialised high-tech products makes it unlikely Medsafe could recruit the ad- ditional staff required under this option.
The estimated budget for Medsafe regulating the full range of therapeutic products to inter- national standards is $43 million per annum.

Enhancing the regulatory framework, but adopting a unilateral recognition scheme Under this option, the regulatory framework would be extended to in- corporate pre- and post-market controls for the full range of therapeu- Explanatory note Therapeutic Products and Medicines Bill 93 tic products.

Local evaluation would not occur.


Instead, evaluations carried out by competent overseas regulatory authorities would be recognised by Medsafe.

Products intended only for the New Zealand market and not approved by any of the recognised overseas author- ities would be evaluated under contracts with other regulators that would be managed by Medsafe.
New Zealand would maintain a list of overseas regulatory author- ities in whom it had confidence, and only evaluations carried out by those authorities would be recognised for the purposes of approving products for the New Zealand market.

New Zealand would have no input into the standards or procedures adopted by those overseas au- thorities, and no direct access to their medical and scientific expert- ise.
The scheme would be backed up by enhanced local post-mar- ket surveillance in recognition of the increased potential for New Zealand to receive product that did not match the safety, quality and efficacy standards of that originally evaluated.

The estimated annual budget for Medsafe operating a unilateral recognition scheme covering all therapeutic products is $29.4 mil- lion.
Establishing a joint Australia/New Zealand therapeutic products agency Under this option, New Zealand and Australia would adopt a single comprehensive regulatory scheme for all therapeutic products mar- keted in either country.

The scheme would be administered by a sin- gle trans-Tasman regulatory agency, applying international best prac- tice.

The agency would operate on the basis of full cost recovery with an estimated annual budget of $68 million.
The New Zealand industry’s share of these costs is estimated at $20 million per annum, based on the assumption that 30% of product licence holders will be based in New Zealand.

Ministers agreed in principle to the establishment of a joint trans-Tas- man agency to regulate therapeutic products supplied in Australian and New Zealand markets in December 2000, subject to the devel- opment of governance arrangements satisfactory to New Zealand.
The proposed governance arrangements would ensure an equal voice for each country through a Ministerial Council consisting of the Aus- 94 Therapeutic Products and Medicines Bill Explanatory note tralian Commonwealth and New Zealand Ministers of Health.

A Board, appointed by the Ministerial Council, would be accountable to the Ministerial Council for the strategic and financial direction of the agency.
The Managing Director would be accountable to the Board for financial and administrative matters, and would be the statutory decision maker accountable to stakeholders through an internal ap- peal process as well as external judicial review and merits review mechanisms.

Options for resolving the existing special exemption under the TTMRA The current Special Exemption for therapeutic products will expire on 30 April 2007 and a further 12-month extension will be sought.
The longer-term options are permanent exemption, harmonisation of regulatory requirements, or mutual recognition.

Mutual recognition is not a feasible option because New Zealand does not have a sustainable regulatory capacity, the regulatory frame- works are not matched, and there is not an acceptable level of confi- dence that equivalent regulatory outcomes are achievable under the existing separate schemes.
Creation of a joint regulatory scheme is a specialised form of harmonisation that would achieve the trade ob- jectives of the TTMRA, whereas permanent exemption would main- tain current trade barriers.
Net benefit of the proposal A lack of accurate data about some sectors of the therapeutic products industry, the products they market, and the risks arising from use of those products means that any analysis of the costs and benefits is reliant on a qualitative assessment of whether or not any change from the status quo would be of net benefit to New Zealand society.
This assessment involves making a judgement about— • the additional benefits to consumer health and safety and the value of better information for consumers; and the value to New Zealand of potential additional trade oppor- tunities, and improved trans-Tasman and international rela- tionships.
• Enhancing the regulatory framework with local evaluation to inter- national standards would fail to meet public health and safety ob- Explanatory note Therapeutic Products and Medicines Bill 95 jectives, as it would not be viable in light of the global shortage of appropriate expertise.

It is already very difficult to get the expertise needed to evaluate pharmaceutical products to international stand- ards in a timely fashion, and the situation is expected to get worse over time.
The same problem would occur with high-risk medical devices.

Compliance costs would be high, and existing trade barri- ers would be maintained.

Enhancing the regulatory framework, but adopting a unilateral recog- nition scheme could meet public health and safety objectives and be sustainable over time.
It would, however, result in a loss of New Zealand’s ability to reach independent decisions about therapeutic products supplied in New Zealand or to have any voice in deciding the standards applied in evaluating products.

Because of the need for enhanced post-market activities, compliance costs would be high.

Existing trade barriers would be maintained and could increase if New Zealand was seen to be adopting a third-world approach to ther- apeutic product regulation.
Establishing a joint Australia/New Zealand therapeutic products agency would meet public health and safety objectives, and be sustainable over time.

While there would be a risk that the joint scheme may not always result in decisions that were the best fit for New Zealand, this risk would be managed by ensuring New Zealand had an equal voice and there was no lesser accountability to Gov- ernment, stakeholders and the public than at present.
An opt-out mechanism would ensure that New Zealand would not be forced to adopt a position to which it had a fundamental objection.

The economies of scale and removal of duplication that would result from regulating jointly with Australia would lower overall admin- istrative and compliance costs.
The actual impact on New Zealand would depend on how the costs were shared between the two coun- tries in the longer term, but the overall compliance costs for New Zealand industry would be lower in a joint scheme.

The joint agency option would also meet CER objectives.

The imme- diate impact on trade is likely to be small, given New Zealand’s sig- nificant reliance on imports from across the globe.
An approval from a trans-Tasman regulator with international credibility may make it easier for local manufacturers to break into export markets.

How- ever, compared with the status quo, the added compliance costs for medical devices and complementary medicines would reduce export 96 Therapeutic Products and Medicines Bill Explanatory note competitiveness and local profitability, which could result in some beneficial products not being marketed locally, and some businesses in those sectors closing.
The following table provides a summary assessment of the benefits and costs of the unilateral recognition and joint agency options, com- pared with continuation of the status quo.
Consumers Industry Government Additional compliance cost Unilateral recognition Benefits Meets health objectives through • higher standards • • better post-market surveillance better consumer information for complementary medicines and medical devices Costs Small price increases likely for pharmaceuticals Larger price increases for medical devices and complementary medicines Reduced choice likely A precautionary stance may further reduce choice Overseas regulatory decisions may not always “fit” NZ circumstances Meets health objectives through • higher standards Joint agency Benefits • • better post-market surveillance better consumer information for complementary medicines and medical devices Reduced business compliance costs for pharmaceuticals to partly offset higher fees from full cost recovery Reduced cost and increased efficiency of managing product alert/recalls Reduced trans-Tasman import duties if Tariff amended to exclude complementary medicines Higher regulatory fees for all product groups will reduce profitability and be passed on to consumers Higher costs for local manufacturers would reduce international competitiveness Reliance on other regulators resolves sustainability concerns Some impact on ACC and health budgets $24.5 million Does not contribute to CER objectives Loss of import duties of approx.
$3.5m (a transfer to industry and possibly consumers) As above.
Improves wider CER relationship Overall compliance costs will reduce, particularly for importing pharmaceutical companies Explanatory note Therapeutic Products and Medicines Bill 97 Consumers A possible reduction in pharmaceutical prices Industry Single regime facilitates trans-Tasman trade Import duties reduce if Tariff is amended to exclude complementary medicines Costs: Price increases for medical devices and complementary medicines (but lower than unilateral recognition option), and some reduction in choice Increased compliance costs and reduced competitiveness for complementary medicines and medical devices, but less so than for unilateral recognition option Additional compliance cost $8.3 million Government Lower pharmaceutical costs may increase Health and ACC purchasing power Combined regulatory resources addresses sustainability concerns Stronger trans-Tasman agency may improve international reputation Higher cost of medical devices will have some impact on ACC and health budgets, but smaller than unilateral recognition option Foregone tax revenues from duty removal and firms relocating regulatory affairs to Australia Given the costs of compliance, whether any change from the status quo is seen to be of net benefit to New Zealand depends on judge- ments as to the additional benefits to consumer health and safety, and the value to New Zealand of potential additional trade opportunities and improved trans-Tasman and international relationships.
For medical devices and complementary medicines, this trade-off de- pends on a judgement of the emerging risk profile, whether added regulation in New Zealand can influence this, and how much society values the risk reduction.

No data are available to assess the magni- tude of these factors.
Given the degree of uncertainty, the decision on whether the regula- tory framework needs to be extended involves a qualitative assess- ment about all of the following: • • how well consumers are equipped to deal with the risks: the ability to rectify harm (and the relevance of the precaution- ary principle): the perceived bias of producers to understate risks or regula- tors to over-regulate: how much risk reduction is valued: different notions of liberty and responsibility.
• • With these caveats, the overall conclusion is that, relative to the other regimes considered in this paper, a move to a joint agency has the • 98 Therapeutic Products and Medicines Bill Explanatory note potential to yield a small net benefit to government, industry, con- sumers and other stakeholders in both countries.

Consultation undertaken Medsafe has consulted widely in developing these proposals.
In 2000, Medsafe published a discussion document seeking comment on the proposed form of a joint therapeutic products agency.

This in- formed decisions by Ministers in December 2000.

In further devel- oping its proposals Medsafe has held regular meetings with consulta- tive groups comprising representatives of the key stakeholder groups affected by the proposal, primarily therapeutic products suppliers.
In December 2001 and June 2002, Medsafe distributed further discus- sion documents, seeking feedback on the design and role of the pro- posed agency.

Response to discussion paper released in June 2002 While a large number of responses was received, fewer than 15% were commenting on the proposals set out in the discussion paper.

Government departments, representative bodies, consumer groups and those in the pharmaceutical and medical device industries broadly supported the proposals.
The bulk of the responses came from consumers, health practitioners and industry players from the complementary medicines sector who did not appear to have seen the proposals in the discussion paper but were reacting to some of the misinformation being circulated during the consultation period.

They claimed there was no risk and therefore no need to regulate complementary medicines.
They were fearful of increasing prices and decreasing product choice, and objected to decisions about which products they could access being made by an Australian bureaucrat.

Opinion expressed in submissions on the proposals contained in the discussion paper ranged from strong support for the proposals, to support for some aspects and concern about others, to outright re- jection of any proposal to enter into a joint agency arrangement with Australia.
All sectors of industry rejected the concept of 100% cost recovery, and there was considerable concern about Australian dom- ination and loss of voice for New Zealand, although much of this Explanatory note Therapeutic Products and Medicines Bill 99 concern was based on a misunderstanding of both the current system and the proposed governance and accountability arrangements.
Pharmaceutical sector The pharmaceutical industry generally supported the proposals, al- though there was some concern about loss of expertise within New Zealand.

Most of the comments related to more detailed aspects that would be the subject of further consultation with stakeholders as sub- ordinate legislation is developed.
Medical device sector The medical device industry strongly supported the adoption of the GHTF approach to device regulation and was broadly supportive of the joint agency proposals, provided certain aspects of the detail of the regulatory scheme for medical devices can be satisfactorily re- solved.

those with an interest Complementary medicines sector in the complementary Opinion amongst medicines sector was divided.
Some rejected any proposal to regulate the sector at all, although much of the industry supported regulation of product quality and claims, recognising that while the ingredients were generally very safe, there were risks from poor quality products and outrageous claims, and these were damaging to the industry.

Much of the negative comment centred on the current Australian regulatory scheme, which was seen as draconian, bureaucratic and expensive.
There was considerable concern about the impact of com- pliance costs on small businesses, with claims that hundreds of small distributors would go out of business if the proposed scheme were introduced.

The larger manufacturing companies (about 10 companies that ac- count for around 80% of the total market value) are broadly support- ive of the joint agency concept and the overall approach to regulation.
Most of their concerns relate to the detail of how the scheme would be administered and how the agency’s accountability to the fee-pay- ing industry would be ensured.

100 Therapeutic Products and Medicines Bill Explanatory note There is no accurate record of the number of small manufacturers and importers who account for the remaining 20% of the market, al- though it is estimated there could be more than 200 small businesses involved.
It was claimed that many of the products they distribute would be low value/low volume products that would not be viable in a regulated market.

It is therefore likely that rationalisation of large product ranges or multiple distributors of the same or very similar products would result in some job losses for this group.
The impact on importers and small manufacturers would depend on the size and distribution of fees, and on some aspects of the detail of the regula- tory scheme, such as labelling requirements and interpretation of the Code of Good Manufacturing Practice.
There was support for the concept of a joint regulatory scheme for aspects such as advertising controls, adverse reactions monitoring and scheduling of medicines, but mandatory licensing of export-only products was considered inappropriate as it would not facilitate ex- port or add any value for exporters.
Business compliance cost statement Sources of compliance costs Compliance costs under the joint agency proposal would arise from the following: • for pharmaceutical companies— • increases in regulatory fees for product licences and variations, manufacturing licences, and the introduction of annual product licence fees for all products due to a shift to full cost recovery (offset by a reduction in the total number of licensed products as most products would need only one licence for both New Zealand and Australia): • for complementary medicine and medical device companies— the introduction of regulatory fees for product licensing • (upfront and annual fees), licence variations, approval of new substances for use in complementary medicine, and licensing of manufacturing sites: (for some manufacturers) the cost of upgrading manu- facturing facilities and procedures: • Explanatory note Therapeutic Products and Medicines Bill 101 • • • time required to submit applications to the regulator, and gain an understanding of the new requirements: costs of introducing new labels: delay in getting new product to market (where an ingre- dient is not on the permitted list of substances in low risk products).
• Parties likely to be affected The compliance costs of this proposal will fall directly on— • about 78 pharmaceutical companies and 24 pharmaceutical manufacturing sites with total industry turnover of around $900 million per annum.

Two large manufacturing compan- ies are New Zealand based, and are exporting to Australia.

Almost all of the remainder are multinational companies marketing in both New Zealand and Australia.
Only a small percentage would be expected to maintain separate products licences in the two countries, so that rationalisation of prod- ucts and regulatory activities will result in reduced compliance costs.

Compliance costs will increase for the few companies whose products are only available in New Zealand: about 10 local manufacturers and about 170 importers of med- ical devices.

It is believed that at least one-third of these com- panies distribute products in both Australia and New Zealand.
Compliance costs will, therefore, fall mainly on those im- porters sourcing product from countries other than Australia.
There would be little impact on compliance costs for those manufacturing locally and exporting: manufacturers (about 10 large-to-medium companies, half of whom are believed to be exporting to Australia, plus an un- known number of small manufacturers) and importers of com- plementary medicines (estimated to be 11 major companies and 200 or more small businesses) with local sales of over $100 million per annum.
The larger local manufacturers ac- count for at least three-quarters of the total industry turnover.

The complementary medicines industry comprises a broad range of businesses, from large companies with multi-million dollar turnovers that manufacture, distribute and export a range of products, to one- person businesses importing and distributing 1 or 2 products.
Be- • 102 Therapeutic Products and Medicines Bill Explanatory note cause the industry is so diverse and is not currently regulated in New Zealand, it has not been possible to obtain complete and accurate in- formation about the numbers and types of businesses involved.

Dur- ing research for the cost benefit analysis, it was found that there were no official statistics and no comprehensive and reliable data avail- able from industry organisations.
Information provided by industry members was inconsistent and sometimes contradictory.

Compliance cost spread for complementary medicines sector Without accurate information about the makeup of the industry it is difficult to estimate the impact of compliance costs on different types of businesses with any accuracy.
For companies trading in both countries, the extent to which compli- ance costs will increase will depend on the degree of overlap in prod- uct ranges between the two markets, which is currently unknown.

For these companies, there would be no additional costs associated with licensing manufacturing premises.
For the unknown number of local manufacturers who do not currently meet Good Manufacturing Practice requirements, costs will vary de- pending on the extent to which they need to upgrade their premises in order to obtain a manufacturing licence.

The greatest impact will be on smaller businesses requiring significant upgrading.

Compliance costs should not change significantly for those compan- ies importing product from Australia (estimated to account for 50% of the total value of imports).
For companies importing products from countries other than Australia, the greatest compliance cost im- pact would fall on businesses with a large product range.

The proposed annual product licence fee is intended to cover the costs of post-market activities such as adverse reactions monitoring, product testing, and handling complaints and recalls.
If there were a standard fee per product, the impact would be greatest for those com- panies with large product ranges, and particularly for those that also had a small annual turnover.

Possible mechanisms for managing the impact of compliance costs on small businesses include a fee waiver for low value/low volume products, or charging each company a fee based on a percentage of turnover.
The latter is based on the premise that the costs of post-market activities relating to a company’s prod- Explanatory note Therapeutic Products and Medicines Bill 103 ucts will be proportional to the level of risk exposure and therefore to the volume of product the company has in the marketplace.

Key issues identified in consultation Complementary medicines/dietary supplements are viewed by the in- dustry as very low risk.
A number of stakeholders questioned the need for additional regulation, particularly if the Dietary Supple- ments Regulations 1985 were updated.

Industry members are con- cerned that a number of small suppliers in New Zealand, particularly importers, would be likely to exit the market as a result of the addi- tional costs from the proposed regulation.
This would be primarily a distributional issue, as most ingredients in imported products are likely to be available in locally manufactured products, and where this is not the case, larger firms would introduce substitutes for af- fected product lines where sufficient profits could be made.

How- ever, some low value/low volume products would be likely to be re- moved from the market.

The major source of concern for the other sectors is the magnitude of fees.
The Medical Industry Association of New Zealand (repre- senting the medical device industry) raised concerns that fees may force many small importers out of business and reduce the range of product available in New Zealand.

The Association is also con- cerned that the proposed harmonisation with Australia would cause many international device manufacturers to cancel contracts with New Zealand-based distributors, and rely on their distributors in Aus- tralia to supply product in both countries.
The latter appears unlikely, however, as there is nothing to prevent this happening now.

Overlapping compliance requirements with other agencies Some dietary supplement manufacturers are also covered by regula- tions administered by the Ministry of Agriculture and Forestry cover- ing meat and dairy based products.

However, those controls would not be duplicated by the proposed joint agency controls.
The Environmental Risk Management Authority (ERMA) regulates products incorporating genetically modified organisms.

Medicines and medical devices using genetically modified organisms must gain approval from ERMA and from the regulator of therapeutic products 104 Therapeutic Products and Medicines Bill Explanatory note before being marketed in New Zealand, as each agency is regulating different aspects of product safety.
Steps to minimise compliance costs All options employ a risk-based approach, with pre-market entry re- quirements based on the level of risk.

Under the proposed product licensing scheme, suppliers of low-risk therapeutic products would be able to self-certify that the product met specified requirements, and subject to electronic validation of key requirements such as the licence status of the manufacturer, a product licence would be issued immediately.
In this way, pre-market evaluation of individual prod- ucts and delays in getting the product to market would be avoided for an estimated 95% of complementary medicines and a significant proportion of medical devices.

Mutual recognition agreements can continue under each of the op- tions to reduce duplication.

Under each of the options, the regulator recognises manufacturing licences and audits conducted by overseas regulators in which it has confidence.
Under the joint agency proposal, product or ingredient approvals need to occur only once to cover both the Australian and New Zealand markets.

This reduces duplication, and so reduces the sum of regulatory fees for all (benefiting particularly manufacturers of products that are traded across the Tasman).
Transitional arrangements There will be a period of transition during which firms will be able to learn about the requirements, compile the required information, and adjust their production, labelling and distribution processes.

There would be no application fee for existing complementary medicines and medical devices to get onto an interim product licence register.

They could continue to be sold in New Zealand during the transition period.
Once full compliance with the joint agency’s requirements was achieved, a joint agency product licence would be issued and the product could then be sold in both countries.

Annual licence fees would apply from commencement of the new scheme, but there would be no initial licensing fee for products that are not currently required to be registered.
Explanatory note Therapeutic Products and Medicines Bill 105 Substances used in existing complementary medicines but not cur- rently permitted in low-risk products in Australia would undergo a safety assessment for inclusion in a new joint agency list.

This work would be completed as part of the implementation process for the joint agency, at no cost to industry.
Much of the impact of the new scheme could be managed by— • allowing distributors to place products on the product licence register free of charge (ie, no application fee, although annual licence fees would apply): adopting appropriate transition times to allow licence holders to achieve compliance with any new requirements.
• Distributors of complementary medicines would be required to place their products on an interim register (at no charge), but could continue selling existing products in New Zealand for a transition period of up to five years while full compliance with the new requirements was achieved (such as manufacturers upgrading premises to meet Good Manufacturing Practice requirements).
Similarly, a suitable transi- tion period can be selected to permit label stock to be substantially exhausted before new labels are required.

Establishment of an interim register of medical devices It is proposed to amend the Medicines Regulations 1984 to enable establishment of a register of medical devices as an interim step to- wards GHTF-style device regulation.

There would be no fee for plac- ing devices on the register.
This would facilitate transition to the proposed joint agency regulatory scheme, and is well supported by the medical device industry.

Many medical devices have a relatively short lifespan and will have been superseded by newer products be- fore the transition period expires.
Regulatory impact and compliance cost statement for Parts 6 and 7 Statement of the nature and magnitude of the problem and the need for government action Parts 1 to 5 of this Bill implement a new joint trans-Tasman regu- latory scheme for therapeutic products.
Therapeutic products in- clude prescription and over-the-counter medicines, complementary medicines (currently regulated under the Dietary Supplement Regu- 106 Therapeutic Products and Medicines Bill Explanatory note lations 1985 under the Food Act 1981) and medical devices (ranging from low-risk products such as dressings to high-risk products such as heart valves).
Parts 1 to 5 will house those aspects of therapeutic product regula- tion that are part of the joint regulatory scheme, including pre-mar- ket controls, licensing of manufacturers, and post-market monitoring and surveillance activities.

However, controls on activities relating to medicines in the supply chain in New Zealand will not be part of the joint scheme and will remain as New Zealand-specific provisions.
These include— • storage, and record-keeping requirements for provisions setting out when, how, and by whom medicines can be prescribed, dispensed, or administered: transport, medicines: provisions covering the ownership and licensing of pharma- cies: a licensing regime covering the supply of scheduled medicines by retail and wholesale (but the holder of an approval to manu- facture medicines, issued by the joint agency, will not also re- quire a separate licence to supply those medicines by whole- sale): enforcement provisions for such controls (eg, offences, penal- ties, powers for enforcement officers).
• • • • Currently, both the provisions that will be covered by the joint regu- latory scheme and the New Zealand-specific provisions are housed in the Medicines Act 1981.

Repealing those provisions covered by the new joint regulatory scheme and retaining the New Zealand-specific provisions would result in a Medicines Act that was very piecemeal and difficult to use.
A number of the New Zealand-specific provisions in the Medicines Act 1981 are out of date or will be rendered ineffective when the le- gislation for the joint regulatory scheme is enacted.
These include— problems with the current offences and penalties in the Act • include the following: • the Act uses a general penalty for a range of offences, with no differentiation between more serious and less serious offences: Explanatory note Therapeutic Products and Medicines Bill 107 • • • • • the amounts of penalties in the Act are out of date and not in line with other more modern legislation: some penalties do not cater for offending by a body corporate.
Because such offending is usually on a larger scale than offending by individuals, larger penalties are warranted: the Act does not have a higher offence for offending where it can be proved the conduct was wilful and en- dangered public health: the mechanism to allow an extra penalty for every day the offence continues has not been applied by the courts under the Act and is no longer considered appropriate by the Ministry of Justice.
This is because it is difficult to use this mechanism in practice, and there are other simpler ways of dealing with multiple offending: some offences require the defendant to establish a rea- sonable excuse defence and this is inconsistent with the Bill of Rights Act: licence applicants have a under the Medicines Act 1981, statutory right of appeal to the Medicines Review Committee (section 88) and a subsequent right of appeal to the District Court on questions of law.
The Medicines Review Committee has not been convened to consider a licensing issue for many years, and is no longer thought to be necessary: current regulation-making powers relating to prescribing, dis- pensing and record keeping are not empowering enough to en- able the making of regulations to deal with changes in tech- nology or prescribing practice (for example, to provide for robotic dispensing under prescribed conditions, inclusion of unique patient and prescriber identifiers on prescriptions, elec- tronic storage and transmission of information, or substitution of medicines): regulations 27 and 28 of the Medicines Regulations 1984 relate to infected persons handling medicines.
Regulation 27 prohibits people with communicable diseases (and other conditions) from engaging in, or being employed in, the sale, manufacture, packing, labelling, storage or supply of medicines.

Regulation 28 empowers Medical Officers of • • • 108 Therapeutic Products and Medicines Bill Explanatory note • Health to serve written notices on those who have been in contact with such people and prevent them from engaging or being employed in the same activities.
These controls are unduly restrictive in relation to the risks they were originally intended to manage: the prescribing controls in regulation 39 of the Medicines Regulations 1984 are too restrictive in 3 respects.

Firstly, the regulation restricts dentists to prescribing prescription medicines only for dental treatment.

This means that a dentist cannot prescribe for an associated condition, such as prevent- ing or treating a side effect caused by a medicine used for dental treatment.
The patient must be referred to a medical practitioner for such treatment.

Similarly, registered mid- wives are restricted to prescribing for antenatal, intrapartum and post-natal care.

Secondly, the regulation restricts a den- tist to prescribing for a maximum treatment period of 10 days (5 days and a repeat of 5 days), whereas other existing prescribers may prescribe up to 3 months’ treatment (or 6 months for an oral contraceptive).
These restrictions on den- tist prescribing are no longer appropriate given the changes to the practice of dentistry and the medicines used in den- tal treatment.

Thirdly, the regulation restricts the period of supply of a prescription medicine that can be prescribed by a medical practitioner or registered midwife to 3 months (or 6 months for an oral contraceptive prescribed by a medical practitioner).
This restriction can create a safety risk for New Zealanders travelling for extended periods to places where there is no reliable source of the medicines they require for the treatment of an ongoing condition (eg, army personnel serving overseas for an extended period of time).

Statement of the public policy objective To ensure that New Zealand has high-quality, modern and effi- cient medicines legislation that is seamless across the whole of the medicines regulatory regime.
Explanatory note Therapeutic Products and Medicines Bill 109 Statement of feasible options Status quo The status quo is the repeal of those parts of the Medicines Act 1981 and Medicines Regulations 1984 that will be covered by the joint regulatory scheme, and the retention of the remaining provisions without amendment.
The status quo would see— • retention of the current offences and penalties regime in the Act, with the following features: • a general penalty of imprisonment for a term not ex- ceeding 3 months or a fine not exceeding $500 will apply for a range of offences, with no differentiation be- tween more serious and less serious offences: some penalties do not include offending by a body cor- porate: the Act has no offence for offending where it can be proved the conduct was wilful and endangered public health: the Act has a mechanism to allow an extra penalty for every day an offence continues: some offences require the defendant to establish a rea- sonable excuse defence: • • • • • • • • • retention of the current appeals process on licensing issues under which licence applicants have a statutory right of ap- peal to the Medicines Review Committee (section 88 of the Medicines Act 1981) and a subsequent right of appeal on ques- tions of law to the District Court: retention of the current prescribing, dispensing, and informa- tion-keeping requirements: retention of regulations 27 and 28 prohibiting people with communicable diseases (and other conditions) and those who have been in contact with such people from engaging in medicine-related activities: dentists able to prescribe only 10 days supply of prescription medicines (5 days and a repeat of 5 days): the Medicines Regulations 1984 would restrict dentists to pre- scribing for "dental treatment only" and registered midwives to prescribing for "antenatal, intrapartum and post-natal care: 110 Therapeutic Products and Medicines Bill Explanatory note • prescribers other than dentists able to be prescribe prescription medicines for a maximum of 3 months (or 6 months in the case of an oral contraceptive prescribed by a medical practitioner).
While feasible, the status quo would render parts of the legislation unworkable, and the remaining Medicines Act would be piecemeal, fragmented and out of date.

It would not be responsive to future technological changes.

This option does not address the public policy objective.
Repealing the Medicine Act 1981 and passing new medicines legislation (preferred option) Under this option, the Medicines Act 1981 would be repealed and its New Zealand-specific provisions consolidated, reorganised, and recast in a new Bill.
The opportunity would also be taken to— • overcome problems with the current offences/penalties regime in the Act, including: • providing a specific penalty for each offence (rather than using the same general penalty for many offences): introducing a continuum of penalties proportionate to the seriousness of the offence in the Act.
This will fea- ture a range of penalties from a fine of up to $5 000 for an individual to a fine of up to $40,000 for a body corporate for less serious offending; and a fine of up to $40,000 or up to 12 months imprisonment for an indi- vidual or a fine of up to $100,000 for a body corporate for serious offending: introducing a higher penalty for all body corporate of- fending, set at a fine not exceeding $100,000: introducing a higher-level penalty provision for offend- ing where it can be proved the conduct was wilful and endangered public health.
The penalty, on indictment, for this conduct is to be a fine of up to $100,000 or up to 12 months imprisonment (or both) for an individual and a fine of up to $250,000 for a body corporate: removing the “continuing offence” penalty provisions: changing some offences from strict liability offences to normal offences: and • • • • • Explanatory note Therapeutic Products and Medicines Bill 111 • a design feature of implementing the above changes may result in loss of the ability to obtain a search war- rant for some of the offences in the Act.
A new provi- sion is required to ensure this ability is retained: streamline the appeals process on licensing issues in the Act by providing for a first right of appeal to the Licensing Authority while retaining the existing appeal process to the courts.

The Licensing Authority will be the Director-General of Health (or delegate).

A statutory requirement will be included that the person who hears such appeals cannot have been involved in the original decision that is being appealed.
This process is consistent with other statutory licensing appeal processes (eg, section 114(2) of the Wine Act 2003 provides a mechanism for a person who is dissatisfied with a decision to seek a re- view of that decision by the Director-General or by a person designated by the Director-General who was not involved in making the original decision): amending prescribing, dispensing and record-keeping infor- mation requirements so that regulations can be made to incorp- orate advances in technology, such as requiring the inclusion of unique patient and prescriber identifiers on prescriptions, permitting electronic transmission and storage of information, or allowing robotic dispensing.
Any regulations developed in the future to implement such changes would be subject to con- sultation and regulatory impact assessment: expanding regulation 26 of the Medicines Regulations 1984 so those handling or coming into contact with medicines in the dispensing process will be required to ensure that any open lesions are appropriately covered: revoking regulations 27 and 28 of the Medicines Regulations 1984: revoking regulations 39(3) and 39(6)(b) of the Medicines Regulations 1984 and using the framework in the Health Practitioners Competence Assurance Act 2003 to ensure that dentists and midwives prescribe in accordance with the scopes of practice developed by their registering authorities: removing restrictions on dentists’ prescribing of prescription medicines by revoking regulation 39(4) of the Medicines • • • • • • 112 Therapeutic Products and Medicines Bill Explanatory note • Regulations 1984 so that dentists can prescribe prescription medicines for up to 3 months, consistent with other pre- scribers: allowing medicines to be prescribed for longer than 3 months in special circumstances (eg, to allow army personnel serv- ing overseas to be prescribed more than 3 months supply) by expanding regulation 43 of the Medicines Regulations 1984, which allows the Director-General of Health to waive certain regulatory requirements regarding prescription medicines in special circumstances.
Standard operating procedures devel- oped by the Ministry of Health and approved by the Director- General of Health would define the special circumstances in which the waiver could apply.
Statement of the net benefit of the proposal, including the total regulatory costs (administrative, compliance and economic costs) and benefits (including non-quantifiable benefits) of the proposal, and other feasible options Government Government will have high-quality and modern medicines legis- lation to help ensure medicines are safe and used safely, including facilitating the recording and follow-up of adverse reaction re- ports.
The direction and specific provisions of the current domestic medicines control will be retained, but updated to ensure their con- tinued applicability.

Potential interface issues with the trans-Tasman regulatory scheme will be explicitly dealt with, and all efforts made to ensure a seamless regulatory scheme for medicines and medical devices.
The proposed new offences and penalties regime would alleviate some of the problems with the current Act, including— • providing appropriate deterrent penalties for individuals and bodies corporate; and repealing continuing offence provisions which have not been applied under the Act; and addressing some offence provisions which are inconsistent with the Bill of Rights Act 1990.
• • Explanatory note Therapeutic Products and Medicines Bill 113 Subsidisation under the Pharmaceutical Schedule for prescriptions written by dentists is currently limited to 10 days (5 days and a re- peat).

If PHARMAC was to remove this restriction to bring subsidy rules into line with legal prescribing rights, there should be no in- creased cost to the pharmaceutical budget.
The proposed change to dentist prescribing will mean a shift in who prescribes longer-term treatments, rather than altering the number of patients requiring treat- ment, the medicines prescribed, or the length of the treatment period.

There is potential for cost savings because consumers will only need one prescription to cover the required treatment period, rather than re- peat dispensings or multiple prescriptions.
In addition, patients will not require a consultation with a medical practitioner, resulting in a cost saving where the patient qualifies for a subsidy.

PHARMAC will monitor the impact of dentist prescribing on the pharmaceutical budget in accordance with its operating procedures following any change in the subsidisation rules.

If there is a concern about expend- iture, PHARMAC may still act to re-impose restrictions on access to subsidies.
Dentists and midwives Changing the prescribing restrictions for dentists and midwives will align the regulatory arrangements for dentists and midwives with those for other existing prescribers.

The change should not impact significantly on the dental registering authority, the Dental Council of New Zealand, as they are already well advanced in the process of defining scopes of practice for dentists and dental specialists (eg, orthodontists, dental surgeons).
There is not likely to be a result- ing increase in Dental Council registration fees for dentists.

Using the Health Practitioners Competence Assurance Act 2003 instead of the Medicines Regulations 1984 to regulate prescribing by midwives would not affect the scope of midwifery prescribing and is supported by the Midwifery Council.

Society Redrafting of the medicines legislation will make it less cumbersome and easier to understand.
The result will be a modern, high-quality medicines regulation scheme that operates seamlessly across both the jointly regulated and New Zealand-specific aspects of the scheme.

114 Therapeutic Products and Medicines Bill Explanatory note Consumers will benefit from a reduction in costs arising from changes to the prescribing rules for dentists.
Savings will arise because there will no longer be a requirement for multiple prescrip- tions to cover an extended treatment period, or the need to consult a medical practitioner for treatment of a condition related to dental treatment.

There may be benefits to the health sector overall through a reduction in secondary illnesses or complications as a result of den- tists being able to prescribe prompt and appropriate treatment.
There may also be benefits to consumers of medicines through the pro- posed changes to the offences/penalties regime because this should deter offending under the Act, therefore enhancing consumer safety.

Statement of consultation undertaken Stakeholder consultation In late 2002, Medsafe undertook a targeted consultation with key health professional groups and stakeholders on ways to update or im- prove the parts of the Medicines Act 1981 that would not be covered by the new joint regulatory regime.
A discussion paper was pro- duced after meetings with key sector players, including the councils for the different health professions (eg, the Medical Council, the Den- tal Council).

The paper was also circulated to District Health Boards, universities, and other stakeholders with a direct interest.

This was thought to be appropriate given the limited nature of the change and the fact that the main reforms were as a result of the joint scheme.
The consultation emphasised that the focus was not on radically over- hauling the New Zealand-specific medicines legislation, or making significant policy changes.

There was broad agreement with this approach.

Medsafe also consulted with Medical Officers of Health about proposals affecting them.
The main themes identified by submitters were the need to update the legislation to implement or enable the future implementation of— • • • electronic prescribing; and robotic dispensing; and modernised information and record-keeping requirements al- lowing electronic records; and substitution of medicines.

• The majority of submissions received on the dentist prescribing issues were in support of the proposed changes.
Explanatory note Therapeutic Products and Medicines Bill 115 Government departments/agencies consulted The following government agencies were consulted on the proposal in this paper: the Ministries of Justice, Economic Development, Pa- cific Island Affairs and Consumer Affairs, the Ministry for the Envir- onment, The Treasury, Te Puni Kokiri, the Police, the New Zealand Customs Service, the New Zealand Food Safety Authority, PHAR- MAC, the Office of the Privacy Commissioner, and the Parliamen- tary Counsel Office.
No significant issues were raised.
Hon Annette King Therapeutic Products and Medicines Bill Government Bill Contents Title Commencement Object Part 1 Preliminary, and Rules and Orders Subpart 1—Preliminary provisions Purpose of Parts 1 to 5 Overview of Parts 1 to 5 Interpretation Crown exemption for products specified by Minister Parts 1 to 5 bind the Crown Subpart 2—General provisions about Rules and Orders Rules and Orders have force of law Effect of this subpart and subpart 3 When Rules and Orders come into force Involvement of Finance Minister in making certain Rules Subpart 3—Publication, presentation, and disallowance of Rules and Orders Definition 13 Meaning of Rule and Order in this subpart 103—1 Page 27 27 28 28 28 29 33 34 34 35 35 36 36 1 Therapeutic Products and Medicines Bill Publication of Rules and Orders Publication of Rules, Orders, and compilations on Internet site Correction of Rules, Orders, and compilations on Internet site Status of Rules, Orders, and compilations published on Internet site Hard copies of Rules and Orders No copyright in Rules and Orders Presentation of Rules and Orders Presenting Rules and Orders Presenting explanatory statements Disallowance of Rules and Orders Explanation of sections 22 to 27 Rules and Orders to be disallowed in whole only Notice of motion to disallow Rule or Order How and when Rule or Order disallowed Lapse of notice of motion to disallow Rule or Order Giving notice when Rule or Order disallowed Effect of failure to table in, or disallowance by, Australian
 Parliament Part 2 Enforcement of regulatory scheme Subpart 1—General provisions relating to Part Definitions and jurisdiction Definitions of terms used primarily in subparts 1 to 3 Jurisdiction extended to conduct in Australia General provisions about offences Six-year time limit for bringing summary offences Sentencing guidelines for offences involving harm Strict liability offences Alternative verdicts Notice required to adduce evidence for certain defences Certificates to provide evidence of certain matters
 Proceedings for civil penalties Application for civil penalty Imposition of civil penalty When and how civil penalty proceedings brought Therapeutic Products and Medicines Bill Relationship between civil penalty and criminal proceedings Civil penalty proceedings in New Zealand after proceedings in Australia for civil penalty Criminal proceedings in New Zealand after criminal proceedings in Australia Relationship between concurrent civil penalty proceedings and criminal proceedings One penalty only rule Effect of withdrawal or discontinuation of proceedings on limitation period Restriction on use of evidence given in civil penalty proceedings Abuse of process jurisdiction not affected Liability of executive officers Criminal liability of executive officers Liability of executive officers to civil penalty How to establish whether executive officer took all reasonable steps Notice required to adduce evidence Subpart 2—Regulatory offences and civil penalties Manufacture, import, export, and supply Manufacture without manufacturing licence or correct manufacturing licence Breaching conditions of manufacturing licence Manufacture, import, export, or supply without product licence or correct product licence Breaching conditions of product licence Breaching conditions of special purpose approval or requirements of exemption Import,
 export, or supply of product that does not conform to applicable standards Breaching conditions of authorisation not to conform to applicable standards Breaching conditions of conformity assessment certificate Manufacturer supplying or exporting therapeutic product to which conformity assessment procedures not applied Other persons supplying or exporting products to which conformity assessment procedures not applied 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 50 51 51 52 52 53 53 53 54
 54 55 55 58 60 62 64 66 68 69 70 72 3 Therapeutic Products and Medicines Bill Advertising Purpose Meaning of circumstances Publishing or broadcasting proscribed advertisements Advertisements for which approval required Advertisements containing restricted representations Advertising in breach of direction by Authority Failing to comply with information requirement notice Guidelines for setting penalty levels relating to advertising offences and civil penalties Misrepresentation Dealing with counterfeit products Relief from liability in civil penalty proceedings relating to counterfeit products Setting out false product licence number Falsely representing that product is subject to product licence Claiming to supply when product cannot be lawfully supplied Product tampering Notifying Authority if product subject to actual or proposed tampering False or misleading information in applications and declarations False or misleading statements in applications False or misleading statements in declarations relating to conformity assessment procedures Adverse effect information Product licence holders failing to give adverse effect information Compliance with information requirement notice References to information include references to documents Applicants, holders, and former holders failing to comply with information requirement notice Applicants, holders, and former holders giving false or misleading information Persons exempt from requirement to hold product licence
 failing to comply with information requirement notice Therapeutic Products and Medicines Bill Self-incrimination not ground for refusing to supply information Persons exempt from requirement to hold product licence giving false or misleading information Ex-applicant for product licence failing to comply with information requirement notice Ex-applicant for product licence giving
 false or misleading information Compliance with recovery notice Failing to comply with recovery notice Relief from civil liability for failing to comply with recovery notice Export or supply of therapeutic products subject to recovery notice Information about sponsors Identifying sponsor when required to do so Subpart 3—Non-compliance notices and enforceable undertakings Non-compliance notices Authority may issue non-compliance notice Authority may withdraw non-compliance notice Date by which monetary penalty must be paid Amount and payment of monetary penalty Non-compliance notice is bar to proceedings unless not paid by due date Payment of monetary penalty not admission of guilt or liability Regulations prescribing form of non-compliance notice Enforceable undertakings Giving enforceable undertaking Consequence of breach of enforceable undertaking Subpart 4—Search and seizure Definition of terms used primarily in subparts 4 and 5 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 Authorised officers 99 100 Appointment of authorised officers Issue of identity cards to authorised officers Entry, search, and seizure without warrant 101 Searches for monitoring purposes 94 95 96 97 98 99 100 101 102 103 103 103 104 104 104 106 106 107 108 108 108 5 Therapeutic Products and Medicines Bill Entry and search on serious public health grounds without search warrant Searches at request of manufacturer Search warrants Search warrant to seize evidential material Powers
 under search warrant Conduct of entry, search, and seizure Assistance with searches Authorised officers to show identity card on request Announcement before entry Details of warrant to be given to occupier Occupier entitled to be present during search Use of electronic equipment Copies of documents seized to be provided Receipts for things seized What happens to things seized Return and retention of things seized Order to retain things seized Forfeiture on conviction or imposition of civil penalty Testing and
 analysis of samples Samples for testing or analysis Analysis and testing of samples in accordance with Rules and Orders Evidence of analysis Cost of testing and analysis 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 Offences relating to search and seizure 121 Offences relating to search and seizure Subpart 5—Miscellaneous Information sharing for law enforcement purposes 122 Disclosure of information Customs Right to inspect therapeutic products imported or for export Non-compliant therapeutic products held at customs controlled area Special provisions relating to consignments Relationship with Customs and Excise Act Therapeutic Products and Medicines Bill 127 Therapeutic products protected by Australian patents 122 Patents Part 3 Administrative law matters 128 Definitions of terms used primarily in this Part Subpart 1—Merits review General provisions 129 Purpose and overview Application for review 130 Who may apply for merits review 131 What happens if Rules provide for internal review 132 When Authority not required to give reasons 133 134 No application if review already sought in Australia Application for merits review does not affect decision Review Tribunal 135 Establishment and constitution of Review Tribunal 136 Members of Review Tribunal not personally liable 137 Fees for Review Tribunal members Conduct of
 review Parties to proceedings 138 Procedure of Review Tribunal 139 Decision by majority 140 141 Powers and decisions of Review Tribunal 142 Matters remitted to Authority for reconsideration 143 New information received by Review Tribunal Transfer of review proceedings Transfer of proceedings to Australian Review Tribunal Proceedings transferred from Australian Review Tribunal Effect of decisions Effect of decision by Review Tribunals Appeals and stating case Appeal on question of law Stating case for High
 Court Subpart 2—Judicial review Application of subpart Availability of judicial review Therapeutic Products and Medicines Bill 151 152 153 154 155 156 157 158 159 160 161 Effect of orders made in judicial review proceedings Stay of judicial review proceedings Determination of stay proceedings Subpart 3—Action by Ombudsmen Authority subject to Ombudsmen Act 1975 and to Australian Ombudsman Act Co-operation between Ombudsmen New Zealand Ombudsman transferring complaints to Australian Ombudsman Australian Ombudsman transferring complaints to New Zealand Ombudsman Refusal to deal with complaints investigated by Australian Ombudsman Immunity for Australian Ombudsman and others Other protections for Australian Ombudsman and others Subpart 4—Action by Privacy Commissioners Authority subject to Privacy Act 1993 and to Australian Privacy Act 162 Modification of information privacy principle 11 163 164 Co-operation between Privacy Commissioners New Zealand Privacy Commissioner transferring complaints to Australia Australian Privacy Commissioner transferring complaints to New Zealand Taking no action on complaints dealt with by Australian Privacy Commissioner Immunity for Australian Privacy Commissioner and others Other protections for Australian Privacy Commissioner and others Extended immunity for New Zealand Privacy Commissioner Subpart 5—Information
 management Application of Official Information Act 1982 Application of Privacy Act 1993 Release of therapeutic product information to World Health Organisation Release of therapeutic product information to New Zealand and Australian authorities with therapeutic product functions Therapeutic Products and Medicines Bill 174 175 176 177 178 179 180 181 182 183 184 185 Release of
 therapeutic product information to other national authorities with therapeutic product functions Release of therapeutic product information relating to product tampering and law enforcement Release of therapeutic product information required to be provided Release of therapeutic product information in accordance with international co-operative arrangements Release of therapeutic product information to public Protection against action if lawfully making information available Protected active ingredient information Purpose of sections 181 to 184 Definition of protected active ingredient information Periods when protected active ingredient information may not normally be disclosed Limited circumstances in which protected active ingredient information may be disclosed Continuation of protections under Medicines Act 1981 Use of information by Authority Protection against action for use by Authority of information 186 Management of Authority’s records Archives Part 4 Governance and accountability Definitions of terms used primarily in this Part 187 Subpart 1—Ministerial Council, Board, and Board members Ministerial Council 188 Overview of Ministerial Council General provisions relating to Board 189 190 191 192 193 Overview of Board Parliament’s expectations of Board Restrictions on Minister’s discretion to appoint Vacancies in membership of Board and flaws in appointment Effect of flaws in Board processes 145 146 146 147 147 148 148 148 149 149 150 150 151 151 152 153
 153 153 154 154 9 Therapeutic Products and Medicines Bill 194 Overview of Managing Director Managing Director Subpart 2—General matters relating to Authority 195 Overview of Authority Providing information Authority to provide information to Minister Authority to comply with request for information from Finance Minister Authority to comply with request for information by Secretary to the Treasury Compliance with directions Authority to comply with directions of Ministerial Council Review of operations Review
 of operations and performance Employees and others Employees and others not to disclose Authority information Employees not to misuse position Immunities, indemnities, and insurance Application of sections 204 to 207 General protection from liability Immunities Indemnities Insurance Immunity for Authority Application of Health and Safety in Employment Act 1992 Miscellaneous matters Seal of Authority Signature of Managing Director Subpart 3—Financial and associated matters Restriction on borrowing, etc Restriction on giving guarantees and indemnities Restriction on use of derivative transactions Banking Restriction on acquiring securities Restriction on Authority’s involvement in other entities Therapeutic Products and Medicines Bill 218 219 220 221 222 223 Subsidiaries not to do what Authority cannot or must not do Aligning accounting periods of subsidiaries Banking and accounting for trust money Investment of trust money Exemption of Authority from income tax Authority’s input tax under Goods and Services Tax Act 1985 224 Overview Subpart 4—Reporting Overview Statement of intent 225 226 227 228 229 230 231 Obligation to prepare statement of intent Board to ensure Authority complies with statement of intent Direction by Ministerial Council to amend statement of intent Amendments
 to statement of intent Statement of intent to be presented to House of Representatives and be published Annual report Obligation to prepare annual report Annual report to be presented to House of Representatives and be published Audit 232 Auditor-General is auditor of Authority 233 Obligation to keep accounting records Keeping accounting records 234 235 Offence of failing to keep accounting records Offences relating to reporting Offences Subpart 5—Board members and other senior officers Board member
 conflict of interest 236 What Board member must do if interested in matter 237 238 239 How disclosures of interest are made Permission to act despite being interested in matter Consequences of failing to comply with section 236 165 166 166 167 167 167 167 168 169 169 170 170 170 171 172 172 172 173 173 174 175 175 11 Therapeutic Products and Medicines Bill 240 241 242 243 244 245 246 247 248 Authority may avoid some acts done in breach of conflict of interest rules Duties of senior officers Duties apply regardless of where senior officer located Duty to act with honesty and integrity Duty to comply with Acts and Rules Duty of care, diligence, and skill Duties of good faith, etc Duty not to misuse information Criminal consequences of failing to comply with duties Offences relating to failure to comply with certain duties Requirement to provide information in connection with criminal proceedings Civil consequences of failing to comply with duties Application for civil penalty Imposition of civil penalty 249 250 251 When and how civil penalty proceedings brought 252 253 Authority involvement in proceedings Relief from liability in civil penalty proceedings under section 249 Requirement to provide information in connection with civil penalty proceedings Disqualification for breach of duty Disqualification for breach of duty Application to quash or amend disqualification order Effect of disqualification under Australian Act Compensation orders Compensation order 258 259
 When application for compensation order may be made Civil liability of others involved Others involved in breach of certain senior officer duties 260 Defence in criminal or civil penalty proceedings 261 Defence to rely on information and advice 262 Relief from civil liability General relief from civil liability 12 254 255 256 257 175 176 176 177 177 177 178 178 179 180 180 180 181 181 181 182 183 183 184 184 185 185 186 Therapeutic Products and Medicines Bill Restriction on use of evidence 263 Restriction
 on use of evidence given in proceedings for civil penalty Relationship between criminal and civil penalty proceedings Civil penalty proceedings in New Zealand after proceedings in Australia for pecuniary penalty Criminal proceedings in New Zealand after criminal proceedings in Australia Relationship between concurrent civil penalty proceedings and criminal proceedings Effect of withdrawal or discontinuation of proceedings on limitation period Abuse of process jurisdiction not affected Part 5 Regulations, and transitional and miscellaneous provisions Subpart 1—Regulations Regulations providing for departures from the Scheme Regulations for fees and charges for non-Scheme work Transitional and savings regulations General regulation-making power Subpart 2—Transitional provisions relating to Scheme Preliminary Outline of transitional regime Definitions of terms used in this subpart Saving and application of former Act and former regulations Prescribed fees and charges Medicines: transitional approvals Deemed grant of transitional approval Duration of transitional approval Related products: transitional approvals Deemed grant of transitional approval Duration of transitional approval Medicines and related products: material changes Determination of pending notices for medicines and related products Therapeutic Products
196 196 197 197 198 198 13 Therapeutic Products and Medicines Bill 282 283 284 285 286 287 288 Grant of transitional approval Duration of transitional approval Medicines and related products: pending applications Kinds of pending applications covered by sections 285 to 288 Pending applications on which evaluation work started by start date Pending applications on which no evaluation work done by start date Pending applications that lapse Protection of confidential supporting information Medicines: existing exemptions under former Act Authorised
 prescribers 289 290 Medicine required by medical practitioner Medicines: clinical trials approved under former Act Clinical trials covered by sections 292 to 294 Deemed grant of transitional approval Duration of transitional approval Request to modify clinical trial Medicines: pending application for approval of clinical trial Determination of pending application for approval of clinical trial Grant of transitional approval Duration of transitional approval Medicines: transitional approvals for existing licences Kinds of existing licences covered by sections 299 and 300 Deemed grant of transitional approval Duration of transitional approval Medicines: pending applications for licences Kinds of pending applications covered by sections 302 to 304 Determination of pending applications Grant of transitional approval Duration of transitional approval Medical devices: transitional approval Deemed grant of transitional approval Duration of transitional approval Therapeutic Products and Medicines Bill Declaration of lawful supply Information to be supplied by sponsor 307 308 309 Medical devices subject to existing approvals, etc 310 Medical device required by medical practitioner Medical devices: exemptions 311 312 313 314 315 316 317 318 319 320 Dietary supplements: transitional approvals Deemed grant of
 transitional approval Duration of transitional approval Declaration of lawful supply Information to be supplied by sponsor Dietary supplements subject to existing approvals, etc Newly designated therapeutic products: transitional approvals Deemed grant transitional approval Duration of transitional approval Declaration of lawful supply Information to be supplied by sponsor Notices Notice issued under section 36 of former Act before start date 321 Advertising Advertising Appeals 322 When section 323 applies
 323 Appeals of decisions under former Act Offences Offences and breaches of former Act Sections 50 to 76 do not apply to holders of transitional approvals Proceedings Barred proceedings Pending proceedings Subpart 3—Transitional provisions relating to employees Transfer of Medsafe employees to Authority Transfer does not break continuity of employment No compensation for technical redundancy Therapeutic Products and Medicines Bill Protection of status as contributor to Government Superannuation Fund Subpart 4—Transitional provisions relating to assets Purpose of sections 333 and 334 Health Sector (Transfers) Act 1993 amended Agreement of Ministerial Council required for transfers Subpart 5—Miscellaneous provisions Consequential amendments relating to establishment of Authority Other consequential amendments Part 6 General provisions Purpose Outline Interpretation Application and administration Application Parts 6 and 7 to bind the Crown Employees and employers Part 7 Substantive provisions relating to medicines Subpart 1—Controlled activities 343 Outline of this subpart Supplying scheduled medicines by wholesale Supplying scheduled medicines by wholesale: controlled activity Regulations may authorise supplying scheduled medicines by wholesale Licence may authorise supplying scheduled
 medicines by wholesale as fixed vendor or mobile vendor Supplying scheduled medicines other than by wholesale Supplying scheduled medicines other than by wholesale: controlled activity Prescriber may supply scheduled medicines other than by wholesale in limited circumstances Pharmacist may supply scheduled medicines other than by wholesale in limited circumstances Therapeutic
235 350 351 352 353 354 355 356 357 Therapeutic Products and Medicines Bill Veterinarian may supply scheduled medicines other than by wholesale in limited circumstances Employee working with prescriber may supply scheduled medicines other than by wholesale in limited circumstances Employee working with pharmacist may supply scheduled medicines other than by wholesale in limited circumstances Employee working with veterinarian may supply scheduled medicines other than by wholesale in limited circumstances Deemed licence may authorise supply of scheduled medicines other than by wholesale in limited circumstances Licence may authorise supply of pharmacy medicines other than by wholesale in limited circumstances Regulations or standing order may authorise supply of scheduled medicines other than by wholesale Supply of scheduled medicines to medicines control officer not supply other than by wholesale Standing orders for supply of scheduled medicines other than by wholesale 358 Standing orders for supply of scheduled medicines 359 Supplying medicines by auction: controlled activity Supplying medicines by auction 360 361 362 363 364 365 366 Supplying medicines by vending machine Supplying scheduled medicines by vending machine: controlled activity Dispensing medicines Dispensing medicines: controlled activity Prescriber may dispense medicines in limited circumstances Pharmacist may dispense medicines in course of pharmacy practice Certain other persons associated with pharmacies may dispense medicines in limited
 circumstances Veterinarian may dispense medicines in limited circumstances Employee working with veterinarian may dispense medicines in limited circumstances 235 236 236 237 237 238 238 238 239 239 240 240 240 241 241 241 241 17 Therapeutic Products and Medicines Bill 367 368 369 370 371 372 Regulations may authorise dispensing of medicines Licence may authorise dispensing medicines by automated dispensing machine Prescribing prescription medicines Prescribing prescription medicines: controlled activity
 Authorised prescriber may prescribe prescription medicines in limited circumstances Designated prescriber may prescribe prescription medicines in limited circumstances Veterinarian may prescribe prescription medicines in limited circumstances Prescribing notices Prescribing authorities to issue prescribing notice Review of prescribing notice Prescribing authority to make list available 373 374 375 376 Minister’s powers in relation to prescribing authority’s obligations under sections 373 to 375 Administering prescription medicines Administering prescription medicines: controlled activity Prescriber may administer prescription medicines in limited circumstances Veterinarian may administer prescription medicines in limited circumstances Person may administer prescription medicines in limited circumstances Standing orders authorising administering certain medicines Standing orders authorising administering of prescription and pharmacist-only medicines Possessing prescription medicines Possessing prescription medicines: controlled activity Reasonable excuse for possessing prescription medicines Operating pharmacy Operating pharmacy: controlled activity Subpart 2—Instruments prohibiting and restricting activities with medicines Outline of this subpart Effect of certain instruments issued under this subpart Therapeutic Products and Medicines Bill
250 250 Therapeutic Products and Medicines Bill Minister may prohibit certain activities 387 Minister may prohibit specific persons prescribing and 250 exercising authority 388 Minister must have health authority or Veterinary Council 251 recommendation to prohibit in certain circumstances Restriction notice 389 Medical Officer of Health may restrict prescribing and supplying to individual by restriction notice Prescribing or supplying in contravention of restriction notice Restricted individual procuring or attempting to procure in contravention of
 restriction notice Review or appeal of restriction notice 390 391 392 Statement relating to dependency 393 Statement relating to dependency 394 Outline of this subpart Subpart 3—Licences Applying for licence 395 Who may apply 396 Form of application 397 398 399 400 Contents of application Application must set out medicines to which it relates Application must contain sufficient information Granting of licence Granting of licence Additional matter when granting licence to supply pharmacy medicines other than by wholesale 401 Refusal of licence Refusal of licence 402 403 404 Authority conferred on licence holder by licence Licence to supply scheduled medicines by wholesale as fixed vendor Licence to supply scheduled medicines by wholesale as mobile vendor Licence to supply pharmacy medicines other than by wholesale 252 253 253 253 254 255 255 255 256 256 257 258 259 259 259 260 19 Therapeutic Products and Medicines Bill 405 406 407 408 409 410 411 412 413 414 415 416 Licence to dispense medicines by using automated dispensing machine Licence to operate pharmacy Conditions of licence Conditions of licence Reasons for imposing conditions on licence Complying with conditions on licence Suspending, cancelling, and disqualifying holding of licence Effect of false or misleading statement made in application for licence Reasons for cancelling licence Effect of charge or conviction on licence Producing licence to court Duration of licence Duration of licence Superseding
 licence Surrendering licence on ceasing controlled activity Register of licences and records of licensing authority 417 Register of licences and records of licensing authority Subpart 4—Operating pharmacies Outline of this subpart 418 419 Meaning of holds an interest in pharmacy Additional information for pharmacy licence Additional matters to be satisfied for pharmacy licence Additional information required for pharmacy licence Companies Restrictions on companies being granted pharmacy licence 420 421 422 423
 Licence and majority interest restrictions for persons Majority interest in pharmacy 424 Exception for mortgagees in possession Mortgagees in possession Mandatory condition on pharmacy licence 425 Mandatory condition on pharmacy licence 426 Failure to comply with conditions on pharmacy licence 260 260 260 261 261 262 262 262 263 263 264 264 265 265 265 266 267 267 269 270 270 271 20 Therapeutic Products and Medicines Bill 427 428 429 Restrictions on operating and holding interests in pharmacies Prescriber restricted from holding interest in pharmacy Prohibition on operating or holding of majority interest in more than 5 pharmacies Fee on prescriptions Offence for persons associated with pharmacies to take fee on prescriptions Subpart 5—Certain requirements, restrictions, and offences associated with medicines 430 Outline of this subpart Security, storage, and premises Security of medicines in pharmacy Storage of scheduled medicine in person’s possession or charge Storage of scheduled medicine in unattended building or vehicle Powers of Medical Officer of Health in respect of premises Containers and packages Containers and packages when supplying and transporting medicine Container for medicine in person’s possession or charge 431 432 433 434 435 436 Packing and preparing medicines 437 Packing and preparing medicines for use Delivering medicines 438 Delivering medicines 439 Disposal of medicines Disposal of medicines Record keeping 440 441 Records relating to
 supplying medicine Providing information about records for supplying medicine 442 Offence to knowingly risk public health Knowingly risking public health Subpart 6—Enforcement and certain procedural matters Outline of this subpart 443 271 272 272 273 273 274 274 275 276 277 277 278 279 279 280 280 281 21 Therapeutic Products and Medicines Bill 444 Interpretation Medicines control officers 445 Medicines control officers Identification cards 446 Powers of entry, search, and seizure Powers of entry to inspect
 compliance Entry on serious risk to public health ground Search warrant Issue of search warrants Powers of entry with search warrant Matters associated with search Occupier entitled to be present during search Use of electronic equipment Copies of documents seized to be provided What happens to seized property Disposal of property seized Order to retain seized property Analysis of samples Analysis of sample Analysis of samples and certificate of analyst Evidence of analysis Cost of analysis 447 448 449 450 451 452 453 454 455 456 457 458 459 460 Offence of wilfully obstructing Wilfully obstructing False or misleading statement, declaration, or answer 461 False or misleading statement, declaration, or answer Powers of Director-General and Medical Officer of Health Director-General or Medical Officer of Health may require documents or records Offence not to comply with requirement in section 462 462 463 464 Disclosure of information Disclosure of information Matters relating to proceedings 465 Matters relating to information and summons 466 Service of documents 22 281 282 282 283 284 285 285 287 287 288 288 289 290 290 291 291 292 293 293 294 294 295 296 Therapeutic Products and Medicines Bill 467 468 469 470 471 472 473 474 475 Contents of container presumed in proceedings Certificate signed by licensing authority Copies of documents or records in proceedings Matters arising from conviction Forfeiture on conviction Notifying health authority or Veterinary Council of
 conviction Matters effecting liability Strict liability Liability of employer for act of employees Liability of executive officers for acts of body corporate Protection of persons acting in performance of functions under Parts 6 and 7 476 Outline of this subpart Subpart 7—Appeals Appeals against decision of Medical Officer of Health in respect of premises 477 Appeal against decision in respect of premises Licensing appeals Appeal against decision of licensing authority Status of decision of licensing
 authority pending appeal Proceedings before District Court Appeal to High Court on question of law Status of decision of District Court pending appeal Procedure for appeal No person may be deprived of right to appeal Licensing authority to implement decision of Court Subpart 8—Restrictions on xenotransplantation Outline of subpart Interpretation Restriction on xenotransplantation Authorisation for particular xenotransplantation given by Minister Authorisation given for xenotransplantation by Order in Council Criteria for authority Advice on applicability of criteria Applications No compensation Therapeutic Products and Medicines Bill 495 496 497 498 Enforcement powers Director-General or Medical Officer of Health may require information relating to xenotransplantation Offence not to comply with requirement to produce under section 496 Expiry of subpart Subpart 9—Regulations, Orders in Council, Ministerial notices, and other instruments Regulations 499 Regulations 500 501 502 503 504 Regulations designating designated prescribers Regulations designating health practitioners as designated prescribers Regulations relating to prescribing notices Regulations relating to prescribing notices and prescription medicines that designated prescribers may prescribe Regulations designating authorised
 prescribers Regulations designating health practitioners as authorised prescribers Regulations relating to qualifications, training, and competence of prescribers and veterinarians when prescribing Regulations relating to qualifications, training, and competence of prescribers and veterinarians when prescribing Regulations relating to pharmacy ownership and operation Orders in Council providing for exemption from, or modifications of, restrictions on pharmacy ownership and operation Approval and appointments
 relating to laboratories and analysts 505 Minister may approve laboratory 506 Minister may appoint analyst in charge Analyst in charge may authorise analyst 507 Appointment of advisory and technical committees 508 Advisory and technical committees 308 308 309 309 310 319 320 320 321 323 323 324 324 324 24 Therapeutic Products and Medicines Bill Certain powers of Director-General 509 510 Statement of Director-General Director-General may authorise Medical Officer of Health to issue notices and statements 325 325 Subpart 10—Scheduled medicines and referring to medicines Scheduled medicines 511 Standard for Uniform Scheduling of Medicines and Poisons or SUSMP Scheduled medicines 512 513 Ministerial notice declaring scheduled medicine 514 Ministerial notice departing from managing director’s listing Director-General to keep Internet register of declarations and departures Evidence of SUSMP 515 516 517 How to refer to or specify medicines Referring to medicines Subpart 11—Miscellaneous matters Relationship to other enactments Relationship with Misuse of Drugs Act 1975 Transitional regime for designated prescribers Designated prescriber under former Act deemed to be designated prescriber 518 519 Transitional regime for standing orders 520 Standing orders issued under former Act 521 522 523 524 525 Transitional regime for licences Application for licence to sell medicines by wholesale under former Act Licence to sell any medicine by wholesale granted under former Act
 Application for licence to sell any medicine by retail under former Act Licence to sell medicines by retail granted under former Act Application for licence to hawk medicines under former regulations 325 326 326 327 327 327 328 328 329 330 330 331 331 332 332 25 Therapeutic Products and Medicines Bill 526 527 528 529 530 531 532 533 534 Licence to hawk medicines granted under former regulations Application for licence to operate pharmacy under former Act Licence to operate pharmacy granted under former Act
 Other licences granted under former Act Condition on deemed licence Transitional regime for proceedings and appeals under former Act Proceedings commenced under former Act Appeal from decision under former Act Transitional regime for officers under former Act Officers appointed under former Act No compensation for loss of office or appointment Transitional regime for xenotransplantation 535 Xenotransplantation 536 537 538 539 540 Transitional regime for approved laboratory and analyst under former Act Approved laboratory under former Act Analyst in charge under former Act Repeal Repeal Transitional and savings regulations Expiry of section 539 Revocations 541 Revocations 542 Savings Validity of actions under former Act and regulations not affected 543 Medicines (Approved Laboratories and Analysts in Charge) Notice 2000 saved 544 Medicines (Standing Order) Regulations 2002 saved 545 Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 saved 546 Medicines (Designated Prescriber: Optometrists) Regulations 2005 saved Orders in Council made under section 96D(1) of former Act saved 547 26 333 333 334 334 334 335 335 335 336 336 336 336 336 336 337 337 337 337 338 338 338 338 Therapeutic Products and Medicines Bill cl 2 548 Consequential amendments Consequential amendments Schedule 1 Text of Agreement Schedule 2 Provisions applying to Review Tribunal Schedule 3 Consequential amendments relating to establishment of Authority Schedule 4 Powers of Minister
 in relation to prescribing authorities’ obligations Schedule 5 Powers of health authority or Veterinary Council when making inquiries Schedule 6 Review or appeal of restriction notice Schedule 7 Regulations and orders revoked Schedule 8 Consequential amendments to enactments 338 339 373 378 379 383 386 387 388 The Parliament of New Zealand enacts as follows: 1 2 (1) (2) Title This Act is the Therapeutic Products and Medicines Act 2006.
Commencement Parts 1 to 5 (which relate to therapeutic products) come 5 into force on a date to be appointed by the Governor-General by Order in Council; and 1 or more Orders in Council may be made bringing different provisions into force on different dates.
Parts 6 and 7 (which relate to medicines) come into force 10 on a date to be appointed by the Governor-General by Order 27 cl 3 Therapeutic Products and Medicines Bill in Council; and 1 or more Orders in Council may be made bringing different provisions into force on different dates.
Object The object of this Act is— (a) to give effect, by way of a Therapeutic Products Act, 5 to the Agreement between the Government of Australia and the Government of New Zealand for the Establish- ment of a Joint Scheme for the Regulation of Therapeu- tic Products, done at Wellington on 10 December 2003; and to consequentially repeal the Medicines Act 1981 and replace it with a new Medicines Act 2006.
10 (b) Part 1 Preliminary, and Rules and Orders Subpart 1—Preliminary provisions 15 Purpose of Parts 1 to 5 The purpose of Parts 1 to 5 is to give effect to the Agreement and, in particular, to the Parties’ primary objective in conclud- ing the Agreement, which is to safeguard public health and safety in Australia and New Zealand by establishing and main- 20 taining a joint scheme consistent with international best prac- tice for the regulation of— (a) the quality, safety, and efficacy or performance of ther- apeutic products; and the manufacture, supply, import, export, and promotion 25 of therapeutic products.
(b) Overview of Parts 1 to 5 The manufacture, supply, import, export, and promotion of therapeutic products is primarily regulated by the Authority under the joint scheme established by the Agreement, the text 30 of which is set out in Schedule 1.

The Agreement provides for the Authority to be established under Australian law and for it to be overseen by a Ministerial Council comprising the New Zealand Minister and the Aus- tralian Minister.
35 3 4 5 (1) (2) 28 (3) (4) (5) (6) 6 (1) Therapeutic Products and Medicines Bill Part 1 cl 6 The details of the Scheme are set out in Rules (made by the Ministerial Council) and Orders (made by the Authority).
Rules and Orders— (a) are enforced in New Zealand under Parts 1 to 5 (and are enforced in Australia under the Australian Act); and have the force of law in New Zealand as if they were regulations; and are capable of disallowance by the House of Represen- tatives and also by either House of the Parliament of Australia.

(b) (c) The supply of medicines to consumers in New Zealand is pri- marily regulated through the Medicines Act 2006.

This section is by way of explanation only.


If any provision of Parts 1 to 5, the Agreement, or any Rule or Order, conflicts with this section, the other provision prevails.
Interpretation In Parts 1 to 5, unless the context otherwise requires,— Agreement— (a) means the Agreement between the Government of Aus- 5 10 15 tralia and the Government of New Zealand for the Es- 20 tablishment of a Joint Scheme for the Regulation of Therapeutic Products, done at Wellington on 10 Decem- ber 2003, a copy of the text of which is set out in Sched- ule 1; and includes that Agreement as amended from time to time 25 (b) applicable standard has the meaning given in section 28 approval has the meaning given by Article 1 of the Agreement approved bank has the meaning given in section 187 Australia, when used in a geographical sense, includes— (a) (b) (c) Australian Act means the Therapeutic Products Act 2006 (Aust) Australian Finance Minister means the Minister of the Gov- 35 ernment of Australia who is responsible for administering the Commonwealth Authorities and Companies Act 1997 (Aust) Norfolk Island; and the Territory of Christmas Island; and the Territory of Cocos (Keeling) Islands 30 29 Part 1 cl 6 Therapeutic Products and Medicines Bill 10 Australian Minister has the meaning given by Article 1 of the Agreement Australian Ombudsman has the meaning given in section 128 Australian Ombudsman Act has the meaning given in sec- 5 tion 128 Australian Privacy Act has the meaning given in section 128 Australian Privacy Commissioner has the meaning given in section 128 Australian Review Tribunal has the meaning given in sec- tion 128 authorised officer has the meaning given in section 98 Authority
 means the agency established by the Australian Act in accordance with Article 5 of the Agreement as the Australia 15 New Zealand Therapeutic Products Authority Board has the meaning given by Article 1 of the Agreement Board member means a member of the Board appointed by the Ministerial Council under paragraph 2 of Article 6 of the Agreement; and includes any acting Board member appointed 20 in accordance with the Rules civil penalty provision means a provision under which a per- son may be liable to a civil
 penalty compilation, in relation to a Rule or Order, means the text of the Rule or Order as amended by amendments that are in force 25 at the date specified as the date of compilation condition, in relation to an approval or other authorisation given by the Authority, has the meaning given in section 28 contravention of a civil penalty provision means doing something, or not doing something, that makes a person liable 30 to a civil penalty under a civil penalty provision Deputy Australian Ombudsman has the meaning given in section 128 document has the meaning given in section 98 dwelling house has the meaning given in section 98 evidential material has the meaning given in section 98 executive officer has the meaning given in section 28 35 30 Therapeutic Products and Medicines Bill Part 1 cl 6 15 expert advisory committee means a committee established in accordance with a Rule made under subparagraph (kk) of paragraph 1 of Article 9 of the Agreement export means to export from New Zealand or from Australia Finance Minister means the Minister of the Crown who, 5 under the authority of any warrant or with the authority of the Prime Minister, is for the time being responsible for adminis- tering the Public Finance Act 1989 financial year has the meaning given in section 187 forecast financial statements has the meaning given in sec- 10 tion 187 generally accepted accounting practice has the meaning given in section 187 import means to import into New Zealand or into Australia label has the meaning given in section 28 Managing Director has the meaning given by Article 1 of the Agreement manufacture has the meaning given by Article 1 of the Agree- ment, but means specifically to manufacture in New Zealand or Australia manufacturing licence has the meaning given in section 28 Medsafe means the business unit of the Ministry of Health that is known as Medsafe merits review has the meaning given by Article 1 of the Agreement Merits Review Panel has the meaning given in
 section 128 Minister means the Minister of the Crown who, under the au- thority of any warrant or with the authority of the Prime Min- ister, is for the time being responsible for the Health portfolio (referred to in the Agreement as the “New Zealand Minister”) 30 Ministerial Council has the meaning given by Article 1 of the Agreement New Zealand Ombudsman has the meaning given in sec- tion 128 New Zealand Privacy Commissioner has the meaning given 35 in section 128 non-compliance notice has the meaning given in section 28 20 25 31 Part 1 cl 6 Therapeutic Products and Medicines Bill 10 occupier has the meaning given in section 98 Order has the meaning given by Article 1 of the Agreement, and includes a provision of an Order, except as provided in section 13 Parties, when referring to the Parties to the Agreement, means 5 the Government of New Zealand and the Government of Aus- tralia penalty unit means the amount of $110 place has the meaning given in section 98 principal member has the meaning given in section 128 product licence has the meaning given in section 28 Review Tribunal means the New Zealand therapeutic prod- ucts Review Tribunal established by section 135 in accord- ance with Article 13 reviewable decision has the meaning given in section 128 Rule has the meaning given by Article 1 of the Agreement, and includes a provision of a Rule, except as provided in section 13 seize has the meaning given in section 98 Scheme has the meaning given by Article 1 of
 the Agreement 20 senior manager has the meaning given in section 187 senior officer has the meaning given in section 187 special purpose approval has the meaning given in section 28 sponsor, in relation to a therapeutic product,— (a) means— (i) 25 15 (ii) (iii) a person who imports, or arranges the import of, the product; or a person who exports, or arranges the export of, the product; or a person who, in New Zealand or Australia, manufactures the product, or arranges for an- other person to manufacture the
 product, for supply (whether in New Zealand, Australia, or elsewhere); but 30 35 (b) does not include the following: 32 Therapeutic Products and Medicines Bill Part 1 cl 7 (i) (ii) a person who imports, exports, or manufactures the therapeutic product on behalf of another per- son who, at the time of the import, export, or manufacture, is a resident of, or is carrying on business in, New Zealand or Australia: a person who arranges the import, export, or manufacture of the therapeutic product on behalf of another person who, at the time of the arrange- ments, is a resident of, or is carrying on business in, New Zealand or Australia.
5 10 subject to actual or proposed tampering has the meaning given in section 28 subsidiary has the meaning given in section 187 supply has the meaning given by Article 1 of the Agreement, but means specifically to supply for use in New Zealand or use 15 in Australia therapeutic product has the meaning given by Article 1 of the Agreement therapeutic product information has the meaning given in section 128 thing has the meaning given in section 98.
20 (2) A reference to an Australian enactment that is repealed is a ref- erence to any Australian enactment that, with or without modi- fication, replaces or corresponds to the repealed enactment.

Terms that relate only to the transitional provisions in Part 5 25 are not defined in this section.

They are defined in section 274 instead.


(3) 7 (1) Crown exemption for products specified by Minister The Minister may specify that a therapeutic product (product A) is subject to a Crown exemption if— (a) the Minister is satisfied that the product is identical in every material respect to another therapeutic product (product B); and product B is the subject of a product licence that author- ises its import into, and supply within, New Zealand.
(b) 30 35 (2) If product A is subject to a Crown exemption,— 33 Part 1 cl 8 Therapeutic Products and Medicines Bill (a) Parts 1 to 5 apply as if product A were subject to a product licence that— (i) authorises its import into, and supply within, New Zealand (but not into or within Australia), but does not authorise its manufacture in, or ex- 5 port from, either New Zealand or Australia; and is in all other respects identical to the product licence applying to product B; and (ii) (b) the Minister is to be treated for the purposes of Parts 1 to 5 as if he or she were the holder of a product licence, 10 as described in paragraph (a), for product A.
The Minister may not specify that a product is subject to a Crown exemption unless he or she has first consulted with the Australian Minister.

(3) (5) (4) A product becomes subject to a Crown exemption on the date 15 specified, by notice in the Gazette, as the date on which the Crown exemption applies.

The Minister must ensure that any product that is subject to a Crown exemption and that is supplied in New Zealand bears a label that clearly indicates that the product is subject to a 20 Crown exemption.
This section applies despite anything in Parts 1 to 5, the Agreement, or the Rules or Orders.

(6) 8 Parts 1 to 5 bind the Crown Parts 1 to 5, and the Rules and Orders, bind the Crown.

25 Subpart 2—General provisions about Rules and Orders 9 (1) Rules and Orders have force of law Rules and Orders have the force of law as if they were regula- tions made under an Act.
30 (2) However, by way of explanation,— (a) (b) Rules and Orders are not enactments, as that term is defined in section 29 of the Interpretation Act 1999, and therefore that Act does not apply to them; and Rules and Orders are not regulations, as that term is 35 defined in section 2 of the Regulations (Disallowance) 34 Therapeutic Products and Medicines Bill Part 1 cl 11 Act 1989, and therefore that Act (and other Acts that rely on that definition, such as the Acts and Regulations Publication Act 1989) does not apply to them.
10 Effect of this subpart and subpart 3 The effect of this subpart and subpart 3, and the equivalent 5 provisions of the Australian Act, is that Rules and Orders can- not be in force as part of the law of New Zealand without also being in force as part of the law of Australia, and vice versa.
11 When Rules and Orders come into force (1) In accordance with paragraph 5 of Article 9 of the Agreement, 10 Rules come into force on the later of— (a) the date (if any) specified in the Rule as the date on which the Rule commences; and the date on which the requirements of paragraph 7 of Article 9 of the Agreement are satisfied.
(b) 15 (2) (3) (4) The requirements of paragraph 7(a) of Article 9 of the Agree- ment are satisfied by— (a) publishing the Rule on the Authority’s Internet site, as required by section 14(1); or publishing the Rule, or notifying the making of the 20 Rule, in the Gazette, as provided in paragraph 7 of Art- icle 9 of the Agreement.
(b) In accordance with paragraph 5 of Article 10 of the Agree- ment, Orders come into force on the later of— (a) the date (if any) specified in the Order as the date on 25 which the Order commences; and the date on which the requirements of paragraph 7 of Article 10 of the Agreement are satisfied.
(b) The requirements of paragraph 7(a) of Article 10 of the Agree- ment are satisfied by— (a) publishing the Order on the Authority’s Internet site, as required by section 14(1); or publishing the Order, or notifying the making of the Order, in the Gazette, as provided in paragraph 7 of Article 10 of the Agreement.
(b) 30 35 35 Part 1 cl 12 Therapeutic Products and Medicines Bill 12 (1) (2) Involvement of Finance Minister in making certain Rules The Minister must not agree to the Ministerial Council making a Rule dealing with the governance or accountability of the Authority unless the Finance Minister has, in writing, either agreed to the making of the Rule or indicated that his or her 5 agreement is not required.
For the purposes of this section, governance and account- ability includes, without limitation, all the matters referred to or dealt with in Part 4.

(3) A failure to comply with subsection (1) does not affect the 10 validity of any Rule.

Subpart 3—Publication, presentation, and disallowance of Rules and Orders Definition 13 Meaning of Rule and Order in this subpart For the purposes only of this subpart, an instrument that con- tains 2 or more Rules or Orders is taken to be a single Rule or Order.
Publication of Rules and Orders every Rule; and every Order; and the explanatory statement of every Rule and Order.

Publication of Rules, Orders, and compilations on Internet site The Authority must publish and maintain on its Internet site— (a) (b) (c) The Authority must publish every Rule and Order on its Inter- net site as soon as practicable after the Rule or Order is made.
The Internet site must clearly indicate— (a) (b) which Rules and Orders are in force; and the date on which each Rule or Order is published on 30 the Internet site; and the date on which each Rule or Order comes into force and, if any provision of a Rule or Order will come into force at a later date, an indication of when the provision will come into force; and (c) 35 15 20 25 14 (1) (2) (3) 36 (4) (5) 15 (1) Therapeutic Products and Medicines Bill Part 1 cl 15 (d) the date on which a Rule or Order that is no longer in force ceased to be in force.
Failure to comply with subsection (1)(c), (2), or (3) does not affect the validity or enforceability of any Rule or Order.
The Authority may also publish compilations on its Internet 5 site, in which case— (a) a copy of every compilation published must be main- tained on the Authority’s Internet site; and the Internet site must clearly indicate the date of publi- cation of each compilation; and a failure to comply with paragraphs (a) or (b) does not affect the validity or enforceability of the Rule or Order that is compiled.
(b) (c) Correction of Rules, Orders, and compilations on Internet site The Authority must arrange for the correction of a Rule, Order, or compilation published on its Internet site if,— (a) in the case of a Rule or Order, the Authority becomes aware that the Rule or Order is not identical to the Rule or Order as made; and in the case of a compilation of a Rule or Order, the Authority becomes aware that the compilation does not accurately reproduce the text of the Rule or Order with all amendments in force on the date of compilation.
(b) 10 15 20 (2) When a Rule, Order, or compilation is corrected, it must be 25 annotated to show the date and time of the correction and the reason for it.

The correction of a Rule, Order, or compilation— (a) (3) does not affect any right or privilege that was acquired, or that accrued, by reason of reliance on the content of 30 the repository before the correction was made; and does not impose or increase any obligation or liability that was incurred before the correction was made.
(b) Compare: Legislative Instruments Act 2003 s 23 (Aust) 37 Part 1 cl 16 Therapeutic Products and Medicines Bill 16 Status of Rules, Orders, and compilations published on Internet site (1) A Rule or Order published on the Authority’s Internet site is taken, unless the contrary is proved, to be a complete and ac- curate record of the Rule or Order as made.
5 (2) A compilation of a Rule or Order published on the Authority’s Internet site is taken, unless the contrary is proved, to be a complete and accurate record of that Rule or Order as amended and in force on the date of compilation.

In any proceedings, proof is not required about the provisions 10 and the coming into force (in whole or in part) of a Rule or Order as it appears on the Authority’s Internet site.
(3) (4) A court or tribunal may inform itself about those matters in any way that it thinks fit.
It is presumed, unless the contrary is proved, that— (a) a copy of a Rule or Order (or a provision of a Rule or Order) that purports to be printed from the Authority’s Internet site is what it purports to be; and the Rule or Order (or the provision of a Rule or Order) was published on the date specified on the site as the 20 date on which the Rule or Order (or the Rule or Order containing the provision) was first published.
(b) 15 The failure or unavailability of the Authority’s Internet site does not affect the validity of any Rule or Order that was pub- lished on the site before the site failed or became unavailable.

25 Compare: Legislative Instruments Act 2003 s 22 (Aust) Hard copies of Rules and Orders The original signed copy of every Rule and Order must be retained by the Authority until the original is passed to the appropriate archival authority (see section 186).
The Authority must make certified copies of an original Rule or Order available— (a) (b) (c) to the Minister, on request; and to the Australian Minister, on request; and to any other person, on request and payment of the fee 35 (if any) prescribed by the Rules.

30 (5) (6) 17 (1) (2) 38 Therapeutic Products and Medicines Bill Part 1 cl 20 No copyright in Rules and Orders 18 (1) No copyright exists in Rules or Orders.
(2) Nothing in subsection (1) affects the copyright in any mater- ial incorporated by reference in a Rule or Order.

Presentation of Rules and Orders 5 19 (1) (2) Presenting Rules and Orders The Minister must present a certified copy of every Rule and Order to the House of Representatives within 6 sitting days after the date on which the Rule or Order is made.
If a copy of a Rule or Order is not presented to the House of 10 Representatives as required by subsection (1), then,— (a) if the Rule or Order is not in force on the last day on which it should have been presented, it does not come into force after that day; and if the Rule or Order is in force on the last day on which 15 it should have been presented, it ceases to be in force at the close of that day.
(b) Compare: 1989 No 143 s 4 Presenting explanatory statements 20 (1) When the Minister presents a Rule or Order to the House of 20 Representatives, he or she must, at the same time, present an explanatory statement about the Rule or Order.
If the Minister fails to present the explanatory statement at the same time as the Rule or Order, he or she— (a) must present the explanatory statement as soon as pos- 25 (2) sible; and (b) must at the same time present a statement explaining the reason for the late presentation of the explanatory statement.
(3) If a Rule or Order incorporates material by reference, the ex- 30 planatory statement must give the following information: (a) where in New Zealand hard copies of the incorporated material may be viewed free of charge: (b) whether the incorporated material may be viewed elec- tronically, and if so, how: 35 39 Part 1 cl 21 Therapeutic Products and Medicines Bill (c) how members of the public may acquire copies of the incorporated material at no more than a reasonable cost: (d) whether the incorporated material refers to that material as at a particular date, or if the incorporated material includes that material as from time to time amended or 5 replaced.
Failure by the Minister to comply with any of subsections (1) to (3) does not affect the validity or enforceability of the Rule or Order.

Disallowance of Rules and Orders 10 Explanation of sections 22 to 27 The purpose of sections 22 to 27 is to provide for the dis- allowance of Rules and Orders by the New Zealand House of Representatives.
(4) 21 (1) (2) A discrete disallowance scheme is required because Rules and 15 Orders are not regulations for the purposes of the Regulations (Disallowance) Act 1989 and are therefore not subject to dis- allowance under that Act.
The disallowance scheme set out in sections 22 to 27 differs from that in the Regulations (Disallowance) Act 1989 be- 20 cause, in order to reflect the joint nature of Rules and Orders, it needs to be consistent with the equivalent disallowance scheme under the Australian Act as far as possible.

(3) 22 Rules and Orders to be disallowed in whole only A Rule or Order may be disallowed in whole only, and not in 25 part.
Notice of motion to disallow Rule or Order 23 (1) Any member of Parliament may give a notice of motion to disallow a Rule or Order that has been presented to the House of Representatives.

The notice of motion must be given within 3 months of the date on which the Rule or Order was presented to the House of Representatives.
For the purpose of calculating 3 months from the date of pres- entation, the following periods are not to be counted: (3) (2) 30 35 40 Therapeutic Products and Medicines Bill Part 1 cl 25 (a) (b) any period during which Parliament is prorogued: any period between the dissolution or expiry of one Par- liament and the first sitting day of the next Parliament.
How and when Rule or Order disallowed 24 (1) A Rule or Order is disallowed if— 5 (a) a notice of motion to disallow a Rule or Order is given by a member of the committee of the House of Rep- resentatives responsible for the review of regulations and, by the close of the 21st sitting day after the date on which the notice is given, no decision on the motion 10 has been made; or a notice of motion to disallow a Rule or Order is given by any member of the House of Representatives and is called on, moved, and agreed to within 21 sitting days after the date on which the notice is given.
(2) A Rule or Order that is disallowed ceases to be in force on the (b) 15 later of the following: (a) the date specified in the notice of motion as the date on which the disallowance takes effect; or the day after the date on which the Rule or Order is 20 disallowed.

(b) (3) A Rule or Order cannot be disallowed under a notice of motion that has lapsed under section 25, unless it is reinstated in accordance with section 25(2).
Compare: 1989 No 143 ss 5, 6 Lapse of notice of motion to disallow Rule or Order 25 (1) A notice of motion to disallow a Rule or Order lapses if— (a) (b) the notice is called upon and moved but is not agreed to; or the notice— (i) was given by a member of Parliament who is not a member of the committee of the House of Rep- resentatives responsible for the review of regula- tions; and has not been agreed to within 21 sitting days after 35 the date on which the notice was given; or (ii) (c) the member who gave the notice withdraws it.
41 25 30 Part 1 cl 26 Therapeutic Products and Medicines Bill If Parliament is dissolved or expires within 21 sitting days after the date on which the notice is given, the notice of motion lapses but may be reinstated in the new Parliament.
If it is reinstated, the notice of motion is to be treated— (a) as if it had originally been given on the first sitting day 5 of the new Parliament; and as if that date were within 3 months of the date on which the Rule or Order was presented to the House of Repre- sentatives.
(b) 10 Giving notice when Rule or Order disallowed If a Rule or Order is disallowed under section 24, or is dis- allowed or taken to have been disallowed by either House of the Parliament of Australia, the Minister must arrange for the publication in the Gazette of a notice identifying the Rule or Order that has been disallowed and the date on which the Rule 15 or Order ceases to have effect.
The Authority must, as soon as practicable after a Rule or Order has been disallowed, give notice of that fact on its Inter- net site.
Compare: 1989 No 143 s 10 20 Effect of failure to table in, or disallowance by, Australian Parliament A Rule or Order is not in force if, under the Australian Act, it is not in force as a result of— (a) a failure to table the Rule or Order in both Houses of the 25 Parliament of Australia, as required by the Australian Act; or disallowance of the Rule or Order by either House of the Parliament of Australia.
(b) (2) 26 (1) (2) 27 42 28 Therapeutic Products and Medicines Bill Part 2 cl 28 Part 2 Enforcement of regulatory scheme Subpart 1—General provisions relating to Part Definitions and jurisdiction 5 15 Definitions of terms used primarily in subparts 1 to 3 In Parts 1 to 5, unless the context otherwise requires,— applicable standard, in relation to a therapeutic product, means a standard that, under the Rules, applies to that thera- peutic product, whether the standard is set out in the Rules or 10 in Orders condition, in relation to an approval or other form of author- isation given by the Authority, means a condition that is im- posed by or under the approval or authorisation itself, or by or under the Rules or Orders conformity assessment certificate means an approval of a kind defined in the Rules as a conformity assessment certifi- cate executive officer means, in relation to a body corporate (other than the Authority), a person, by whatever name called and 20 whether or not a director of the body, who is concerned in, or takes part in, the management of the body label, in relation to a therapeutic product, means a display of printed information— (a) (b) on or attached to the therapeutic product; or on or attached to a container or primary pack (as those terms are defined in the Rules) in which the therapeutic product is supplied; or supplied with such a container or pack (c) manufacturing licence means an approval of a kind defined 30 in the Rules as a manufacturing licence non-compliance notice means a
 notice issued under section 89 product licence means an approval of a kind defined in the Rules as a product licence 35 25 43 Part 2 cl 29 Therapeutic Products and Medicines Bill special purpose approval means an approval that authorises a person to manufacture, import, export, or supply a therapeutic product without a product licence subject to actual or proposed tampering means, in relation to a therapeutic product, that the product has been, or is pro- 5 posed to be, interfered with in a way that affects or could affect the quality, safety, efficacy, or performance of the therapeutic product; and (a) the interference has the potential to cause harm to any person; or the interference is done for the purpose of causing harm to any person.
(b) 10 Jurisdiction extended to conduct in Australia For the purpose of jurisdiction, a person may be convicted of an offence under this Part if any act or omission forming part 15 of the offence, or any event necessary for the completion of the offence, occurs in either New Zealand or Australia— (a) whether or not any other act or omission forming part of the offence, or event necessary for completing the of- fence, occurs outside either New Zealand or Australia; 20 and (b) whether or not the person charged with the offence was in New Zealand or Australia at the time of the act, omis- sion, or event.
For the purpose of jurisdiction, a person may be liable to a civil 25 penalty under this Part if any part of the conduct giving rise to the liability occurs in either New Zealand or Australia— (a) whether or not any other part of the conduct occurs out- side either New Zealand or Australia; and (b) whether or not the person proceeded against was in New 30 Zealand or Australia at the time of the conduct consti- tuting the contravention.
Compare: 1961 No 43 s 7 29 (1) (2) 44 Therapeutic Products and Medicines Bill Part 2 cl 32 General provisions about offences 30 Six-year time limit for bringing summary offences (1) Despite section 14 of the Summary Proceedings Act 1957, pro- ceedings in respect of the summary offences in this Part may be commenced at any time within 6 years after the conduct 5 that constituted the offence occurred.

In this section, summary offence has the meaning given in section 2 of the Summary Proceedings Act 1957.
(2) 31 (1) Sentencing guidelines for offences involving harm In determining the appropriate level of penalty for an offence 10 in which the defendant’s conduct caused, or caused a risk of, harm to any person, the sentencing Judge must take into ac- count the following matters: (a) how likely was it that harm would have been caused to any person by the conduct constituting the offence 15 (disregarding the fact that steps were, or might have been, taken to prevent or mitigate the harm or risk of harm): how many people were at risk of harm by the conduct constituting the offence: whether the conduct constituting the offence did in fact cause harm to any person: how serious was the harm that was caused, or was likely to have been caused, by the conduct constituting the offence.
25 20 (b) (c) (d) (2) Nothing in subsection (1) limits the application of the Sen- tencing Act 2002.
32 (1) Strict liability offences In a prosecution for a strict liability offence under this Part,— (a) it is not necessary for the prosecution to prove that the 30 defendant— (i) intended the conduct that constitutes the offence; or knew or was reckless as to any fact or circum- stance that is an element of the offence; or (ii) 35 45 Part 2 cl 33 Therapeutic Products and Medicines Bill (b) (iii) knew, or was reckless as to whether, any result that is an element of the offence would occur; and except as otherwise specified in this Part, it is not a defence to a strict liability offence that the defendant— (i) took all reasonable steps to avoid or prevent the 5 commission of the offence; or (ii) mistakenly believed in the existence of facts that, if true, would have meant that the defendant’s conduct did not constitute an offence.
(2) Despite subsection (1)(b), it is a defence to a strict liability 10 offence under this Part that the defendant believed, on reason- able grounds, in the existence of facts that, if true, would have meant that the defendant’s conduct did not constitute an of- fence.
In a prosecution for a strict liability offence under this Part, the 15 defence mentioned in subsection (2), and any defence iden- tified in this Part as a defence specifically to a strict liability offence, is made out if— (a) (3) the defendant points to evidence before the court that the existence of the defence is a reasonable possibility; 20 and the prosecution does not disprove the existence of the defence.
(b) Subsection (3) does not apply if the provision setting out a defence to a strict liability offence states that the defendant 25 must prove that defence.

Alternative verdicts The Australian Act makes provision for alternative verdicts in relation to certain offences.

This Act does not contain equiva- lent provisions because section 339 of the Crimes Act 1961 30 already makes similar provision.
Notice required to adduce evidence for certain defences This section applies if a defendant wishes to raise any of the following defences in connection with the associated offence: (a) the defence in section 50(8) to a charge under section 35 50(6) (indictable offence relating to manufacturing a (4) 33 34 (1) 46 Therapeutic Products and Medicines Bill Part 2 cl 34 (b) (c) therapeutic product without a manufacturing licence or the correct manufacturing licence): the defence in section 52(9) to a charge under section 52(7) (indictable offence relating to the manufacture, import, export, or supply without a product licence or 5 correct product licence): the defence in section 58(8) to a charge under sec- tion 58(6) (indictable offence relating to a manufac- turer who supplies or exports a therapeutic product to which conformity assessment procedures have not been 10 applied).
(2) The defendant must not adduce evidence in support of the de- fence unless— (a) the defendant gives notice, more than 30 days before the date of the trial, of the particulars of the defence; or if the notice is not given more than 30 days before the date of the trial, the court gives leave, in the interests of justice, for the evidence to be adduced.
(b) (3) A defendant must not, without leave of the court, call any other person to give evidence in support of the defence unless— (a) 15 20 25 the notice includes the name and address of the person or, if the name and address is not known to the defendant at the time he or she gives the notice, any information in his or her possession that might be of material assistance in finding the person; and if the name or the address is not given in the notice, the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address; and if the name or address is not included in the notice, but the defendant subsequently ascertains the name or ad- dress or receives information that might be of material assistance in finding the person, the defendant immedi- ately gives notice of the name, address, or other infor- 35 mation; and if the defendant is told by or on behalf of the prosecutor that the person has not been found by the name, or at the address, given by the defendant, then— 30 (b) (c) (d) 47 Part 2 cl 35 Therapeutic Products and Medicines Bill (i) (ii) the defendant immediately gives notice of any information in the defendant’s possession that might be of material assistance in finding the per- son; and if the defendant later receives any such informa- 5 tion, the defendant immediately gives notice of the information.
(4) Any evidence given to disprove the defence may, subject to direction by the court, be given before or after evidence given by the defendant in support of the defence.

10 (5) When a defendant is committed for trial for any offence re- ferred to in subsection (1), he or she must be informed of the requirements of this section and be given a copy of it.
Certificates to provide evidence of certain matters The Managing Director may certify that, at a specified time, 15 or at all times during a specified period,— (a) 20 there was no exemption relating to a therapeutic prod- uct; or an approval was not granted to a particular person under the Rules in relation to a therapeutic product; or there was not a product licence for a therapeutic prod- uct; or there was a manufacturing licence or product licence for a therapeutic product but the licence was suspended; or a manufacturing licence or product licence was subject 25 to conditions (including conditions specified in the li- cence); or a manufacturing licence or product licence had been re- voked in relation to therapeutic products of a particular kind; or a declaration had not been made under the Rules that a therapeutic product is a therapeutic product or a thera- peutic product of a particular kind; or a person was, or was not, the holder of: a manufacturing licence; or (i) a product licence; or (ii) a conformity assessment certificate; or (iii) 35 30 (b) (c) (d) (e) (f) (g) (h) 35 (1) 48 Therapeutic Products and Medicines Bill Part 2 cl 37 (i) (j) (k) (l) an authorisation was not granted to a person under the Rules in relation to a therapeutic product so that the product was required to conform to applicable standards in order to import, export, or supply the product; or a conformity assessment certificate had been issued re- 5 lating to a particular kind of therapeutic product; or a conformity assessment certificate was subject to conditions (including conditions specified in the cer- tificate); or a conformity assessment certificate had been suspended 10 or revoked.
(2) A certificate under subsection (1) must be in writing, and may relate to more than 1 of the matters referred to in sub- section (1)(a) to (l).

In civil penalty or criminal proceedings under this Part,— (a) (3) a certificate under subsection (1) is prima facie evi- dence of the matters specified in the certificate; and a document purporting to be a certificate given under subsection (1) is, unless the contrary is proved, taken to be such a certificate and to have been duly given.
(b) 15 20 (4) Subsection (3) does not apply in relation to criminal proceed- ings under the Australian Act.

36 37 (1) Proceedings for civil penalties Application for civil penalty The Authority may apply to the High Court for an order re- 25 quiring a person to pay a civil penalty.
Imposition of civil penalty The High Court may order a person to pay a civil penalty if it is satisfied that the person— (a) (b) has contravened a civil penalty provision; or has aided, abetted, counselled, or procured any other person to contravene a civil penalty provision; or induced, or attempted to induce, by threats or otherwise, the contravention of a civil penalty provision; or conspired with any other person to contravene a civil 35 penalty provision.
(c) (d) 30 49 Part 2 cl 38 Therapeutic Products and Medicines Bill (2) In determining the amount of civil penalty to be paid, the Court must have regard to all relevant matters, including the follow- ing: (a) (b) the nature and extent of the contravention: the nature and extent of any loss or damage suffered as 5 a result of the contravention: the circumstances in which the contravention took place: (c) (d) whether the person has previously been found by a court in proceedings under this Act, the Australian Act, or 10 under any predecessor of those Acts, to have engaged in any similar conduct.
(3) A civil penalty is payable to the Crown.

38 When and how civil penalty proceedings brought (1) An application for a civil penalty under this Part may be made 15 no later than 6 years after the conduct giving rise to the liability to pay the civil penalty occurred.

In proceedings for a civil penalty under this Part,— (a) (2) the standard of proof is the standard of proof that applies in civil proceedings; and the Authority may, by order of the Court, obtain discov- ery and administer interrogatories.
(b) Compare: 1996 No 30 s 124E Relationship between civil penalty and criminal proceedings 39 Civil penalty proceedings in New Zealand after proceedings in Australia for civil penalty (1) No proceedings for a civil penalty under this Part may be com- menced against a person in relation to particular conduct if— (a) proceedings against the person for a civil penalty under 30 the Australian Act are underway, or have been com- pleted, in Australia; and the proceedings are related to the same or substantially the same conduct as was to be the subject of the pro- ceedings in New Zealand.
35 (b) 50 20 25 Therapeutic Products and Medicines Bill Part 2 cl 41 (2) To avoid doubt, this section does not prevent subsequent pro- ceedings in New Zealand for a civil penalty if earlier proceed- ings for a civil penalty in Australia have been discontinued.
40 Criminal proceedings in New Zealand after criminal proceedings in Australia 5 (1) No criminal proceedings for an offence under this Part may be commenced against a person in relation to particular conduct if— (a) criminal proceedings against the person for an offence under the Australian Act are underway, or have been 10 completed, in Australia; and the proceedings are related to the same or substantially the same conduct as was to be the subject of the pro- ceedings in New Zealand.
(b) (2) 41 (1) (2) To avoid doubt, this section does not prevent subsequent crim- 15 inal proceedings in New Zealand if earlier criminal proceed- ings in Australia have been withdrawn.
Relationship between concurrent civil penalty proceedings and criminal proceedings Criminal proceedings for an offence under this Part may be 20 commenced against a person in relation to particular conduct whether or not— (a) proceedings in New Zealand for a civil penalty under this Part have been commenced against the person in relation to the same or substantially the same conduct; 25 or proceedings in Australia for a civil penalty under the Australian Act have been commenced against the per- son in relation to the same or substantially the same con- duct.
(b) 30 Proceedings under this Part for a civil penalty against a person in relation to particular conduct are stayed if— (a) criminal proceedings in New Zealand against the person are or have been commenced for an offence under this Part in relation to the same or substantially the same 35 conduct; or 51 Part 2 cl 42 Therapeutic Products and Medicines Bill (b) criminal proceedings in Australia against the person are or have been commenced for an offence under the Aus- tralian Act in relation to the same or substantially the same conduct.
(3) After the criminal proceedings referred to in subsection 5 (2)(a) or (b) have been completed or withdrawn, a person may apply to have the stay lifted on the civil penalty proceed- ings referred to in that subsection.
One penalty only rule If civil penalty or criminal proceedings under this Part are 10 brought against a person in relation to particular conduct, a court may not impose a penalty (whether civil or criminal) on the person if a court in New Zealand or Australia has already imposed a penalty under this Part or under the Australian Act in proceedings relating to the same or substantially the same 15 conduct.
If a person is or may be liable to more than one civil penalty under this Part in respect of the same or substantially the same conduct, civil penalty proceedings may be brought against the person for more than one civil penalty, but the person may not 20 be required to pay more than one civil penalty in respect of the same or substantially the same conduct.
25 (b) Effect of withdrawal or discontinuation of proceedings on limitation period This section applies if— (a) proceedings against a person have been commenced in Australia in relation to certain conduct, and the proceed- ings are then withdrawn or discontinued; and an application is subsequently made, or proceedings are subsequently commenced, in New Zealand against the 30 person in relation to the same or substantially the same conduct for an offence or civil penalty under this Part.
If this section applies, the period between the commencement of the Australian proceedings and the date on which they were withdrawn or discontinued is not to be included when deter- 35 mining whether the New Zealand application or proceedings 42 (1) (2) 43 (1) (2) 52 Therapeutic Products and Medicines Bill Part 2 cl 46 are brought within the limitation period applying to the appli- cation or proceedings.
For the purposes of subsection (2), limitation period means the period during which criminal proceedings must be com- menced under this Part or during which an application must 5 be made under section 36 for a civil penalty order.
Restriction on use of evidence given in civil penalty proceedings Evidence of information given, or evidence of production of documents, by a person is not admissible in criminal proceed- 10 ings against the person for an offence under this Part or any other enactment if— (a) the person previously gave the evidence or produced the documents in civil penalty proceedings (under this Part or the Australian Act) against him or her in New 15 Zealand or Australia, whether or not a civil penalty was imposed; and the proceedings for the civil penalty related to conduct that was the same or substantially the same as the con- duct constituting the offence.
(b) 20 This section does not apply to criminal proceedings in respect of the falsity of the evidence given by the person in the pro- ceedings for the civil penalty.

Abuse of process jurisdiction not affected To avoid doubt, nothing in sections 39 to 44 affects the 25 abuse of process jurisdiction of any court.
(3) 44 (1) (2) 45 Liability of executive officers Criminal liability of executive officers 46 (1) An executive officer of a body corporate commits an offence if— (a) (b) the body corporate commits an offence under this Part; and the officer knew that the offence was being or would be committed; and 30 53 Part 2 cl 47 Therapeutic Products and Medicines Bill (c) (d) the officer was in a position to influence the conduct of the body corporate in relation to the commission of the offence; and the officer failed to take all reasonable steps to prevent the commission of the offence.
5 (2) The maximum penalty for an offence under this section is the maximum penalty that could have been imposed if an indi- vidual had been convicted of the offence that the body corpo- rate committed.

(3) An offence under this section is triable (whether summarily or 10 on indictment) in whatever manner the offence that the body corporate has committed could be tried.
Compare: 1981 No 118 s 79(3) Liability of executive officers to civil penalty 47 (1) An executive officer of a body corporate is liable to a civil 15 penalty if— (a) the body corporate contravenes a civil penalty provi- sion; and the officer knew that contravention was occurring or would occur; and the officer was in a position to influence the conduct of the body corporate in relation to the contravention; and the officer failed to take all reasonable steps to prevent the contravention.
20 (b) (c) (d) The maximum civil penalty for a contravention under this sec- 25 tion is the maximum civil penalty that could have been im- posed if an individual had contravened the civil penalty provi- sion that the body corporate contravened.
Compare: 1981 No 118 s 79(3) How to establish whether executive officer took all reasonable steps For the purposes of sections 46 and 47, in determining whether an executive officer of a body corporate failed to take all reasonable steps to prevent the commission of an offence or contravention of a civil penalty provision, a court must have 35 regard to the following: 30 (2) 48 (1) 54 Therapeutic Products and Medicines Bill Part 2 cl 50 (a) what action (if any) the officer took to ensure that the body corporate’s employees, agents, and contractors had a reasonable knowledge and understanding of the requirements to comply with this Act and the Rules and Orders, so far as they affect the employees, agents, or 5 contractors concerned: (b) what action (if any) the officer took when he or she became aware that the body corporate was committing an offence under this Act or contravening a civil penalty provision.
10 This section does not limit the generality of sections 46 and 47.

Notice required to adduce evidence Section 34 applies to a defendant in proceedings for an of- fence under section 46(1) relating to an offence by a body 15 corporate under any provision listed in subsection (2) as if the defendant were a defendant in proceedings for an offence against any of those provisions.

The relevant provisions are as follows: (a) (b) (c) section 50(6): section 52(7): section 58(6).
20 (2) 49 (1) (2) Subpart 2—Regulatory offences and civil penalties Manufacture, import, export, and supply 25 50 Manufacture without manufacturing licence or correct (1) manufacturing licence The offences and civil penalty in this section apply if, under the Rules, a person must not carry out a step in the manufacture of a therapeutic product at premises in New Zealand or Australia 30 unless— (a) the person holds a manufacturing licence for the thera- peutic product or for therapeutic products of that kind; and 55 Part 2 cl 50 Therapeutic Products and Medicines Bill (b) the manufacturing licence authorises the carrying out of that step in the manufacture of the therapeutic product at those premises.
Civil penalty provision (2) A person is liable to a civil penalty if— 5 (a) (b) the person carries out a step in the manufacture of a therapeutic product in premises in New Zealand or Aus- tralia; and the person— (i) does not hold a manufacturing licence in respect 10 of that therapeutic product or kind of a therapeu- tic product; or holds a manufacturing licence, but it does not authorise the carrying out of that step in the manufacture of that therapeutic product at those 15 premises.
(ii) (3) The maximum civil penalty that a person is liable to under subsection (2) is— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
Summary offence (4) A person commits an offence if— (a) (b) the person intentionally carries out a step in the manu- facture of a therapeutic product in premises in New Zealand or Australia; and the person— (i) does not hold a manufacturing licence in respect of that therapeutic product or kind of a therapeu- tic product; or holds a manufacturing licence, but it does not 30 authorise the carrying out of that step in the manufacture of that therapeutic product at those premises; and (ii) 20 25 (c) the person knows of the facts referred to in paragraph (b), or is reckless as to those facts.
35 (5) A person who commits an offence under subsection (4) is liable, on summary conviction, to,— (a) in the case of individual, either or both of the following: 56 Therapeutic Products and Medicines Bill Part 2 cl 50 (i) a term of imprisonment of not more than 12 months: a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 penalty units.
(b) Indictable offence (6) A person commits an offence if— the person intentionally carries out a step in the manu- facture of a therapeutic product in premises in New Zealand or Australia; and the person either— (i) does not hold a manufacturing licence in respect of that therapeutic product or kind of a therapeu- tic product; or holds a manufacturing licence, but it does not 15 authorise the carrying out of that step in the manufacture of that therapeutic product at those premises; and (ii) the person knows of the facts referred to in paragraph (b), or is reckless as to those facts; and either— (i) use of the therapeutic product harms any person; or there is a serious risk that use of the therapeutic product will harm any person; and (ii) the person knows, or is reckless as to whether, harm or a serious risk of harm will result from use of the therapeutic product.
5 10 20 25 30 (7) A person who commits an offence under subsection (6) is liable, on conviction on indictment, to,— (a) in the case of an individual, either or both of the follow- ing: (i) (ii) in the case of a body corporate, a fine of up to 20 000 35 penalty units.
a term of imprisonment of not more than 5 years: a fine of up to 4 000 penalty units; and (8) Defence to indictable offence It is a defence to an offence under subsection (6) if the de- fendant proves that the harm or serious risk of harm is not a 57 (a) (b) (c) (d) (e) (b) Part 2 cl 51 Therapeutic Products and Medicines Bill result of a step carried out by the defendant in the manufacture of the therapeutic product.
Strict liability offence (9) A person commits a strict liability offence if— (a) (b) the person carries out a step in the manufacture of a 5 therapeutic product in premises in New Zealand or Aus- tralia; and the person either— (i) does not hold a manufacturing licence in respect of that therapeutic product or kind of a therapeu- 10 tic product; or holds a manufacturing licence, but it does not authorise the carrying out of that step in the manufacture of that therapeutic product at those premises; and 15 (ii) (c) use of the product harms or is likely to harm any person.
(10) A person who commits a strict liability offence under this sec- tion is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 2 000 penalty units; and in the case of a body corporate, a fine of up to 10 000 penalty units.

(b) 51 Breaching conditions of manufacturing licence Civil penalty provision (1) A person is liable to a civil penalty if— (2) (a) (b) the person holds a manufacturing licence; and the person breaches a condition of the manufacturing licence.
The maximum civil penalty that a person is liable to under subsection (1) is,— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
Summary offence (3) A person commits an offence if— (a) (b) the person holds a manufacturing licence; and the person breaches a condition of the manufacturing licence; and 58 20 25 30 35 Therapeutic Products and Medicines Bill Part 2 cl 51 (c) the person knows that he or she is in breach of a con- dition of the manufacturing licence, or is reckless as to that fact.
(4) A person who commits an offence under subsection (3) is liable, on summary conviction, to,— (a) in the case of an individual, either or both of the follow- ing: (i) a term of imprisonment of not more than 12 months: a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 penalty units.
(b) Indictable offence (5) A person commits an offence if— (a) (b) (c) (d) (e) the person holds a manufacturing licence; and the person breaches a condition of the manufacturing licence; and the person knows that he or she is in breach of a con- dition of the manufacturing licence, or is reckless as to that fact; and the breach of the condition results in harm to any person or a serious risk of harm to any person; and the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the breach.
5 10 15 20 (6) A person who commits an offence under subsection (5) is 25 liable, on conviction on indictment, to,— (a) in the case of an individual, either or both of the follow- ing: (i) (ii) in the case of a body corporate, a fine of up to 20 000 penalty units.
a term of imprisonment of not more than 5 years: a fine of up to 4 000 penalty units; and (b) Strict liability offence (7) A person commits a strict liability offence if— (a) (b) the person holds a manufacturing licence; and the person breaches a condition of the manufacturing licence; and 59 30 35 Part 2 cl 52 Therapeutic Products and Medicines Bill (c) the breach of the condition results in harm or is likely to result in harm to any person.
(8) A person who commits a strict liability offence under this sec- tion is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 2 000 penalty 5 units; and in the case of a body corporate, a fine of up to 10 000 penalty units.
(b) 52 Manufacture, import, export, or supply without product (1) (2) 10 licence or correct product licence The civil penalty and offences in this section apply if, under the Rules, a person must not manufacture, import, export, or supply a therapeutic product unless the person holds a product licence of the sort that the Rules require a manufacturer, im- porter, exporter, or supplier of that therapeutic product to hold.
15 For the purposes of this section, a person who manufactures, imports, exports, or supplies a therapeutic product is presumed to be the sponsor of the therapeutic product at the time of its manufacture, import, export, or supply (as the case may be), unless the person proves that he or she was not the sponsor at 20 that time.
Civil penalty provision (3) A person is liable to a civil penalty if— (4) (a) the person manufactures, imports, exports, or supplies a therapeutic product; and the person does not hold the required product licence.

(b) The maximum civil penalty that a person is liable to under subsection (3) is— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
25 30 Summary offence (5) A person commits an offence if— (a) (b) the person intentionally manufactures, imports, exports, or supplies a therapeutic product; and the person does not hold the required product licence; 35 and 60 Therapeutic Products and Medicines Bill Part 2 cl 52 (c) the person knows that he or she does not hold the re- quired product licence, or is reckless as to that fact.
(6) A person who commits an offence under subsection (5) is liable, on summary conviction, to,— (a) in the case of an individual, either or both of the follow- 5 ing: (i) a term of imprisonment of not more than 12 months: a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 10 penalty units.
(b) Indictable offence (7) A person commits an offence if— (a) (b) (c) (d) (e) the person intentionally manufactures, imports, exports, or supplies a therapeutic product; and the person does not hold the required product licence; and the person knows that he or she does not hold the re- quired product licence, or is reckless as to that fact; and either— (i) (ii) use of the product harms any person; or there is a serious risk that use of the product will harm any person; and 15 20 the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the manufacture, 25 import, export, or supply of the therapeutic product.
(8) A person who commits an offence under subsection (7) is liable, on conviction on indictment, to,— (a) in the case of an individual, either or both of the follow- ing: (i) (ii) in the case of a body corporate, a fine of up to 20 000 penalty units.
a term of imprisonment of not more than 5 years: a fine of up to 4 000 penalty units; and (b) (9) Defence to indictable offence It is a defence to a charge for an offence under subsection (7) that— 61 30 35 Part 2 cl 53 Therapeutic Products and Medicines Bill (a) (b) the harm or serious risk of harm is a direct result of the improper use of the therapeutic product; or the harm or serious risk of harm is not a direct or in- direct result of the quality, performance, or efficacy of the therapeutic product, or of a matter relating to its la- 5 belling or packaging (10) The defence described in subsection (9) is made out if— (a) (b) the defendant points to evidence before the court that the existence of the defence is a reasonable possibility; and the prosecution does not disprove the existence of the defence.
10 Strict liability offence (11) A person commits a strict liability offence if— (a) (b) (c) the person manufactures, imports, exports, or supplies 15 a therapeutic product; and the person does not hold the required product licence; and use of the product harms or is likely to harm any person.
(12) A person who commits a strict liability offence under this sec- 20 tion is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 2 000 penalty units; and in the case of a body corporate, a fine of up to 10 000 penalty units.

(b) 53 Breaching conditions of product licence Civil penalty provision (1) A person is liable to a civil penalty if— (2) the person holds a product licence; and (a) (b) the person breaches a condition of the product licence.
The maximum civil penalty that a person is liable to under subsection (1) is,— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
Summary offence (3) A person commits an offence if— (a) the person holds a product licence; and 62 25 30 35 Therapeutic Products and Medicines Bill Part 2 cl 53 (b) (c) the person breaches a condition of the product licence; and the person knows that he or she is in breach of a condi- tion of the product licence or is reckless as to that fact.
(4) A person who commits an offence under subsection (3) is 5 liable on, summary conviction, to,— (a) in the case of an individual, either or both of the follow- ing: (i) a term of imprisonment of not more than 12 months: a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 penalty units.
(b) Indictable offence (5) A person commits an offence if— 10 15 (a) (b) (c) (d) (e) the person holds a product licence; and the person breaches a condition of the product licence; and the person knows that he or she is in breach of a condi- tion of the product licence, or is reckless as to that fact; 20 and the breach of the condition results in harm to any person or a serious risk of harm to any person; and the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the breach.
25 (6) A person who commits an offence under subsection (5) is liable, on conviction on indictment, to,— (a) in the case of an individual, either or both of the follow- ing: (i) (ii) in the case of a body corporate, a fine of up to 20 000 penalty units.
a term of imprisonment of not more than 5 years: 30 a fine of up to 4 000 penalty units; and (b) Strict liability offence (7) A person commits a strict liability offence if— 35 (a) (b) the person holds a product licence; and the person breaches a condition of the product licence; and 63 Part 2 cl 54 Therapeutic Products and Medicines Bill (c) the breach of the condition results in harm or is likely to result in harm to any person.
(8) A person who commits a strict liability offence under this sec- tion is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 2 000 penalty 5 units; and in the case of a body corporate, a fine of up to 10 000 penalty units.
(b) 54 (1) 10 Breaching conditions of special purpose approval or requirements of exemption The civil penalty and offences in this section apply to a person who, under the Rules, is not required to have a product licence in order to manufacture, import, export, or supply a therapeutic product because— (a) the person holds a special purpose approval in respect 15 of the therapeutic product; or the person is otherwise exempt under the Rules from the requirement to hold a product licence in respect of the manufacture, import, export, or supply of the thera- peutic product (in this section referred to as holding an 20 exemption).
(b) Civil penalty provision (2) A person is liable to a civil penalty if the person breaches a condition of the special purpose approval or a requirement of the exemption.

The maximum civil penalty that a person is liable to under subsection (2) is,— (a) (b) in the case of an individual, 3 000 penalty units; and in the case of a body corporate, 30 000 penalty units.
(3) Summary offence (4) A person commits an offence if— 25 30 (a) (b) the person breaches a condition of the special purpose approval or a requirement of the exemption; and the person knows that he or she is in breach of a condi- tion of the special purpose approval or requirement of 35 the exemption, or is reckless as to that fact.
64 Therapeutic Products and Medicines Bill Part 2 cl 54 (5) A person who commits an offence under subsection (4) is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 500 penalty units; and in the case of a body corporate, a fine of up to 2 500 5 penalty units.
(b) Indictable offence (6) A person commits an offence if— (a) (b) (c) (d) 10 the person breaches a condition of the special purpose approval or a requirement of the exemption; and the person knows that he or she is in breach of a condi- tion of the special purpose approval or requirement of the exemption, or is reckless as to that fact; and the breach of the condition or requirement results in harm to any person or a serious risk of harm to any 15 person; and the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the breach.
(7) A person who commits an offence under subsection (6) is liable, on conviction on indictment, to,— (a) in the case of an individual, a fine of up to 2 000 penalty units; and in the case of a body corporate, a fine of up to 10 000 penalty units.
(b) Strict liability offence (8) A person commits a strict liability offence if— (a) (b) the person breaches a condition of the special purpose approval or a requirement of the exemption; and the breach of the condition or requirement results in harm or is likely to result in harm to any person.
(9) A person who commits a strict liability offence under this sec- 20 25 30 tion is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 1 000 penalty units; and in the case of a body corporate, a fine of up to 5 000 35 penalty units.
(b) 65 Part 2 cl 55 Therapeutic Products and Medicines Bill 55 (1) Import, export, or supply of product that does not conform to applicable standards The civil penalty and offences in this section apply if, under the Rules, a person must not import, export, or supply a ther- apeutic product unless it conforms to applicable standards.
5 Civil penalty provision (2) A person is liable to a civil penalty if— (a) (b) the person imports, exports, or supplies a therapeutic product; and the therapeutic product does not conform to applicable 10 standards.

The maximum civil penalty that a person is liable to under subsection (2) is,— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
15 (3) Summary offence (4) A person commits an offence if— (a) (b) (c) the person intentionally imports, exports, or supplies a therapeutic product; and the therapeutic product does not conform to applicable 20 standards; and the person knows that the product does not conform to applicable standards, or is reckless as to that fact.
(5) A person who commits an offence under subsection (4) is liable, on summary conviction, to,— (a) in the case of an individual, either or both of the follow- ing: (i) a term of imprisonment of not more than 12 months: a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 penalty units.
(b) 25 30 Indictable offence (6) A person commits an offence if— (a) (b) the person intentionally imports, exports, or supplies a 35 therapeutic product; and the therapeutic product does not conform to applicable standards; and 66 Therapeutic Products and Medicines Bill Part 2 cl 55 (c) (d) (e) the person knows that the product does not conform to applicable standards, or is reckless as to that fact; and as a result of the therapeutic product not conforming to applicable standards— (i) (ii) use of the product harms any person; or there is a serious risk that use of the product will harm any person; and the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the therapeutic product not conforming to applicable standards.
5 10 (7) A person who commits an offence under subsection (6) is liable, on conviction on indictment, to,— (a) in the case of an individual, either or both of the follow- ing: (i) (ii) in the case of a body corporate, a fine of up to 20 000 penalty units.
a term of imprisonment of not more than 5 years: 15 a fine of up to 4 000 penalty units; and (b) Strict liability offence (8) A person commits a strict liability offence if— 20 (a) (b) (c) the person imports, exports, or supplies a therapeutic product; and the therapeutic product does not conform to applicable standards; and as a result of the therapeutic product not conforming 25 to applicable standards, use of the product harms or is likely to harm any person.
(9) A person who commits a strict liability offence under this sec- tion is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 2 000 penalty 30 units; and in the case of a body corporate, a fine of up to 10 000 penalty units.
(b) Exceptions (10) A person does not commit an offence, and is not liable to a 35 civil penalty, under this section if,— (a) in relation to the import of a therapeutic product, the standard that the therapeutic product did not conform to 67 Part 2 cl 56 Therapeutic Products and Medicines Bill (b) is a standard that relates only to labelling or packaging; or in relation to the export of a therapeutic product, the standard that the therapeutic product did not conform to is a standard that relates only to labelling.
5 56 (1) Breaching conditions of authorisation not to conform to applicable standards In this section, authorisation means an authorisation given by the Authority under the Rules that permits the holder to import, export, or supply a therapeutic product even though the 10 therapeutic product does not conform to applicable standards.

Civil penalty provision (2) A person is liable to a civil penalty if he or she breaches a (3) condition of an authorisation.
The maximum civil penalty that a person is liable to under 15 subsection (2) is,— (a) (b) in the case of an individual, 3 000 penalty units; and in the case of a body corporate, 30 000 penalty units.

Summary offence (4) A person commits an offence if— (a) (b) the person breaches a condition of an authorisation; and the person knows that he or she is in breach of a condi- tion of the authorisation, or is reckless as to that fact.
(5) A person who commits an offence under subsection (4) is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 500 penalty units; and in the case of a body corporate, a fine of up to 2 500 penalty units.
(b) Indictable offence (6) A person commits an offence if— (a) (b) (c) the person breaches a condition of an authorisation; and the person knows that he or she is in breach of a con- dition of the authorisation, or is reckless as to that fact; and the breach of the condition results in harm to any person or a serious risk of harm to any person; and 68 20 25 30 35 Therapeutic Products and Medicines Bill Part 2 cl 57 (d) the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the breach.
(7) A person who commits an offence under subsection (6) is liable, on conviction on indictment, to,— (a) in the case of an individual, a fine of up to 2 000 penalty 5 units; and in the case of a body corporate, a fine of up to 10 000 penalty units.

(b) Strict liability offence (8) A person commits a strict liability offence if— (a) (b) the person breaches a condition of an authorisation; and the breach of the condition results in harm or is likely to result in harm to any person.
(9) A person who commits a strict liability offence under this sec- tion is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 1 000 penalty units; and in the case of a body corporate, a fine of up to 5 000 penalty units.
(b) 10 15 Breaching conditions of conformity assessment certificate 57 (1) A person commits an offence if— 20 (a) (b) (c) the person holds a conformity assessment certificate; and the person breaches a condition of the conformity as- sessment certificate; and the person knows that he or she is in breach of a condi- tion of the conformity assessment certificate, or is reck- less as to that fact.
(2) A person who commits an offence under subsection (1) is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 60 penalty units; and in the case of a body corporate, a fine of up to 300 penalty units.
(b) 25 30 69 Part 2 cl 58 Therapeutic Products and Medicines Bill 58 Manufacturer supplying or exporting therapeutic product (1) to which conformity assessment procedures not applied The civil penalty and offences in this section apply if, under Rules, the manufacturer of a therapeutic product must not sup- ply or export the therapeutic product unless specified conform- 5 ity assessment procedures have been applied to it.
Civil penalty provision (2) A person is liable to a civil penalty if— (a) (b) the person manufactures a therapeutic product; and the specified conformity assessment procedures have 10 not been applied to the therapeutic product.

(3) The maximum civil penalty that a person is liable to under subsection (2) is,— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
Summary offence (4) A person commits an offence if— (a) (b) (c) (d) the person manufactures a therapeutic product; and the specified conformity assessment procedures have not been applied to the therapeutic product; and the person knows that the specified conformity assess- ment procedures have not been applied to the therapeu- tic product, or is reckless as to that fact; and the person intentionally supplies or exports the thera- peutic product.
(5) A person who commits an offence under subsection (4) is 15 20 25 liable, on summary conviction, to,— (a) in the case of an individual, either or both of the follow- ing: (i) a term of imprisonment of not more than 12 30 months: a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 penalty units.
(b) Indictable offence (6) A person commits an offence if— 35 (a) the person manufactures a therapeutic product; and 70 Therapeutic Products and Medicines Bill Part 2 cl 58 (b) (c) (d) (e) (f) the specified conformity assessment procedures have not been applied to the therapeutic product; and the person knows that the specified conformity assess- ment procedures have not been applied to the therapeu- tic product, or is reckless as to that fact; and the person intentionally supplies or exports the thera- peutic product; and either— (i) (ii) use of the product harms any person; or there is a serious risk that use of the product will 10 harm any person; and 5 the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the supply or export of the therapeutic product.
(7) A person who commits an offence under subsection (6) is 15 liable, on conviction on indictment, to— (a) in the case of an individual, either or both of the follow- ing: (i) (ii) in the case of a body corporate, a fine of up to 20 000 penalty units.
a term of imprisonment of not more than 5 years: a fine of up to 4 000 penalty units; and (b) 20 (8) Defence to indictable offence It is a defence to a charge for an offence under subsection (6) if the defendant proves that the harm, or serious risk of harm, 25 is not a result of the failure to apply the specified conformity assessment procedures to the therapeutic product.
Strict liability offence (9) A person commits a strict liability offence if— (a) (b) (c) (d) the person manufactures a therapeutic product; and the specified conformity assessment procedures have not been applied to the therapeutic product; and the person supplies or exports the therapeutic product; and use of the product harms or is likely to harm any person.
35 30 (10) A person who commits the strict liability offence under this section is liable, on summary conviction, to,— 71 Part 2 cl 59 Therapeutic Products and Medicines Bill (a) (b) in the case of an individual, a fine of up to 2 000 penalty units; and in the case of a body corporate, a fine of up to 10 000 penalty units.
59 (1) (2) 5 Other persons supplying or exporting products to which conformity assessment procedures not applied The offences in this section apply if, under the Rules, a per- son (being a person other than a manufacturer) must not sup- ply or export a therapeutic product unless specified conform- ity assessment procedures have been applied to the therapeutic 10 product.
For the purposes of this section, a person who exports or sup- plies a therapeutic product is presumed to be the sponsor of the therapeutic product at the time of its export or supply (as the case may be) unless the person proves that he or she was 15 not the sponsor at that time.
Summary offence (3) A person commits an offence if— (a) (b) the person intentionally exports or supplies a therapeu- tic product; and the specified conformity assessment procedures have not been applied to the therapeutic product; and the person knows that the specified conformity assess- ment procedures have not been applied to the therapeu- tic product, or is reckless as to that fact.
(4) A person who commits an offence under subsection (3) is (c) 20 25 liable, on summary conviction, to,— (a) in the case of an individual, either or both of the follow- ing: (i) a term of imprisonment of not more than 12 30 months: a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 penalty units.
(b) Indictable offence (5) A person commits an offence if— 35 72 Therapeutic Products and Medicines Bill Part 2 cl 61 (a) (b) (c) (d) (e) the person intentionally exports or supplies a therapeu- tic product; and the specified conformity assessment procedures have not been applied to the therapeutic product; and the person knows that the specified conformity assess- 5 ment procedures have not been applied to the therapeu- tic product, or is reckless as to that fact; and as a result of the failure to apply the specified conform- ity assessment procedures to the therapeutic product— use of the product harms any person; or (i) there is a serious risk that use of the product will (ii) harm any person; and 10 the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the failure to apply the specified conformity assessment procedures to the 15 therapeutic product.
(6) A person who commits an offence under subsection (5) is liable, on conviction on indictment, to,— (a) in the case of an individual, either or both of the follow- ing: (i) (ii) in the case of a body corporate, a fine of up to 20 000 penalty units.
a term of imprisonment of not more than 5 years: a fine of up to 4 000 penalty units; and (b) Advertising 20 25 60 Purpose The purpose of sections 61 to 67 (about advertising) is to provide for the enforcement of the Advertising Code estab- lished under the Rules, and of any Rules and Orders relating to advertising, in order to ensure that advertisements for ther- 30 apeutic products are truthful, balanced, substantiated, do not mislead, and observe a high standard of social responsibility.
61 Meaning of circumstances In sections 62 to 67, the circumstances in which an ad- vertisement is published or broadcast includes, without limi- 35 tation,— 73 Part 2 cl 62 Therapeutic Products and Medicines Bill (a) (b) (c) (d) the media in which the advertisement is published or broadcast: the target audience that the advertisement is aimed at: the persons who publish or broadcast the advertisement: the kind of therapeutic product that the advertisement is 5 about.
62 (1) Publishing or broadcasting proscribed advertisements In this section, proscribed advertisement means an adver- tisement about a therapeutic product that does any of the fol- lowing: (a) contains information, or makes a claim or representa- tion, about a therapeutic product that is false or mislead- ing in a material particular: (b) makes a claim or representation about a therapeutic 10 product, or kind of therapeutic product, that is not con- 15 sistent with— (i) the intended purpose of the manufacturer of the therapeutic product or kind of therapeutic prod- uct; or a standard that, under the Rules or Orders, applies 20 to the therapeutic product or therapeutic products of that kind; or the essential principles that, under the Rules or Orders, the therapeutic product or therapeutic products of that kind must comply with: 25 (ii) (iii) (c) targets healthcare practitioners and— (i) makes claims about an active ingredient in the product advertised that cannot be substantiated by the supplier of that product; or (ii) makes claims about indications for a therapeutic 30 product that have not been approved by the Au- thority under the Rules; or the Rules or information that omits product Orders require to be included in such an adver- tisement when targeted to healthcare practition- 35 ers: (iii) 74 (d) (e) (f) (g) (h) (i) Therapeutic Products and Medicines Bill Part 2 cl 62 targets people who are not healthcare practitioners and makes claims about an active ingredient in a therapeutic product: omits
 information that the Rules or Orders require to be included in the advertisement, or in advertisements of 5 that type, or in advertisements published or broadcast in the circumstances in which the advertisement is pub- lished or broadcast: claims or implies endorsement by a government (in- cluding an overseas government) or government author- 10 ity, or a hospital or other healthcare provider: refers to a therapeutic product that is not subject to a product licence but for which a product licence is re- quired under the Rules: refers to Parts 1 to 5, the Australian Act, the Rules, or 15 the Orders: includes a testimonial that— is falsely attributed; or (i) is not current; or (ii) refers to a type or level of benefit that is not con- 20 (iii) sistent with any indications for the therapeutic product approved by the Authority; or does not include acknowledgement of any pay- ment or other benefit given as consideration for the testimonial.
(iv) 25 Civil penalty provision (2) A person is liable to a civil penalty if the person publishes or (3) broadcasts a proscribed advertisement.

The maximum civil penalty that a person is liable to under subsection (2) is the amount in the second or third column (as 30 appropriate) that corresponds to the proscribed advertisement to which the liability relates, as identified in the first column by reference to a provision of this section.
Type of Individual: proscribed maximum number advertisement penalty units Body corporate: maximum number of penalty units (1)(a) (1)(b) (1)(c) 5 000 5 000 5 000 50 000 50 000 50 000 75 Part 2 cl 62 Therapeutic Products and Medicines Bill Type of proscribed advertisement Individual: maximum number penalty units Body corporate: maximum number of penalty units (1)(d) (1)(e) (1)(f) (1)(g) (1)(h) (1)(i) 5 000 3 000 3 000 2 000 2 000 1 000 50 000 30 000 30 000 20 000 20 000 10 000 Summary offence (4) A person commits an offence if the person— (a) (b) (c) intentionally publishes or broadcasts an advertisement; and the advertisement is a proscribed advertisement identi- 5 fied in any of paragraphs (a), (b), (c), (d), (e), (f), or (i) of subsection (1); and the person knows, or is reckless as to whether, the ad- vertisement is a proscribed advertisement identified in any of those paragraphs.
10 (5) A person who commits an offence under subsection (4) is liable, on summary conviction, to a penalty of up to the maxi- mum specified in the second or third column (as appropriate) that corresponds to the proscribed advertisement to which the liability relates, as identified in the first column by reference 15 to a provision of this section.
Type of proscribed advertisement Individual: maximum number of penalty units Body corporate: maximum number of penalty units (1)(a) (1)(b) (1)(c) (1)(d) (1)(e) (1)(f) (1)(i) 2 000 2 000 2 000 2 000 1 000 1 000 500 10 000 10 000 10 000 10 000 5 000 5 000 2 500 Strict liability offence (6) A person commits an offence if the person— 76 Therapeutic Products and Medicines Bill Part 2 cl 63 (a) (b) intentionally publishes or broadcasts an advertisement; and the advertisement is a proscribed advertisement identi- fied in either of paragraphs (g) or (h) of subsection (1).
5 (7) A person who commits an offence under subsection (6) is liable, on summary conviction, to a penalty of up to the maxi- mum specified in the second or third column (as appropriate) that corresponds to the proscribed advertisement to which the liability relates, as identified in the first column by reference 10 to a provision of this section.
Type of proscribed advertisement Individual: maximum number of penalty units Body corporate: maximum number of penalty units (1)(g) (1)(h) 1 000 500 5 000 2 500 (8) (9) Defence In proceedings for an offence or a civil penalty under this sec- tion it is a defence that— (a) the Rules or Orders provide that the relevant proscribed 15 advertisement may be published or broadcast in speci- fied circumstances; and the defendant published or broadcast the proscribed ad- vertisement in, or in accordance with, those specified circumstances.
20 (b) The defence in subsection (8) is made out if— (a) the defendant points to evidence before the court that the existence of the defence is a reasonable possibility; and the prosecution does not disprove the existence of the 25 defence.

(b) 63 (1) Advertisements for which approval required This section applies only to advertisements for which, under the Rules or Orders, an approval is required.
Civil penalty provision (2) A person is liable to a civil penalty if— 30 (a) the person publishes or broadcasts an advertisement in circumstances specified by the Rules or Orders as cir- 77 Part 2 cl 63 Therapeutic Products and Medicines Bill (b) cumstances in which the advertisement, or advertise- ments of that kind, must have an approval; and the person— (i) does not have an approval for the advertisement; or has an approval, but the advertisement differs from the advertisement as approved; or has an approval that is subject to conditions, and any condition of the approval is not complied with; or has an approval but fails to display the approval number as required.
(ii) (iii) (iv) (3) The maximum civil penalty that a person is liable to under subsection (2) is,— (a) (b) in the case of an individual, 1 000 penalty units; and in the case of a body corporate, 5 000 penalty units.
Strict liability offence (4) A person commits a strict liability offence if— 5 10 15 (a) (b) the person publishes or broadcasts an advertisement in circumstances specified by the Rules or Orders as cir- 20 cumstances in which that advertisement, or advertise- ments of that kind, must have an approval; and the person— (i) does not have an approval for the advertisement; or has an approval, but the advertisement differs from the advertisement as approved; or has an approval that is subject to conditions, and any condition of the approval is not complied with.
25 30 (ii) (iii) (5) A person who commits an offence under subsection (5) is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 1 000 penalty units; and in the case of a body corporate, a fine of up to 5 000 35 penalty units.
(b) 78 Therapeutic Products and Medicines Bill Part 2 cl 64 Exceptions (7) (6) A person does not commit an offence, and is not liable to a civil penalty, under this section if the person is a person who received the advertisement for publication or broadcast in the ordinary course of business.
For the purposes of this section, an advertisement does not differ from the advertisement as approved if the advertisement differs only in respect of one of the following: (a) (b) the price of the therapeutic product: the locations or times at which the therapeutic product 10 is offered for sale: any other information reasonably necessary to identify the person offering the therapeutic product for sale.
(c) 5 64 (1) Advertisements containing restricted representations In this section, restricted representation means a represen- 15 tation, or a representation of a kind, that the Rules or Orders provide must not be included in an advertisement for a thera- peutic product unless the representation has been approved by the Authority.
Civil penalty provision (2) A person is liable to a civil penalty if— 20 (ii) (a) (b) the person publishes or broadcasts an advertisement that contains a restricted representation; and either— (i) the restricted representation has not been ap- 25 proved by the Authority; or the restricted representation has been approved by the Authority but is subject to conditions, and a condition has not been complied with.
The maximum civil penalty that a person is liable to under 30 subsection (2) is,— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
(3) Summary offence (4) A person commits an offence if— 35 (a) the person intentionally publishes or broadcasts an ad- vertisement; and 79 Part 2 cl 65 Therapeutic Products and Medicines Bill the advertisement contains a restricted representation; and the person knows that the advertisement contains a rep- resentation that is a restricted representation, or is reck- less as to that fact; and either— (i) the restricted representation is not approved by the Authority; or the restricted representation is approved by the Authority, but a condition of that approval is not 10 complied with; and (ii) 5 (b) (c) (d) (e) the person knows that, or is reckless as to whether,— (i) if paragraph (d)(i) applies, the restricted repre- sentation is not approved by the Authority; or if paragraph (d)(ii) applies, a condition of the 15 approval is not complied with.
(5) A person who commits an offence under subsection (4) is (ii) liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 2 000 penalty units; and in the case of a body corporate, a fine of up to 10 000 penalty units.

20 (b) 65 (1) Advertising in breach of direction by Authority In this section, direction means a direction that— (a) relates to an advertisement for a therapeutic product; 25 and is made by the Authority under and in accordance with the Rules and Orders.
(b) Civil penalty provision (2) A person is liable to a civil penalty if the person— is issued with a direction; and fails to comply with the direction.

(a) (b) The maximum civil penalty that a person is liable to under subsection (2) is— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
(3) 80 30 35 Therapeutic Products and Medicines Bill Part 2 cl 66 Strict liability offence (4) A person commits a strict liability offence if the person— (a) (b) is issued with a direction; and fails to comply with the direction.

(5) A person who commits a strict liability offence under subsec- 5 tion (4) is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 1 000 penalty units; and in the case of a body corporate, a fine of up to 5 000 penalty units.
(b) 10 66 Failing to comply with information requirement notice Civil penalty provision (1) A person is liable to a civil penalty if the person— (2) (a) (b) is an applicant for, or holder of,— (i) an approval for an advertisement in respect of a 15 therapeutic product; or an approval for the use of a restricted representa- tion in an advertisement; and (ii) is given an information requirement notice by the Au- thority in relation to information concerning the ap- 20 proval; and fails to comply with the notice.
(c) The maximum civil penalty that a person is liable to under subsection (1) is,— (a) in the case of an applicant for, or holder of, an approval 25 for an advertisement,— (i) in the case of an individual, 2 000 penalty units; and in the case of a body corporate, 20 000 penalty units; and (ii) 30 (b) in the case of an applicant for, or holder of, an approval for the use of a restricted representation,— (i) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty 35 units.
(ii) 81 Part 2 cl 67 Therapeutic Products and Medicines Bill Guidelines for setting penalty levels relating to advertising offences and civil penalties This section applies to every court that— (a) imposes a civil penalty on a person under any of sec- tions 62 to 66; or sentences a person who is convicted of an offence under any of sections 62 to 65.
(b) The court must take into account the extent and degree to which the advertisement that is the subject of the proceedings displays any or all of the following characteristics: (a) 5 10 15 the advertisement makes a claim, direct or indirect, about the expected consequences of using a therapeutic product, or about its efficacy, utility, or safety, where the statement cannot be substantiated by the person by scientific evidence: the advertisement makes claims, direct or indirect, about the benefits or risks of using the therapeutic prod- uct, that are manifestly exaggerated or unbalanced, having regard to available scientific evidence: the advertisement makes comparisons, direct or indi- 20 rect, between different therapeutic products, where the claims are manifestly exaggerated or unbalanced, hav- ing regard to available scientific evidence: the advertisement encourages, or is likely to encourage, excessive use of a therapeutic product: the advertisement encourages, or is likely to encourage, use of the therapeutic product for a purpose other than the purpose intended by its manufacturer: the advertisement manifestly exaggerates the need for the product by any person or class of person in respect 30 of a particular disease or condition: the advertisement is calculated, or is likely, to provoke unwarranted fear, shock, or distress in vulnerable indi- viduals: the advertisement is calculated, or is likely, to provoke 35 superstitious or irrational beliefs: the advertisement encourages, or is likely to encourage, persons to engage in conduct that creates a real risk of serious harm to themselves or others.
25 (b) (c) (d) (e) (f) (g) (h) (i) 67 (1) (2) 82 Therapeutic Products and Medicines Bill Part 2 cl 68 (3) Nothing in subsection (2) limits the matters that a court may take into account when sentencing a person or determining the amount of civil penalty the person is liable to pay.
Misrepresentation 68 (1) 5 10 Dealing with counterfeit products In this section, counterfeit product means a product where the label or presentation of the product, any advertisement for the product, or any document or record relating to the product or its manufacture, contains a false representation about any of the following: (a) (b) the identity or name of the product: the formulation, composition, or design specification of the product or of any ingredient or component of the product: the presence or absence of any ingredient or component 15 of the product: the strength or size of the product (other than the size of any pack in which the product is contained): the strength or size of any ingredient or component of the product: the sponsor, source, manufacturer, or place of manufac- ture of the product.
(c) (d) (e) (f) 20 Civil penalty provision (2) A person is liable to a civil penalty if— 25 (a) the person— (i) manufactures a therapeutic product Zealand or Australia; or imports, exports, or supplies a product; and in New (ii) the product is a counterfeit product.

(b) The maximum civil penalty that a person is liable to under 30 subsection (2) is,— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
(3) Indictable offence (4) A person commits an offence if— (a) the person intentionally— 35 83 Part 2 cl 69 Therapeutic Products and Medicines Bill (i) (ii) manufactures a therapeutic product Zealand or Australia, or imports, exports or supplies a therapeutic prod- uct; and in New (b) (c) (d) the person knows, or is reckless as to whether, the prod- 5 uct is a therapeutic product; and the product is a counterfeit product; and the person knows, or is reckless as to whether, the prod- uct is a counterfeit product.
(5) A person who commits an offence under subsection (4) is 10 liable, on conviction on indictment, to,— (a) in the case of an individual, either or both of the follow- ing: (i) (ii) in the case of a body corporate, a fine of up to 10 000 penalty units.
a term of imprisonment of not more than 7 years: a fine of up to 2 000 penalty units; and (b) 15 69 (1) (2) (b) Relief from liability in civil penalty proceedings relating to counterfeit products If civil penalty proceedings are commenced against a person 20 under section 68(2), the High Court may relieve the person, either wholly or partly, from a liability to which the person would otherwise be subject if— (a) the proceedings relate to the import, export, or supply of a therapeutic product; and it appears to the High Court that the person has or may have contravened section 68(2) but that— (i) (ii) the person has a reasonable excuse; and having regard to all the circumstances of the case, the person ought fairly to be excused.
If a person thinks that civil penalty proceedings relating to the import, export, or supply of a therapeutic product will or may be commenced against him or her, the person may apply to the High Court for prospective relief from liability.

25 30 (3) On an application under subsection (2), the High Court may 35 grant prospective relief from liability if subsection (1)(b) ap- plies.
84 Therapeutic Products and Medicines Bill Part 2 cl 70 70 Setting out false product licence number Civil penalty provision (1) A person is liable to a civil penalty if— (a) (b) (c) the person sets out, or causes to be set out, a number on a container or package that contains therapeutic products, 5 or on a label of a therapeutic product; and the number purports to be the unique identifier (as de- fined in the Rules) of the product licence for the thera- peutic product; and the number is not the unique identifier of the product 10 licence for the therapeutic product.
(2) The maximum civil penalty that a person is liable to under subsection (1) is,— (a) (b) in the case of an individual, 100 penalty units; and in the case of a body corporate, 1 000 penalty units.
15 Summary offence (3) A person commits an offence if— (a) (b) (c) (d) the person intentionally sets out, or causes to be set out, a number on a container or package that contains ther- apeutic products, or on a label of a therapeutic product; 20 and the number purports to be the unique identifier of the product licence for the therapeutic product; and the number is not the unique identifier of the product licence for the therapeutic product; and the person knows that the number is not the unique iden- tifier of the therapeutic product, or is reckless as to that fact.
25 (4) A person who commits an offence under this section is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 60 penalty units; and in the case of a body corporate, a fine of up to 300 penalty units.
(b) 30 85 Part 2 cl 71 Therapeutic Products and Medicines Bill 71 Falsely representing that product is subject to product licence Civil penalty provision (1) A person is liable to a civil penalty if the person represents that— (a) (c) (b) a therapeutic product that is not subject to a product licence is in fact subject to a product licence; or a therapeutic product that is not subject to a special pur- pose approval is in fact subject to a special purpose ap- proval; or a therapeutic product that is not exempt from the re- quirement to have a product licence is in fact exempt from the requirement to have a product licence.
The maximum civil penalty that a person is liable to under subsection (1) is,— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
(2) 72 Claiming to supply when product cannot be lawfully supplied Summary offence (1) A person commits an offence if— 5 10 15 20 (a) (b) (c) the person intentionally claims that he or she or another person is, or will be, able to supply a therapeutic prod- uct; and under the Rules, a product licence is required for the 25 supply of the therapeutic product; and there is no product licence for the supply of the thera- peutic product.
(2) A person who commits an offence under subsection (1) is 30 liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 60 penalty units; and in the case of a body corporate, a fine of up to 300 penalty units.
(b) 86 73 (1) (2) Therapeutic Products and Medicines Bill Part 2 cl 73 Product tampering Notifying Authority if product subject to actual or proposed tampering This section applies if a person manufactures or supplies, or is a sponsor of, therapeutic products, or proposes to manufacture, 5 supply, or become a sponsor of, therapeutic products and the person— (a) knows that, or is aware of a substantial risk that, par- ticular therapeutic products are subject to actual or pro- posed tampering; or receives a demand or information in relation to particu- lar therapeutic products and— (i) knows that the information or demand indicates that the therapeutic products are or may be sub- ject to actual or proposed tampering; or is negligent as to whether the information or de- mand indicates that the therapeutic products are or may be subject to actual or proposed tamper- ing.
(ii) (b) 10 15 20 Summary offence If this section applies, a person commits an offence if the per- son intentionally fails to notify the Authority within 24 hours of,— (a) where subsection (1)(a) applies, knowing or becom- ing aware of a substantial risk that the therapeutic prod- 25 ucts are subject to actual or proposed tampering; or (b) where subsection (1)(b) applies, receiving an infor- mation or demand relating to those therapeutic prod- ucts.
(3) A person who commits an offence under subsection (2) is 30 liable, on summary conviction, to— (a) in the case of an individual, either or both of the follow- ing: (i) a term of imprisonment of not more than 12 months: a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 penalty units.
35 (b) 87 Part 2 cl 74 Therapeutic Products and Medicines Bill (4) 74 (1) 5 10 If subsection (1)(b) applies, it is irrelevant whether, at the time of receipt of the information or demand,— (a) the person has possession or control of the therapeutic product or therapeutic products to which the informa- tion or demand relates; or the therapeutic product is, or the therapeutic products are, in existence.
(b) False or misleading information in applications and declarations False or misleading statements in applications In this section, relevant application means any of the follow- ing: (a) an application for a manufacturing licence, a product licence, or a conformity assessment certificate: an application for renewal of a manufacturing licence 15 or product licence: an application for a variation of a manufacturing licence or a product licence: a certification of any matter relating to an application for, or a renewal or variation of, a product licence: a certification of any matter relating to an application for a conformity assessment certificate.
20 (b) (c) (d) (e) Civil penalty provision (2) A person is liable to a civil penalty if— (a) (b) the person makes a statement in, or in connection with, 25 a relevant application; and the statement is false or misleading in a material par- ticular.

(3) The maximum civil penalty that a person is liable to under subsection (2) is— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
Indictable offence (4) A person commits an offence if— (a) (b) the person intentionally makes a statement; and the statement is in, or in connection with, a relevant application; and 30 35 88 Therapeutic Products and Medicines Bill Part 2 cl 75 (c) (d) (e) the person knows, or is reckless as to whether, the state- ment is in, or in connection with, a relevant application; and the statement is false or misleading in a material par- ticular; and the person knows, or is reckless as to whether, the state- ment is false or misleading in a material particular.
5 (5) A person who commits an offence under this section is liable, on conviction on indictment, to,— (a) in the case of an individual, either or both of the follow- 10 ing: (i) (ii) in the case of a body corporate, a fine of up to 20 000 penalty units.
a term of imprisonment of not more than 5 years: a fine of up to 4 000 penalty units; and 15 (6) However, if a person commits an offence under this section in relation to a certificate in relation to a patent in connection with an application for a product licence, then the person is liable, on conviction on indictment, to,— (a) in the case of an individual, either or both of the follow- 20 ing: (i) (ii) in the case of a body corporate, a fine of up to 40 000 penalty units.
a term of imprisonment of not more than 5 years: a fine of up to 8 000 penalty units; and 25 (b) (b) 75 False or misleading statements in declarations relating to conformity assessment procedures Civil penalty provision (1) A person is liable to a civil penalty if— (a) (b) (c) the person manufactures a therapeutic product; and the person makes a statement in, or in connection with, a declaration relating to the application of conformity assessment procedures to the therapeutic product; and the statement is false or misleading in a material par- ticular.
30 35 (2) The maximum civil penalty that a person is liable to under subsection (1) is,— 89 Part 2 cl 76 Therapeutic Products and Medicines Bill (a) (b) in the case of an individual, 3 000 penalty units; and in the case of a body corporate, 30 000 penalty units.
Summary offence (3) A person commits an offence if— (a) (b) (c) (d) (e) (f) 5 the person manufactures a therapeutic product; and the person intentionally makes a statement; and the statement is in, or in connection with, a declar- ation relating to the application of conformity assess- ment procedures applied to a therapeutic product; and the person knows, or is reckless as to whether, the state- 10 ment is in, or in connection with, a declaration relating to the application of conformity assessment procedures applied to a therapeutic product; and the statement is false or misleading in a material par- ticular; and the person knows, or is reckless as to whether, the state- ment is false or misleading in a material particular.
15 (4) A person who commits an offence under this section is liable, on summary conviction, to,— (a) in the case of an individual, either or both of the follow- 20 ing: (i) a term of imprisonment of not more than 12 months: a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 25 penalty units.
(b) Adverse effect information Product licence holders failing to give adverse effect information The civil penalty and offences in this section apply if, under the 30 Rules, the holder of a product licence for a therapeutic product is required, on becoming aware of adverse effect information (as defined in the Rules), to give written notice to the Authority of that information in accordance with the pharmacovigilance requirements set out in the Orders.
35 76 (1) 90 5 10 15 Therapeutic Products and Medicines Bill Part 2 cl 76 Civil penalty provision (2) A person to whom this section applies is liable to a civil penalty if— (a) (b) (c) the person is the holder of the product licence for a ther- apeutic product; and the person becomes aware of adverse effect information relating to the therapeutic product; and the person fails to give the information to the Author- ity— (i) (ii) (iii) in writing; and as soon as he or she becomes aware of it; and in accordance with the pharmacovigilance re- quirements.
(3) The maximum civil penalty that a person is liable to under subsection (2) is,— (a) (b) in the case of an individual, 3 000 penalty units; and in the case of a body corporate, 30 000 penalty units.
Summary offence (4) A person to whom this section applies commits an offence if— (a) (b) (c) the person is the holder of the product licence for a ther- 20 apeutic product; and the person becomes aware of adverse effect information relating to the therapeutic product; and the person intentionally fails to give the information to the Authority— (i) (ii) (iii) in writing; and as soon as he or she becomes aware of it; and in accordance with the pharmacovigilance re- quirements.
25 (5) A person who is convicted of an offence under this section is 30 liable, on summary conviction, to,— (a) in the case of an individual, either or both of the follow- ing: (i) a term of imprisonment of not more than 12 months: (ii) a fine of up to 1 000 penalty units; and in the case of a body corporate, 5 000 penalty units.
35 (b) 91 Part 2 cl 77 Therapeutic Products and Medicines Bill Compliance with information requirement notice 77 78 (1) References to information include references to documents In sections 78 to 84— (a) a reference to giving or providing information includes a reference to giving or providing specific documents; 5 and a reference to information being false or misleading in- cludes a reference to a document that is forged.
(b) Applicants, holders, and former holders failing to comply with information requirement notice This section applies to a person who is— (a) an applicant for, or holder or former holder of, a product licence or conformity assessment certificate in respect of a therapeutic product; or an applicant for a renewal or variation of a product li- 15 cence in respect of a therapeutic product.
(b) 10 Strict liability offence (2) A person to whom this section applies commits a strict liability offence if— (a) the person is given an information requirement notice 20 (as defined in the Rules) relating to the therapeutic prod- uct; and the person fails to comply with the notice.
(3) A person who commits an offence under this section is liable, (b) on summary conviction, to,— (a) in the case of an individual, a fine of up to 500 penalty units; and in the case of a body corporate, a fine of up to 2500 penalty units.
(b) 25 Applicants, holders, and former holders giving false or misleading information This section applies to a person who is— (a) an applicant for, or holder or former holder of, a product licence or conformity assessment certificate in respect of a therapeutic product; or 30 35 79 (1) 92 5 10 15 Therapeutic Products and Medicines Bill Part 2 cl 79 (b) an applicant for a renewal or variation of a product li- cence in respect of a therapeutic product.
Civil penalty provision (2) A person to whom this section applies is liable to a civil penalty if— (a) the person is given an information requirement notice (as defined in the Rules) in relation to a therapeutic product; and the person gives information in purported compliance with the notice; and the information is false or misleading in a material par- ticular.
(b) (c) (3) The maximum civil penalty a person is liable to under sub- section (2) is,— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
Indictable offence (a) (b) (4) A person to whom this section applies commits an offence if— the person is given an information requirement notice (as defined in the Rules) in relation to a therapeutic 20 product; and the person intentionally gives information in purported compliance with the notice; and the information is false or misleading in a material par- ticular; and the person knows, or is reckless as to whether, the in- formation is false or misleading in a material particular.
(5) A person who is convicted of an offence under this section is (d) (c) 25 liable, on conviction on indictment, to,— (a) in the case of an individual, either or both of the follow- 30 ing: (i) (ii) in the case of a body corporate, a fine of up to 20 000 penalty units.
a term of imprisonment of not more than 5 years: a fine of up to 4 000 penalty units; and 35 (b) 93 Part 2 cl 80 Therapeutic Products and Medicines Bill 80 (1) Persons exempt from requirement to hold product licence failing to comply with information requirement notice This section applies to a person who is not required, under the Rules, to have a product licence or conformity assessment certificate in order to import, export, or supply a therapeutic 5 product because— (a) the person holds a special purpose approval in respect of the import, export, or supply of the therapeutic product; or is otherwise exempt under the Rules from the require- 10 ment to hold a product licence or conformity assessment certificate in respect of the import, export, or supply of the therapeutic product.
(b) Summary offence (2) A person to whom this section applies commits an offence if— 15 (a) (b) the person is given an information requirement notice (as defined in the Rules) relating to the therapeutic prod- uct; and the person intentionally fails to comply with the notice.
(3) A person who commits an offence under this section is liable, 20 on summary conviction, to,— (a) in the case of an individual, a fine of up to 400 penalty units; and in the case of a body corporate, a fine of up to 2 000 penalty units.
25 (b) 81 Self-incrimination not ground for refusing to supply information (1) A person to whom section 80 applies is not excused from giving information about a therapeutic product, when required to do so by an information requirement notice (as defined in 30 the Rules), on the ground that the information would tend to incriminate the person or expose the person to a penalty.
Subsection (1) applies despite anything to the contrary in any enactment (including the New Zealand Bill of Rights Act 1990) or rule of law.
(2) 35 (3) However, information referred to in subsection (1), and any other information, document, or other thing, obtained as a di- 94 Therapeutic Products and Medicines Bill Part 2 cl 82 rect or indirect consequence of that information, is not admis- sible in any civil penalty or criminal proceedings against the person, other than civil penalty or criminal proceedings under section 82.
82 (1) Persons exempt from requirement to hold product licence 5 giving false or misleading information This section applies to a person who is not required, under the Rules, to have a product licence or conformity assessment certificate in order to import, export, or supply a therapeutic product because— (a) the person holds a special purpose approval in respect of the import, export, or supply of the therapeutic product; or is otherwise exempt under the Rules from the require- ment to hold a product licence or conformity assessment 15 certificate in respect of the import, export, or supply of the therapeutic product.
(b) 10 Summary offence (2) A person to whom this section applies commits an offence if— (a) (b) the person is given an information requirement notice 20 (as defined in the Rules); and the person intentionally gives information in purported compliance with the notice; and the information is false or misleading in a material par- ticular; and the person knows, or is reckless as to whether, the in- formation is false or misleading in a material particular.
(3) A person who commits an offence under this section is liable, (d) (c) 25 on summary conviction, to,— (a) in the case of an individual, either or both of the follow- 30 ing: (i) a term of imprisonment of not more than 12 months: a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 35 penalty units.
(b) 95 Part 2 cl 83 Therapeutic Products and Medicines Bill 83 (1) Ex-applicant for product licence failing to comply with information requirement notice This section applies to a person whose application for a prod- uct licence, or for a renewal or variation of a product licence, for a therapeutic product has lapsed or been withdrawn.
5 Civil penalty provision (2) A person to whom this section applies is liable to a civil penalty if— (a) (b) the person is given an information requirement notice (as defined in the Rules) relating to the therapeutic prod- 10 uct; and the person fails to comply with the requirements of the notice within the period specified in the notice.
The maximum civil penalty that a person is liable to under subsection (1) is,— (a) (b) in the case of an individual, 3 000 penalty units; and in the case of a body corporate, 30 000 penalty units.
15 (3) Summary offence (4) A person to whom this section applies commits an offence if— (a) (b) the person is given an information requirement notice 20 (as defined in the Rules) relating to the therapeutic prod- uct; and the person intentionally fails to comply with the require- ments of the notice within the period specified in the no- tice.
25 (5) A person who commits an offence under this section is liable, on summary conviction, to,— (a) in the case of an individual, either or both of the follow- ing: (i) a term of imprisonment of not more than 12 30 months: (ii) a fine of up to 1 000 penalty units; and in the case of a body corporate, 5 000 penalty units.
(b) 96 Therapeutic Products and Medicines Bill Part 2 cl 84 84 (1) Ex-applicant for product licence giving false or misleading information This section applies to a person whose application for a prod- uct licence, or for a renewal or variation of a product licence, for a therapeutic product has lapsed or been withdrawn.
5 Civil penalty provision (2) A person to whom this section applies is liable to a civil penalty if— (a) the person is given an information requirement notice (as defined in the Rules) relating to the therapeutic prod- 10 uct; and the person gives information in purported compliance with the notice; and the information is false or misleading in a material par- ticular.
15 (b) (c) (3) The maximum civil penalty that a person is liable to under subsection (2) is,— (a) (b) in the case of an individual, 3 000 penalty units; and in the case of a body corporate, 30 000 penalty units.
Summary offence 20 (a) (b) (4) A person to whom this section applies commits an offence if— the person is given an information requirement notice (as defined in the Rules) relating to the therapeutic prod- uct; and the person intentionally gives information in purported 25 compliance with the notice; and the information is false or misleading in a material par- ticular; and the person knows, or is reckless as to whether, the in- formation is false or misleading in a material particular.
30 (d) (c) (5) A person who commits an offence under this section is liable, on summary conviction, to,— (a) in the case of an individual, either or both of the follow- ing: (i) a term of imprisonment of not more than 12 35 months: a fine of up to 1 000 penalty units; and (ii) 97 Part 2 cl 85 Therapeutic Products and Medicines Bill (b) in the case of a body corporate, a fine of up to 5 000 penalty units.
Compliance with recovery notice 85 (1) Failing to comply with recovery notice In this section and sections 86 and 87, recovery notice 5 means a notice (as defined in the Rules) given by the Authority and requiring the recipient to undertake specified steps involv- ing or related to the recovery of a specified therapeutic product or kind or batch of therapeutic product.
Civil penalty provision (2) A person is liable to a civil penalty if— (3) the Authority gives the person a recovery notice; and the person fails to comply with the recovery notice.

(a) (b) The maximum civil penalty that a person is liable to under subsection (2) is,— (a) (b) in the case of an individual, 5 000 penalty units; and in the case of a body corporate, 50 000 penalty units.
Summary offence (4) A person commits an offence if— (a) (b) the Authority gives the person a recovery notice; and the person knows, or is reckless as to whether, the Au- thority has given the person a recovery notice; and the person intentionally fails to comply with the notice.
(5) A person who commits an offence under subsection (4) is (c) liable, on summary conviction, to,— (a) in the case of an individual, either of both of the follow- ing: (i) a term of imprisonment of not more than 12 months: a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 penalty units.
(b) Indictable offence (6) A person commits an offence if— (a) (b) the Authority gives the person a recovery notice; and the person knows, or is reckless as to whether, the Au- thority has given the person a recovery notice; and 98 10 15 20 25 30 35 Therapeutic Products and Medicines Bill Part 2 cl 86 (c) (d) (e) the person intentionally fails to comply with the notice; and as a result of failing to comply with the notice— (i) use of the therapeutic product referred to in the notice harms any person; or there is a serious risk that use of the therapeutic product will harm any person; and (ii) 5 the person knows, or is reckless as to whether, harm or a serious risk of harm will result from the failure to comply with the notice.
10 (7) A person who commits an offence under subsection (6) is liable, on summary conviction, to,— (a) in the case of an individual, either of both of the follow- ing: (i) (ii) in the case of a body corporate, a fine of up to 20 000 penalty units.
a term of imprisonment of not more than 5 years: 15 a fine of up to 4 000 penalty units; and (b) Strict liability offence (8) A person commits a strict liability offence if— (a) (b) (c) the Authority gives the person a recovery notice; and the person fails to comply with the notice; and as a result of failing to comply with the notice, use of the therapeutic product referred to in the notice harms or is likely to harm any person.
(9) A person who commits a strict liability offence under this sec- 20 25 tion is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 2 000 penalty units; and in the case of a body corporate, a fine of up to 10 000 30 penalty units.
(b) 86 (1) Relief from civil liability for failing to comply with recovery notice If civil penalty proceedings are commenced against a person under section 85(2), the High Court may relieve the person, 35 either wholly or partly, from a liability to which the person would otherwise be subject if— 99 Part 2 cl 87 Therapeutic Products and Medicines Bill (a) (b) the recovery notice to which the proceedings relate was issued on the grounds of actual or proposed tampering; and it appears to the High Court that the person has or may have contravened section 85(2) but that— (i) (ii) the person has acted honestly; and having regard to all the circumstances of the case, the person ought fairly to be excused.
If a person thinks that civil penalty proceedings relating to a recovery notice issued on the grounds of actual or proposed 10 tampering will or may be commenced against him or her, the person may apply to the High Court for prospective relief from liability.

5 (2) (3) On an application under subsection (2), the High Court may grant prospective relief from liability if subsection (1)(b) ap- 15 plies.
87 Export or supply of therapeutic products subject to recovery notice Summary offence (1) A person commits an offence if— 20 (a) (b) (c) (d) (e) the person intentionally exports or supplies a therapeu- tic product; and the therapeutic product is, at the time of its export or supply, subject to a recovery notice (as defined in the Rules); and the recovery notice had been issued because the Au- thority was satisfied that the therapeutic product was, or therapeutic products in that batch were, subject to actual or proposed tampering; and the person knows that the therapeutic product is subject 30 to a recovery notice at the time of its export or supply, or is reckless as to that fact; and the Authority has not consented in writing to the supply or export (as the case may be) of the therapeutic product or therapeutic products in that batch.
35 25 (2) A person who is convicted of an offence under subsection (1) is liable, on summary conviction, to,— 100 5 10 15 Therapeutic Products and Medicines Bill Part 2 cl 88 (a) (b) in the case of an individual, either or both of the follow- ing: (i) a term of imprisonment of not more than 12 months: a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 penalty units.
Information about sponsors 88 Identifying sponsor when required to do so Civil penalty provision (1) A person is liable to a civil penalty if— (a) (b) (c) (d) the person manufactures, imports, exports, or supplies a therapeutic product; and the person claims not to be the sponsor of the therapeu- tic product; and the person is required by the Authority, in accordance with the Rules, to provide information about the identity of the sponsor of the therapeutic product, and the person— (i) fails to provide that information within the time 20 specified by the Authority; or provides information that is false or misleading in a material particular.
(ii) (2) The maximum civil penalty that a person is liable to under subsection (1) is,— (a) (b) in the case of an individual, 3 000 penalty units; and in the case of a body corporate, 30 000 penalty units.
25 Summary offence (3) A person commits an offence if— (a) (b) (c) (d) the person manufactures, imports, exports, or supplies 30 and therapeutic product; and the person claims not to be the sponsor of the therapeu- tic product; and the person is required by the Authority, in accordance with the Rules, to provide information about the identity 35 of the sponsor of the therapeutic product, and the person intentionally— 101 Part 2 cl 89 Therapeutic Products and Medicines Bill (i) (ii) fails to provide that information within the time specified by the Authority; or provides information that is false or misleading in a material particular.
(4) A person who commits an offence under this section is liable, 5 on summary conviction, to— (a) in the case of an individual, either or both of the follow- ing: (i) a term of imprisonment of not more than 12 months; or a fine of up to 1 000 penalty units; and (ii) in the case of a body corporate, a fine of up to 5 000 penalty units.
(b) Subpart 3—Non-compliance notices and enforceable undertakings Non-compliance notices 10 15 Authority may issue non-compliance notice The Authority may issue a non-compliance notice to a person if, within the 12 months preceding the issue of the notice, the person has engaged in conduct that the Authority has reason- 20 able cause to believe— (a) renders the person liable to a civil penalty under this Part; or constitutes a strict liability offence against this Part.
(b) Every non-compliance notice must— (a) specify the monetary penalty to be paid in respect of the conduct described in the notice; and be in the form prescribed by regulations made under section 95.
(b) 25 The Authority may not issue a non-compliance notice to a per- 30 son in respect of particular conduct if— (a) civil penalty or criminal proceedings relating to that conduct have been commenced in New Zealand or Aus- tralia (whether or not they have been concluded) and have not been withdrawn; or 35 89 (1) (2) (3) 102 Therapeutic Products and Medicines Bill Part 2 cl 92 (b) a non-compliance notice relating to that conduct has already been issued in New Zealand or Australia and it has not been withdrawn.
Authority may withdraw non-compliance notice The Authority may withdraw a non-compliance notice at any 5 time before the monetary penalty specified in the notice is paid in full.

Date by which monetary penalty must be paid The date by which the monetary penalty specified in a non- compliance notice is to be paid is the date that is 28 days after 10 the date of the notice, or any later date specified by the Au- thority.
If the recipient of the non-compliance notice makes submis- sions to the Authority before the date referred to in subsec- tion (1), the date by which the monetary penalty is to be paid 15 (assuming that the Authority does not withdraw the notice) is the date that is 14 days after the date on which the Authority responds to the submissions.
(b) Amount and payment of monetary penalty The monetary penalty specified in a notice issued in respect of 20 liability to a civil penalty must be determined by the Authority, but may not exceed,— (a) in the case of an individual, one tenth of the maximum civil penalty that could be imposed on an individual for contravening the relevant civil penalty provision; and in the case of a body corporate, one tenth of the maxi- mum civil penalty that could be imposed on a body cor- porate for contravening the relevant civil penalty.
The monetary penalty specified in respect of conduct consti- tuting a strict liability offence must be determined by the Au- 30 thority, but may not exceed,— (a) in the case of an individual, one fifth of the maximum fine that could be imposed on an individual convicted of the relevant offence; and 25 90 91 (1) (2) 92 (1) (2) 103 Part 2 cl 93 Therapeutic Products and Medicines Bill (b) in the case of a body corporate, one fifth of the maxi- mum fine that could be imposed on a body corporate convicted of the relevant offence.
(3) A monetary penalty is payable to the Crown.
93 Non-compliance notice is bar to proceedings unless not paid by due date 5 (1) No civil penalty or criminal proceedings may be taken against the recipient of a non-compliance notice (whether the notice was issued in New Zealand or in Australia) in respect of con- duct referred to in the notice— (a) before the date by which the monetary penalty is to be paid (as determined under section 92 or the Australian Act, as the case requires); or if the recipient pays the specified amount by the date on which the monetary penalty is to be paid.
(b) 10 15 Subsection (1) does not apply if, before the date by which the monetary penalty is to be paid, the Authority withdraws the notice.
Payment of monetary penalty not admission of guilt or liability The fact that the recipient of a non-compliance notice pays the monetary penalty specified in the notice is not to be taken by the Authority or any court as an admission by the recipient that he or she is or was liable to any civil penalty for the conduct referred to in the notice, or had committed a strict liability 25 offence by that conduct.
20 Regulations prescribing form of non-compliance notice The Governor-General may, by Order in Council, make regu- lations prescribing the form of non-compliance notices.
Every non-compliance notice must (without limitation) set out 30 or provide for the following: (a) (b) the name of the recipient: the contact details of the officer authorised to deal with the notice: (2) 94 95 (1) (2) 104 (c) (d) (e) (f) (g) (h) (i) Therapeutic Products and Medicines Bill Part 2 cl 95 a description of the conduct giving rise to the notice, in- cluding the time and place (if known) when the conduct is alleged to have occurred: the amount of the monetary penalty to be paid: the date by which the monetary penalty is to be paid: a statement of whether the Authority believes that the conduct referred to— renders the recipient liable to a civil penalty; or (i) (ii) constitutes a strict liability offence: the matters referred to in subsection (3): if the conduct relates to liability for a civil penalty,— (i) the reason for setting the monetary penalty at the level specified in the notice; and the maximum penalty that the recipient would be liable to pay if found liable to a civil penalty: (ii) 5 10 15 if the conduct relates to a strict liability offence,— (i) the reason for setting the monetary penalty at the level specified in the notice; and the maximum fine that the recipient would be liable to pay if found guilty of the strict liability 20 offence.
(ii) (3) Every non-compliance notice must inform the recipient— (a) that if the monetary penalty is not paid within the re- quired time, civil or criminal proceedings may be com- menced against the recipient in respect of the conduct 25 referred to in the notice; and that the recipient should make written submissions to the Authority if he or she wishes to explain why the notice should be withdrawn; and that the Authority will respond in writing to any sub- 30 missions made, but if the notice is not withdrawn then the monetary penalty must be paid within 14 days after the Authority responds; and that payment of the monetary penalty may not be taken by the Authority or any court as an admission by the 35 recipient of liability for a civil penalty or as guilt of the strict liability offence, as the case may be.
(b) (c) (d) 105 Part 2 cl 96 Therapeutic Products and Medicines Bill Enforceable undertakings 96 (1) Giving enforceable undertaking The Authority may accept a written undertaking (an enforce- able undertaking) given by a person in connection with a matter in relation to which the Authority has a power or func- 5 tion relating to the regulation of therapeutic products.

(2) A person who has given an enforceable undertaking may with- draw or vary it at any time, but only with the consent of the Authority.
The Authority must publish on the Internet details of every 10 enforceable undertaking currently in force.

(3) 97 (1) (2) Consequence of breach of enforceable undertaking If the Authority considers that the person who gave an enforce- able undertaking has breached any of its terms, the Authority may apply to the High Court for an order under subsection 15 (2).
If the Court is satisfied that the person has breached a term of the undertaking, the Court may make all or any of the follow- ing orders: (a) an order directing the person to comply with the term of 20 the undertaking: an order directing the person to pay to the Crown an amount up to the amount of any financial benefit that the person has obtained directly or indirectly and that is reasonably attributable to the breach: any order (subject to subsection (3)) that the Court considers appropriate directing the person to compen- sate any other person who has suffered loss or damage as a result of the breach: any other order that the Court considers appropriate.
25 30 (b) (c) (d) (3) An order for compensation may not be made under subsec- tion (2)(c) if the person who suffered the loss or damage would be prevented by section 317 or 318 of the Injury Preven- tion, Rehabilitation, and Compensation Act 2001 from bring- ing proceedings for damages in respect of the loss or damage 35 suffered.
106 Therapeutic Products and Medicines Bill Part 2 cl 98 (4) An application may not be made under subsection (1) in re- spect of a breach of an enforceable undertaking if the Author- ity has applied to a court in Australia under the equivalent pro- vision in the Australian Act in respect of the breach, unless the Australian proceedings are discontinued or stayed by the Aus- 5 tralian court on the ground that the application should be made in New Zealand.
98 10 (c) Subpart 4—Search and seizure Definition of terms used primarily in subparts 4 and 5 In Parts 1 to 5, unless the context otherwise requires,— authorised officer means a person appointed under section 99 document means any record of information, and includes— anything on which there is writing or any image; and (a) anything on which there are marks, figures, symbols, or 15 (b) perforations that have a meaning for persons qualified to interpret them; and anything from which sounds, images, or writing can be reproduced, with or without the aid of anything else dwelling house means a building, or an apartment, flat, or unit 20 within a building, that is used as a private residence and is not used for any commercial purpose associated with therapeutic products evidential material means any thing that there are reasonable grounds for believing is or may be evidence, or may provide 25 or contain evidence, of— (a) (b) (c) occupier, in relation to any place, includes— (a) an offence under this Part; or an attempt to commit an offence under this Part; or the contravention of a civil penalty provision a person who is present at the place and is in apparent control of it; and any person acting on behalf of the occupier (b) place means anywhere on, under, or over any land or water, and includes all or any part of a building, structure, or con- 35 veyance seize includes to secure against interference 30 107 Part 2 cl 99 Therapeutic Products and Medicines Bill thing includes— (a) any substance, article, document, container, or equip- ment; and anything in electronic or magnetic form.
(b) Authorised officers 5 99 Appointment of authorised officers The Managing Director may appoint any person as an author- ised officer for all or specified purposes under Parts 1 to 5.

100 (1) Issue of identity cards to authorised officers The Managing Director must issue every authorised officer 10 with an identity card.

The identity card must be in a form prescribed by the Rules and must carry a photograph of the authorised officer.
(3) An authorised officer must carry his or her identity card at all (2) times when acting as an authorised officer under Parts 1 to 5.

15 (4) A person who has been issued with an identity card commits an offence, and is liable, on summary conviction, to a fine not exceeding 50 penalty units if he or she fails, without reason- able excuse, to return his or her identity card to the Managing Director immediately upon ceasing to be an authorised officer.
20 Entry, search, and seizure without warrant 101 Searches for monitoring purposes (1) An authorised officer may, at any reasonable time, enter a place (other than a dwelling house or marae) in order to moni- tor compliance with the Rules and Orders.
25 (2) An authorised officer who enters a place under subsection (1) may do any of the following: (a) (b) search the place and any thing at the place: inspect, examine, and take measurements of any thing at the place that relates to the manufacture, import, export, 30 supply, or promotion of therapeutic products: test things, and take samples of things, for the purpose of testing or analysis: (c) 108 (3) Therapeutic Products and Medicines Bill Part 2 cl 102 (d) (e) (f) take photographs and video recordings, and make sketches, of the place or any thing at the place: inspect any document at the place: take into or onto the place whatever equipment and ma- terial the authorised officer requires for the search.
If, during a search under this section, an authorised officer forms the reasonable belief that an offence or a contravention of a civil penalty provision under Parts 1 to 5 has been, is being, or is likely to be committed at the place, the officer may— (a) (b) seize any evidential material; and require the occupier to do either or both of the follow- ing: (i) hold any thing at the place in an unaltered state for a specified period of up to 5 working days: provide a copy of particular documents within a specified period (which must be a period that is reasonable in the circumstances).
(ii) 102 Entry and search on serious public health grounds without search warrant 5 10 15 20 (1) An authorised officer or a member of the police may enter any place (other than a dwelling house or a marae) if the authorised officer or member of the police has reasonable grounds for believing that— (a) an offence or a contravention of a civil penalty provision 25 under Parts 1 to 5 has been, is being, or is likely to be committed at the place; and it is necessary in the interests of public health to exercise powers under this section in order to avoid an imminent risk of death, serious illness, or serious injury; and it is not practicable in the circumstances to obtain a search warrant.
30 (b) (c) (2) An authorised officer who enters a place under this section may exercise the powers listed in section 101(2) and (3).

109 Part 2 cl 103 Therapeutic Products and Medicines Bill 103 Searches at request of manufacturer (1) The occupier of a place at which therapeutic products are be- ing manufactured may ask the Authority to arrange for an au- thorised officer to inspect the place.

(2) An authorised officer may make an inspection in accordance 5 with arrangements under subsection (1).
Search warrants 104 Search warrant to seize evidential material (1) A District Court Judge, Justice of the Peace, Community 15 20 Magistrate, or Registrar may issue a search warrant in respect 10 of a place if satisfied that— (a) there are reasonable grounds for believing that there is evidential material at that place; or a search is unable to be undertaken or completed under section 101.

(b) (2) (3) The application for the warrant must be made in writing, on oath, by an authorised officer.
Every search warrant must be in the form prescribed by regu- lations made under Parts 1 to 5 and be directed to— (a) (b) (c) an authorised officer by name; or a member of the police by name; or every member of the police.

(4) Despite a warrant being directed to another person under sub- section (3), it may be executed by any member of the police.

The Judge, Justice of the Peace, Community Magistrate, or 25 Registrar issuing the warrant may impose reasonable condi- tions on its execution.
(5) 105 Powers under search warrant (1) A search warrant issued under section 104 authorises the au- thorised officer or member of the police who is executing it, 30 and any person called on by that officer or member to assist, to do any of the following: (a) enter and search the place at any reasonable time, on 1 occasion within 14 days after the date of the warrant being issued: use reasonable force to— 35 (b) 110 (c) (d) (e) (f) (g) (h) (i) (j) (b) Therapeutic Products and Medicines Bill Part 2 cl 105 (i) (ii) make entry (for example, by breaking open a door); and open any thing at the place that it is reasonable in the circumstances to open: 5 search the place and any thing at the place: seize any evidential material found at the place: inspect, examine, and take measurements of any thing at the place: test things, or take samples of things, or require the oc- cupier to supply samples of things, for the purpose of 10 testing or analysis: take photographs and video recordings, and make sketches of, the place or any thing at the place: inspect and copy any document; and for that purpose may also do any of the following: (i) 15 require any person at the place to produce a par- ticular document: require any person at the place who has control or knowledge of a document to reproduce, or assist in reproducing, the document in usable form: operate any equipment at the place: remove a document temporarily to another place in order to copy it: (ii) (iii) (iv) 20 take into or onto the place whatever equipment and ma- terials the authorised officer or member of the police re- 25 quires for the search: require the occupier of the place to answer any ques- tions put by the authorised officer or member of the po- lice.
(2) An authorised officer or member of the police may require the 30 occupier of the place to do the following: (a) hold any thing at the place in an unaltered state for a specified period of up to 5 working days: provide a copy of particular documents within a speci- fied period (which must be a period that is reasonable 35 in the circumstances).

(3) Nothing in this section limits or affects the privilege against self-incrimination.
111 Part 2 cl 106 Therapeutic Products and Medicines Bill Conduct of entry, search, and seizure 106 Assistance with searches (1) An authorised officer or member of the police may ask any person to assist the authorised officer or member of the police with a search under this Part.

5 (2) A person who assists an authorised officer or member of the police must be under the supervision of an authorised officer or member of the police.
107 Authorised officers to show identity card on request (1) An authorised officer must produce his or her identity card (as 10 issued under section 100) for inspection— (a) (b) on entering a place under this Part; and at any later time, on request, during a search under this Part.

(2) An authorised officer who fails to comply with subsection 15 (1) ceases to be authorised to enter the place or to exercise any power under Parts 1 to 5 with respect to the search.
108 Announcement before entry (1) (2) This section applies whenever an authorised officer or member of the police enters a place pursuant to a provision of this Part, 20 unless the entry is made by consent.

Before entering the place, the authorised officer or member of the police must— (a) announce that he or she is authorised to enter the place; and give any person at the place an opportunity to consent to the entry.
(b) (3) However, subsection (2) does not apply if the authorised of- ficer or member of the police believes on reasonable grounds that— (a) announcing entry would frustrate the purpose of the en- try; or immediate entry to the place is required to ensure the safety of any person.
(b) 112 25 30 Therapeutic Products and Medicines Bill Part 2 cl 112 109 Details of warrant to be given to occupier If a place is being searched under a warrant, the authorised officer or member of the police must give a copy of the warrant to the occupier or, if no person is present at the time, must leave a copy of the warrant in a prominent situation, marked for the 5 attention of the occupier.
110 Occupier entitled to be present during search (1) The occupier of a place that is subject to a search under this Part, and who is present at any time during the search, is en- titled to observe the search as it is being carried out.

The right to observe the search ceases if the person observing impedes the search.

This section does not prevent 2 or more parts of the place being searched at the same time.
(2) (3) 111 Use of electronic equipment (1) If an authorised officer, member of the police, or person as- sisting a search operates electronic equipment found at a place during a search, the officer, member, or person must take all reasonable care not to damage the equipment or corrupt infor- mation stored on it.
If, as a result of a failure to take the care required by subsec- tion (1), the owner of equipment or information, or the occu- pier of the place that was searched, suffers damage, the owner or occupier may seek damages from the Authority in respect of that damage.
(2) 10 15 20 25 112 Copies of documents seized to be provided (1) When a document that is capable of being copied is seized from a place, it must (if practicable) be copied before the ori- ginal is removed, and the copy must be left at the place.

If it is not practicable to copy the document before removing 30 it, it must be copied as soon as practicable after it is removed, and (if practicable) the copy must be promptly delivered to the occupier of the place.
Subsection (1) does not apply— (3) (2) 113 Part 2 cl 113 Therapeutic Products and Medicines Bill (a) (b) (c) to documents obtained as a result of operating electronic equipment found at the place, if the equipment is not seized and the documents remain stored on it; or to any documents which it is or may be an offence or a contravention of a civil penalty provision to possess; or 5 if an order under subsection (4) has been made.
(4) A District Court Judge, Community Magistrate, or Justice of the Peace may make an order waiving the application of sub- sections (1) and (2) if satisfied that the volume of material to be copied is such that copying it will involve substantial cost, 10 and that the cost is not justified.

(5) An order under subsection (4) may be subject to whatever conditions the person making the order thinks are necessary to protect the interests of the person from whom the documents have been seized.
15 113 Receipts for things seized (1) A person who seizes any thing during a search under this Part must provide the occupier with a receipt for the thing seized.

(2) A single receipt may be given for more than one thing.
What happens to things seized 20 114 Return and retention of things seized (1) An authorised officer or member of the police must (subject to any order of a court) immediately return any thing seized under this Part to the person from whom it was seized if— (a) the thing was seized during a search without a warrant 25 under section 101 or 102; and either the reason for its seizure no longer exists or it is decided that the thing is not to be used in evidence.
(b) If a thing has not been returned under subsection (1) within 90 days of its seizure, the authorised officer must return the 30 thing unless— (a) proceedings in respect of which the thing may afford evidence were instituted within 90 days of its seizure, and those proceedings (including any appeal) have not been completed, or the time within which an appeal may 35 be lodged in those proceedings has not expired; or (2) 114 Therapeutic Products and Medicines Bill Part 2 cl 115 (c) (b) there is an order in force under section 115 in respect of the thing; or the authorised officer or member of the police is other- wise authorised to retain, destroy, or dispose of the thing other than by returning it to the person from whom it 5 was seized; or the person to whom it is to be returned cannot be found or does not wish to take back the thing.
(3) A thing may be returned conditionally or under such terms and (d) conditions as the Managing Director thinks fit.

10 (4) A thing may not be returned if it is, or is liable to be, forfeited to the Crown.

115 Order to retain things seized (1) If an authorised officer or member of the police wishes to retain any thing seized under this subpart for more than 90 days, he 15 or she may apply to a District Court for an order under this section.
(2) A District Court Judge, Community Magistrate, or Justice of the Peace may make an order under this section if he or she is satisfied that retention of the thing is necessary for— (a) the purpose of investigating an alleged offence or a contravention of a civil penalty provision under this Part; or as evidence of an alleged offence or a contravention of a civil penalty provision under this Part; or to secure evidence of an alleged offence or a contraven- tion of a civil penalty provision under this Part.
(b) (c) 20 25 (3) An order under this section may be for any period of up to 4 years.

If made for a shorter period, it may be renewed at any interval, but the total period of the order, with any renewals, 30 may not exceed 4 years.
Before making an application, the authorised officer or mem- ber of the police must— (a) (4) take reasonable steps to discover who has an interest in the thing; and if practicable, notify each person whom the authorised officer or member of the police believes to have such an (b) 35 115 Part 2 cl 116 Therapeutic Products and Medicines Bill interest in the proposed application and any application for a renewal.
116 Forfeiture on conviction or imposition of civil penalty (1) If a person is convicted of an offence under this Part, or is ordered to pay a civil penalty under this Part, a court may order 5 that the following be forfeited to the Crown: (a) any therapeutic product or substance to which the con- viction or civil penalty order relates: any packages or containers containing the therapeutic product or substance.
(b) 10 (2) Any thing forfeited to the Crown under this section must be disposed of as the Minister directs.

Testing and analysis of samples Samples for testing or analysis 117 (1) An authorised officer who obtains a sample for testing or ana- 15 lysis, other than under a search warrant, must, either before or immediately after taking the sample, inform the owner of the sample, or the person from whom it was obtained, that the sample may be submitted for testing or analysis.
If the authorised officer fails to comply with subsection (1), 20 the results of any testing or analysis of the sample may not be used in any proceedings for an offence or civil penalty under Parts 1 to 5.

(2) (3) A sample taken for the purpose of testing or analysis does not (4) have to be submitted for testing or analysis.

If a sample is not submitted for testing or analysis, it must be treated in the same way as any other thing that is seized.
Compare: 1981 No 118 s 69(5)(a) 25 118 Analysis and testing of samples in accordance with Rules and Orders The analysis and testing of samples under this Part must be conducted in accordance with the Rules and Orders.

30 116 Therapeutic Products and Medicines Bill Part 2 cl 120 119 Evidence of analysis (1) In any proceedings under Parts 1 to 5, a certificate of analysis issued in accordance with the Rules and Orders is conclusive proof of the matters set out or stated in the certificate.
(2) However, a certificate is admissible in evidence only if— 5 (a) (b) (c) at least 14 days before the hearing at which the cer- tificate is given in evidence, a copy of the certificate (in addition to any copy served with any summons) is served by the prosecutor; and at the same time, the defendant is informed in writing 10 that prosecutor does not propose to call the analyst as a witness at the hearing; and the defendant does not, by notice in writing to the pros- ecutor at least 7 days before the hearing, require the ana- lyst to be called by the prosecutor as a witness at the 15 hearing.
(3) A certificate is not admissible in evidence if a court, of its own motion, directs that the result of the analysis must be disre- garded unless the result is proved by the oral evidence of the analyst.

(4) A certificate of analysis may not be ruled inadmissible or be disregarded by reason only of the fact that the Rules and Orders relating to the taking or analysing of samples have not been strictly complied with, if there has been reasonable compliance with the Rules and Orders.
Compare: 1981 No 118 s 71 20 25 120 Cost of testing and analysis (1) If a person is convicted of an offence under this Part, or is ordered to pay a civil penalty under this Part, a court may order that all fees and other expenses incidental to the testing or ana- 30 lysis of any article or substance must be paid by the defendant.

The fees and expenses are part of the costs attending the con- viction or order to pay the civil penalty and are recoverable accordingly.
(2) 117 Part 2 cl 121 Therapeutic Products and Medicines Bill Offences relating to search and seizure 121 Offences relating to search and seizure (1) A person commits an offence if he or she intentionally does any of the following: (a) actively or passively obstructs an authorised officer, 5 member of the police, or person assisting during the exercise of a power under this Part: fails to comply with a requirement under section 101(3)(b), 105(1)(j), or 105(2): removes, alters, or interferes with any thing seized 10 under this Part: tampers with any sample or container of a sample taken under this Part: (b) (c) (d) (e) misleads an authorised officer, member of the police, or person assisting as to the whereabouts of any thing, the 15 operation of any equipment, or how to gain access to any thing.
(2) A person who commits an offence under this section is liable, on summary conviction, to a term of imprisonment of up to 3 months, a fine of up to 200 penalty units, or both.
20 Subpart 5—Miscellaneous Information sharing for law enforcement purposes 122 Disclosure of information (1) The purpose of this section is to ensure that New Zealand gov- 25 ernment agencies and the Authority are able to disclose infor- mation to each other for the purpose of ensuring compliance with the law, and for law enforcement purposes.
(2) Despite privacy principles 2 and 11 of the Privacy Act 1993, an approved agency, or an officer or employee of an approved 30 agency, may disclose to any other approved agency, or officer or employee of that agency, any information supplied or ob- tained under or for the purposes of an enactment listed in sub- section (4)(b), if the disclosure of that information is neces- sary or desirable for the purpose of ensuring compliance with 35 the law, or for law enforcement purposes.
118 Therapeutic Products and Medicines Bill Part 2 cl 124 (3) Nothing in subsection (2) authorises the disclosure of com- (4) mercially sensitive information.
In this section, approved agency means— (a) (b) the Authority; and a government agency exercising powers or functions 5 under any of the following: (i) (ii) Agricultural and Veterinary Compounds this Act: Medicines Act 1997: (iii) Biosecurity Act 1993: (iv) Customs and Excise Act 1996: (v) (vi) Hazardous Substances and New Organisms Act Food Act 1981: 1996; and (c) (vii) Medicines Act 2006; and any other individual or agency involved in monitoring therapeutic products.
Customs 123 Right to inspect therapeutic products imported or for export (1) An authorised officer may inspect any therapeutic product, and any documents associated with the import or export of the ther- apeutic product, if the therapeutic product is in a customs con- trolled area (as that term is defined in the Customs and Excise Act 1996).
The power to inspect includes the power to do anything neces- sary to determine whether or not the Rules, Orders, and any regulations made under Parts 1 to 5, so far as they relate to the import or export of the therapeutic product, are being com- plied with.
(2) 10 15 20 25 30 124 Non-compliant therapeutic products held at customs (1) controlled area This section applies if an authorised officer believes on rea- sonable grounds that a therapeutic product imported into New Zealand, or for export from New Zealand, does not comply 35 with the Rules, Orders, or any regulations made under Parts 119 Part 2 cl 124 Therapeutic Products and Medicines Bill 1 to 5, or constitutes a risk to public health (a non-compliant therapeutic product).
(2) An authorised officer may seize a non-compliant therapeutic product and deal with it in accordance with— (a) any Rules or Orders relating to the disposal, treatment, 5 destruction, or other dealing with non-compliant thera- peutic products; or a direction by the Authority in a particular case.

(b) The authorised officer may offer to return a therapeutic product to its place of origin; and, if the offer is accepted, the importer 10 or exporter must pay the costs associated with that return.
The authorised officer may arrange, at the request of the im- porter or exporter, to hold a therapeutic product that has been seized in order to allow the importer or exporter to satisfy the requirements that will permit the therapeutic product to be im- 15 ported into, or exported from, New Zealand.

If therapeutic products are held under subsection (4), the importer or exporter must pay to the Authority, in advance, the estimated costs of holding and maintaining the products in New Zealand.
In exercising powers under this section, an authorised officer must, so far as is practicable, act in a manner that avoids or minimises the loss to the importer or exporter of any therapeu- tic products that are seized.

The costs and expenses incurred by the Authority as a result 25 of holding and disposing of therapeutic products seized under this section are the liability of the importer or exporter, and are recoverable as a debt due to the Authority.
20 (3) (4) (5) (6) (7) (8) However, the Authority may waive payment of the costs and expenses referred to in subsection (7) if the Authority is 30 satisfied that the importer or exporter believed on reasonable grounds that the proposed importation into, or export from, New Zealand complied with all applicable Rules, Orders, and regulations made under Parts 1 to 5.
120 Therapeutic Products and Medicines Bill Part 2 cl 125 125 Special provisions relating to consignments (1) When an authorised officer takes a sample of a therapeutic product at a port for the purpose of analysis or testing, the following applies: (a) (b) (c) (d) (e) 10 the authorised officer must immediately notify the im- 5 porter or exporter that a sample has been taken: the authorised officer must direct the Customs to detain the remainder of the consignment in the port under the Control of the Customs until the analysis or testing has been completed: the consignment may, with the approval of the author- ised officer and a Customs officer, be removed at the expense of the importer or exporter from the port to a specified place, if the importer or exporter undertakes in writing, in a form approved by the authorised officer, 15 that the importer or exporter will detain the consign- ment for as long as is necessary to obtain the results of the analysis or testing: if the consignment is in a bulk cargo container, the au- thorised officer may, with the agreement of a Customs 20 officer, approve the removal of the container to a speci- fied place: if a consignment is moved under paragraph (c) or (d), the authorised officer must mark it to indicate that it may be dealt with only by an authorised officer or Customs 25 officer.
(2) If, as a result of the analysis or testing, the authorised offi- cer reasonably believes that the consignment does not comply with the requirements of the Rules, Orders, or any product li- cence, the authorised officer may— seize and detain the goods; or (a) order the goods to be returned by the importer or ex- (b) porter to their place of origin, or to some other place outside New Zealand or Australia; or permit the goods to be released subject to conditions, 35 including conditions that a new label be substituted for any existing label relating to the therapeutic products.
(3) When goods are seized under this section, the authorised offi- (c) 30 cer must— 121 Part 2 cl 126 Therapeutic Products and Medicines Bill (a) (b) serve notice on the importer or exporter that the goods have been seized; and serve a copy of the notice on the Customs, who must en- sure that the goods are not delivered from the control of the Customs without the written consent of the officer.
5 Compare: 1981 No 118 s 72(1), (2), (3) 126 Relationship with Customs and Excise Act 1996 (1) Nothing in Parts 1 to 5 limits or affects the Customs and (2) (3) (4) Excise Act 1996.

The import or export of a therapeutic product in breach of any 10 requirement of the Rules or Orders, or of a product licence, is, for the purposes of the Customs and Excise Act 1996, the importation or exportation of a prohibited good.
It is the duty of every officer of the Customs to— (a) (b) assist in carrying out the provisions in section 125; and 15 prevent the introduction into New Zealand of anything contrary to the Rules.

For the purpose of carrying out the duties in subsection (3), an officer of the Customs may exercise his or her powers under the Customs and Excise Act 1996 in relation to uncustomed or 20 prohibited goods.
Compare: 1981 No 118 s 72(1)(g), (4) Patents 127 Therapeutic products protected by Australian patents To avoid doubt, the fact that a therapeutic product is protected 25 by an Australian patent does not in itself prevent any person marketing the product in New Zealand.
Part 3 Administrative law matters 128 Definitions of terms used primarily in this Part 30 In Parts 1 to 5, unless the context otherwise requires,— Australian Ombudsman means the Commonwealth Om- budsman appointed under the Australian Ombudsman Act 122 Therapeutic Products and Medicines Bill Part 3 cl 128 Australian Ombudsman Act means the Ombudsman Act 1976 of the Commonwealth of Australia Australian Privacy Act means the Privacy Act 1988 of the Commonwealth of Australia Australian Privacy Commissioner means the Privacy Com- 5 missioner appointed under the Australian Privacy Act Australian Review Tribunal means the Australian Review Tribunal provided for by the Australian Act, in accordance with Article 13 of the Agreement, to conduct merits reviews Deputy Australian Ombudsman means a Deputy Ombuds- 10 man appointed under the Australian Act Merits Review Panel means the Merits Review Panel ap- pointed by the Ministerial Council under paragraph 5 of Art- icle 13 of the Agreement New Zealand Ombudsman means an Ombudsman appointed 15 under the Ombudsmen Act 1975 New Zealand Privacy Commissioner means the Privacy Commissioner appointed under the Privacy Act 1993 principal member means the member of the Merits Review Panel who is designated by the Ministerial Council, in accord- 20 ance with paragraph 6 of Article 13 of the Agreement, as the principal member in respect of merits reviews conducted in New Zealand Review Tribunal means the New Zealand Review Tribunal established by section 135, in accordance with Article 13 of 25 the Agreement, to conduct merits reviews reviewable decision means a decision of the Authority in re- lation to— (a) (b) an application for an approval; or the amendment, suspension, or revocation of an ap- 30 proval; or any other matter specified in the Rules as being open to merits review (c) therapeutic product information means information relating to therapeutic products that the Authority holds in connection 35 with the performance of its functions.
123 Part 3 cl 129 Therapeutic Products and Medicines Bill Subpart 1—Merits review General provisions 129 Purpose and overview (1) (b) The purpose of this subpart is to give effect to Article 13 of the Agreement, which requires New Zealand to provide for 5 the review by a merits review tribunal of the merits of certain decisions made by the Authority.
By way of overview, this subpart provides that— (a) reviewable decisions may be reviewed in New Zealand by the Review Tribunal; and the Review Tribunal is constituted by members of the Merits Review Panel selected by the principal member to review a particular decision; and generally, the same reviewable decision cannot be re- viewed by both the Review Tribunal in New Zealand 15 and the Australian Review Tribunal; and reviews can be transferred between the merits review tribunals of each country; and an Authority decision has effect in New Zealand subject to any decision of either merits review tribunal.
This section is by way of explanation only.

If a provision of Parts 1 to 5, the Agreement, the Rules, or any other enactment conflicts with this section, the other provision prevails.

(d) (e) (c) 10 20 (2) (3) Application for review 130 Who may apply for merits review 25 A person whose interests are affected by a reviewable decision may apply to the Review Tribunal for a review of that decision.
131 What happens if Rules provide for internal review If the Rules provide for the internal review of a reviewable decision, a person may not apply under section 130 for a 30 merits review of that decision unless the person has applied for an internal review of the decision in accordance with the Rules and— (a) the internal review has been completed but the person is dissatisfied with the outcome; or 35 124 Therapeutic Products and Medicines Bill Part 3 cl 134 (b) (c) the time (if any) specified in the Rules within which any internal review must be completed has expired; or if no time is specified in the Rules, the internal review has not been completed within a reasonable time.
5 132 When Authority not required to give reasons (1) Nothing in Parts 1 to 5 or the Rules requires the Authority to provide reasons, or to provide any other information, in re- lation to a reviewable decision if the Attorney-General of the Commonwealth of Australia has issued a public interest cer- tificate under section 28(2) of the Administrative Appeals Tri- 10 bunals Act 1975 of the Commonwealth of Australia in relation to a matter contained in those reasons or included in that in- formation.
If reasons or information are withheld on the basis of a public interest certificate, the Authority must advise any person who 15 would otherwise have received the reasons or information— (a) (b) of the existence of the certificate; and that the issue of the certificate may be challenged in Australia through judicial review proceedings.
(2) 133 No application if review already sought in Australia (1) No application may be made for review of a reviewable deci- sion if the applicant has already applied to the Australian Re- view Tribunal for review of the decision.

Subsection (1) does not apply if the proceedings before the Australian Review Tribunal have been transferred to New 25 Zealand.
(2) 20 134 Application for merits review does not affect decision (1) A decision of the Authority is not affected by an application for a review of that decision.

(2) However, an applicant for a review may apply to the Review 30 Tribunal for an order staying the operation or implementation of the decision under review; and the Tribunal may make the order.
125 Part 3 cl 135 Therapeutic Products and Medicines Bill Review Tribunal 135 Establishment and constitution of Review Tribunal (1) (2) The Review Tribunal is established.

The Review Tribunal for a particular review is constituted by a minimum of 3 members of the Merits Review Panel, all of 5 whom are selected by the principal member to constitute the Review Tribunal for that particular review.
The principal member must select members so as to ensure that the Review Tribunal for a particular review is constituted by people with a sufficient range of expertise to properly consider 10 that review.

The principal member must identify one member to be the chairperson of the Review Tribunal for the purpose of a par- ticular review.

The rules relating to members’ conflict of interest are set out 15 in the Rules.
(3) (4) (5) 136 Members of Review Tribunal not personally liable No member of the Review Tribunal is personally liable for any act done or omitted to be done by the Review Tribunal or any member of it in good faith in pursuance or intended pursuance 20 of the functions, duties, powers, or authorities of the Tribunal.
Compare: 1997 No 60 s 52 137 Fees for Review Tribunal members (1) A member of the Review Tribunal is entitled— (a) (b) to be paid remuneration for services as a member at a 25 rate and of a kind determined by the Minister in accord- ance with the fees framework; and to be reimbursed for actual and reasonable travelling and other expenses incurred while carrying out duties as a member in accordance with the fees framework.
30 In subsection (1), fees framework means the framework de- termined by the Government from time to time for the classifi- cation and remuneration of statutory and other bodies in which the Crown has an interest.
(2) 126 Therapeutic Products and Medicines Bill Part 3 cl 140 Conduct of review 138 Parties to proceedings (1) The parties to proceedings before the Review Tribunal are— (a) (b) (c) the applicant; and the Authority; and any person whom the Review Tribunal is satisfied (on its own motion or on application in writing) is a person whose interests are affected by the decision.

(2) Any party to proceedings before the Review Tribunal may ap- 5 10 pear and be heard personally or by a representative.
The Attorney-General may present written submissions in any proceedings, and may appear and be heard at any hearing, as if the Attorney-General were a party to the proceedings, if the Attorney-General— (a) considers that the public interest is or may be involved 15 in the proceedings; and has advised the Ministerial Council of his or her inten- tion to present written submissions in any proceedings, or to appear at a hearing; and has given such notice to the parties to the proceedings 20 as the Review Tribunal directs.
(b) (c) 139 Procedure of Review Tribunal (1) The Review Tribunal may, as provided in paragraph 12 of Art- icle 13 of the Agreement, regulate its own procedure, subject to the Agreement, the Rules, and Parts 1 to 5.

Schedule 2 prescribes procedures for the Review Tribunal.

Clause 1 of Schedule 2 identifies specific provisions of that schedule that are subject to any Rules that override them.
25 140 Decision by majority (1) The decision of the majority of the members of the Review 30 Tribunal is the decision of the Review Tribunal.

If the Review Tribunal cannot reach a majority decision on a matter, the decision of the chairperson is the decision of the Review Tribunal.
(3) (2) (3) (2) 127 Part 3 cl 141 Therapeutic Products and Medicines Bill 141 Powers and decisions of Review Tribunal (1) For the purpose of reviewing a decision, the Review Tribunal must reconsider the merits of the decision under review and may exercise all the powers and discretions that the Authority had when it made the decision.

(2) At any stage of a review of a decision, the Review Tribunal (3) may remit the decision to the Authority for reconsideration.
Following a review of a decision, the Review Tribunal may— (a) (b) (c) affirm the decision under review; or vary the decision under review; or set aside the decision under review and make a decision in substitution of the decision set aside; or set aside the decision under review and remit the matter to the Authority for reconsideration in accordance with any directions or recommendations of the Tribunal.
(d) 5 10 15 (4) A decision by the Review Tribunal to do any of the things in subsection (2) or (3) must be in writing, and written reasons must be provided either with the decision or as soon as prac- ticable after it is delivered.
142 Matters remitted to Authority for reconsideration 20 If the Review Tribunal remits a matter to the Authority for reconsideration, the Authority must— (a) take the reasons and any recommendations of the Re- view Tribunal for the remit into account; and give effect to any directions of the Review Tribunal; and 25 having reconsidered the matter, issue a fresh decision.
(b) (c) Compare: 2004 No 72 s 337 143 New information received by Review Tribunal (1) In this section, new information, in relation to a decision under review, means— (a) information that— (i) was in existence at the time of the original deci- sion; and (ii) was not made available to the Authority for the purpose of making the original decision; and is relevant to the original decision; and (iii) 128 30 35 Therapeutic Products and Medicines Bill Part 3 cl 144 (iv) was not taken into account in the internal review of the original decision; and (b) includes opinions that are wholly or substantially based on such information (whether or not the opinions were formed before or after the initial decision was made).
5 If an applicant for review lodges new information with the Re- view Tribunal, the Tribunal must not consider the new infor- mation, except to the extent that it indicates that the quality, safety, efficacy, or performance of the therapeutic product that is the subject of the decision under review is unacceptable.

10 (2) (3) However, if the Review Tribunal remits the matter for recon- sideration to the Authority, the Authority may take the new in- formation into account in coming to its fresh decision.
Transfer of review proceedings 144 Transfer of proceedings to Australian Review Tribunal (1) At any time after an application for review is made, the Re- view Tribunal may order that the proceedings be transferred to the Australian Review Tribunal if it is satisfied that it is in the interests of justice for the review to be conducted by the Australian Review Tribunal.
15 20 (2) An order under subsection (1) may be made— (a) (b) on the application of any party; or on the initiative of the Review Tribunal; but in this case the order may not be made unless the Tribunal has given all parties to the proceedings a reasonable opportunity 25 to make submissions on the proposal to transfer the pro- ceedings.
(3) The Review Tribunal must order proceedings to be transferred to the Australian Review Tribunal if— (a) the Attorney-General of the Commonwealth of Aus- 30 tralia has issued a public interest certificate under sec- tion 28(2) or 36(1) of the Administrative Appeals Tri- bunal Act 1975 of the Commonwealth of Australia in respect of any information, or any matter contained in a statement or document; and 35 129 Part 3 cl 145 Therapeutic Products and Medicines Bill (b) the information or matter is, or is likely to be, or would have been (but for the certificate), produced in evidence before the Review Tribunal.
(4) On making an order under subsection (1) or (3), the Review Tribunal must— (a) (b) notify the parties of the order; and transfer the following to the Australian Review Tri- bunal: (i) any transcript of evidence or proceedings before the Review Tribunal: all documents, materials, and exhibits that were before, or had been produced to, the Review Tri- bunal in connection with the application.
(ii) 5 10 145 Proceedings transferred from Australian Review Tribunal (b) (c) If, under a provision in the Australian Act that is equivalent 15 to section 144, a review is transferred from the Australian Review Tribunal to the Review Tribunal,— (a) the principal member must ensure that the Review Tri- bunal is constituted as provided for in section 135; and the Review Tribunal must conduct the review proceed- 20 ings, as far as possible, as if the application for the re- view had been made in New Zealand; and the following things received from the Australian Re- view Tribunal must be taken into account by the Review Tribunal: (i) any transcript of evidence or proceedings before the Australian Review Tribunal: all documents, materials, and exhibits that were before, or had been produced to, the Australian Review Tribunal in connection with the applica- 30 tion.
(ii) 25 146 Effect of decision by Review Tribunals Effect of decisions If the Review Tribunal or the Australian Review Tribunal, or a court on appeal from either tribunal, makes an order that 35 varies, suspends, sets aside, or otherwise affects a decision of 130 Therapeutic Products and Medicines Bill Part 3 cl 148 the Authority, the Authority’s decision has effect subject to the order.
Appeals and stating case 147 Appeal on question of law (1) If a party to proceedings before the Review Tribunal is dis- 5 satisfied with any of its decisions or determinations as being wrong in law, the party may appeal to the High Court on the question of law.

The appeal must be brought within 28 days of the decision, or within any further period that the High Court allows, on 10 application made before or after the end of the 28-day period.
The appeal must otherwise be dealt with in accordance with rules of Court (being rules made under section 51C of the Ju- dicature Act 1908).

(2) (3) 148 Stating case for High Court (1) The Review Tribunal may state a case for the opinion of the High Court on any question of law arising in any proceedings before the Tribunal.
15 (2) A case may be stated— (a) (b) at any time before the Review Tribunal delivers its de- 20 cision; and on the application of any party to the proceedings or on the initiative of the Tribunal.

(3) (4) The Review Tribunal must give notice to the parties to the proceedings of its intention to state a case under this section, 25 specifying the registry of the High Court in which the case is to be filed.
The question for the High Court must set out the facts and the question of law to be determined by the High Court, and must be drawn up— (a) 30 by the Review Tribunal, if the case is stated on the ini- tiative of the Tribunal; or in any other case, by the parties; but if the parties cannot agree on how the case should be drawn up, the Tribunal must settle the matter.
(b) 35 131 Part 3 cl 149 Therapeutic Products and Medicines Bill (5) (6) Every case stated for the High Court must be dealt with in accordance with rules of Court.

The High Court must hear and determine any question submit- ted to it by the Review Tribunal and must remit the case with its opinion to the Tribunal.

Subpart 2—Judicial review 149 Application of subpart This subpart applies only to judicial review proceedings relat- ing to the following: (a) (b) (c) decisions of the Authority: Rules: Orders.
5 10 150 Availability of judicial review For the purpose of allowing for the judicial review, under the Judicature Amendment Act 1972, of decisions of the Author- 15 ity, and of Rules and Orders,— (a) decisions of the Authority are deemed to be decisions made in the exercise of a power conferred by an Act; and Rules and Orders are deemed to be made in the exercise 20 of a power conferred by an Act.
(b) 151 Effect of orders made in judicial review proceedings (1) If, in judicial review proceedings taken in New Zealand or in Australia, a court makes an order that varies, suspends, sets aside, or otherwise affects a decision of the Authority relating 25 to the Scheme, or a Rule or Order, then that decision, Rule, or Order has effect subject to the order of the court.

By way of explanation, the Australian Act provides that the decision, Rule, or Order also has effect in Australia subject to the order.
30 (2) 152 Stay of judicial review proceedings (1) A court may stay judicial review proceedings, either on the court’s own motion or on the application of any party to the proceedings.
132 Therapeutic Products and Medicines Bill Part 3 cl 153 (2) (3) The court may stay the judicial review proceedings if it is sat- isfied that— (a) it would be more appropriate, in the interests of the ef- fective, just, and efficient determination of those pro- ceedings (taking into account the matters in subsec- 5 tion (3)(a) to (d)), for the proceedings to be heard and determined in a court in Australia; or the matter, or substantially the same matter, is the sub- ject of final orders made by a court in Australia.
(b) In determining whether it would be more appropriate for the 10 proceedings to be heard and determined in an Australian court, the court may not take into account the fact that the proceed- ings were commenced in New Zealand, but must take into ac- count the following matters: (a) the place of residence of the applicant and of the wit- 15 nesses likely to be called in the proceedings: the relative cost and convenience of proceeding in each jurisdiction: any agreement between the parties about the court or place in which the proceedings should be instituted: (b) (c) 20 (d) whether proceedings involving substantially the same issues or questions of fact have been commenced by the applicant or another person in a court in Australia.
(4) An order staying judicial review proceedings may be made subject to whatever conditions the court considers are just and 25 appropriate in order to facilitate the determination of the mat- ter at issue without delay or undue expense.

(5) Nothing in subsection (2) affects the court’s power to stay proceedings on any other ground.
153 Determination of stay proceedings (1) A court may order the stay of judicial review proceedings without a hearing, unless the applicant or a party to the pro- ceedings objects.

For the purposes of determining the application, the court may hold a hearing by video link or telephone.
Sections 19 to 31 of the Evidence Amendment Act 1994 apply, with all necessary modifications, to submissions made in pro- (2) (3) 30 35 133 Part 3 cl 154 Therapeutic Products and Medicines Bill (4) ceedings under section 152 for a stay of judicial review pro- ceedings, even if no evidence is being taken.

Subsection (3) does not limit or affect the application of the Evidence Amendment Act 1994 to any other proceedings under Parts 1 to 5.
5 Subpart 3—Action by Ombudsmen 154 Authority subject to Ombudsmen Act 1975 and to (1) (2) Australian Ombudsman Act By way of overview and explanation— (a) the Authority is subject to the Ombudsmen Act 1975 10 by virtue of being named as an organisation in Part 2 of Schedule 1 of that Act; and the Authority is also subject to the Australian Ombuds- man Act.
(b) For the purpose of reports concerning the Authority given 15 under the Ombudsmen Act 1975, the Minister is the Minister responsible for the Authority.

155 Co-operation between Ombudsmen (1) A New Zealand Ombudsman must advise the Australian Om- budsman whenever an investigation of the Authority is com- 20 menced under the Ombudsmen Act 1975, and must advise the Australian Ombudsman of the outcome of every such investi- gation.
If the Australian Ombudsman asks a New Zealand Ombuds- man to assist with an investigation relating to the Authority— 25 the New Zealand Ombudsman may exercise his or her (a) powers under the Ombudsmen Act 1975 in relation to the investigation; and the exercise of those powers is for all purposes to be treated as the exercise of the New Zealand Ombuds- 30 man’s functions under that Act; and the New Zealand Ombudsman may give the Australian Ombudsman any information obtained as a result of ex- ercising those powers; and (b) (c) (2) 134 Therapeutic Products and Medicines Bill Part 3 cl 156 (d) any inquiry or proceeding arising from the exercise of those powers is for all purposes to be treated as an in- quiry or proceeding under that Act.
(3) A New Zealand Ombudsman may disclose to the Australian Ombudsman any information held by the New Zealand Om- 5 budsman that is or may be relevant to an investigation by the Australian Ombudsman of an action by the Authority.

(4) A New Zealand Ombudsman must not disclose any infor- mation concerning the Authority that was obtained from the Australian Ombudsman without first consulting with the Aus- 10 tralian Ombudsman about the proposed disclosure.
(5) Under the Australian Act, the Australian Ombudsman has obligations that are reciprocal to those imposed on a New Zealand Ombudsman by this section.
156 New Zealand Ombudsman transferring complaints to 15 (1) Australian Ombudsman If a New Zealand Ombudsman receives a complaint about the Authority under the Ombudsmen Act 1975, he or she may transfer the complaint, or part of the complaint, to the Aus- tralian Ombudsman if the New Zealand Ombudsman— (a) considers that the complaint, or part of the complaint, can be more conveniently or effectively dealt with by the Australian Ombudsman; and has consulted with the Australian Ombudsman about the proposed transfer, and the Australian Ombudsman 25 has agreed; and is satisfied that it is appropriate in all the circumstances for the transfer to be made.
(b) (c) 20 (2) A New Zealand Ombudsman must tell the complainant if the complaint, or part of the complaint, is transferred to the Aus- 30 tralian Ombudsman.

(3) A New Zealand Ombudsman may investigate, or continue to investigate, any part of the complaint that is not transferred.
135 Part 3 cl 157 Therapeutic Products and Medicines Bill 157 Australian Ombudsman transferring complaints to New (1) (2) Zealand Ombudsman Following a request by the Australian Ombudsman, a New Zealand Ombudsman may agree to the transfer of a complaint (or any part of a complaint) that concerns the Authority, to a 5 New Zealand Ombudsman, if the New Zealand Ombudsman is satisfied that the matter can be conveniently and effectively dealt with by a New Zealand Ombudsman.
If a complaint or part of a complaint is transferred from Aus- tralia to New Zealand, a New Zealand Ombudsman must (sub- 10 ject to sections 17 to 17C of the Ombudsmen Act 1975) inves- tigate the complaint or part of a complaint under the Ombuds- men Act 1975.
158 Refusal to deal with complaints investigated by Australian 15 Ombudsman Without limiting any of sections 17 to 17C of the Ombudsmen Act 1975, a New Zealand Ombudsman may refuse to inves- tigate, or further investigate, a complaint concerning the Au- thority if— (a) the complaint, or a substantially similar complaint, is 20 being, or has been, investigated by the Australian Om- budsman; or the Australian Ombudsman has agreed that the com- plaint should be transferred from New Zealand to Aus- tralia.
25 (b) 159 (1) Immunity for Australian Ombudsman and others This section applies to a person who is or was— (a) (b) (c) the Australian Ombudsman or a Deputy Australian Om- budsman; or a person employed by, or holding office under, the Aus- 30 tralian Ombudsman; or a person acting under the direction or authority of the Australian Ombudsman, or an employee of the Aus- tralian Ombudsman.
(2) No proceedings, civil or criminal, may be taken against a per- 35 son to whom this section applies for any act or omission done in the course of giving assistance to a New Zealand Ombuds- 136 Therapeutic Products and Medicines Bill Part 3 cl 160 man in accordance with the reciprocal obligations referred to in section 155(5).
(3) However, subsection (2) does not apply— if the defendant acted in bad faith; or in respect of proceedings for— (i) (a) (b) (ii) an offence against any of sections 78, 78A(1), 105, 105A, or 105B of the Crimes Act 1961; or the offence of conspiring to commit, or of at- tempting to commit, an offence against any of those sections.
Compare: 1975 No 9 s 26(1)(a), (2) 160 Other protections for Australian Ombudsman and others (1) This section applies to a person who is or was— (a) the Australian Ombudsman or a Deputy Australian Om- budsman; or a person employed by, or holding office under, the Aus- tralian Ombudsman.
(b) (2) No person to whom this section applies may be required— 5 10 15 (a) to give evidence in New Zealand in any court, or in any proceedings of a judicial nature, in respect of anything 20 coming to the knowledge of the Ombudsman or em- ployee in the course of giving assistance under Parts 1 to 5 to a New Zealand Ombudsman; or to disclose any information obtained in the course of giving such assistance.
(3) However, subsection (2) does not apply— if the defendant acted in bad faith; or in respect of proceedings for— (i) (a) (b) (b) 25 (ii) an offence against any of sections 78, 78A(1), 105, 105A, or 105B of the Crimes Act 1961; or the offence of conspiring to commit, or of at- tempting to commit, an offence against any of those sections.
Compare: 1975 No 9 s 26(1)(b), (2) 30 137 Part 3 cl 161 Therapeutic Products and Medicines Bill Subpart 4—Action by Privacy Commissioners 161 Authority subject to Privacy Act 1993 and to Australian (1) Privacy Act By way of overview and explanation— (a) the Authority is subject to the Privacy Act 1993 by virtue of being an agency as defined in section 2(1) of that Act; and the Authority is also subject to the Australian Privacy Act.
(b) (2) A request, complaint, or any other kind of application that is made by a person in New Zealand to the Authority under the Privacy Act 1993 must be dealt with by the Authority under that Act, unless the matter is transferred to the Australian Pri- vacy Commissioner under section 164.
5 10 15 162 Modification of information privacy principle 11 Paragraph (a) of information privacy principle 11, as set out in section 6 of the Privacy Act 1993, is modified so far as it relates to the Authority as if the words “or is directly related to the purposes in connection with which the information was 20 obtained” were omitted.
163 Co-operation between Privacy Commissioners (1) The New Zealand Privacy Commissioner must advise the Aus- tralian Privacy Commissioner whenever he or she commences an investigation involving the Authority, and must advise the 25 Australian Privacy Commissioner of the outcome of the inves- tigation.
If the Australian Privacy Commissioner asks the New Zealand Privacy Commissioner to assist with an investigation or audit involving the Authority,— (a) the New Zealand Privacy Commissioner may exercise his or her powers under the Privacy Act 1993 in relation to that investigation or audit; and the exercise of those powers is for all purposes to be treated as the exercise of the New Zealand Privacy 35 Commissioner’s functions under that Act; and (b) 30 (2) 138 Therapeutic Products and Medicines Bill Part 3 cl 164 (c) (d) the New Zealand Privacy Commissioner may give the Australian Privacy Commissioner any information ob- tained as a result of exercising those powers; and any inquiry or proceeding arising from the exercise of those powers is for all purposes to be treated as an in- 5 quiry or proceeding under that Act.
The New Zealand Privacy Commissioner may disclose to the Australian Privacy Commissioner any information held by the New Zealand Privacy Commissioner that is or may be relevant to— (a) an investigation by the Australian Privacy Commis- sioner of an action by the Authority; or an audit by the Australian Privacy Commissioner in- volving the Authority.
(b) 10 The New Zealand Privacy Commissioner must not disclose 15 any information concerning the Authority or any person that was obtained from the Australian Privacy Commissioner with- out first consulting with the Australian Privacy Commissioner about the proposed disclosure.

(3) (4) (5) Under the Australian Act, the Australian Privacy Commis- 20 sioner has obligations that are reciprocal to those imposed on the New Zealand Privacy Commissioner by this section.
164 New Zealand Privacy Commissioner transferring (1) complaints to Australia If the New Zealand Privacy Commissioner is satisfied that a 25 complaint relating to the Authority that is received under the Privacy Act 1993 may be more conveniently or effectively dealt with by the Australian Privacy Commissioner under the Australian Privacy Act, the New Zealand Privacy Commis- sioner must— (a) consult with the Australian Privacy Commissioner about the possible transfer of the complaint; and consult with the complainant about the possible transfer of the complaint.
(b) 30 (2) If both the Australian Privacy Commissioner and the com- 35 plainant agree to the transfer, the complaint may be transferred to Australia, and from then on it is to be treated as if it was made under the Australian Privacy Act.

139 Part 3 cl 165 Therapeutic Products and Medicines Bill (3) (4) If the Australian Privacy Commissioner does not agree to the transfer, the New Zealand Privacy Commissioner may not transfer it.
If the complainant does not agree to the transfer, the New Zealand Privacy Commissioner may not transfer the complaint 5 unless— (a) the complainant is not the individual (or is not the only individual) whose privacy is purported to have been interfered with; and the New Zealand Privacy Commissioner considers that 10 the interests of the person whose privacy is purported to have been interfered with (or any other such person) would be better served by having the complaint dealt with under the Australian Privacy Act.
(b) (5) (6) The New Zealand Privacy Commissioner may investigate, or 15 continue to investigate, a complaint, that is not transferred.

In this section and section 165, a reference to a complaint includes a reference to part of a complaint.
165 Australian Privacy Commissioner transferring (1) (2) complaints to New Zealand Following consultation with the Australian Privacy Commis- sioner, the New Zealand Privacy Commissioner may agree to the transfer of a complaint that concerns the Authority to New Zealand if he or she is satisfied that the complaint may be more conveniently or effectively dealt with in New Zealand.
If a complaint is transferred from Australia to the New Zealand Privacy Commissioner, the New Zealand Privacy Commis- sioner must investigate it under the Privacy Act 1993.
166 Taking no action on complaints dealt with by Australian 20 25 30 Privacy Commissioner Without limiting section 71 of the Privacy Act 1993, the New Zealand Privacy Commissioner may decide to take no action, or no further action, on a complaint if— (a) he or she is satisfied that the complaint, or a substan- tially similar complaint by or relating to the same in- 35 140 Therapeutic Products and Medicines Bill Part 3 cl 168 dividual, has been, or is being, dealt with by the Aus- tralian Privacy Commissioner; or the complaint is being transferred to the Australian Pri- vacy Commissioner.
(b) 167 (1) Immunity for Australian Privacy Commissioner and others This section applies to a person who is or was— the Australian Privacy Commissioner; or (a) an officer or employee of the Australian Privacy Com- (b) missioner.

(2) No proceedings, civil or criminal, may be taken against a per- son to whom this section applies for any act or omission done in the course of giving assistance to the New Zealand Privacy Commissioner in accordance with the reciprocal obligations referred to in section 163(5).
(3) However, subsection (2) does not apply— if the defendant acted in bad faith; or in respect of proceedings for— (i) (a) (b) (ii) an offence against any of sections 78, 78A(1), 105, 105A, or 105B of the Crimes Act 1961; or the offence of conspiring to commit, or of at- tempting to commit, an offence against any of those sections.
Compare: 2004 No 115 ss 121, 126 5 10 15 20 168 Other protections for Australian Privacy Commissioner 25 (1) and others This section applies to a person who is or was— the Australian Privacy Commissioner; or (a) a person engaged or employed in connection with the (b) work of the Australian Privacy Commissioner.
(2) A person to whom this section applies may not be required to give evidence in New Zealand in any court, or in any pro- ceedings of a judicial nature, in respect of anything coming to his or her knowledge in the course of giving assistance under Parts 1 to 5 to the New Zealand Privacy Commissioner.
30 35 141 Part 3 cl 169 Therapeutic Products and Medicines Bill (3) Nothing in subsection (2) applies in respect of proceedings for— (a) an offence against any of sections 78, 78A(1), 105, 105A, or section 105B of the Crimes Act 1961; or the offence of conspiring to commit an offence against 5 any of those sections.
Compare: 1993 No 28 s 96(1)–(3) (b) 169 Extended immunity for New Zealand Privacy (1) (2) Commissioner The immunities in section 167 apply to the New Zealand 10 Privacy Commissioner in respect of anything he or she does in the course of the exercise or intended exercise of his or her duties under the Privacy Act 1993 that relate to therapeutic products.

This section applies despite section 121 of the Crown Entities 15 Act 2004.
Subpart 5—Information management 170 Application of Official Information Act 1982 (1) By way of overview and explanation, the Official Informa- tion Act 1982 applies to information held by the Authority by 20 virtue of the Authority being subject to that Act (which it is as a result of being named as an organisation in Part 2 of Sched- ule 1 of the Ombudsmen Act 1975).
(2) However, the following information held by the Authority is not official information for the purposes of the Official Infor- 25 mation Act 1982: (a) Australian Government information, which is— (i) information about or relating to an activity that falls outside the scope of the Scheme, and that the Authority engages in for Australian purposes 30 only, and that has been approved by the Minis- terial Council in accordance with paragraph 3 of Article 5; or information that is given to the Australian Gov- ernment under a power given to the Australian 35 (ii) 142 (2) (1) (2) Therapeutic Products and Medicines Bill Part 3 cl 172 Government or the Australian Minister under the Australian Act: (b) information that was in the possession of the Australian Therapeutic Goods Agency on the date of its disestab- lishment.
5 (3) Nothing in sections 172 to 178 affects the application of the Official Information Act 1982 so far as it relates to information disclosed to any person or agency referred to in those sections.

171 Application of Privacy Act 1993 (1) The Authority is also subject to the Privacy Act 1993 by virtue 10 of being an agency as defined in section 2(1) of that Act.

See sections 161 to 169 for details about action by the Pri- vacy Commissioner under the Privacy Act 1993.
172 Release of therapeutic product information to World Health Organisation The Authority may release the information referred to in sub- section (2) to the World Health Organisation— (a) for use in developing policies relating to the regulation of therapeutic products; or to allow information to be provided to regulatory au- 20 thorities of member countries of the World Health Or- ganisation.
(b) 15 The information that the Authority may release under subsec- tion (1) is therapeutic product information relating to any of the following: (a) notifications about a therapeutic product whose supply in New Zealand or Australia has been prohibited or severely restricted, or reasons for either of those actions: the issue or revocation of manufacturing licences: conditions imposed on manufacturing licences: the compliance by New Zealand or Australian manufac- turers with requirements relating to manufacturing set out in Rules and Orders: the content of reports to the Authority concerning ad- verse effects of a therapeutic product: the issue or revocation of conformity assessment certifi- cates: (b) (c) (d) (e) (f) 25 30 35 143 Part 3 cl 173 Therapeutic Products and Medicines Bill (g) conditions imposed on conformity assessment certifi- cates.
(3) In addition, the Authority may release therapeutic product in- formation to the World Health Organisation if the informa- tion— (a) concerns the proceedings of an expert advisory commit- tee; and is released in confidence.
(b) 173 Release of therapeutic product information to New 5 10 Zealand and Australian authorities with therapeutic product functions If subsection (2) applies, the Authority may release the in- formation referred to in subsection (3) to the following: (a) a Department or Crown entity (as those terms are de- fined in section 2 of the State Sector Act 1988) that has 15 functions relating to therapeutic products: an authority of the Commonwealth of Australia or any State or Territory of Australia that has functions relating to therapeutic products.
(b) Information may be released under subsection (1) only if 20 the Authority is reasonably satisfied that the information is to be used by the recipient only for purposes relating to the performance of its therapeutic product functions.
The information that the Authority may release under subsec- tion (1) is therapeutic product information relating to any of 25 the following: (a) reported problems and complaints concerning therapeu- tic products, the Authority’s investigation of those prob- lems and complaints, and any action that the Authority has taken or proposes to take in relation to those prob- 30 lems and complaints: reports of inspections conducted under Parts 1 to 5, the Australian Act, or the Rules or Orders: decisions to issue, revoke, or suspend, or not to issue, a manufacturing licence: conditions of manufacturing licences: reports of the testing of samples of therapeutic products: 35 (b) (c) (d) (e) (1) (2) (3) 144 Therapeutic Products and Medicines Bill Part 3 cl 174 (f) (g) the issue or revocation of conformity assessment certifi- cates: conditions imposed on conformity assessment certifi- cates.
174 Release of therapeutic product information to other 5 (1) (2) (3) national authorities with therapeutic product functions The Authority may release information referred to in subsec- tion (3), for a purpose referred to in subsection (2), to a na- tional regulatory authority (other than one of the bodies re- ferred to in section 173(1)) that has national responsibility 10 relating to therapeutic products.
Information may be released for the following purposes: (a) for use by the national regulatory authority in perform- ing its functions relating to therapeutic products: to further international co-operation in the regulation of 15 therapeutic products.
(b) The information that the Authority may release under subsec- tion (1) is therapeutic product information relating to any of the following: (a) recommendations of an expert advisory committee on 20 therapeutic products supplied in, or proposed for supply in, New Zealand or Australia and any conditions that apply, or will apply, to the supply: decisions to grant, suspend, or revoke a product licence: the withdrawal of a therapeutic product from supply in 25 New Zealand or Australia, and the reasons for that ac- tion: the licensing status of New Zealand or Australian manu- facturers of therapeutic products: the compliance by New Zealand or Australian manufac- 30 turers with conditions of a manufacturing licence: the proceedings of expert advisory committees: the issue or revocation of conformity assessment certifi- cates: conditions imposed on conformity assessment certifi- 35 cates.
(b) (c) (d) (e) (f) (g) (h) 145 Part 3 cl 175 Therapeutic Products and Medicines Bill 175 Release of therapeutic product information relating to (1) (2) product tampering and law enforcement The Authority may release information of the kind referred to in subsection (2) to any of the following: (a) a Department or Crown entity (as those terms are de- 5 fined in section 2 of the State Sector Act 1988) that has functions relating to therapeutic products, health, or law enforcement: an authority of the Commonwealth of Australia or any State or Territory of Australia that has functions relating 10 to therapeutic products, health, or law enforcement: any national regulatory authority outside New Zealand or Australia that has national responsibility relating to therapeutic products, health, or law enforcement: an international organisation that has a function relating 15 to therapeutic products, health, or law enforcement.
The kinds of information that may be released under subsec- tion (1) are the following: (a) information about or relating to therapeutic products that are, or may be, or have been, subject to actual or 20 potential tampering: information about offences committed, or alleged to have been committed, under Parts 1 to 5 or the Aus- tralian Act concerning therapeutic products: information about the contravention, or alleged contra- 25 vention, of civil penalty provisions under Parts 1 to 5 or the Australian Act concerning therapeutic products: information that relates to the breach of a requirement relating to a therapeutic product under Parts 1 to 5, the Australian Act, the Rules, Orders, or regulations made 30 under this Act.
(b) (c) (d) (b) (c) (d) 176 Release of therapeutic product information required to be provided This section applies if the Authority gives a notice under the Rules requiring information about a therapeutic product to be 35 given to any of the following: (a) an authorised prescriber who administers therapeutic products: (l) 146 Therapeutic Products and Medicines Bill Part 3 cl 178 (b) (c) the holder of, or an applicant for, a product licence: the holder of, or an applicant for, a conformity assess- ment certificate.
(2) The Authority may release information provided pursuant to a notice referred to in subsection (1) to the following: (a) 5 a Department or Crown entity (as those terms are de- fined in section 2 of the State Sector Act 1988) that has functions relating to therapeutic products or health: an authority of the Commonwealth of Australia or any State or Territory of Australia that has functions relating 10 to therapeutic products or health: an authority that, under the Health Practitioners Com- petence Assurance Act 2003, is responsible for the registration and oversight of practitioners of a particu- lar health profession: an Australian pharmaceutical professional body (being a body that is responsible for the registration of pharma- cists in a State or Territory of Australia).
15 (b) (c) (d) 177 Release of therapeutic product information in accordance 20 with international co-operative arrangements The Authority may release therapeutic product information to a national regulatory authority or an international organisation if— (a) New Zealand or Australia has co-operative arrange- ments with the country or organisation that relate to the 25 assessment or regulation of therapeutic products; and the release of the information is consistent with those arrangements.
(b) 178 Release of therapeutic product information to public The Authority may release therapeutic product information to 30 the public if— (a) the information relates to any decision or action taken under Parts 1 to 5, the Australian Act, or the Rules or Orders; or the release of the information is necessary to ensure the 35 safe use of particular therapeutic products; or (b) 147 Part 3 cl 179 Therapeutic Products and Medicines Bill (c) the information relates to the reasons for the withdrawal of therapeutic products from supply in New Zealand or Australia.
179 Protection against action if lawfully making information (1) (2) 5 available If a person, in good faith, makes information available under any of sections 170 to 178, or section 183, or under the Medicines Act 1981 (in a case where section 184 applies),— no civil penalty or criminal proceedings lie against the (a) person in respect of making the information available or 10 for any of the consequences of making it available; and in respect of any publication involved in, or resulting from, making the information available, no civil or criminal proceedings lie against the author of the infor- mation, or any other person, by reason of that author 15 or other person having supplied the information to the Agency.
(b) For the purpose of the law relating to defamation, breach of confidence, or infringement of copyright, if information is made available under this subpart, the disclosure of the infor- 20 mation does not constitute an authorisation or approval of the publication of the information by the person who discloses it.
Compare: 1982 No 156 s 48 Protected active ingredient information 180 Purpose of sections 181 to 184 25 The purpose of sections 181 to 184 is to provide for compli- ance by New Zealand with its obligations under article 39 of the General Agreement on Tariffs and Trade (Uruguay Round) Agreement on Trade-related Aspects of Intellectual Property Rights, Annex 1C of the Marrakesh Agreement Establishing 30 the World Trade Organization (commonly referred to as the TRIPS Agreement).
181 Definition of protected active ingredient information (1) Protected active ingredient information is information that— 35 148 Therapeutic Products and Medicines Bill Part 3 cl 183 (a) (b) (c) is about, or relates to, the active moiety of a therapeutic product; and is submitted in support of an application for a product licence; and is not in the public domain on the date on which the 5 application is received by the Authority.
For the purposes of this definition, active moiety means the molecule, or part or portion of a molecule, that— (a) has a characteristic chemical or pharmacological prop- erty; and is the portion of the active ingredient of a therapeutic product that is responsible for the effect of the active ingredient.
(b) 10 (2) 182 Periods when protected active ingredient information (1) (2) (3) 15 may not normally be disclosed The Authority must not disclose protected active ingredient in- formation during either of the periods of protection that apply to that information, except as provided in section 183.
The first period of protection for protected active ingredient information about a therapeutic product starts on the date on 20 which an application is first received by the Authority for a product licence for the therapeutic product, and ends on the earlier of— (a) (b) The second period of protection starts on the date on which the Authority either grants or declines the application, and ends on the date that is 5 years later.
the date that is 5 years later; or the date on which the second period of protection starts.
25 183 Limited circumstances in which protected active ingredient information may be disclosed Despite section 182, the Authority may disclose protected active ingredient information during either period of protec- tion that applies to the information if— (a) the disclosure is made under and in accordance with any of sections 172 to 178; or the applicant or licence holder (as the case requires) agrees in writing to the disclosure; or (b) 30 35 149 Part 3 cl 184 Therapeutic Products and Medicines Bill (c) the information has entered the public domain and is therefore no longer confidential.
184 Continuation of protections under Medicines Act 1981 (1) Sections 23B and 23C of the Medicines Act 1981 continue to apply to all confidential supporting information (as defined in 5 section 23A of that Act) that was contained in an application for an innovative medicine received by Medsafe in relation to which, before the date on which Part 5 comes into force, the Minister (as defined in that Act)— (a) had notified consent (not being provisional consent) in 10 the Gazette; or had refused to grant consent.
(b) To avoid doubt, nothing in this section applies to information received by the Australian Therapeutic Goods Agency before its disestablishment, even if the information is the same as the 15 confidential supporting information received by Medsafe.

(2) Use of information by Authority 185 Protection against action for use by Authority of information This section applies if Rules limit the use that the Authority 20 may make of information.
If a person, in good faith, uses information in breach of those Rules,— (a) no civil or criminal proceedings lie against the person in respect of using the information or for any of the 25 consequences of using it; and in respect of any publication involved in, or resulting from, using the information, no civil or criminal pro- ceedings lie against the author of the information, or any other person, by reason of that author or other per- 30 son having supplied the information to the Agency.
(b) For the purpose of the law relating to defamation, breach of confidence, or infringement of copyright, if information is used under this subpart, the use does not constitute an author- isation or approval of the publication of the information by 35 the person who uses it.
(1) (2) (3) 150 Therapeutic Products and Medicines Bill Part 4 cl 187 Archives 186 Management of Authority’s records By way of overview and explanation— (1) (a) (b) (c) the Authority is subject to the Public Records Act 2005 by virtue of being identified as a public office in section 5 4 of that Act; and the Authority is also subject to the Archives Act 1983 of the Commonwealth of Australia; and the Chief Archivist appointed under the Public Records Act 2005, and the Director-General of the National 10 Archives of Australia, may enter into memorandums of understanding concerning the management and disposal of public records (as defined in the Public Records Act 2005) of the Authority.
(2) The Chief Archivist may not authorise the disposal of public 15 records of the Authority except in accordance with any memo- randum of understanding entered into with the Director-Gen- eral of the National Archives of Australia.
Part 4 Governance and accountability 20 187 Definitions of terms used primarily in this Part In Parts 1 to 5, unless the context otherwise requires,— approved bank means— (a) an institution— (i) that carries on a business in New Zealand or Aus- 25 tralia that consists of or includes taking money on deposit; and the operations of which are subject to prudential supervision or regulation under the law of New Zealand or of the Commonwealth of Australia or 30 of an Australian State or Territory; and that satisfies a credit rating test specified in the Rules; or (ii) (iii) (b) an institution identified in or under the Rules as a fi- nancial institution with which the Authority may keep 35 a bank account or similar account 151 Part 4 cl 188 Therapeutic Products and Medicines Bill financial year means— a period of 12 months commencing on 1 July; or (a) (b) another 12-month period specified in the Rules forecast financial statements has the meaning set out in sec- tion 2(1) of the Public Finance Act 1989 generally accepted accounting practice means either of the following, as determined by the Rules (if any) or, in the ab- sence of Rules, by the Authority: (a) generally accepted accounting practice (as that term is defined in section 3 of the Financial Reporting Act 10 1993); or accounting standards made or formulated by the Aus- tralian Accounting Standards Board (b) 5 senior manager means, in relation to the Authority, a person (other than a Board member or a Minister) who— (a) makes, or participates in making, decisions that affect the whole or a substantial part of the operations of the Authority; or has the capacity to significantly affect the Authority’s financial standing (b) 15 20 a Board member; or a senior manager senior officer means a person who is— (a) (b) subsidiary means an entity controlled by the Authority, where entity and controlled have the meanings they have in gener- 25 ally accepted accounting practice.
Subpart 1—Ministerial Council, Board, and Board members Ministerial Council 188 Overview of Ministerial Council (1) The Ministerial Council is established by Article 4 of the Agreement.

The role of the Ministerial Council is set out in subparagraph (b) of paragraph 2 of Article 2 of the Agreement.

The functions of the Ministerial Council are set out in para- 35 graph 2 of Article 4 of the Agreement.
30 (2) (3) 152 Therapeutic Products and Medicines Bill Part 4 cl 191 General provisions relating to Board 189 Overview of Board (1) The Board is established by Article 6 of the Agreement, which also sets out its role and functions.

(2) Article 6 of the Agreement also provides that the 5 members 5 (3) of the Board are appointed by the Ministerial Council.

The responsibilities of the Board are set out in paragraphs 5 and 6 of Article 6 of the Agreement.
(4) More detailed matters relating to the Board, such as Board procedures, the remuneration of members, and delegations, 10 are provided for in Rules.

190 Parliament’s expectations of Board Parliament intends that the Board, in fulfilling its responsibil- ity under paragraph 5 of Article 6 of the Agreement, will en- sure that the Authority acts consistently with its functions and 15 in a manner consistent with the spirit of service to the public.
Compare: 2004 No 115 ss 49, 50 191 Restrictions on Minister’s discretion to appoint (1) The Minister may not recommend for appointment to the Board, and may not concur in the appointment to the Board 20 of, any person who— (a) (b) is an undischarged bankrupt; or is prohibited from being a director or promoter of, or being concerned or taking part in the management of, a company under section 382, 383, or 385 of the Com- 25 panies Act 1993; or is subject to a property order under the Protection of Personal and Property Rights Act 1988; or is a person in respect of whom a personal order has been made under that Act that reflects adversely on the 30 person’s — (i) (c) (d) competence to manage his or her own affairs in relation to his or her property; or capacity to make or to communicate decisions relating to any particular aspect or aspects of his 35 or her personal care and welfare; or (ii) 153 Part 4 cl 192 Therapeutic Products and Medicines Bill (e) (f) (g) has been convicted of an offence punishable by impris- onment for a term of 2 years or more, or who has been sentenced to imprisonment for any other offence, unless that person has obtained a pardon, served the sentence, or otherwise suffered the penalty imposed on the per- 5 son; or is a member of Parliament; or is subject to a disqualification order under section 255, or is disqualified under section 383 of the Companies Act 1993, section 30 of the Crown Entities Act 2004, or 10 any other similar provision of another enactment.
The Minister must not recommend a person’s appointment to the Board if the Australian Act prevents the Australian Min- ister from concurring in the appointment of the person to the Board.

Compare: 2004 No 115 s 30(2) 15 (2) 192 Vacancies in membership of Board and flaws in (1) (2) appointment The powers, functions, and duties of the Board are not affected by a vacancy in its membership.
The actions of a person as a Board member are not invalidated by— (a) a defect in the person’s appointment as a Board mem- ber; or in the case of an acting Board member, the fact that, 25 unknown to the acting Board member, the occasion to act had not arisen or had ceased.

(b) 20 Compare: 2004 No 115 ss 34, 77 193 Effect of flaws in Board processes The actions of the Board may not be challenged by any per- 30 son solely on the grounds that the Board did not comply with Board procedures.
154 Therapeutic Products and Medicines Bill Part 4 cl 195 Managing Director 194 Overview of Managing Director (1) The Managing Director is a Board member appointed by the Ministerial Council under paragraph 2 of Article 6 of the Agreement.

The Managing Director has roles and responsibilities as set out in Article 7 of the Agreement.

(2) Subpart 2—General matters relating to Authority 195 Overview of Authority (1) (2) The Authority is established by the Australian Act.
The Authority’s functions are those conferred by the Aus- tralian Act, namely— (a) the functions specified in paragraph 2 of Article 5 of the Agreement; and any other function conferred on the Authority in accord- ance with paragraph 3 of Article 5 of the Agreement (which may include, for example, functions that relate only to New Zealand or only to Australia).

(b) 5 10 15 (3) (4) The Authority’s powers are conferred by the Australian Act 20 and by Parts 1 to 5.
The Authority is not a Crown entity and is not subject to the Crown Entities Act 2004.

(5) However, Parts 1 to 5 and the Rules impose accountability requirements and financial controls on the Authority that are 25 broadly equivalent to the accountability requirements and fi- nancial controls that would apply if the Authority were subject to the Crown Entities Act 2004.

This section is by way of explanation only.


If any provision of Parts 1 to 5, the Agreement, or the Rules conflicts with this 30 section, the other provision prevails.
(6) 155 Part 4 cl 196 Therapeutic Products and Medicines Bill Providing information 196 Authority to provide information to Minister (1) The Authority must ensure that the Minister is promptly in- formed of any regulatory decision, or proposed regulatory de- cision, that affects or is likely to affect— (a) (b) the financial position of the Government; or existing government policies or programmes.
5 (2) On request by the Minister, the Authority must provide the (b) Minister with the following information: (a) information about the operations and performance of 10 the Authority and its subsidiaries: information about activities— (i) that fall outside the scope of the scheme but that the Authority engages in, or could engage in, in accordance with paragraph 3 of Article 5 of the 15 Agreement; and that relate to New Zealand.
(ii) (3) The Authority must provide the Minister with the information within the time, and in the manner (if any), specified in the request.
20 197 Authority to comply with request for information from Finance Minister If the Finance Minister makes a written request to the Au- thority for information about the Authority’s operations and performance, or about the operations and performance of any 25 of its subsidiaries, the Authority must supply the information within the time and in the manner (if any) specified by the Fi- nance Minister.
The Finance Minister must supply a copy of the request to both the Australian Finance Minister and the Ministerial Council.

If the Australian Finance Minister, or the Ministerial Council, or both, ask for a copy of the information received, the Finance Minister must supply it.
Compare: 2004 No 115 ss 133(2), 134(1), (2), (3) 30 (1) (2) (3) 156 Therapeutic Products and Medicines Bill Part 4 cl 199 198 Authority to comply with request for information by (1) (2) Secretary to the Treasury If the Secretary to the Treasury makes a written request to the Authority for information about the Authority’s operations and performance, or about the operations and performance of any 5 of its subsidiaries, the Authority must supply the information within the time and in the manner (if any) specified by the Secretary.
The Secretary to the Treasury may only request information under this section if it is for the purpose of— (a) 10 preparing fiscal forecasts and projections required by or under any Act; or preparing Appropriation Bills, Estimates, Supplemen- tary Estimates, and other supporting information re- quired by or under any Act; or preparing the annual and monthly financial statements of the Government; or allowing the Secretary to the Treasury to perform the functions imposed on him or her by the Government or any enactment.
15 20 (b) (c) (d) Compliance with directions 199 Authority to comply with directions of Ministerial Council This section applies if the Ministerial Council gives the Au- (1) thority a written direction under this section.

The Authority must give effect to a written direction from the 25 Ministerial Council.
(2) (3) A written direction under this section— (a) must be about a matter of government policy; and (b) must not relate to a regulatory function (as defined in Article 1 of the Agreement) of the Authority; and (c) must not require the performance or non-performance of a particular act, or the bringing about of a particular result, in respect of a particular person or persons.
30 (4) A written direction may not be given under this section unless, before it is given, the Board has been consulted about its con- 35 tents.

157 Part 4 cl 200 Therapeutic Products and Medicines Bill (5) As soon as practicable after a direction is given under this sec- tion— (a) (b) the Minister must present a copy of the direction to the House of Representatives; and the Authority must publish the text of the direction on 5 its Internet site.
(6) Under section 230(5), the Authority’s annual report must re- port on directions given under this section.

Compare: 2004 No 115 ss 103, 108(1), (2), 113, 114 Review of operations 200 Review of operations and performance (1) The Ministerial Council, or the Minister, or the Australian Minister may, in accordance with any relevant Rules, review the following: the operations or performance of the Authority: (a) (b) the operations or performance of any of its subsidiaries.
The Authority must take all reasonable steps to co-operate with the review.

Employees and others 201 Employees and others not to disclose Authority information This section applies to— (a) (b) every employee of the Authority; and every person who performs functions on behalf of the Authority under— (i) (ii) every member of a Board Committee or expert advisory committee.
a contract for service; or a delegation; and (c) (2) However, this section does not apply to senior officers (includ- 30 ing the Managing Director), because they are subject to sec- tions 246 and 247(3) instead.
(3) A person to whom this section applies commits an offence if he or she intentionally or recklessly uses, discloses, or acts upon information obtained solely as a result of his or her role with 35 the Authority, unless the use, disclosure, or action— 158 10 15 20 25 (2) (1) Therapeutic Products and Medicines Bill Part 4 cl 204 (a) (b) (c) is in, or relates to, the performance of the Authority’s functions; or is required or authorised by law (such as, for example, when the information is disclosed in good faith under the Official Information Act 1982); or is authorised by a senior officer.
(4) A person who commits an offence under this section is liable, on conviction on indictment, to a term of imprisonment of not more than 2 years, a fine of not more than 300 penalty units, or both.
5 10 202 Employees not to misuse position (1) An employee of the Authority (not being the Managing Dir- ector or a senior manager) commits an offence if he or she in- tentionally uses his or her position as an employee to— (a) gain, or with the intention of gaining, an improper ad- 15 vantage for himself, herself, or someone else; or cause detriment to the Authority.
(b) (2) A person who commits an offence under this section is liable, on conviction on indictment, to a term of imprisonment of not more than 2 years, or a fine of not more than 300 penalty units, 20 or both.
Immunities, indemnities, and insurance 203 Application of sections 204 to 207 Sections 204 to 207 apply to the following people: (a) senior officers and former senior officers: (b) members and former members of Board committees: (c) members and former members of expert advisory com- mittees: employees and former employees of the Authority.

(d) 204 General protection from liability A person referred to in section 203 is not liable for a liability of the Authority merely because he or she is such a person.
Compare: 2004 No 115 s 120 25 30 159 Part 4 cl 205 Therapeutic Products and Medicines Bill Immunities 205 (1) No proceedings, civil or criminal, may be taken against any person referred to in section 203 for anything that the person may do or say, or fail to do or say, in the course of the oper- ations of the Authority, unless the person acted in bad faith.
(2) However, subsection (1)— (a) (b) (c) (d) is not a defence to a prosecution under any provision of section 247; and is not a defence to any liability under subpart 5 of this Part; and does not affect the right of any person to apply for judi- cial review; and does not apply in respect of proceedings for— (i) an offence against any of sections 78, 78A, 105, or 105A of the Crimes Act 1961; or the offence of conspiring to commit an offence against any of those sections; or the offence of attempting to commit an offence against any of those sections.
(ii) (iii) 5 10 15 Compare: 2004 No 115 ss 120, 121(2), and definition of excluded act or omis- 20 sion in s 126 (2) Indemnities 206 (1) Despite section 213, the Authority may agree to indemnify any person referred to in section 203, subject to this section.
The Authority may not agree to indemnify the person for— 25 (a) (b) acts or omissions done in bad faith; or acts or omissions that are not done in the course of per- forming, or intending to perform,— a function of the Authority; or (i) a function conferred on the person (in that cap- 30 (ii) acity) by a New Zealand Act or an Act of the Commonwealth of Australia.
(3) No indemnity may be provided by the Authority to the person in respect of any legal costs that relate in any way to proceed- ings for an offence for which the person is convicted, unless 35 the conviction is subsequently overturned.

160 Therapeutic Products and Medicines Bill Part 4 cl 208 (4) Subsection (3) applies despite any contrary agreement en- tered into under subsection (1).
Compare: 2004 No 115 s 123; Commonwealth Authorities and Companies Act 1997 ss 27M, 27N (Aust) (2) Insurance 207 (1) Despite section 213, the Authority may insure, or pay insur- ance cover for, any person referred to in section 203, subject to this section.
The Authority may not insure, or pay insurance cover for, the person in respect of— (a) (b) acts or omissions done in bad faith; or acts or omissions that are not done in the course of per- forming, or intending to perform,— a function of the Authority; or (i) a function conferred on the person (in that cap- 15 (ii) acity) by an Act or an Act of the Commonwealth of Australia; or 5 10 (3) (4) (c) any legal costs that relate in any way to proceedings for an offence for which the person is convicted, unless the conviction is subsequently overturned.
If the Authority insures, or pays insurance cover for, the person in breach of subsection (2), the person must repay to the Authority the cost of the insurance cover to the extent that the insurance cover exceeds that which could have been provided under subsection (1) in accordance with subsection (2).

The Authority may recover the amount as a debt due in a court of competent jurisdiction.
Compare: 2004 No 115 ss 123, 125; Commonwealth Authorities and Compan- ies Act 1997 s 27N (Aust) 20 25 Immunity for Authority 208 (1) No proceedings, civil or criminal, may be taken against the Authority for anything it may do or fail to do in the course of the exercise or intended exercise of its functions, unless it is shown that the Authority acted without reasonable care or in bad faith.
30 35 (2) Nothing in subsections (1) and (2) applies in respect of pro- ceedings for— 161 Part 4 cl 209 Therapeutic Products and Medicines Bill (a) (b) an offence against any of sections 78, 78A, 105, or 105A of the Crimes Act 1961; or the offence of conspiring to commit an offence against any of those sections; or the offence of attempting to commit an offence against 5 any of those sections.
Compare: 1986 No 5 s 106(1)–(3) (c) 209 Application of Health and Safety in Employment Act 1992 (1) Despite section 208, the Authority is subject to prosecution under the Health and Safely in Employment Act 1992 because 10 it is within the definition of Crown organisation for the pur- poses of that Act (by virtue of being a government–related or- ganisation under the Crown Organisations (Criminal Liability) Act 2002).
(2) However, the only officers, agents, or employees of the Au- 15 thority who may be prosecuted under section 56(2) of the Health and Safety in Employment Act 1992 are— (a) (b) Board members who are resident in New Zealand; and other officers, agents, or employees of the Authority whose work for the Authority is primarily based in New 20 Zealand.
Miscellaneous matters 210 Seal of Authority The imprint of the seal of the Authority that appears on a docu- ment is presumed, unless the contrary is proved, to be the im- 25 print of the Authority’s seal, and the document is presumed, unless the contrary is proved, to have been sealed as it pur- ports to have been sealed.
Signature of Managing Director 211 (1) A document that purports to have been signed by the Man- 30 aging Director, or by a person on behalf of the Managing Dir- ector, is presumed, unless the contrary is proved, to have been signed by the Managing Director, or by the person on behalf of the Managing Director, acting in an official capacity.
162 (2) (3) Therapeutic Products and Medicines Bill Part 4 cl 213 (2) A document that has been signed by the Managing Director on behalf of the Authority is taken to have been signed with the authority of the Authority, unless the contrary is proved.

Subpart 3—Financial and associated matters 212 Restriction on borrowing, etc (1) The Authority must not borrow, or amend the terms of a bor- rowing, except in accordance with the Rules.
Subsection (1) applies to each of the following in the same way as it applies to borrowing: (a) 5 (b) (c) (d) (e) issuing or amending a security or other financial instru- 10 ment: entering into, or amending, a hire purchase agreement or similar agreement: entering into, or amending, a finance lease arrangement or similar arrangement: accepting debt on assignment or amending the terms of the assignment: recording in the financial statements of the Authority the debt of another entity to an entity other than the Authority, or amending that record, whether or not the 20 Authority is legally obliged to repay the debt because of the novation of an agreement or otherwise.
15 Subsections (1) and (2) do not apply to— (a) the purchase of goods or services on credit extended for 90 days or less; or the obtaining of an advance for 90 days or less by— (i) (ii) the use of a credit card; or the supply of credit for the purchase of goods or services; or (b) (c) (d) an operating lease; or bailment on hire.
213 Restriction on giving guarantees and indemnities (1) The Authority must not give or amend a guarantee, whether the guarantee is given or amended with or without security, except in accordance with the Rules.

163 25 30 35 Part 4 cl 214 Therapeutic Products and Medicines Bill (2) (3) The Authority must not indemnify any person, or amend any indemnity, except in accordance with the Rules.

Subsection (2) does not prevent the Authority from indem- nifying a person under section 206.
214 Restriction on use of derivative transactions (1) The Authority must not enter into, or amend the terms of, a derivative transaction, except in accordance with the Rules.
For the purposes of this section, derivative transaction means— (a) (2) 5 a transaction that is a forward, swap, future, option (put 10 or call), swaption, cap, floor, or collar on 1 or more rates, currencies, commodities, equity or debt instru- ments, economic indices or measures of economic risk or value, environmental or climatic variables, or other benchmarks against which payments or deliveries are to 15 be made; or any other similar transaction that is, or in the future be- comes, recurrently entered into in the financial markets and whose value derives from, or varies with, move- ments in the value of 1 or more underlying assets, rates, 20 indices, indicators, or benchmarks; or a transaction that is identified by or under the Rules as a derivative transaction for the purposes of this section.
(b) (c) 215 Banking (1) The Authority must pay all money received by it into an ac- 25 count maintained with an approved bank.

The Authority must not keep a bank account in a currency other than New Zealand currency or Australian currency, ex- cept in accordance with the Rules.

The circumstances in which the Authority may keep a bank 30 account may be further defined in the Rules.
(2) (3) 216 Restriction on acquiring securities (1) The Authority may exercise its powers to acquire securities only by way of 1 or more of the following: (a) a deposit with an approved bank: 35 164 Therapeutic Products and Medicines Bill Part 4 cl 218 (c) (b) a public security (as defined in section 2(1) of the Public Finance Act 1989): a security issued or guaranteed by the Commonwealth of Australia or by an Australian State or Territory: a debt security identified in or under the Rules.
(d) The circumstances in which the Authority may acquire secur- ities may be further defined in the Rules.

(2) (3) However, this section does not limit what the Authority may do under section 217(1) in accordance with the Rules.
217 Restriction on Authority’s involvement in other entities (1) The Authority must not do any of the following, except in accordance with the Rules: (a) (b) (c) (d) form a company or participate in the formation of a company: acquire an interest in a company: participate in a partnership, trust, unincorporated joint venture, or similar arrangement: increase the Authority’s interest in a company, partner- ship, trust, unincorporated joint venture, or similar ar- rangement.
5 10 15 20 (2) (3) Before disposing of an interest in a company, partnership, trust, unincorporated joint venture, or similar arrangement, the Authority must give written notice to the Ministerial Council.

Subsection (2) does not apply in relation to the disposal of an interest if the Rules provide that the subsection does not apply.
25 218 Subsidiaries not to do what Authority cannot or must not do The Authority must ensure that none of its subsidiaries— (a) does anything that the Authority does not itself have power to do; or exercises any of the Managing Director’s powers (in- cluding powers that the Managing Director exercises in performing the Authority’s regulatory functions in ac- cordance with Article 7 of the Agreement).
(b) 30 165 Part 4 cl 219 Therapeutic Products and Medicines Bill 219 Aligning accounting periods of subsidiaries (1) If the annual accounting period of a subsidiary of the Author- ity is not the same as the financial year of the Authority, the Board members must, within 12 months of the subsidiary be- coming a subsidiary, do whatever is necessary to ensure that 5 the subsidiary’s annual accounting period is the same as the Authority’s financial year.
If the annual accounting period of a subsidiary is already the same as the Authority’s financial year, the Board members must do whatever is necessary to ensure that it continues to 10 be the same.

(2) (3) However, the Finance Minister may, with the agreement of the Australian Finance Minister, by notice in writing, exempt Board members from the requirements of subsection (1), either generally or in relation to 1 or more specific subsidiaries, 15 whether the exemption is with or without conditions.
(4) A Board member who, intentionally or recklessly, contra- venes, or fails to take all reasonable steps to comply or secure compliance with, subsections (1) or (2) commits an offence and is liable, on summary conviction, to a fine of not more 20 than 50 penalty units.
Compare: Commonwealth Authorities and Companies Act 1997 ss 30, 31 (Aust) 220 Banking and accounting for trust money (1) This section and section 221 apply only to money received 25 or held by the Authority on trust (in these sections referred to as trust money).
(2) Unless provided otherwise in the Rules, as soon as practicable after identifying any trust money, the Authority must pay it into a bank account that is— kept in accordance with section 215; and (a) (b) not used to hold money other than trust money.

The Authority must account for trust money separately from money that it holds on its own account.

(3) 30 (4) Money held under one trust must be accounted for separately 35 from money held under any other trust.
166 Therapeutic Products and Medicines Bill Part 4 cl 224 221 (1) (2) (3) Investment of trust money The Authority may invest trust money and, if it does, must do so in accordance with the Rules.

Income from the investment of trust money is also trust money.

The income from any investment of trust money must be held, 5 accounted for, apportioned, and paid in accordance with the Rules.
222 Exemption of Authority from income tax (1) The Authority is a public authority for the purposes of the In- land Revenue Acts (as that term is defined in section 3(1) of 10 the Tax Administration Act 1994).

The effect of subsection (1) is that the income of the Author- ity is exempt from income tax.
(2) 223 Authority’s input tax under Goods and Services Tax Act (1) 1985 For the purpose of working out the Authority’s input tax under the Goods and Services Tax Act 1985, goods and services ac- quired by the Authority are treated as being acquired for the principal purpose of making taxable supplies, unless they were acquired for the principal purpose of making exempt supplies.
20 15 (2) A term used in this section and defined in the Goods and Ser- vices Tax Act 1985 has the same meaning in this section as it has in that Act.

Subpart 4—Reporting Overview 25 224 Overview (1) In order to ensure that the Authority is accountable to each Party to the Agreement, the Authority is required by Article 8 of the Agreement to produce various reporting documents.

Paragraph 1 of Article 8 of the Agreement sets out principles 30 guiding the design of the reporting regime for the Authority.
In order to give effect to those principles— (2) (3) 167 Part 4 cl 225 Therapeutic Products and Medicines Bill (a) (b) the requirements for planning and reporting documents set out in the Rules are augmented by requirements set out in Parts 1 to 5 and the Australian Act; and the obligations imposed under the Acts are based on the obligations that each country would normally apply to 5 a comparable regulatory agency of that Party, but are modified in order to reduce unnecessary duplication.
(4) Accordingly,— (a) New Zealand requires the Authority to prepare and pro- vide an annual statement of intent, in addition to any 10 other planning documents required by the Rules; and (b) Australia requires the Authority to prepare and provide budget estimates in accordance with the Australian Act, in addition to any other planning documents required by the Rules; and both Parties to the Agreement require the Authority to prepare a single annual report that complies with the requirements of Parts 1 to 5, the Australian Act, and any other requirements specified in the Rules.
(c) 15 (5) This section is by way of explanation only.

If any other provi- 20 sion of Parts 1 to 5, the Australian Act, or the Rules conflicts with this section, the other provision prevails.

Statement of intent 225 Obligation to prepare statement of intent (1) Before the start of each financial year, the Board must prepare 25 a statement of intent for the Authority and provide it to the Ministerial Council.
The statement of intent must include information that covers— the forthcoming financial year and at least the 2 subse- (a) quent financial years; and (b) the Authority and all of its subsidiaries (if any).

The statement of intent must be prepared in accordance with the Rules.
30 (2) (3) (4) Without limiting subsection (3), the statement of intent must include— (a) information on the nature and scope of the Authority’s functions and intended operations; and 35 168 Therapeutic Products and Medicines Bill Part 4 cl 227 (b) (c) the main financial and non-financial measures and standards by which the performance of the Authority may be judged during the period covered by the state- ment of intent; and for the forthcoming financial year— (i) forecast financial statements for the Authority that have been prepared in accordance with gen- erally accepted accounting practice; and a statement of forecast service performance pre- pared in accordance with the Rules.
The requirement to prepare a statement of intent is additional to the requirement imposed by paragraph 4 of Article 8 of the Agreement to prepare and provide any other documents re- quired by the Rules.
Compare: 2004 No 115 s 139 (ii) 5 10 15 (5) 226 Board to ensure Authority complies with statement of intent Parliament intends that the Board, in fulfilling its responsibil- ities under paragraph 5 of Article 6 of the Agreement, will en- sure that the Authority acts in accordance with the statement 20 of intent for the Authority that is currently in force.
Compare: 2004 No 115 s 49 227 Direction by Ministerial Council to amend statement of (1) (2) intent The Ministerial Council may direct the Board to amend any 25 provision of the Authority’s statement of intent.

If the Ministerial Council intends to so direct, it must consult with the Board before giving the direction.
(3) A direction to amend a statement of intent— (a) must be presented to the House of Representatives, and 30 be published in the Gazette, as soon as practicable; and (b) may not require the performance or non-performance of a particular act, or the bringing about of a particular result, in respect of a particular person or persons.
Compare: 2004 No 115 s 147 35 169 Part 4 cl 228 Therapeutic Products and Medicines Bill 228 Amendments to statement of intent (1) (2) The Board may amend a statement of intent for the Authority.
The Board must amend a statement of intent if— (a) (b) (c) the Board is directed under section 227 to amend the statement of intent; or the information contained in the statement of intent is false or misleading in a material particular; or the intentions and undertakings in the statement of in- tent are significantly altered or affected by— (i) (ii) (iii) a direction given under section 199; or any change in the law; or any other change in the entity’s operating envir- onment.
5 10 (3) The Board must make the amendment required under subsec- tion (2) as soon as practicable after the Board becomes aware 15 of the facts that give rise to the obligation to amend the state- ment.
229 Statement of intent to be presented to House of (1) Representatives and be published The Minister must present a copy of the statement of intent, 20 and of every amendment to a statement of intent, to the House of Representatives— (a) no later than 5 working days after the statement of intent or amendment (as the case may be) is received by the Ministerial Council; or if Parliament is not in session, as soon as practicable after the commencement of the next session of Parlia- ment.
(b) 25 (2) The Authority must publish its statement of intent, and every amendment to it, on its Internet site as soon as practicable after 30 it has been presented to the House of Representatives.

Annual report 230 Obligation to prepare annual report (1) Paragraph 3 of Article 8 of the Agreement requires the Board to prepare an annual report for the Authority for each financial 35 year, and provide it to the Ministerial Council.
170 Therapeutic Products and Medicines Bill Part 4 cl 231 (2) (3) (4) The annual report must be provided to the Ministerial Council by the 15th day of the fourth month after the end of the finan- cial year, unless the Ministerial Council grants an extension of time.

The Ministerial Council may grant an extension of time only 5 in special circumstances.

The annual report must be prepared in accordance with the Rules.
(5) Without limiting subsection (4), the annual report must in- 10 clude all of the following: (a) (b) (c) (d) (e) information about the operations of the Authority and its subsidiaries (if any) during the financial year: a statement of service performance, prepared in accord- ance with the Rules: financial statements for the Authority, prepared in ac- 15 cordance with generally accepted accounting practice: the auditors’ reports on the statement of service per- formance and financial statements: particulars of all directions given to the Authority by the Ministerial Council under section 199 that are relevant 20 to the financial year.
231 Annual report to be presented to House of Representatives (1) (2) and be published The Minister must present the Authority’s annual report to the House of Representatives as soon as practicable after it has 25 been provided to the Ministerial Council.
The Authority must publish the annual report on its Internet site— (a) as soon as practicable after it has been presented to— the House of Representatives; or (i) (ii) either House of Parliament of Australia; but in any case, not later than 10 working days after the annual report is received by the Ministerial Council.
(b) 30 171 Part 4 cl 232 Therapeutic Products and Medicines Bill Audit (2) 232 Auditor-General is auditor of Authority (1) The Auditor-General is appointed as an auditor of the Author- ity and of each of its subsidiaries.

The Australian Act appoints the Australian Auditor-General 5 to also be an auditor of the Authority and its subsidiaries, as required by paragraph 5 of Article 8 of the Agreement.
(3) A reference to the Authority’s “auditors” is therefore a ref- erence to both the Auditor-General and the Australian Audi- tor-General; and a reference to “an auditor” of the Authority 10 is a reference to either the Auditor-General or the Australian Auditor-General.

Both the appointed auditors will work jointly, in a manner to be agreed by the auditors, to audit the financial statements of the Authority and its subsidiaries.
The Public Audit Act 2001 applies to the Authority and each of its subsidiaries as if the Authority was a public entity for the purpose of that Act.

(4) (5) 15 Keeping accounting records 233 Obligation to keep accounting records (1) The Authority must keep accounting records that properly record and explain its transactions and financial position.
The Authority must keep the records in a way that— (a) enables the Authority’s financial statements to be pre- pared in the form required by the Rules (if any); and allows those financial statements to be conveniently and properly audited.

(b) 20 25 The Authority must retain the records for at least 7 years after the completion of the transactions to which they relate.

The Authority must make the records available at all reason- 30 able times for inspection by a Board member.
(2) (3) (4) Offences 234 Offence of failing to keep accounting records (1) A senior officer commits an offence if the senior officer inten- tionally contravenes section 233.

35 172 Therapeutic Products and Medicines Bill Part 4 cl 236 (2) A person who commits an offence under this section is liable, on summary conviction, to a term of imprisonment of not more than 6 months, a fine of not more than 30 penalty units, or both.
235 Offences relating to reporting (1) A person commits an offence if he or she knowingly— 5 (a) refuses or fails to produce any information, when re- quired to do so under this Part or the Rules, that is— (i) is in that person’s possession or under that per- son’s control; and relates to the management, performance, or op- 10 erations of the Authority; or (ii) (c) (b) resists or obstructs any person acting in the discharge of that person’s functions or in the exercise of that person’s powers under this Part or the Rules; or represents directly or indirectly that he or she holds any 15 authority under this Part or under the Rules, knowing that he or she does not hold that authority.
(2) A person commits an offence if he or she makes any statement or declaration, or gives any information or certificate, required by this Part or the Rules, knowing it to be false or misleading.

20 (3) A person who commits an offence under this section is liable, on summary conviction, to,— (a) in the case of an individual, a fine of up to 200 penalty units; and in the case of a body corporate, a fine of up to 500 25 penalty units.
(b) Compare: 2004 No 115 ss 171(1), 172(1) Subpart 5—Board members and other senior officers Board member conflict of interest 30 236 What Board member must do if interested in matter (1) A Board member who has a material personal interest in a matter relating to the Authority— (a) must disclose details of the interest as soon as practic- able after the member becomes aware that he or she has 35 the interest; and 173 Part 4 cl 237 Therapeutic Products and Medicines Bill (2) (b) must not participate in any way in the Board’s (or any Board committee’s ) consideration of, decisions about, or voting on, the matter; and (c) must not sign any document relating to the entry into a transaction relating to the matter, or that initiates the 5 matter.
If the Rules specify circumstances in which a Board member is taken to have a material personal interest in a matter, or the circumstances in which a person is taken not to have a mater- ial personal interest in a matter, then those Rules apply when 10 determining whether or not a Board member has a material personal interest for the purposes of this section.
Compare: 2004 No 115 ss 63(1), 66; Commonwealth Authorities and Compan- ies Act 1997 ss 27F(1), 27J(1) (Aust) 237 How disclosures of interest are made (1) The details of a material personal interest must be disclosed— in an interests register kept by the Authority; and (a) to either— (b) (i) (ii) the Chair of the Board; or the Ministerial Council, if there is not a Chair 20 of the Board or the Chair is unavailable or has a material personal interest.
15 (2) The details of a material personal interest that must be dis- closed are— (a) the nature and extent of the interest, including the mon- 25 etary value of the interest (if the interest is a monetary interest and the value of that interest can be quantified); and how the interest relates to the affairs of the Authority.

(b) (3) A Board member may make a standing disclosure of a present 30 or future material personal interest by way of a general notice of the interest.
(4) A standing disclosure is effective only if it is disclosed in ac- cordance with subsections (1) and (2).

174 Therapeutic Products and Medicines Bill Part 4 cl 240 (5) A standing disclosure ceases to have effect if the nature of the interest materially alters or the extent of the interest materially increases.
Compare: 2004 No 115 ss 63, 64, 65; Commonwealth Authorities and Com- panies Act 1997 ss 27F(3)(a), 27G (Aust) 5 238 Permission to act despite being interested in matter (1) If the Board is satisfied that it is in the public interest to do so, the Board may permit a member, or members with a specified class of material personal interest, to participate in a matter in a way that would otherwise contravene section 236(1)(b) 10 and (c).
The permission may state conditions that the member or mem- bers must comply with.

The Ministerial Council may give permission in place of the Board doing so, in accordance with the Rules (if any).

(4) A permission may be amended or revoked in the same way as (3) (2) 15 it may be given.
Compare: 2004 No 115 s 68 239 Consequences of failing to comply with section 236 (1) If a Board member fails to comply with section 236, the Min- 20 isterial Council must be notified of that fact as soon as prac- ticable after the failure becomes known to the Board.

(2) A failure to comply with section 236 does not affect the val- idity of the relevant act or matter, but the Authority may avoid the act in accordance with section 240.
Subsection (1) does not limit the right of any person to apply for judicial review.

Compare: 2004 No 115 s 67(2), (3); Commonwealth Authorities and Compan- ies Act 1997 ss 27F(4), 27G(7), 27J(4) (Aust) (3) 25 240 Authority may avoid some acts done in breach of conflict 30 (1) of interest rules This section applies if the Ministerial Council is notified under section 239(1) of a Board member’s failure to comply with section 236.
(2) Within 3 months of the notification, the Authority may avoid 35 the act, if the Authority did not receive fair value for the act.

175 Part 4 cl 241 Therapeutic Products and Medicines Bill (3) The Authority has the onus of establishing that it did not re- ceive fair value.
(4) However, a person seeking to prevent the act from being avoided has the onus of establishing that the Authority re- ceived fair value for the act, if at the time of the act the person 5 knew, or ought reasonably to have known, of the Board mem- ber’s interest.

(5) Whether the Authority receives fair value for an act must be determined on the basis of the information known to the Au- thority and to the interested Board member at the time the act 10 is done.
(7) (6) However, the Authority is presumed to receive fair value for the act if the Authority did it in the ordinary course of its busi- ness and on usual terms and conditions.

The avoidance of the act does not affect a person’s title to, or 15 interest in, property that the person acquired— (a) (b) (c) from a person (person B) other than the Authority; and for valuable consideration; and without knowledge of the circumstances of the act under which person B acquired the property from the 20 Authority.
(8) An act in which a Board member is interested may be avoided on the ground of the member’s interest only under this section.

Compare: 2004 No 115 ss 69(1)–(3), 70(1), 70(2), 71(1), 71(2), 72 Duties of senior officers 241 Duties apply regardless of where senior officer located The duties of senior officers that are set out in sections 242 to 246 apply to every act or omission of a senior officer, while acting as such, wherever the officer is located at the time of the act or omission.
25 30 242 Duty to act with honesty and integrity A senior officer must, when acting as a senior officer, act with honesty and integrity.

Compare: 2004 No 115 s 54 176 Therapeutic Products and Medicines Bill Part 4 cl 245 243 Duty to comply with Acts and Rules A senior officer must not contravene, cause the contravention of, or agree to the Authority contravening, Parts 1 to 5, the Australian Act, or the Rules.
Compare: 2004 No 115 s 53 244 Duty of care, diligence, and skill (1) A senior officer must, when acting as such, exercise his or her powers and discharge his or her duties with the degree of care, diligence, and skill that a reasonable person would exercise— (a) (b) in those circumstances; and if he or she held the position, and had the same respon- sibilities, as the officer.
5 10 (2) For the purposes of this section, a senior officer who makes a business judgment is taken to meet the requirements of sub- section (1), and his or her equivalent duties at common law 15 and in equity, in respect of the judgment if he or she— (a) makes the judgment in good faith for a proper purpose; (b) (c) (d) and does not have material personal interest in the subject matter of the judgment; and informs himself or herself about the subject matter of the judgment to the extent he or she reasonably believes to be appropriate; and rationally believes that the judgment is in the best inter- ests of the Authority.
20 25 The senior officer’s belief that the judgment is in the best inter- ests of the Authority is a rational one unless the belief is one that no reasonable person in his or her position would hold.

In this section, business judgment means any decision to take or not to take action in respect of a matter relevant to the Au- 30 thority.
Compare: 2004 No 115 s 56; Commonwealth Authorities and Companies Act 1997 s 22 (Aust) (3) (4) 245 Duties of good faith, etc (1) A senior officer must exercise his or her powers and discharge 35 his or her duties— (a) in good faith; and 177 Part 4 cl 246 Therapeutic Products and Medicines Bill (b) for a proper purpose.

(2) A senior officer must not pursue his or her own interests at the expense of the Authority’s interests.
(3) A senior officer must not use his or her position as a senior officer to— (a) gain an improper advantage for himself, herself, or an- other person; or cause a detriment to the Authority.
(b) Compare: 2004 No 115 s 55; Commonwealth Authorities and Companies Act 1997 ss 23, 24 (Aust) 246 Duty not to misuse information (1) A senior officer or former senior officer who has information solely as a result of being or having been a senior officer, must not disclose, use, or act upon the information except— (a) (b) (c) in the performance of the Authority’s functions; or as required or permitted by law; or in complying with a requirement to disclose his or her interests.
(2) A senior officer or former senior officer may disclose, make use of, or act upon information if— (a) the senior officer or former senior officer is first author- ised to do so by the Board; and the disclosure, use, or act in question will not, or will not be likely to, prejudice the Authority.
(b) 5 10 15 20 Compare: 2004 No 115 s 57; Commonwealth Authorities and Companies Act 25 1997 s 25(1) (Aust) Criminal consequences of failing to comply with duties 247 Offences relating to failure to comply with certain duties (1) A senior officer commits an offence if he or she intentionally 30 or recklessly fails to exercise his or her powers and discharge his or her duties— (a) (b) in good faith; or for a proper purpose.
(2) A senior officer commits an offence if he or she pursues his or 35 her own interests at the expense of the Authority’s interests.

178 Therapeutic Products and Medicines Bill Part 4 cl 248 (3) A person who has information solely as a result of being, or having been, a senior officer commits an offence if he or she intentionally discloses, uses, or acts upon the information in breach of section 246, knowing that the disclosure, use, or action is in breach of section 246.
5 (4) A person who commits an offence under this section is liable, on conviction on indictment, to a term of imprisonment of not more than 5 years, a fine of not more than 300 penalty units, or both.
Compare: Commonwealth Authorities and Companies Act 1997 s 26(1), (2), 10 (3) (Aust) 248 Requirement to provide information in connection with (1) (2) criminal proceedings The Finance Minister may, by notice in writing, require a per- son to give all reasonable assistance in connection with crim- 15 inal proceedings under section 247.
The requirement may be made only if— (a) 20 the Finance Minister believes on reasonable grounds that the person has information that is relevant to the proceedings; and the person is not, or is not likely to be, a defendant in any criminal proceedings under section 247; and the person is not an employee, agent (including banker or auditor), or business partner of a person who is, or is likely to be, a defendant in the proceedings; and the person is not a lawyer who has acted for the de- fendant, or likely defendant, in any current or previous criminal or civil penalty proceedings under this Part; and the information that the Finance Minister believes the 30 person has cannot be readily obtained by any other means or from any other person.
25 (b) (c) (d) (e) (3) (4) The Finance Minister may require the person to give all rea- sonable assistance, whether or not criminal proceedings have commenced.

The High Court may, on application by the Finance Minister, order a person to comply with a requirement under this section in a specified way.
35 179 Part 4 cl 249 Therapeutic Products and Medicines Bill (5) Information provided pursuant to a requirement under this sec- tion may not be used in any proceedings as evidence against the person who provided the information, except in criminal proceedings in respect of the falsity of information provided by the person.
Compare: Commonwealth Authorities and Companies Act 1997 Schedule 2 cl 13 (Aust) Civil consequences of failing to comply with duties 249 Application for civil penalty The Minister or the Finance Minister may apply to the High Court for an order requiring a senior officer or former senior officer to pay a civil penalty.
5 10 250 (1) Imposition of civil penalty The High Court may make the order to pay a civil penalty if it 15 is satisfied that— (a) the senior officer or former senior officer breached any of the duties referred to in sections 243 to 246; and the breach— (i) materially prejudices the interests of the Author- 20 ity; or (b) (ii) materially prejudices the Authority’s ability to pay its creditors; or is serious.

(iii) (2) (3) The civil penalty may be any amount up to 2 000 penalty units.
25 The amount of civil penalty is payable to the Crown.

Compare: Commonwealth Authorities and Companies Act 1997 Schedule 2 cls 3, 14(2) (Aust) 251 When and how civil penalty proceedings brought (1) An application for a civil penalty may be made no later than 6 30 years after the alleged breach.
In proceedings for a civil penalty under this Part— (a) the standard of proof is the standard of proof that applies in civil proceedings; and (2) 180 Therapeutic Products and Medicines Bill Part 4 cl 254 (b) the Authority may, by order of the High Court, obtain discovery and administer interrogatories.
Compare: 1996 No 30 s 12E 252 Authority involvement in proceedings In any proceedings under this Part for a civil penalty, the Au- 5 thority is entitled to intervene and be heard on all matters other than whether an order for a civil penalty should be made.
Compare: Commonwealth Authorities and Companies Act 1997 Schedule 2 cl 6(3) (Aust) 253 Relief from liability in civil penalty proceedings under 10 (1) (2) section 249 If civil penalty proceedings are commenced against a person under section 249, the High Court may relieve the person, either wholly or partly, from a liability to which the person would otherwise be subject if— (a) it appears to the Court that the person has or may have breached any duty referred to in sections 243 to 246; but the person has acted honestly and, having regard to all the circumstances of the case, the person ought fairly to 20 be excused of the breach.
(b) 15 If a person who thinks that civil penalty proceedings relating to a breach or possible breach of any duty in sections 243 to 246 will or may be commenced against him or her, the person may apply to the High Court for relief under subsection (1) 25 on the grounds set out in paragraph (b) of that subsection.

(3) On application under subsection (2), the High Court may grant prospective relief from liability as if proceedings had been commenced against the applicant.
254 Requirement to provide information in connection with 30 (1) civil penalty proceedings The Finance Minister may, by notice in writing, require a per- son to give all reasonable assistance in connection with an ap- plication for a civil penalty under this Part.
(2) A person may be required to assist only if— 35 181 Part 4 cl 255 Therapeutic Products and Medicines Bill (a) (b) (c) it appears to the Finance Minister that someone other than the person required to assist may be liable to a civil penalty under this Part; and the Finance Minister suspects or believes that the person required to assist can give information relevant to the 5 application; and the person is not, and has not been, a lawyer for the person in respect of whom the application is made.
(3) A requirement to assist may be made whether or not an appli- cation for a civil penalty has been made.

(4) On application by the Finance Minister, the High Court may order a person who has been required under this section to assist to provide that assistance.

Disqualification for breach of duty 255 Disqualification for breach of duty (1) The Finance Minister may apply to the High Court for a dis- qualification order against a senior officer or former senior of- ficer.
(b) (2) A disqualification order must disqualify the person from being a Board member and may also do all or any of the following: disqualify the person from being a director or promoter (a) of a company in New Zealand: prohibit the person from being in any way, directly or indirectly, concerned in the management of a company in New Zealand: disqualify the person from being a member of any Crown entity (as defined in section 10(1) of the Crown Entities Act 2004).
(c) 10 15 20 25 (3) A disqualification order must specify the period or periods to which the disqualifications or prohibitions apply, which may 30 be for no longer than 10 years.

The High Court may make a disqualification order if the Court is satisfied that the disqualification order is justified and— (a) a civil penalty has been imposed on the person under this Part; or a declaration of breach has been made against the person in Australia.
(b) 35 (4) 182 Therapeutic Products and Medicines Bill Part 4 cl 257 (5) In determining whether the disqualification order is justified, and the period for which it is imposed, the High Court may have regard to— (a) the person’s conduct in relation to the management, business, or property of the Authority and any other 5 body corporate; and any other matters that the Court considers appropriate (such as, for example, matters mentioned in section 383 of the Companies Act 1993).
(b) (6) A person who breaches a disqualification order commits an 10 offence and is liable, on conviction on indictment, to a term of imprisonment of not more than 5 years, a fine of not more than 2 000 penalty units, or both.
Compare: 1993 No 105 s 383; Commonwealth Authorities and Companies Act 1997 s 27C (1)–(4) (Aust) 15 256 Application to quash or amend disqualification order (1) A person who is subject to a disqualification order under sec- tion 255 may apply to the High Court for the order to be quashed or amended.

The High Court may not consider an application under this 20 section unless it is satisfied that the Finance Minister has had at least 21 days’ notice of the application.
The High Court may quash or amend an order made under section 255.

(3) (2) (4) No amendment to a disqualification order may— 25 (a) (b) extend the period for which a disqualification or prohib- ition applies; or add a disqualification or prohibition that was not in- cluded in the original order.
257 Effect of disqualification under Australian Act (1) A person who is subject to a disqualification order under the Australian Act is disqualified from appointment to the Board of any Crown entity (as defined in section 10(1) of the Crown Entities Act 2004).
30 (2) A person who is subject to a disqualification order under the 35 Australian Act commits an offence if the person— 183 Part 4 cl 258 Therapeutic Products and Medicines Bill (a) is a director or promoter of a company in New Zealand; or is in any way, directly or indirectly, concerned in the management of a company in New Zealand.
(3) A person who commits an offence under subsection (2) is 5 (b) liable, on conviction on indictment, to a term of imprisonment of not more than 5 years, a fine of not more than 2 000 penalty units, or both.

Compensation orders 258 Compensation order (1) 10 The Authority, or the Finance Minister on behalf of the Au- thority, may apply to the High Court for a compensation order against a senior officer or former senior officer.
The High Court may order a senior officer or former senior officer to compensate the Authority for damage suffered by 15 the Authority if the Court is satisfied that— (a) the person has breached any of the duties referred to in sections 243 to 246; and (b) the Authority suffered damage as a result of that breach.

The order must specify the amount of compensation payable 20 to the Authority.
In determining the amount of compensation payable, the High Court may take into account any profits made by any person as a result of the breach.

To avoid doubt,— (a) proceedings for a compensation order are in addition to, and not in substitution for, any other cause of action; and a compensation order may not be made in the course of any criminal proceedings for a breach of duty.
(b) 25 (2) (3) (4) (5) Compare: Commonwealth Authorities and Companies Act 1997 Schedule 2 cls 30 4, 5, 6(1), (2) (Aust) 259 When application for compensation order may be made An application for a compensation order may be made no later than 6 years after the alleged breach.
Compare: Commonwealth Authorities and Companies Act 1997 Schedule 2 cl 35 7 (Aust) 184 Therapeutic Products and Medicines Bill Part 4 cl 261 Civil liability of others involved 260 Others involved in breach of certain senior officer duties (1) A person who is involved in the breach by a senior officer of any of the duties specified in section 245 or 246 is liable, as if he or she were the senior officer who breached the duty, to 5 any of the following: (a) (b) (c) For the purposes of this section, a person is involved in a 10 breach of a senior officer’s duties if he or she— (a) (b) a civil penalty under this Part: a disqualification order under section 255: a compensation order under section 258. aids, abets, counsels, or procures the breach; or induces the breach, whether by threats, promises or otherwise; or in any way, by act or omission, directly or indirectly, is 15 knowingly concerned in or party to the breach; or conspires with others to effect the breach.
(2) (c) (d) Sections 261 and 262 are available to a person charged under this section in the same way that they are available to senior officers.
Compare: Commonwealth Authorities and Companies Act 1997 ss 6 (definition of “involved”), 24(2), 25(2) (Aust) (3) 20 Defence in criminal or civil penalty proceedings 261 Defence to rely on information and advice (1) This section applies for the purpose of any criminal or civil 25 penalty proceedings under this Part against a senior officer or former senior officer for breach of duty.
(2) A senior officer, when acting as such, may rely on reports, statements, financial data, and other information prepared or supplied, and on professional or expert advice given, by any 30 of the following persons: (a) an employee of the Authority whom the senior officer believes on reasonable grounds to be reliable and com- petent in relation to the matters concerned: a professional adviser or expert in relation to matters 35 that the senior officer believes on reasonable grounds (b) 185 Part 4 cl 262 Therapeutic Products and Medicines Bill (c) (d) to be within the person’s professional or expert compe- tence: any other senior officer in relation to matters within the senior officer’s designated authority: a Board committee on which the senior officer did not 5 serve, in relation to matters within the Board commit- tee’s designated authority.
(3) A senior officer, when acting as a senior officer, may rely on reports, statements, financial data, and other information sup- plied by the New Zealand Government or the Australian Com- 10 monwealth Government.

This section applies to an officer only if the senior officer— (a) (b) makes proper inquiry if the need for inquiry is indicated acts in good faith; and (4) by the circumstances; and has no knowledge that the reliance is unwarranted.
(c) Compare: 2004 No 115 s 61 15 General relief from civil liability 262 Relief from civil liability (1) If civil proceedings are commenced against a senior officer or 20 former senior officer for negligence, default, breach of trust, or breach of duty in a capacity as such an officer, the court before which the proceedings are taken may relieve the person, either wholly or partly, from a liability to which the person would otherwise be subject, if— (a) it appears to the court that the person is or may be liable in respect of the negligence, default, or breach; but the person has acted honestly and, having regard to all the circumstances of the case (including those con- nected with the senior officer’s appointment), the per- 30 son ought fairly to be excused for the negligence, de- fault or breach.
(b) 25 If a person who thinks that civil proceedings relating to negli- gence, default, breach of trust, or breach of duty in his or her capacity as a senior officer will or may be commenced against 35 him or her, the person may apply to the High Court for pro- spective relief from liability.
(2) 186 Therapeutic Products and Medicines Bill Part 4 cl 264 (3) On an application under subsection (2), the High Court may grant prospective relief from liability if it is satisfied of the matters referred to in subsection (1)(a) and (b).
Restriction on use of evidence 263 Restriction on use of evidence given in proceedings for 5 (1) civil penalty Evidence of information given, or evidence of production of documents, by a person is not admissible in criminal proceed- ings against the person for an offence under this Part or any other enactment if— (a) the person previously gave the evidence or produced the documents— (i) in civil penalty proceedings in New Zealand under this Part against him or her, whether or not a civil penalty was imposed; or in proceedings in Australia under the Australian Act against him or her for a declaration of breach or a pecuniary penalty order, whether or not the declaration or order was made; and (ii) 10 15 (b) the proceedings related to conduct that was the same or 20 substantially the same as the conduct constituting the offence.
(2) This section does not apply to criminal proceedings in respect of the falsity of the evidence given by the person in proceed- ings for a civil penalty.
25 Relationship between criminal and civil penalty proceedings 264 Civil penalty proceedings in New Zealand after proceedings in Australia for pecuniary penalty (1) No proceedings for a civil penalty under this Part may be com- 30 menced against a person in relation to particular conduct if— proceedings against the person for a declaration of (a) breach or for a pecuniary penalty under the Australian Act are underway, or have been completed, in Aus- tralia; and 35 187 Part 4 cl 265 Therapeutic Products and Medicines Bill (b) the proceedings relate or related to the same or substan- tially the same conduct that was to be the subject of the proceedings in New Zealand.
(2) To avoid doubt, this section does not prevent subsequent pro- ceedings in New Zealand for a civil penalty if earlier proceed- 5 ings for a declaration of breach or for a pecuniary penalty in Australia have been discontinued.
265 Criminal proceedings in New Zealand after criminal proceedings in Australia (1) No criminal proceedings for an offence under this Part may be 10 commenced against a person in relation to particular conduct if— (a) criminal proceedings against the person for an offence under the Australian Act are underway, or have been completed, in Australia; and the proceedings relate or related to the same or substan- tially the same conduct that was to be the subject of the proceedings in New Zealand.
15 (b) (2) To avoid doubt, this section does not prevent subsequent crim- inal proceedings in New Zealand if earlier criminal proceed- 20 ings in Australia have been withdrawn.
266 Relationship between concurrent civil penalty proceedings and criminal proceedings Criminal proceedings for an offence under this Part may be commenced against a person in relation to particular conduct 25 whether or not— (a) proceedings in New Zealand for a civil penalty under this Part have been commenced against the person in relation to the same or substantially the same conduct; or proceedings in Australia for a declaration of breach or for a pecuniary penalty under the Australian Act have been commenced against the person in relation to the same or substantially the same conduct.
(b) 30 Proceedings under this Part for a civil penalty against a person 35 in relation to particular conduct are stayed if— (1) (2) 188 Therapeutic Products and Medicines Bill Part 4 cl 268 (a) (b) criminal proceedings in New Zealand against the person are or have been commenced for an offence under this Part in relation to the same or substantially the same conduct; or criminal proceedings in Australia against the person are 5 or have been commenced for an offence under the Aus- tralian Act in relation to the same or substantially the same conduct.
(3) After the criminal proceedings referred to in paragraphs (a) or (b) of subsection (2) have been completed or withdrawn, 10 a person may apply to have the stay lifted on the civil penalty proceedings referred to in that subsection.
267 Effect of withdrawal or discontinuation of proceedings (1) (2) (3) 15 on limitation period This section applies if— (a) (b) proceedings against a person have been commenced in Australia in relation to certain conduct, and the proceed- ings are then withdrawn or discontinued; and an application is subsequently made, or proceedings are subsequently commenced, in New Zealand against the 20 person in relation to the same or substantially the same conduct for an offence or civil penalty under this Part.
If this section applies, the period between the commencement of the Australian proceedings and the date on which they were withdrawn or discontinued is not to be included when deter- 25 mining whether the New Zealand application or proceedings are brought within the limitation period applying to the appli- cation or proceedings.
For the purposes of subsection (2), limitation period means the period during which criminal proceedings must be com- 30 menced under this Part or during which an application must be made under section 249 for a civil penalty or section 258 for a compensation order.

268 Abuse of process jurisdiction not affected To avoid doubt, nothing in sections 264 to 267 affects the 35 abuse of process jurisdiction of any court.
189 Part 5 cl 269 Therapeutic Products and Medicines Bill Part 5 Regulations, and transitional and miscellaneous provisions Subpart 1—Regulations 269 Regulations providing for departures from the Scheme (1) The Governor-General may, by Order in Council, make regu- lations providing for departures from the Scheme by New Zealand in respect of a specified therapeutic product or class of therapeutic products (in this section referred to as excluded products), as provided for in Article 12 of the Agreement.
Regulations made under this section must provide an alterna- tive way of regulating all or specified excluded products.
For that purpose, the regulations may (without limitation) do any of the following: (a) 5 10 (b) (c) (d) (e) (f) (g) (h) exclude or modify the application of the Scheme in re- 15 spect of excluded products: prescribe procedures and requirements for approving the manufacture, supply, import, export, or promotion of all or specified excluded products: require the payment of fees and charges for any ap- 20 proval, or for other functions relating to all or speci- fied excluded products, and prescribe those fees and charges: prescribe the circumstances in which, or conditions under which, all or specified excluded products may 25 or may not be manufactured, supplied, imported, ex- ported, or promoted: apply the offence, civil penalty, and enforcement provi- sions of Parts 1 to 5 to all or specified excluded prod- ucts as if they were regulated under the Scheme: require certain information to be kept, provided, or pub- lished concerning all or specified excluded products: require samples of all or specified excluded products, materials, or other things to be retained: provide that authoritative standards (such as the British 35 Pharmacopeia) may be used in relation to all or speci- fied excluded products: 30 (2) 190 Therapeutic Products and Medicines Bill Part 5 cl 271 (i) provide for the Minister to prescribe details of the regu- latory regime by notice in the Gazette.
Such details in- clude (but are not limited to) the following: (i) recognising the regulatory approvals granted by regulators in other countries: identifying the information that must be kept, provided, or published: identifying the therapeutic products, materials, or other things that must be retained: (ii) (iii) 5 (j) (k) provide for the delegation by the Minister of any powers 10 or functions of the Minister under regulations made for the purpose of this subsection: provide for the transition of all or specified excluded products to or from regulation under the Scheme.
270 Regulations for fees and charges for non-Scheme work 15 The Governor-General may, by Order in Council, make regu- lations requiring the payment to the Authority of specified fees and charges for any functions performed by the Authority that fall outside the scope of the Scheme.
(2) 271 Transitional and savings regulations (1) 20 The Governor-General may, by Order in Council, make tem- porary or transitional regulations, not inconsistent with Parts 1 to 5 and the Agreement, that are necessary or expedient to fully implement the Scheme in New Zealand.
Regulations made under this section may include, without 25 limitation, any or all of the following: (a) the savings of provisions, or the effect of provisions, of the former Act and any other enactment, as applied to particular products, persons, conduct, or things, for a specified period: the waiving of the application of specified provisions of any enactment or the Rules or Orders to particular products, persons, conduct, or things during a specified period: the imposition, modification, and revocation of condi- 35 tions applying to particular products, persons, conduct, or things, during a specified period.
30 (b) (c) 191 Part 5 cl 272 Therapeutic Products and Medicines Bill (3) Every regulation made under this section must be stated to expire on a particular date.

272 General regulation-making power The Governor-General may, by Order in Council, make regu- lations for all or any of the following purposes: (a) prescribing the form of search warrant issued under Part 2; providing for such other matters as are contemplated by, or necessary for, giving full effect to Parts 1 to 5 or their due administration.
(b) 5 10 Subpart 2—Transitional provisions relating to Scheme Preliminary 273 Outline of transitional regime (1) The general scheme and effect of the transitional provisions in 15 this subpart are as follows: (a) before the start date, the Authority will be established under the Australian Act.
One of the functions of the Authority is to grant approvals (in this subpart called Scheme approvals) that have effect in both Australia 20 and New Zealand: there will be an establishment period before the start date, which will (among other things) allow Rules and Orders to be made: on the start date, the legislative regime in New Zealand 25 concerning therapeutic products (the former regime) will be replaced with the Scheme, which includes Parts 1 to 5 and the Rules and Orders: to facilitate the smooth transition from the former regime to the Scheme, and to give effect to Article 21 30 of the Agreement (which deals with transitional provi- sions),— (i) transitional approval will be deemed to have been granted in substitution for all existing consents, existing approvals, and existing licences; and 35 (b) (c) (d) 192 Therapeutic Products and Medicines Bill Part 5 cl 274 (ii) (iii) transitional approvals will be deemed to have been granted for certain other activities that were lawful before the start date and that relate to diet- ary supplements, medical devices, and certain other products such as radiopharmaceuticals; and 5 transitional approvals may be granted by the Au- thority for pending applications, in which case they will be granted on the same basis that ap- plied under the former regime: a transitional approval lasts for not more than the tran- 10 sition period that applies to it, and has effect only in New Zealand.
Before a transitional approval expires, the holder will need to apply for, and obtain, a Scheme approval if the holder wishes to lawfully continue doing the activity that the transitional approval authorised: in general terms, a transitional approval for a thera- peutic product will be on the terms and conditions (if any) that applied to the therapeutic product before the Scheme started: Rules will identify which provisions of the former Act 20 (and any regulations made under that Act) apply to which transitional approvals, and also which (if any) Rules, Orders, and provisions of Parts 1 to 5 apply in connection with different transitional approvals.
15 (e) (f) (g) (2) This section is by way of explanation only.

If a provision of 25 Parts 1 to 5, the Agreement, or the Rules or Orders conflicts with this section, the other provision prevails.
274 Definitions of terms used in this subpart In this subpart, unless the context otherwise requires,— applicable Rules means Rules (and any Orders applied by 30 those Rules) that— (a) apply to, or in connection with, transitional approvals or transitional approvals of specified kinds; and are designated as applicable Rules in Rules made under subparagraph (jj) of paragraph 1 of Article 9 of the 35 Agreement (b) 193 Part 5 cl 274 Therapeutic Products and Medicines Bill dietary supplement means a product that,— (a) immediately before the start date, is a dietary supple- ment as defined in the Dietary Supplements Regulations 1985; and on the start date, is a therapeutic product (b) establishment period means the period that— (a) starts on the date that the Authority is established under the Australian Act; and ends on the start date (b) evaluation work, in relation to a pending application, means 10 either or both of the following: (a) the Minister considering and weighing the matters re- ferred to in section 22(1) of the former Act: the appropriate committee considering the matter under section 22(2) of the former Act (b) 5 existing approval means an approval of the Minister given under section 24D of the former Act and in effect immediately before the start date existing consent means any of the following consents that were in effect immediately before the start date: (a) a consent of the Minister given under section 20 of the former Act: a provisional consent of the Minister given under sec- tion 23 of the
 former Act: a consent of the Director-General given under section 25 24(3) of the former Act (b) (c) 15 20 existing licence means a licence to manufacture medicines, or a licence to pack medicines, that was granted under section 51 of the former Act and in effect immediately before the start date former Act means the Medicines Act 1981 as in force imme- diately before its repeal by the Medicines Act 2006 former regulations means regulations made under the former Act, as those regulations are in force
 immediately before the repeal of that Act medical device means a product that,— (a) immediately before the start date, is a medical device as defined in section 2(1) of the former Act; and 30 35 194 Therapeutic Products and Medicines Bill Part 5 cl 274 after the start date, is a therapeutic product (b) medicine means a product that,— (a) 5 immediately before the start date, is a medicine as de- fined in section 2(1) of the former Act; and after the start date, is a therapeutic product (b) newly designated therapeutic product means a product that,— (a) immediately before the start date, is not a medicine or medical device (as defined in section 2(1) of the former Act) or a dietary supplement (as defined in the Dietary 10 Supplements Regulations 1985); but after the start date, is a therapeutic product (b) pending application means an application that was made under the former Act but not determined before the start date related product means a product that,— (a) immediately before the start date, is a related product as defined in section 94 of the former Act; and after the start date, is a therapeutic product (b) Scheme approval means an approval granted by the Authority in accordance with the Rules sponsor has the same meaning as given in section 6, except that that definition must be applied in this subpart as if it did not include any reference to Australia start date means the date on which the Scheme starts transition period means, in relation to a
 transitional approval 25 or transitional approvals of a particular type, the period that— (a) (b) starts on the start date; and ends on a date specified in, or determined in accordance with, Rules that apply to that transitional approval or type of transitional approval 20 15 30 transitional approval means a transitional approval that is re- ferred to in Article 21 of the Agreement and that is granted, or is deemed to have been granted, by the Authority in accord- ance with this Part.
195 Part 5 cl 275 Therapeutic Products and Medicines Bill 275 Saving and application of former Act and former regulations (1) Despite the repeal of the former Act by the Medicines Act 2006, and the revocation of former regulations,— (a) (b) the former Act and the former regulations continue to 5 apply and have effect (with all necessary modifications) for the purpose of completing any matter or thing re- ferred to in this subpart as a matter or thing to which the former Act applies; and the provisions of the former Act and former regulations 10 that are applied by the Rules continue to apply to, or in connection with, transitional approvals— (i) with all necessary modifications, including those listed in subsection (2); and subject to any specific modifications identified in 15 the Rules.
(ii) (2) For the purposes of applying the former Act and former regu- lations, a reference in that Act or those regulations to— (a) the Minister is to be read as if it were a reference to the Authority; and the Director-General is to be read as if it were a refer- ence to the Authority; and the Medicines Review Committee is to be read as if it were a reference to the Review Tribunal; and the licensing authority is to be read as if it were a refer- 25 ence to the Authority.
20 (b) (c) (d) (3) Nothing in this section limits or affects the application of sec- tions 17 to 22 of the Interpretation Act 1999.

276 Prescribed fees and charges A transitional approval is subject to any applicable fees and 30 charges that are prescribed by Rules.
Medicines: transitional approvals 277 Deemed grant of transitional approval (1) On the start date, a transitional approval is deemed to have been granted by the Authority in substitution for every exist- 35 196 Therapeutic Products and Medicines Bill Part 5 cl 279 (2) ing consent and existing approval (as the case may be) for a medicine.
The transitional approval— (a) (b) has effect only in New Zealand; and is subject to the same terms and conditions that applied 5 to the existing consent or existing approval (as the case may be) that it replaced; and is subject to the provisions of the former Act and former regulations that are applied by the Rules, and to any relevant applicable Rules.
(c) 10 278 Duration of transitional approval A transitional approval referred to in section 277 expires on the earliest of the following dates: (a) the date on which the transitional approval is revoked under section 35 of the former Act (if that section is 15 applied by applicable Rules): the date on which the transitional approval ceases to have effect under any relevant applicable Rules: the date on which a Scheme approval is issued that is intended to replace the transitional approval: the date on which the transition period applicable to the transitional approval ends.
20 (b) (c) (d) Related products: transitional approvals (2) 279 Deemed grant of transitional approval (1) On the start date, a transitional approval is deemed to have 25 been granted by the Authority in substitution for every existing consent for a related product.
The transitional approval— (a) (b) has effect only in New Zealand; and is subject to the same terms and conditions that applied 30 to the existing consent that it replaced; and is subject to the provisions of the former Act and former regulations that are applied by the Rules, and to any relevant applicable Rules.
(c) 197 Part 5 cl 280 Therapeutic Products and Medicines Bill 280 Duration of transitional approval A transitional approval referred to in section 279 expires on the earliest of the following dates: (a) the date on which the transitional approval is revoked under section 35 of the former Act (if that section is 5 applied by applicable Rules): the date on which the transitional approval ceases to have effect under any relevant applicable Rules: the date on which a Scheme approval is issued that is intended to replace the transitional approval: the date on which the transition period applicable to the transitional approval ends.
10 (b) (c) (d) Medicines and related products: material changes 281 Determination of pending notices for medicines and 15 (1) related products In this section, pending notice, in relation to a medicine or a related product, means a notice that was— (a) deposited with the Director-General under section 24 of the former Act; and not determined before the start date.
(b) (2) After the start date, the former Act (with all necessary modifi- cations) applies to enable the processes required by section 24 of that Act to be completed by the Authority on the same basis that applied to the pending notice before the start date.
(3) However, if, before or after the start date, the notice has been referred under section 24(5) of the former Act, that referral converts the notification into a pending application for consent to distribute a new medicine under section 20 of that Act, and sections 284 to 288 apply accordingly.

282 Grant of transitional approval (1) A consent granted by the Authority in accordance with section 24(3) of the former Act is a transitional approval.
The transitional approval— (a) has effect only in New Zealand; and (2) 198 20 25 30 35 Therapeutic Products and Medicines Bill Part 5 cl 285 (b) (b) is subject to the same terms and conditions that would have applied had it been a consent granted by the Dir- ector-General; and is subject to the provisions of the former Act and former regulations that are applied by the Rules, and to any 5 relevant applicable Rules.
283 Duration of transitional approval A transitional approval referred to in section 282 expires on the earliest of the following dates: (a) the date on which the transitional approval would have 10 ceased to have effect under the former Act had it been the consent of the Director-General given under section 24(3) of that Act: the date on which the transitional approval ceases to have effect under any relevant applicable Rules: the date on which a Scheme approval is issued that is intended to replace the transitional approval: the date on which the transition period applicable to the transitional approval ends.
15 (b) (c) (d) Medicines and related products: pending applications 284 Kinds of pending applications covered by sections 285 to 288 Sections 285 to 288 apply to the following kinds of pending applications: (a) an application for the consent of the Minister under sec- tion 20 of the former Act: an application for the provisional consent of the Minis- ter under section 23 of the former Act: an application for the approval of the Minister under 30 section 24D of the former Act.
(b) (c) 20 25 285 Pending applications on which evaluation work started (1) by start date If, immediately before the start date, evaluation work has been started in connection with a pending application, the former 35 199 Part 5 cl 286 Therapeutic Products and Medicines Bill Act (with all necessary modifications) applies to the pending application, except that any consent or approval granted by the Authority in accordance with the former Act is a transitional approval.
(2) A transitional approval granted by the Authority in accordance 5 with subsection (1)— (a) (b) has effect only in New Zealand; and is subject to terms and conditions specified by the Au- thority in applying the former Act; and is subject to the provisions of the former Act and former 10 regulations that are applied by the Rules, and to any relevant applicable Rules.
(3) The transitional approval expires on the earliest of the follow- ing dates: (a) the date on which the transitional approval is revoked or 15 suspended (as the case may require) under section 35 of the former Act (if that section is applied by applicable Rules): the date on which the transitional approval ceases to have effect under any relevant applicable Rules: the date on which a Scheme approval is issued that is intended to replace the transitional approval: the date on which the transition period applicable to the transitional approval ends.
20 (c) (b) (c) (d) 286 Pending applications on which no evaluation work done 25 by start date This section applies to a pending application on which, by the start date, no evaluation work has started.
If a pending application to which this section applies is with- drawn within 3 months after the start date— (a) the application fee (less an administration fee to be de- termined by the Authority) must be refunded to the ap- plicant; or on the applicant’s request, the original application fee must be credited towards the new application fee, if the 35 application is resubmitted to the Authority for a Scheme approval.
(b) 30 (1) (2) 200 Therapeutic Products and Medicines Bill Part 5 cl 288 (3) If a pending application to which this section applies is not withdrawn within 3 months after the start date, then (in ac- cordance with section 287(1)(a)) the application lapses.
287 Pending applications that lapse (1) A pending application lapses if— 5 10 (a) (b) no evaluation work has been started on the application by the start date and the application is not withdrawn within 3 months after the start date; or evaluation work has been started on the application by the start date, but any of the following applies: (i) the application was made more than 5 years be- fore the start date: the applicant has been asked (before or after the start date) to provide additional information, and the request has not been satisfied within 6 months 15 of making it: the applicant has been asked 3 times or more (be- fore or after the start date) to provide additional information, and the request has not been satis- fied: an initial evaluation of the application by the Au- thority shows it to be substantially deficient.
20 (ii) (iii) (iv) (2) The fee that was paid for an application that lapses is not re- fundable.

(2) 288 Protection of confidential supporting information (1) 25 This section applies to confidential supporting information (as defined in section 23A of the former Act) that is contained in a pending application for an innovative medicine (as defined in that section).
Subpart 5 of Part 3 applies to confidential supporting infor- 30 mation to which this section applies as if— (a) the confidential supporting information was protected active ingredient information, as defined in section 181; and the reference in section 182(2) to the date on which the 35 application was received by the Authority was a refer- (b) 201 Part 5 cl 289 Therapeutic Products and Medicines Bill ence to the date on which the application was received by the Minister.
Medicines: existing exemptions under former Act 5 289 Authorised prescribers (1) A person authorised under section 25 of the former Act to do any of the things set out in subsection (1)(a), (d), or (e) of that section continues (despite Parts 1 to 5) to be authorised to do those things, subject to provisions of the former Act and former regulations applied by the Rules, and to any relevant 10 applicable Rules.

The authorisation continued by subsection (1) ceases 6 months after the start date.
(2) 290 Medicine required by medical practitioner (1) A person who is authorised under section 29 of the former Act 15 to supply medicine to a medical practitioner for the treatment of a particular patient of the medical practitioner may continue (despite Parts 1 to 5) to so supply that medicine, subject to the provisions of the former Act and former regulations applied by the Rules, and to any applicable Rules.

The authorisation continued by subsection (1) ceases 6 months after the start date.
(2) 20 Medicines: clinical trials approved under former Act 291 Clinical trials covered by sections 292 to 294 25 Sections 292 to 294 apply to an approval for a clinical trial that was given by the Director-General under section 30 of the former Act and in effect immediately before the start date.
292 Deemed grant of transitional approval (1) On the start date, a transitional approval is deemed to have 30 been granted by the Authority in substitution for every ap- proval of the Director-General to which this section applies.
The transitional approval— (a) has the effect only in New Zealand; and (2) 202 Therapeutic Products and Medicines Bill Part 5 cl 296 (b) (c) is subject to the same terms and conditions that applied to the approval that it replaces; is subject to the provisions of the former Act and former regulations that are applied by the Rules, and to any relevant applicable Rules.
5 293 Duration of transitional approval A transitional approval referred to in section 292 expires on the earliest of the following dates: (a) (b) the date on which the clinical trials ends: the date on which the Authority revokes approval of the 10 clinical trial under section 30(8) of the former Act (if that section is applied by applicable Rules): the date on which the transitional approval ceases to have effect under the applicable Rules.
(c) 294 Request to modify clinical trial 15 After the start date, no request may be made under section 30 of the former Act to extend a clinical trial.

Medicines: pending application for approval of clinical trial 295 Determination of pending application for approval of 20 (1) clinical trial This section and sections 296 and 297 apply to a pending application under section 30 of the former Act for the approval of a clinical trial.
(2) After the start date, the former Act (with all necessary modifi- 25 cations) applies to enable the processes required by section 30 of that Act to be completed by the Authority on the same basis that applied to the pending application before the start date.

296 Grant of transitional approval (1) A consent granted by the Authority in accordance with section 30 (2) 30 of the former Act is a transitional approval.
The transitional approval— (a) has effect only in New Zealand; and 203 Part 5 cl 297 Therapeutic Products and Medicines Bill (b) (c) is subject to terms and conditions specified by the Au- thority in applying the former Act; and is subject to the provisions of the former Act and former regulations that are applied by the Rules, and to any relevant applicable Rules.
5 297 Duration of transitional approval A transitional approval referred to in section 296 expires on the earliest of the following dates: (a) the date on which the transitional approval would have ceased to have effect under the former Act had it been 10 an approval of the Director-General under section 30(1) of that Act: the date on which the transitional approval ceases to have effect under the applicable Rules: the date on which a Scheme approval is issued that is 15 intended to replace the transitional approval: the date on which the transition period applicable to the transitional approval ends.
(b) (c) (d) Medicines: transitional approvals for existing licences 20 298 Kinds of existing licences covered by sections 299 and 300 Sections 299 and 300 apply to the following kinds of exist- (1) ing licences: (a) a licence to manufacture medicines (which authorises the manufacture, packing and labelling, and sale by 25 wholesale, of the medicines described in the licence): a licence to pack medicines (which authorises the pack- ing and labelling, and the sale by wholesale, of the medicines described in the licence).
(b) (2) By way of explanation, section 530 of the Medicines Act 30 2006, rather than this subpart, deals with existing licences that authorise the sale by wholesale of the medicines described in those licences (see section 299(2)(b)).

204 Therapeutic Products and Medicines Bill Part 5 cl 300 299 Deemed grant of transitional approval (1) On the start date, a transitional approval is deemed to have been granted by the Authority in substitution for an existing licence to which this section applies.
The transitional approval— (a) (b) (2) has effect only in New Zealand; and is subject to the same terms and conditions that ap- plied to the existing licence that it replaces, except that the transitional approval does not authorise the sale by wholesale of the medicines described in the existing li- 10 cence; and is subject to the provisions of the former Act and former regulations that are applied by the Rules, and to any relevant applicable Rules.
(c) 5 300 Duration of transitional approval 15 A transitional approval referred to in section 299 expires on the earliest of the following: (a) the date on which the existing licence that is replaced by the transitional approval would have expired, unless section 53(3) of the former Act is applied by applicable 20 Rules: if section 53(3) of the former Act is applied by applic- able Rules, the date on which the application for a li- cence that will replace the existing licence is finally de- termined: the date on which the transitional approval is cancelled under section 51(6) or 83 of the former Act (if the rele- vant section is applied by applicable Rules): the date on which the transitional approval ceases to have effect under the applicable Rules: the date on which the transition period for the transi- tional approval ends.
30 25 (b) (c) (d) (e) 205 Part 5 cl 301 Therapeutic Products and Medicines Bill Medicines: pending applications for licences 301 Kinds of pending applications covered by sections 302 to 304 Sections 302 to 304 apply to the following kinds of pending applications under section 50 of the former Act: (a) (b) an application for a licence to manufacture medicines: an application for a licence to pack medicines.
5 302 Determination of pending applications After the start date, the former Act (with all necessary modifi- cations) applies to enable the processes required by section 50 10 of that Act to be completed by the Authority on the same basis that applied to the pending application before the start date.

303 Grant of transitional approval (1) A licence granted by the Authority in accordance with sec- (2) tion 50 of the former Act to manufacture medicines or to pack 15 medicines is a transitional approval.
The transitional approval— (a) authorises the manufacture or the packing (as the case may be) of the medicines, as specified in the approval; and has effect only in New Zealand; and is subject to terms and conditions specified by the Au- thority in applying the former Act; and is subject to the provisions of the former Act and former regulations that are applied by the Rules, and to any 25 relevant applicable Rules.
20 (b) (c) (d) (3) However, the transitional approval does not authorise the sale by wholesale of the medicines.
304 Duration of transitional approval A transitional approval referred to in section 303 expires on 30 the earliest of the following dates: (a) (b) the date on which the transitional approval expires: the date on which the transitional approval is cancelled under section 51(6) or 83 of the former Act (if the rele- vant section is applied by applicable Rules): 35 206 Therapeutic Products and Medicines Bill Part 5 cl 305 (c) (d) (d) the date on which the transitional approval ceases to have effect under the applicable Rules: the date on which a Scheme approval is issued that is intended to replace the transitional approval: the date on which the transition period applicable to the 5 transitional approval ends.
Medical devices: transitional approval 305 Deemed grant of transitional approval (1) On the start date, a transitional approval is deemed to have been granted by the Authority for a medical device if, before 10 the start date,— (a) the Authority has received from the sponsor of the med- ical device— (i) a declaration of lawful supply under section 307; and the information and declaration referred to in section 308; or (ii) 15 (b) information about the device has been entered into the database of medical devices established and maintained under regulation 4 of the Medicines (Database of Med- 20 ical Devices) Regulations 2003.
(2) The transitional approval— (a) authorises the import, export, or supply (as applicable) of the medical device, but only to the extent that the import, export, or supply (as applicable) of the medical 25 device was lawful before the start date; and has effect only in New Zealand; and if the transitional approval replaces an existing consent, existing approval, or existing licence, is subject to the same terms and conditions that applied to the consent, 30 approval, or licence that it replaces; and is subject to the provisions of the former Act and former regulations that are applied by the Rules, and to any relevant applicable Rules.
(b) (c) (d) 207 Part 5 cl 306 Therapeutic Products and Medicines Bill 306 Duration of transitional approval A transitional approval referred to in section 305 expires on the earliest of the following dates: (a) the date on which the transitional approval ceases to have effect under the applicable Rules: the date on which a Scheme approval is issued that is intended to replace the transitional approval: the date on which the transition period applicable to the transitional approval ends.
(b) (c) 307 Declaration of lawful supply (1) The sponsor of a medical device who wishes to supply the medical device after the start date under a transitional approval must, during the establishment period, ensure that the Author- ity receives a declaration by the sponsor, or an employee of the sponsor, that the medical device— (a) is being lawfully supplied in New Zealand on the date of the declaration; and (b) will, to the best of the knowledge of the person making the declaration, continue to be lawfully supplied in New Zealand immediately before the start date.
This section does not apply to the sponsor of a medical device referred to in section 309 or to which section 310 applies.
5 10 15 20 Information to be supplied by sponsor The sponsor of a medical device who wishes to supply the medical device after the start date under a transitional approval 25 must, during the establishment period, ensure that the follow- ing information is received by the Authority: (a) (b) the risk classification of that device: the name of the manufacturer and the sponsor of that device, together with— (i) 30 the address of the registered office or principal place of business in New Zealand of the sponsor; and the address of the registered office or principal place of business of the manufacturer (whether 35 in New Zealand or overseas); and (ii) (2) 308 (1) 208 Therapeutic Products and Medicines Bill Part 5 cl 308 (iii) a contact telephone number or email address for the manufacturer and the sponsor: the product description attributed to the device by the Global Medical Device Nomenclature System (GMDNS): a trade name or brand name, combined if the Authority so requires, with a form of product identification for each Class III and Class AIMD medical device: any other information prescribed in applicable Rules.
5 (c) (d) (e) (2) Despite subsection (1), if a particular sponsor is the spon- 10 sor of 2 or more medical devices, it is only necessary for the sponsor to ensure that the Authority receives the information referred to in that subsection in respect of each kind of device (instead of in respect of each device) for which the sponsor is responsible, if each of the devices of the same kind— was made by the same manufacturer; and (a) has the same GMDNS code; and (b) has the same risk classification; and (c) is a Class I, Class IIa, or Class IIb medical device.
(d) For the purposes of subsection (2), 2 or more medical de- 20 vices are of the same kind if those devices are— (a) (b) substantially similar to one another; and designed to be used in the same way and for the same purpose.

(3) 15 (4) (5) (6) In this section, Class I medical device, Class IIa medical 25 device, Class IIb medical device, Class III medical device, and Class AIMD, have the same meanings as in regulation 3 of the Medicines (Database of Medical Devices) Regulations 2003.
The sponsor must also provide to the Authority a declaration 30 by the sponsor, or an employee of the sponsor, that the infor- mation supplied is accurate and complete.

This section does not apply to the sponsor of a medical device referred to in section 309 or to which section 310 applies.
209 Part 5 cl 309 Therapeutic Products and Medicines Bill 309 Medical devices subject to existing approvals, etc Sections 305 does not apply to a medical device for which, before the establishment period begins, there is an existing consent, existing approval, or existing licence.
Medical devices: exemptions 5 310 Medical device required by medical practitioner (1) This section applies to the following: (a) any medical device that is— (i) manufactured in response to a request by a regis- tered health professional (as defined in section 10 2(1) of the former Act) that specifies the design characteristics of the device; and intended to be used only in relation to a particular patient: (ii) (b) a medical device supplied to a practitioner (as defined 15 in section 2(1) of the former Act) for use in relation to a particular patient of the practitioner.
(2) Nothing in Parts 1 to 5 applies to a medical device to which this section applies, but the provisions of the former Act and former regulations that are applied by the Rules, and any rele- 20 vant applicable Rules, do apply to the device.

Subsection (2) ceases to apply on the date that is 6 months after the start date.
(3) Dietary supplements: transitional approvals 311 Deemed grant of transitional approval (1) On the start date, a transitional approval is deemed to have been granted by the Authority for a dietary supplement if, be- fore the start date, the Authority has received from the sponsor of the dietary supplement— (a) (b) a declaration of lawful supply under section 313; and 30 the information and declaration referred to in section 314.
25 The transitional approval— (a) authorises the supply, import, or export (as applicable) of the dietary supplement, but only to the extent that 35 the supply, import, or export (as applicable) of the diet- (2) 210 Therapeutic Products and Medicines Bill Part 5 cl 314 (b) (c) (d) ary supplement was lawful immediately before the start date; and has effect only in New Zealand; and if the transitional approval replaces an existing consent, existing approval, or existing licence, is subject to the 5 same terms and conditions that applied to that consent, approval, or licence; and is subject to the provisions of the former Act and former regulations that are applied by the Rules, and to any relevant applicable Rules.
10 312 Duration of transitional approval A transitional approval referred to in section 311 expires on the earliest of the following dates: (a) the date on which the transitional approval ceases to have effect under the applicable Rules: the date on which a Scheme approval is issued that is intended to replace the transitional approval: the date on which the transition period applicable to the transitional approval ends.
(b) (c) 313 Declaration of lawful supply (1) The sponsor of a dietary supplement who wishes to supply the dietary supplement after the start date under a transitional approval must, during the establishment period, ensure that the Authority receives a declaration by the sponsor, or an em- ployee of the sponsor, that the dietary supplement— (a) is being lawfully supplied in New Zealand on the date of the declaration; and (b) will, to the best of the knowledge of the person making the declaration, continue to be lawfully supplied in New Zealand immediately before the start date.
This section does not apply to the sponsor of a dietary supple- ment referred to in section 315.
15 20 25 30 Information to be supplied by sponsor The sponsor of a dietary supplement who wishes to supply the dietary supplement after the start date under a transitional 35 211 (2) 314 (1) Part 5 cl 315 Therapeutic Products and Medicines Bill approval must, during the establishment period, ensure that the Authority receives the following information: (a) the name of the manufacturer and the sponsor of that dietary supplement, together with— (i) the address of the registered office or principal 5 place of business in New Zealand of the sponsor; and the address of the registered office or principal place of business of the manufacturer (whether in New Zealand or overseas); and a contact telephone number or email address for the manufacturer and the sponsor: 10 (ii) (iii) (b) (c) (d) (e) (f) (g) the trade name or brand name of the dietary supplement: whether the product is for export only: the dosage: the container type for the dietary supplement: the active ingredient and strength: any other information prescribed by regulations made under Parts 1 to 5.
15 (2) (3) The sponsor must ensure that the Authority receives a declar- 20 ation by the sponsor, or an employee of the sponsor, that the information supplied is accurate and complete.

This section does not apply to the sponsor of a dietary supple- ment referred to in section 315.
315 Dietary supplements subject to existing approvals, etc 25 The requirements in section 311 do not apply to a dietary supplement that is the subject of an existing consent, existing approval, or an existing licence (as the case may be).
Newly designated therapeutic products: transitional approvals 30 316 Deemed grant transitional approval (1) On the start date, a transitional approval is deemed to have been granted by the Authority for a newly designated product if, before the start date, the Authority has received— (a) a declaration of lawful supply under section 318; and 35 212 Therapeutic Products and Medicines Bill Part 5 cl 319 (b) the information and declaration referred to in section 319.
(2) The transitional approval— (a) authorises the manufacture, import, export, or supply (as applicable) of the product, but only to the extent that 5 the manufacture, import, export, or supply (as applic- able) of the product was lawful immediately before the start date; and has effect only in New Zealand; and is subject to the provisions of the former Act and former 10 regulations that are applied by the Rules, and to any relevant applicable Rules.
(b) (c) 317 Duration of transitional approval A transitional approval referred to in section 316 expires on the earliest of the following dates: (a) the date on which the transitional approval ceases to have effect under the applicable Rules: the date on which a Scheme approval is issued that is intended to replace the transitional approval: the date on which the transition period applicable to the 20 transitional approval ends.
(b) (c) 15 318 Declaration of lawful supply 1The sponsor of a newly designated therapeutic product who wishes to supply the product after the start date under a transi- tional approval must, during the establishment period, ensure 25 that the Authority receives a declaration by the sponsor, or an employee of the sponsor, that the newly designated therapeu- tic product— (a) is being lawfully supplied in New Zealand on the date of the declaration; and 30 (b) will, to the best of the knowledge of the person making the declaration, continue to be lawfully supplied in New Zealand immediately before the start date.
319 (1) Information to be supplied by sponsor The sponsor of a newly designated therapeutic product who 35 wishes to supply the product after the start date under a transi- 213 Part 5 cl 320 Therapeutic Products and Medicines Bill tional approval must, during the establishment period, ensure that the Authority receives the following information: (a) the name of the manufacturer and the sponsor of that product, together with— (i) the address of the registered office or principal 5 place of business in New Zealand of the sponsor; and the address of the registered office or principal place of business of the manufacturer (whether in New Zealand or overseas); and a contact telephone number or email address for the manufacturer and the sponsor: 10 (ii) (iii) (b) (c) (d) (e) (f) (g) the trade name (if any) or brand name (if any) of the product: whether the product is for export only: the dosage (if applicable): the container type for the product (if applicable): the active ingredient and strength: any other information prescribed by regulations made under Parts 1 to 5.
15 20 (2) The sponsor must ensure that the Authority receives a declar- ation by the sponsor, or an employee of the sponsor, that the information supplied is accurate and complete.
320 Notice issued under section 36 of former Act before start 25 Notices date This section applies if, before the start date, the Director-Gen- eral— (a) has issued a notice under section 36(1) of the former Act in respect of a therapeutic product; but has not issued a notice under section 36(3) of that Act in respect of the therapeutic product.
(b) If this section applies, the Authority must, after the start date, refer the matter to the appropriate expert committee for con- sideration if— (a) the Authority is not satisfied about the safety and effi- cacy of the therapeutic product; and 30 35 (1) (2) 214 Therapeutic Products and Medicines Bill Part 5 cl 321 (3) (4) (b) the matter has not already been referred under section 36(2) of the former Act to a committee established under that Act.
If, before the commencement date, the matter was referred under section 36(2) of the former Act to a committee estab- 5 lished under that Act, then, as soon as practicable after the start date, the matter must be transferred to the Authority for con- sideration by the appropriate expert committee.
If, before the commencement date, the Minister has issued a notice under section 36(3) of the former Act in respect of a 10 therapeutic product, subsections (4) and (5) of that section con- tinue to apply (with all necessary modifications) to the notice as if those subsections had not been repealed.

Advertising (2) (3) 321 Advertising (1) 15 20 25 This section applies to an advertisement (authorised adver- tisement) that, under the former Act, it was lawful to publish.
If this section applies, then— (a) it is still lawful to publish the authorised advertisement after the start date; and the provisions of the former Act and former regulations apply as if that Act had not been repealed and as if the regulations were still in force; and Parts 1 to 5 and the Rules and Orders do not apply to, or in connection with, the authorised advertisement.
(b) (c) Subsection (2) ceases to apply on the earliest of the following dates: (a) the date on which the authorised advertisement must cease to be published under any applicable Rules: the date on which a Scheme approval is granted for the 30 therapeutic product that is the subject of the authorised advertisement: the date on which the transitional approval for the ther- apeutic product that is the subject of the authorised ad- vertisement ceases to have effect.
35 (b) (c) 215 Part 5 cl 322 Therapeutic Products and Medicines Bill Appeals 322 When section 323 applies (1) (c) (b) Section 323 applies to a person who is aggrieved by any of the following decisions that were made before the Scheme started and for which appeal proceedings were not barred be- 5 fore the start date: (a) a decision of the Director-General made under section 30 or 38 of the former Act: a decision of the licensing authority made under section 51 of the former Act (excluding a decision that relates 10 to a wholesale, retail, or a pharmacy licence): a decision of the Minister refusing, revoking, or sus- pending any consent or approval, or imposing, varying, or adding to any conditions, under any of sections 20, 23, 24, and 35 of the former Act: a decision to issue a notice under section 36(3) or 37(1) of the former Act, or the imposition, variation, or add- ition of conditions under that section: a decision of the Medicines Review Committee made under section 88 of the former Act (excluding a decision 20 that relates to a wholesale, retail, or pharmacy licence).
Section 323 also applies to any of the following decisions that were made after the start date: (a) (d) (e) 15 25 a decision of the Authority made in accordance with section 38 of the former Act: a decision of the Authority made in accordance with section 51 of the former Act: a decision of the Authority refusing, revoking, or sus- pending any consent or approval, or imposing, varying, or adding to any conditions, in accordance with any of 30 sections 20, 23, 24, and 35 of the former Act: a decision to issue a notice in accordance with section 36(3) or 37(1) of the former Act, or the imposition, vari- ation, or addition of conditions in accordance with that section: a decision of the Merits Review Committee made in accordance with section 88 of the former Act.
35 (b) (c) (d) (e) (2) 216 Therapeutic Products and Medicines Bill Part 5 cl 324 323 Appeals of decisions under former Act If this section applies, the aggrieved person may, after the start date, begin and complete appeal proceedings as if the former Act (with all necessary modifications) were still in force.
Offences 5 324 Offences and breaches of former Act (1) This section applies to the following: (a) (b) (c) (d) an offence under, or a breach of, the former Act that was committed before the repeal of that Act: an offence under, or a breach of, any of the revoked 10 regulations that was committed before the revocation of those regulations: an offence under, or a breach of, the former Act (as applied by this subpart) that was committed after the start date: an offence under, or a breach of, the revoked regulations (as applied by this subpart) that was committed after the start date.
15 (2) (3) If this section applies, then for the purpose of doing the things specified in subsection (3),— (a) the former Act continues to have effect (with all neces- sary modifications) as if it had not been repealed; and the revoked regulations continue to have effect (with all necessary modifications) as if they had not been re- voked.
(b) 20 25 The things are: (a) (b) (c) investigating the offence or breach: commencing or completing proceedings for the offence or breach: imposing a penalty for the offence or breach (which, 30 for the avoidance of doubt, must be the same as the penalty that applied to the offence or the breach before the relevant enactment was repealed).
217 Part 5 cl 325 Therapeutic Products and Medicines Bill 325 Sections 50 to 76 do not apply to holders of transitional approvals The offences and civil penalty provisions in sections 50 to 76 do not apply— (a) (b) with respect to any therapeutic product that is the sub- to the holders of transitional approvals; or 5 ject of a transitional approval.

326 Barred proceedings Proceedings Nothing in this subpart enables any proceedings to be brought 10 that were barred before the commencement of this subpart.
327 Pending proceedings Any proceedings that have been commenced under the former Act before the start date may be continued and completed after the start date as if the former Act (with all necessary modifi- 15 cations) were in force, and that Act applies accordingly.
Subpart 3—Transitional provisions relating to employees (2) 328 Transfer of Medsafe employees to Authority (1) Every person who, on the day before this section comes into 20 force (the transfer date), was employed in the Ministry of Health to work at Medsafe transfers to the Authority on the transfer date.
The effect of the transfer is that, in respect of employees trans- ferring to the Authority, on and from the transfer date— (a) every employee’s employment agreement ceases to be between the Ministry of Health and the employee, and is instead between the Authority and the employee; and in the case of employees covered by a collective agree- ment between the Ministry of Health and the Public Ser- 30 vice Association, the Ministry ceases to be a party to that agreement and the Authority is substituted in its place.
(b) 25 (3) No other aspect of the employment agreement is affected by the transfer (but see section 330(2)).

35 218 Therapeutic Products and Medicines Bill Part 5 cl 331 (4) To avoid doubt, this section prevails in the area of employment protection, and section 69L of the Employment Relations Act 2000 is not applicable in the transfer of Medsafe employees to the Authority.
329 Transfer does not break continuity of employment 5 For the purposes of any enactment, law, determination, con- tract, or agreement,— (a) the transfer of an employee from Medsafe to the Au- thority does not break the employee’s continuity of em- ployment, which means that the employee’s employ- 10 ment agreement is to be treated as unbroken; and the employee’s period of service in the Ministry of Health, and any other period of service of the employee that is recognised by the Ministry of Health as continu- ous service, is deemed to have been a period of service 15 with the Authority.
(b) 330 No compensation for technical redundancy (1) No employee who is transferred under section 328 is en- titled to received any redundancy payment, severance, or other benefit on the ground that his or her employment in the Min- 20 istry of Health has ceased, or that his or her position with Med- safe has ceased to exist, or that Medsafe has ceased to exist, or on any other related ground.

This section overrides an employee’s employment agreement, despite section 328(3).
(2) 25 331 Protection of status as contributor to Government Superannuation Fund (1) Any employee who, immediately before transferring to the Authority under section 328, was a contributor to the Gov- ernment Superannuation Fund under the Government Super- 30 annuation Fund Act 1956 is, for the purposes of that Act, deemed to be employed in the Government service so long as he or she continues to be an employee of the Authority.
The Government Superannuation Fund Act 1956 applies to the person in all respects as if the person’s service as an employee 35 of the Authority were government service.

(2) 219 Part 5 cl 332 Therapeutic Products and Medicines Bill (3) Nothing in subsection (1) entitles a person to become a con- tributor to the Government Superannuation Fund if the person has ceased to be a contributor.
For the purposes of applying the Government Superannuation Fund Act 1956, the Managing Director is the controlling au- 5 thority (as defined in section 2 of that Act).
(4) Subpart 4—Transitional provisions relating to assets 332 Purpose of sections 333 and 334 The purpose of sections 333 and 334 is to enable the assets 10 and liabilities of Medsafe, and any associated assets and liabil- ities of the Crown, to be transferred to the Authority by apply- ing the mechanisms provided in the Health Sector (Transfers) Act 1993.
333 Health Sector (Transfers) Act 1993 amended 15 The definition of transferee in section 2(1) of the Health Sec- tor (Transfers) Act 1993 is amended by inserting the following paragraph after paragraph (c): “(ca) the Authority (as defined in section 6(1) of the Ther- apeutic Products Act 2006) that is established as the 20 Australia New Zealand Therapeutic Products Author- ity:”.
334 Agreement of Ministerial Council required for transfers (1) The transferring Ministers (as defined in section 2(1) of the Health Sector (Transfers) Act 1993) may not recommend, 25 under section 5(1) of that Act, a proposal for the transfer of assets or liabilities to the Authority, or an amendment to such a proposal, unless the Ministerial Council has agreed in writ- ing to the proposal or amendment.
The transferring Ministers may not agree to transfer assets or 30 liabilities to the Authority under section 4 of the Health Sec- tors (Transfers) Act 1993 unless the Ministerial Council has approved the agreement.

(2) 220 Therapeutic Products and Medicines Bill Part 6 cl 338 Subpart 5—Miscellaneous provisions 335 Consequential amendments relating to establishment of Authority The enactments specified in Schedule 3 are amended in the manner set out in that schedule.
5 336 Other consequential amendments Schedule 8 of this Act (as inserted by section 548) contains other amendments to enactments that are consequential upon the enactment of Parts 1 to 5.

Part 6 General provisions 10 337 Purpose The purpose of Parts 6 and 7 is to bring together and up- date the law concerning activities undertaken in relation to medicines at the consumer end of the supply chain.

15 338 Outline (1) (2) This Part deals with the preliminary matters of interpretation and application.
Part 7 provides for controls on, and requirements when under- taking, certain activities with medicines.
More specifically,— 20 subpart 1 sets out the circumstances in which a per- (a) son is authorised to undertake otherwise prohibited ac- tivities with medicines (controlled activities): subpart 2 sets out how specified individuals may be prohibited or restricted from undertaking certain activ- 25 ities with medicines in certain circumstances: subpart 3 deals with licences for undertaking the fol- lowing controlled activities: (i) (b) (c) supplying scheduled medicines by wholesale as a fixed vendor or mobile vendor: supplying pharmacy medicines other than by wholesale: dispensing medicines using an automated dis- pensing machine: operating a pharmacy: 30 35 (ii) (iii) (iv) 221 Part 6 cl 339 Therapeutic Products and Medicines Bill (d) (e) (f) (g) (h) (i) (j) (k) subpart 4 sets out requirements and restrictions relat- ing to applying for licences to operate, holding licences to operate, and holding interests in, pharmacies: subpart 5 describes how medicines must be secured, stored, and transported, and provides for matters relat- 5 ing to record keeping and certain offences relating to activities undertaken with medicines: subpart 6 provides for enforcement powers, includ- ing powers under search warrant, and certain procedural matters relating to proceedings under Parts 6 and 7: subpart 7 provides for appeals from certain decisions of the licensing authority and the Medical Officer of Health: subpart 8 sets out restrictions on xenotransplantation: subpart 9 provides for the making of regulations, 15 Orders in
 Council, Ministerial notices, and other in- struments: subpart 10 explains which medicines are prescription medicines, pharmacist-only medicines, and pharmacy medicines (scheduled medicines) and how medicines 20 are to be referred to: subpart 11 provides for— (i) the relationship between this and other enact- ments; and 10 (ii) matters of transition from the former act and 25 (iii) regulations; and repeals, revocations, savings, and consequential amendments.
This overview is by way of explanation only.

If any provision of Parts 6 and 7 conflicts with this overview, that provision 30 prevails.
Interpretation In Parts 6 and 7, unless the context otherwise requires,— acting in the course of employment means an employee undertaking an activity on behalf of his or her employer as 35 part of his or her employment administer— (a) means administering a medicine to an individual— (3) 339 222 Therapeutic Products and Medicines Bill Part 6 cl 339 (iv) (i) (ii) (iii) orally; or by injection; or by introducing it into the body in a way other than orally or by injection; or externally (whether or not involving direct con- 5 tact with the body); and includes administering a medicine— in its existing form; or (i) after it has been dissolved or dispersed in a sub- (ii) stance in order to be administered; or after it has been diluted or mixed with a substance in order to be administered (iii) 10 (b) Agreement has the meaning given in section 7 of Parts 1 to 5 analyst means— (a) a person appointed by the Minister as the analyst in charge of an approved laboratory under section 506(1); or a person who is authorised to act as an analyst under section 507(1) (b) includes a bird, fish, or reptile; but does not include an individual animal— (a) (b) approved laboratory means a laboratory approved under section 505(1) auction includes an auction on the Internet Australian Act means the Therapeutic Products Act 2006 (Australia) authorised prescriber means— (a) (b) (c) (d) a dentist; or a medical practitioner; or a midwife; or health practitioners of a registered class named as au- thorised prescribers by regulations made
 under section 502 Authority has the meaning given in section 7 of Parts 1 to 5 223 15 20 25 30 35 Part 6 cl 339 Therapeutic Products and Medicines Bill professional practice; and an activity carried on for reward business includes— (a) (b) carrier includes a person engaged in carrying goods, for hire or reward, by any mode of transport compound means undertaking an activity with a medicine while it is being prepared for dispensing, including— (a) dissolving a substance or substances to make a medicine; and
 diluting, mixing, or combining a substance or sub- 10 stances to make a medicine suitable for use by a particu- lar individual or for administering to a particular animal (b) 5 container— (a) means a bottle, box, jar, package, or other receptacle in which a medicine is held or is to be held (the inner con- 15 tainer), and, if the inner container is in another bottle, box, jar, package, or other receptacle (the outer con- tainer), includes the inner container but not the outer container; but does not include a capsule, cachet, or other article from 20 which a medicine is administered (b) controlled activity means an activity that is prohibited under subpart 1 of Part 7 unless undertaken by a person otherwise authorised by or under Parts 6 and 7 controlled drug has the meaning given in section 2(1) of the 25 Misuse of Drugs Act 1975 dentist means a health practitioner who is, or is deemed to be, registered with the Dental Council established under the Health Practitioners Competence Assurance Act 2003, as a practitioner of the profession of dentistry designated prescriber means a health practitioner (other than an authorised prescriber)— (a) 30 who belongs to a class or group of health practitioners— named designated prescribers by regulations (i) made under section 500; or deemed to be designated prescribers by section 519(1); and (ii) 35 224 Therapeutic Products and Medicines Bill Part 6 cl 339 (b) who satisfies the prescribed requirements (if any) relat- ing to
 qualifications, training, or competence Director-General means the Director-General of Health; and includes an employee of the department who is for the time be- ing acting with the Director-General’s authority in exercising 5 a function conferred on the Director-General by Parts 6 and 7 (including acting as the Director-General’s delegate under section 41 of the State Sector Act 1988) Dispensary Assistant Certificate means a certificate— (a) issued by the Pharmaceutical Society of New Zealand 10 before
 18 September 2004; and classifying the holder as a Dispensary Assistant (b) dispense includes— (a) preparing a medicine (including compounding a medicine) for supply other than by wholesale (whether 15 in response to a prescription or a request by an indi- vidual to be supplied the medicine); and packaging and labelling a medicine as part of preparing the medicine for supply other than by wholesale (b) document means any record of information, and includes— 20 anything on which there is writing or any image; and (a) anything on which there are marks, figures, symbols, or (b) perforations that have a meaning for persons qualified to interpret them; and anything from which sounds, images, or writing can be 25 reproduced, with or without the aid of anything else (c) employee includes an agent employer includes a principal examine includes count, measure, and weigh former Act means the Medicines Act 1981 former regulations means the Medicines Regulations 1984 health authority means a body corporate appointed by or under the Health Practitioners Competence Assurance Act 2003 as the body corporate that is, in accordance with that Act, responsible for the registration and oversight of practi- 35 tioners of a particular health profession 30 225 Part 6 cl 339 Therapeutic Products and Medicines Bill health practitioner means a person who is, or is deemed to be, registered with a health authority as a practitioner of a par- ticular health profession health profession means the practice of a profession in respect of which a health authority is appointed by or under the Health 5 Practitioners Competence Assurance Act 2003 health service means a service provided for the purpose of assessing, improving, protecting, or managing the physical or mental health of individuals or groups of individuals holds an interest in a pharmacy has the meaning given in 10 section 419 hospital includes a hospital care institution within the mean- ing of section 58(4) of the Health and Disability
 Services (Safety) Act 2001 individual means a natural person licence means a licence authorising a person to undertake the controlled activity to which the licence relates licensing authority means the Director-General majority interest in a pharmacy has the meaning given in section 423(5) Managing Director has the meaning given in section 7 of Parts 1 to 5 Medical Officer of Health— (a) means the Medical Officer of Health appointed under 20 15 25 (b) the Health Act 1956 for a health district; and includes a Deputy Medical Officer of Health and other persons on whom the functions of a Medical Officer of Health are conferred under section 22 of that Act medical practitioner means a health practitioner who is, or is deemed to be, registered with the Medical Council of New 30 Zealand, continued by the Health Practitioners Competence Assurance Act 2003, as a practitioner of the profession of medicine medicine— (a) means a substance or combination of substances that— 35 (i) is presented as having properties for treating or preventing a disease, ailment, defect, or injury in individuals; or 226 Therapeutic Products and Medicines Bill Part 6 cl 339 (ii) may be used on individuals with a view to mak- ing a medical diagnosis or to restoring, correct- ing, maintaining, or modifying physiological functions; or is a therapeutic product declared by an Order to 5 be a medicine; and (iii) (b) (c) includes a scheduled medicine; but does not include a therapeutic product
 declared by an Order not to be a medicine medicines control officer means a person appointed under 10 section 445 midwife means a health practitioner who is, or is deemed to be, registered with the Midwifery Council, established by the Health Practitioners Competence Assurance Act 2003, as a practitioner of the profession of midwifery Minister means the Minister of Health non-scheduled medicine means a medicine that is not a scheduled medicine operating a pharmacy means— (a) establishing, or carrying on pharmacy
 practice in, a 20 pharmacy; or establishing, owning, or being responsible for man- aging or controlling a hospital in which there is a pharmacy; or establishing, or being responsible for managing or con- 25 trolling a pharmacy carried on, on a not-for-profit basis (b) (c) 15 Order has the meaning given in section 7 of Parts 1 to 5 pharmacist means a health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competence Assurance Act 2003 as 30 a practitioner of the profession of pharmacy pharmacist-only medicine means a medicine described in section 512(2) as a pharmacist-only medicine pharmacy means a place— (a) (b) pharmacy graduate means— (a) licensed as a pharmacy; and in which pharmacy practice is carried on a person— 35 227 Part 6 cl 339 Therapeutic Products and Medicines Bill (i) who is not a pharmacist, but who has a qualifica- tion prescribed by the Pharmacy Council under section 12(1) of the Health Practitioners Compe- tence Assurance Act 2003 as a qualification ne- cessary to practise in the profession of pharmacy; 5 and (ii) who is actively taking steps towards registration with the Pharmacy Council as a pharmacist under the Health Practitioners Competence Assurance Act 2003; and a person whose application for registration as a pharma- cist is being dealt with in accordance with section 214 of the Health Practitioners Competence Assurance Act 2003 10 (b) pharmacy medicine means a
 medicine described in section 15 512(3) as a pharmacy medicine pharmacy practice includes undertaking the following activ- ities in a pharmacy: (a) (b) dispensing medicines: supplying medicines other than by wholesale (includ- 20 ing, without limitation, supplying a medicine to suit the needs of a particular individual) pharmacy student means a person who is undertaking, but has not yet completed, a qualification of a kind stated by the Pharmacy Council for the purposes of section 12(2)(a) of the 25 Health
 Practitioners Competence Assurance Act 2003 pharmacy technician means any person who has— (a) (b) a National Certificate in Pharmacy (Technician); or an overseas qualification recognised, by the Pharma- ceutical Society of New Zealand before 18 September 30 2004, as equivalent to the National Certificate in Phar- macy (Technician) possess, in relation to a medicine, includes to procure, receive, store, or use a medicine prescriber means an authorised prescriber or a designated pre- 35 scriber prescribing authority means a health authority that has des- ignated prescribers registered with it 228 Therapeutic Products and Medicines Bill Part 6 cl 339 prescribing notice means a notice issued by a prescribing au- thority under section 373 prescription medicine means a medicine described in sec- tion 512(1) as a prescription medicine record includes an electronic record or part of an electronic 5 record regulations means any regulations made under Parts 6 and 7 responsible person means, in relation to a body corporate that is applying for, or holds a licence, an employee of that body corporate who is,— (a) in the case of a licence to operate a pharmacy, a pharma- cist; or a person approved by the licensing authority as a re- sponsible person for the purposes of the licence (b) 10 restricted individual means an individual who is the subject 15 of a restriction notice restriction notice means a notice issued under section 389(1) Rule has the meaning given in section 7
 of Parts 1 to 5 scheduled medicine means a prescription medicine, pharma- 20 cist-only medicine, or pharmacy medicine scope of practice has the meaning given in section 5(1) of the Health Practitioners Competence Assurance Act 2003 Standard for the Uniform Scheduling of Medicines and Poisons or SUSMP has the meaning given in section 511 standing order means an order issued by an authorised pre- scriber or veterinarian under section 358 (in relation to sup- plying scheduled medicines) or section 381 (in
 relation to administering scheduled medicines) substance means any natural or artificial substance whether in 30 the form of a solid, liquid, gas, or vapour supply includes— (a) (b) supplying without payment; and supplying by way of gift, loan, or sample, whether or not for the purpose of promoting a sale; and bartering; and (c) 25 35 229 Part 6 cl 340 Therapeutic Products and Medicines Bill (d) offering or attempting to sell, having in possession for sale, exposing for sale, or causing or allowing to be sold or offered or exposed for sale supply by wholesale means supplying a medicine to a person whom the supplier reasonably believes will use it for any of 5 the following purposes: (a) supplying it in the course of business carried on by that person: administering it or causing it to be administered to an individual in the course of business carried on by that 10 person: in a commercial, educational, or scientific laboratory: in the process of manufacture or trade, which may in- volve that person supplying it to someone else (b) (c) (d) supply other than by wholesale means supplying a medicine 15 to a person whom the supplier reasonably believes will use it for a purpose other than any of the following purposes: (a) supplying it in the course of business carried on by the person: administering it or causing it to be administered to an 20 individual in the course of business carried on by that person: in a commercial, educational, or scientific laboratory: in the process of manufacture or trade, which may in- volve the person supplying it to someone else (b) (c) (d) 25 therapeutic product has the meaning given in section 7 of Parts 1 to 5 use includes administering veterinarian has the meaning given in section 4 of the Veter- inarians Act 2005 Veterinary Council means the Veterinary Council of New Zealand.
Compare: 1981 No 118 ss 2(1), 5B Application and administration 340 Application (1) The requirements, obligations, and restrictions imposed on ac- tivities undertaken with medicines by or under Parts 6 and 7 230 30 35 Therapeutic Products and Medicines Bill Part 6 cl 342 apply in addition to the requirements, obligations, and restric- tions imposed on activities undertaken with therapeutic prod- ucts by or under Parts 1 to 5, the Agreement, and any Rules or Orders.
(2) Unless a provision in either enactment specifically provides 5 otherwise,— (a) (b) nothing in Parts 6 and 7 limits Parts 1 to 5; and nothing in Parts 1 to 5 limits Parts 6 and 7.

341 Parts 6 and 7 to bind the Crown Parts 6 and 7 bind the Crown.
10 342 Employees and employers (1) For the purposes of Parts 6 and 7,— (a) (b) (c) (d) 15 a person supplies or dispenses a medicine whether the person does so on the person’s own account or as an employee; and a reference to an activity undertaken with a medicine by a person in the course of business includes an activity with a medicine undertaken by the person’s employee in the course of that business; and if an employer who is not authorised by or under Parts 20 6 and 7 to supply or dispense a medicine has an em- ployee who is authorised to do so, and that employee does so in accordance with the relevant authority, the employer must not be held— to have supplied or dispensed the medicine; or (i) (ii) to be in possession of that medicine; and a person who supplies a medicine while working under the supervision and control of a responsible person or another individual authorised by or under Parts 6 and 7 to supply that medicine (an authorised individual), is 30 to be treated as the employee of the responsible person or authorised individual, and the responsible person or authorised individual is to be treated as the employer.
25 (2) Subsection (1)(d) does not affect the liability of any person under section 473 (which relates to the liability of an em- 35 ployer for the act of an employee).

Compare: 1981 No 118 s 7 231 Part 7 cl 343 Therapeutic Products and Medicines Bill Part 7 Substantive provisions relating to medicines Subpart 1—Controlled activities 5 343 Outline of this subpart (1) (2) This subpart deals with the prohibition on, and limited circum- stances for, undertaking controlled activities.
The following are controlled activities: (a) (b) supplying scheduled medicines by wholesale: supplying scheduled medicines other than by whole- 10 sale: supplying medicines by auction: supplying medicines by vending machine: dispensing medicines: prescribing prescription medicines: administering prescription medicines: possessing prescription medicines: operating a pharmacy.
(c) (d) (e) (f) (g) (h) (i) In general terms, a person is prohibited from, and is commit- ting an offence by, undertaking a controlled activity without 20 being authorised to do so by or under Parts 6 and 7.

(4) Despite being authorised to undertake a controlled activity by or under Parts 6 and 7, a person may be subject to a restric- tion on undertaking that activity in— (a) (b) This section is by way of explanation only.
If any provision of Parts 6 and 7 conflicts with this section, that provision prevails.

an instrument referred to in subpart 2; or the regulations.

(5) (3) 25 15 Supplying scheduled medicines by wholesale 30 344 Supplying scheduled medicines by wholesale: controlled activity (1) A person must not supply a scheduled medicine by wholesale unless authorised under section 345 or 346.
Every person who contravenes subsection (1) commits an 35 offence and is liable, on summary conviction,— (2) 232 Therapeutic Products and Medicines Bill Part 7 cl 346 (a) (b) in the case of an individual, to a term of imprison- ment not exceeding 6 months, or a fine not exceeding $40,000, or both; and in the case of a body corporate, to a fine not exceeding $100,000.
Compare: 1981 No 118 ss 17(1)(b), (2), 34 345 Regulations may authorise supplying scheduled medicines by wholesale A person may supply a scheduled medicine by wholesale if authorised by the regulations.
Compare: 1981 No 118 17(1) 346 Licence may authorise supplying scheduled medicines by wholesale as fixed vendor or mobile vendor A person may supply a scheduled medicine by wholesale if the person— (a) 5 10 15 20 holds a licence to supply the scheduled medicine by wholesale as a fixed vendor and is supplying the sched- uled medicine by wholesale in the course of business and in accordance with that licence, including any con- ditions imposed by or under it; or is an employee of a person who holds a licence to supply the scheduled medicine by wholesale as a fixed vendor and is supplying the scheduled medicine by wholesale in the course of employment and in accordance with that licence, including any conditions imposed by or under 25 it; or the person holds a licence to supply the scheduled medicine by wholesale as a mobile vendor and is sup- plying the scheduled medicine by wholesale in the course of business and in accordance with that licence, 30 including any conditions imposed by or under it; or is deemed to hold a licence to supply the scheduled medicine by wholesale as a fixed vendor under sec- tion 518(3) and is supplying the scheduled medicine by wholesale in the course of business and in accordance 35 (b) (c) (d) 233 Part 7 cl 347 Therapeutic Products and Medicines Bill with that licence, including any conditions imposed by or under it.
Compare: 1981 No 118 ss 17(1)(b), 31(1)(a), (3) Supplying scheduled medicines other than by wholesale 347 Supplying scheduled medicines other than by wholesale: controlled activity (1) A person must not supply a scheduled medicine other than by wholesale unless authorised under any of sections 348 to 356.
Every person who contravenes subsection (1) in relation to a prescription medicine commits an offence and is liable, on summary conviction,— (a) (2) (b) (3) in the case of an individual, to a term of imprison- ment not exceeding 6 months, or a fine not exceeding 15 $40,000, or both; and in the case of a body corporate, to a fine not exceeding $100,000.
Every person who contravenes subsection (1) in relation to a pharmacist-only medicine or pharmacy medicine is liable, on 20 summary conviction,— (a) in the case of an individual, to a fine not exceeding $10,000; and in the case of a body corporate, to a fine not exceeding $100,000.
(b) Compare: 1981 No 118 s 18(1), (5), (6) 348 Prescriber may supply scheduled medicines other than by wholesale in limited circumstances A prescriber may supply a scheduled medicine other than by wholesale to— (a) his or her patient or a person who has care of his or her patient; or another prescriber (prescriber B) at prescriber B’s re- quest; or (b) 234 5 10 25 30 Therapeutic Products and Medicines Bill Part 7 cl 350 (c) prescriber B’s patient, or a person who has care of pre- scriber B’s patient, at prescriber B’s request.
Compare: 1981 No 118 ss 18(1), 25(1)(b) 349 Pharmacist may supply scheduled medicines other than by wholesale in limited circumstances (1) A pharmacist may supply a scheduled medicine other than by (2) wholesale,— (a) in the case of a pharmacist employed in a hospital, in the course of employment as a pharmacist in that hospital; and in any other case, in a pharmacy.
(b) Subsection (1) does not authorise a pharmacist— (a) to supply a prescription medicine other than by whole- sale other than in accordance with a prescription or a standing order; or to supply a pharmacist-only medicine other than by wholesale other than— (i) (b) under an order given or a request made by the person to whom the pharmacist-only medicine is being supplied; or in the ordinary course of business in response to the needs expressed by the person to whom the pharmacist-only medicine is being supplied; or in accordance with a prescription or a standing order issued under section 358.
(ii) (iii) Compare: 1981 No 118 ss 18(1), 26(1), (2), (3) 350 Veterinarian may supply scheduled medicines other than by wholesale in limited circumstances A veterinarian may supply a scheduled medicine other than by wholesale for the treatment of an animal under his or her care 30 or an animal under the care of another veterinarian.
Compare: 1981 No 118 ss 18(1), 27(a) 235 Part 7 cl 351 Therapeutic Products and Medicines Bill 351 Employee working with prescriber may supply scheduled medicines other than by wholesale in limited circumstances (1) An employee employed (by any person) to work with a pre- scriber may supply a scheduled medicine other than by whole- 5 sale if doing so— (a) (b) in the course of employment; and at the request of the prescriber with whom he or she is working; and under the supervision of that prescriber.
(c) In order for subsection (1) to apply to an employee,— (a) the employee must comply with the requirements in re- spect of prescribers as set out in section 348; and the prescriber supervising the employee must comply with the requirements of section 348.
(b) 10 15 If the employee referred to in subsection (1) is also an em- ployee for the purposes of section 355(b), the employee— (a) may supply a pharmacy medicine under the authority of (b) section 355(b); and need not comply with subsections (1) and (2) in re- 20 lation to the supply of a pharmacy of that kind.
(2) (3) 352 Employee working with pharmacist may supply scheduled medicines other than by wholesale in limited circumstances (1) An employee employed (by any person) to work in a pharmacy 25 with a pharmacist may supply a scheduled medicine other than by wholesale if doing so— (a) (b) in the course of employment; and at the request of the pharmacist with whom he or she is working; and under the supervision of that pharmacist; and in the pharmacy where he or she is employed.
(c) (d) In order for subsection (1) to apply to an employee,— (a) the employee must comply with the requirements in re- spect of pharmacists as set out in section 349; and the pharmacist supervising the employee must comply with the requirements of section 349.
30 35 (b) Compare: 1981 No 118 s 31(1)(b), (2), (3) (2) 236 Therapeutic Products and Medicines Bill Part 7 cl 354 353 Employee working with veterinarian may supply scheduled medicines other than by wholesale in limited circumstances (1) An employee employed (by any person) to work with a veter- (2) (3) inarian may supply a scheduled medicine other than by whole- 5 sale if doing so— (a) (b) in the course of employment; and at the request of the veterinarian with whom he or she is working; and (c) under the supervision of that veterinarian.
In order for subsection (1) to apply to an employee,— (a) the employee must comply with the requirements in re- spect of veterinarians as set out in section 350; and the veterinarian supervising the employee must comply with the requirements of section 350.
(b) 10 15 If the employee referred to in subsection (1) is also an em- ployee for the purposes of section 355(b), the employee— (a) may supply a pharmacy medicine under the authority of (b) section 355(b); and need not comply with subsections (1) and (2) in re- 20 lation to the supply of a medicine of that kind.
Compare: 1981 No 118 s 31(1)(b), (2), (3) 354 Deemed licence may authorise supply of scheduled medicines other than by wholesale in limited circumstances A person may supply a scheduled medicine other than by wholesale if the person— (a) is deemed to hold a licence to supply the scheduled medicine other than by wholesale under section 518(4); and is supplying the scheduled medicine other than by wholesale in the course of business in accordance with the licence, including any conditions imposed by or under it.
(b) 25 30 237 Part 7 cl 355 Therapeutic Products and Medicines Bill 355 Licence may authorise supply of pharmacy medicines other than by wholesale in limited circumstances A person may supply a pharmacy medicine other than by wholesale if the person— (a) (b) holds a licence that authorises the person to supply the 5 pharmacy medicine other than by wholesale and is do- ing so in the course of business and in accordance with that licence, including any conditions imposed by or under it; or is an employee of a person who holds a licence that 10 authorises the licence holder to supply the pharmacy medicine other than by wholesale, and the employee is supplying the pharmacy medicine other than by whole- sale— (i) (ii) in the course of employment; and under the supervision of the licence holder or a responsible person named in the licence; and in accordance with the licence, including any conditions imposed by or under it.
(iii) 15 Compare: 1981 No 118 s 31(1)(a), (2)(a), (3), (4) 356 Regulations or standing order may authorise supply of scheduled medicines other than by wholesale A person may supply a scheduled medicine other than by wholesale, in the course of a business carried on by that per- son, if— (a) (b) authorised by the regulations; or authorised by and acting in accordance with a standing order issued under section 358.
Compare: 1981 No 118 s 18(1) 20 25 357 Supply of scheduled medicines to medicines control 30 officer not supply other than by wholesale A person who supplies a medicines control officer with a scheduled medicine in response to a request under section 456 (relating to samples for analysis) is not supplying that scheduled medicine other than by wholesale for the purposes 35 of section 347.
Compare: 1981 No 118 s 69(6) 238 Therapeutic Products and Medicines Bill Part 7 cl 359 Standing orders for supply of scheduled medicines other than by wholesale 358 Standing orders for supply of scheduled medicines (1) An authorised prescriber may issue a standing order author- (b) ising a specified class of persons engaged in the delivery of 5 health services to do any or all of the following: (a) supply any specified class or description of prescription medicines or controlled drugs other than by wholesale to any specified class of persons, without a prescription, in the specified circumstances: supply any specified class or description of pharmacist- only medicines other than by wholesale to any specified class of persons in the specified circumstances: supply any specified class or description of pharmacy medicines other than by wholesale to any specified class 15 of persons in the specified circumstances.
(2) A veterinarian may issue a standing order authorising any spe- cified class of persons to do any or all of the following: (a) (c) 10 supply any specified class or description of prescription medicines or controlled drugs other than by wholesale 20 to any specified class of animals, without a prescription, in specified circumstances: supply any specified class or description of pharmacist- only medicines other than by wholesale to any specified class of animals in specified circumstances: supply any specified class or description of pharmacy medicines other than by wholesale to any specified class of animals in specified circumstances.
25 (b) (c) (3) A standing order issued under this section must be in writing.

Compare: 1981 No 118 s 2 Supplying medicines by auction 359 Supplying medicines by auction: controlled activity (1) A person must not supply a medicine by auction.
(2) Every person who contravenes subsection (1) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $40,000; and 30 35 239 Part 7 cl 360 Therapeutic Products and Medicines Bill (b) in the case of a body corporate, to a fine not exceeding $100,000.
Compare: 1981 No 118 s 18(4), (6) Supplying medicines by vending machine 360 Supplying scheduled medicines by vending machine: 5 controlled activity (1) A person must not supply a scheduled medicine by vending (2) machine unless authorised by the regulations.

Every person who contravenes subsection (1) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $40,000; and in the case of a body corporate, to a fine not exceeding $100,000.
(b) Compare: 1981 No 118 s 18(4), (6) Dispensing medicines 361 Dispensing medicines: controlled activity (1) A person must not dispense a medicine unless authorised 10 15 (2) under any of sections 362 to 368.

Every person who contravenes subsection (1) commits an 20 offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $40,000; and in the case of a body corporate, to a fine not exceeding $100,000.
(b) Compare: SR 1984/143 rr 42(1), 64 362 Prescriber may dispense medicines in limited circumstances A prescriber may dispense a medicine for the purposes of sup- plying the medicine to a person who is— (a) the prescriber’s patient or a person who has care of the prescriber’s patient; or another prescriber (prescriber B), at prescriber B’s re- quest; or (b) 240 25 30 Therapeutic Products and Medicines Bill Part 7 cl 366 (c) prescriber B’s patient, or a person who has care of pre- scriber B’s patient, at prescriber B’s request.
Compare: SR 1984/143 r 42(1) 363 Pharmacist may dispense medicines in course of pharmacy practice A pharmacist may dispense a medicine in the course of under- taking pharmacy practice.
Compare: SR 1984/143 r 42(1) 5 364 Certain other persons associated with pharmacies may dispense medicines in limited circumstances The following persons may dispense a medicine in a phar- macy, but may only dispense a prescription medicine if under the direct supervision of a pharmacist who is undertaking phar- macy practice: dispensary technicians: (a) pharmacy graduates: (b) pharmacy students: (c) (d) pharmacy technicians.
Compare: SR 1984/143 r 42(1), (1A) 365 Veterinarian may dispense medicines in limited circumstances A veterinarian may dispense a medicine for the purposes of the treatment of an animal under his or her care or under the care of another veterinarian.
Compare: SR 1984/143 r 42(1) 10 15 20 25 366 Employee working with veterinarian may dispense medicines in limited circumstances (1) An employee employed (by any person) to work with a veter- inarian may dispense medicines for use in the treatment of an animal under the care of that veterinarian.

30 (2) An employee referred to in subsection (1) must not dispense a prescription medicine unless doing so at the direction of the veterinarian.
Compare: SR 1984/143 r 42(2) 241 Part 7 cl 367 Therapeutic Products and Medicines Bill 367 Regulations may authorise dispensing of medicines A person may dispense a medicine if authorised to do so by the regulations.
Compare: 1981 No 118 s 105(1)(t) 368 Licence may authorise dispensing medicines by 5 automated dispensing machine A person may dispense medicines by using an automated dis- pensing machine if the person— (a) holds a licence to dispense a medicine by using an automated dispensing machine and is dispensing the 10 medicine in the course of business and in accordance with that licence, including any conditions imposed by or under it; or is an employee of a person who holds a licence to dis- pense a medicine by using an automated dispensing ma- 15 chine and is dispensing the medicine in the course of employment and in accordance with the licence, includ- ing any conditions imposed by or under it.
(b) Prescribing prescription medicines 369 Prescribing prescription medicines: controlled activity (1) An individual must not prescribe a prescription medicine un- 20 less he or she is a prescriber or veterinarian.

(2) An authorised prescriber must not prescribe a prescription medicine unless authorised by section 370.

(3) A designated prescriber must not prescribe a prescription 25 medicine unless authorised by section 371.
(4) A veterinarian must not prescribe a prescription medicine un- (5) less authorised by section 372.

Every individual who contravenes any of subsections (1) to (4) commits an offence and is liable, on summary conviction, 30 to a fine not exceeding $10,000.
370 Authorised prescriber may prescribe prescription medicines in limited circumstances An authorised prescriber may prescribe a prescription medicine for the treatment of a patient— 35 242 Therapeutic Products and Medicines Bill Part 7 cl 372 (a) under his or her care or under the care of another pre- scriber (prescriber B), at prescriber B’s request; and (b) who is— (i) (ii) in New Zealand; or usually permanently resident in New Zealand but 5 who is outside New Zealand for a limited period.
371 Designated prescriber may prescribe prescription medicines in limited circumstances (1) A designated prescriber may prescribe a prescription medicine for the treatment of a patient— (a) under his or her care or under the care of another pre- scriber (prescriber B), at prescriber B’s request; and 10 (b) who is— (i) (ii) in New Zealand; or usually permanently resident in New Zealand but 15 who is outside New Zealand for a limited period.
(2) Despite subsection (1), a designated prescriber may only prescribe a prescription medicine— that is specified in— (a) (i) a prescribing notice issued by, or deemed to be 20 issued by, the prescribing authority with which he or she is registered; or (ii) regulations made under section 501; and in accordance with any conditions or restrictions speci- fied by a prescribing authority in the prescribing notice 25 or, if applicable, the regulations.
(b) 372 Veterinarian may prescribe prescription medicines in limited circumstances A veterinarian may prescribe a prescription medicine in the practice of his or her profession for the treatment of an animal 30 under his or her care or the care of another veterinarian (vet- erinarian B), at veterinarian B’s request.
243 Part 7 cl 373 Therapeutic Products and Medicines Bill Prescribing notices 373 Prescribing authorities to issue prescribing notice (1) A prescribing authority must, by notice in the Gazette, spe- cify— (a) (b) the prescription medicines or class or description of pre- 5 scription medicines that designated prescribers regis- tered with it may prescribe; and the medicines may be prescribed.
in which those prescription circumstances (2) Subsection (1) does not apply to a prescribing authority if 10 regulations made under section 501 exist in relation to the designated prescribers registered with that prescribing author- ity.
(3) A prescribing authority may only include a prescription medicine in a prescribing notice if— (a) 15 the prescribing of the prescription medicine relates di- rectly to the scope of practice of the designated pre- scribers who are registered with the prescribing author- ity; and the prescribing authority has considered and taken 20 into account all relevant public health and safety concerns associated with authorising designated pre- scribers registered with it to prescribe that prescription medicine.
(b) (4) A prescribing notice may impose any conditions or restrictions 25 on the circumstances in which any designated prescriber regis- tered with the prescribing authority issuing the notice may pre- scribe any prescription medicines listed in it.

(5) A prescribing notice may include a complete prohibition on designated prescribers registered with the prescribing author- 30 ity prescribing certain prescription medicines in certain cir- cumstances.
374 Review of prescribing notice (1) A prescribing authority must review a prescribing notice on a date no later than 6 months after it is issued.
35 (2) A review must consider the following factors: 244 Therapeutic Products and Medicines Bill Part 7 cl 375 (a) whether any prescription medicines (or class or descrip- tion of prescription medicines) that are not specified in the notice are prescription medicines (or a class or description of prescription medicines) that the desig- nated prescribers registered with the prescribing author- 5 ity should, because of the nature of the designated pre- scribers’ scope of practice, be authorised to prescribe; and (b) whether any prescription medicines (or class or descrip- tion of prescription medicines) that are specified in the 10 notice are prescription medicines (or a class or descrip- tion of prescription medicines) that the designated pre- scribers registered with the prescribing authority should no longer, because of public health and safety concerns, be authorised to prescribe.
15 (3) If a review identifies prescription medicines (or a class or description of prescription medicines) that designated pre- scribers registered with a prescribing authority should, or should no longer, be able to prescribe, the prescribing au- thority must, as soon as is practicable after undertaking the 20 review, issue a further prescribing notice under section 373 giving effect to the matters determined in the review.
375 Prescribing authority to make list available A prescribing authority must— (a) make available for inspection by the public, at all rea- 25 sonable times, a consolidated list of the prescription medicines (or a class or description of prescription medicines) that designated prescribers registered with the prescribing authority may prescribe (which may include making the list available on the Internet or 30 making a hard copy of the list available at the prescrib- ing authority’s premises); and (b) make copies of the list available for purchase at a rea- sonable cost.
245 Part 7 cl 376 Therapeutic Products and Medicines Bill 376 Minister’s powers in relation to prescribing authority’s (1) (2) obligations under sections 373 to 375 The Minister has the powers set out in Schedule 4 in relation to a prescribing authority’s obligations under sections 373 to 375.
If, after exercising the powers in Schedule 4, the Minister believes there is, in relation to a prescribing notice, a risk to public health and safety, he or she may recommend that regu- lations be made under section 501(1)(a) to replace the pre- scribing notice.

Administering prescription medicines (2) 377 Administering prescription medicines: controlled activity (1) A person must not administer a prescription medicine knowing that the person is not authorised under any of sections 378 to 380.
Every person who contravenes subsection (1) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a term of imprison- ment not exceeding 6 months, or a fine not exceeding $40,000, or both; and in the case of a body corporate, to a fine not exceeding $100,000.
Compare: 1981 No 118 s 19 (b) 378 Prescriber may administer prescription medicines in limited circumstances A prescriber may administer a prescription medicine to a pa- tient under his or her care or to a patient of another prescriber (prescriber B), at prescriber B’s request.
Compare: 1981 No 118 ss 19, 25(1)(c), (f) 379 Veterinarian may administer prescription medicines in 30 limited circumstances A veterinarian may administer a prescription medicine to an animal under his or her care or an animal under the care of another veterinarian.
Compare: 1981 No 118 ss 19, 27(a) 35 246 Therapeutic Products and Medicines Bill Part 7 cl 381 380 Person may administer prescription medicines in limited circumstances A person may administer a prescription medicine if— (a) doing so in accordance with the direction of the pre- scriber or veterinarian who prescribed the prescription 5 medicine; or authorised by the regulations; or authorised under and acting in accordance with a stand- ing order issued under section 381.
(b) (c) Compare: 1981 No 118 s 19(1) 10 Standing orders authorising administering certain medicines 381 Standing orders authorising administering of prescription and pharmacist-only medicines (1) An authorised prescriber may issue a standing order author- 15 ising a specified class of persons engaged in the delivery of health services to do any or all of the following: (a) administer any specified class or description of pre- scription medicines or controlled drugs to any specified class of persons, without a prescription, in specified cir- 20 cumstances: administer any specified class or description of pharma- cist-only medicines to any specified class of persons in specified circumstances: administer any specified class or description of phar- 25 macy medicines to any specified class of persons in spe- cified circumstances.
(2) A veterinarian may issue a standing order authorising a speci- fied class of persons to do any or all of the following: (a) administer any specified class or description of pre- 30 scription medicines or controlled drugs to any specified class of animals, without a prescription, in specified cir- cumstances: administer any specified class or description of pharma- cist-only medicines to any specified class of animals in 35 specified circumstances: (b) (c) (b) 247 Part 7 cl 382 Therapeutic Products and Medicines Bill (c) administer any specified class or description of phar- macy medicines to any specified class of animals in spe- cified circumstances.
(3) A standing order issued under this section must be in writing.
Compare: 1981 No 118 s 2(1) 5 Possessing prescription medicines 382 Possessing prescription medicines: controlled activity (1) A person must not possess a prescription medicine— (a) without a reasonable excuse (including without being deemed to have a reasonable excuse under section 10 518(5)); or (b) without being authorised by the regulations; or (c) without written authority from the licensing authority stating that the person may possess the prescription medicine for a specific purpose; or unless possessing the prescription medicine is inciden- tal to an activity, business, or purpose that the person is authorised to undertake by or under Parts 6 and 7 or a licence; or unless possessing the prescription medicine is inciden- 20 tal to the person’s business of being a carrier.
15 (d) (e) (2) Every person who contravenes subsection (1) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a term of imprison- ment not exceeding 3 months, or a fine not exceeding 25 $40,000, or both; and in the case of a body corporate, to a fine not exceeding $100,000.

(b) (3) The onus of proving a reasonable excuse in proceedings under this section lies with the defendant.
Compare: 1981 No 118 s 43(1), (3) 30 383 Reasonable excuse for possessing prescription medicines (1) Without limiting the circumstances in which a person has a reasonable excuse under section 382(1)(a), a person has a reasonable excuse if— (a) the person— 35 248 Therapeutic Products and Medicines Bill Part 7 cl 384 (i) (ii) was lawfully supplied the prescription medicine for personal use or use by another person who is a patient of the prescriber who prescribed the prescription medicine; and does not possess any other prescription medicine 5 that has been prescribed or supplied for the same purpose by another prescriber; or the person— (i) was supplied the prescription medicine in order to administer it to another person in accordance 10 with a prescription or standing order; and does not possess any other prescription medicine supplied to the person for the same purpose; or (ii) the person possesses the prescription medicine for the purpose of administering it to the individual to whom it 15 has been prescribed; or possessing the prescription medicine is necessary or in- cidental to the person’s duties in serving the Crown; or the prescription medicine was lawfully supplied for the purpose of administering it to an animal in the person’s 20 care.
(b) (c) (d) (e) (2) It is not by itself a reasonable excuse for the purpose of sec- tion 382(1)(a) that a person did not know that a medicine was a prescription medicine.

Compare: 1981 No 118 s 43(2), (4) Operating pharmacy 384 Operating pharmacy: controlled activity (1) A person must not operate a pharmacy unless— (a) (b) the person holds a licence that authorises that person to operate that pharmacy; and the pharmacy is under the immediate supervision and control of a pharmacist.
25 30 (2) Every person who contravenes subsection (1) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding 35 $40,000; and 249 Part 7 cl 385 Therapeutic Products and Medicines Bill (b) in the case of a body corporate, to a fine not exceeding $100,000.
Compare: 1981 No 118 ss 17(1)(d), (2), 42A Subpart 2—Instruments prohibiting and restricting activities with medicines 5 385 Outline of this subpart (1) This subpart provides for the making of certain instruments that prohibit or restrict persons from undertaking activities with medicines (that are otherwise authorised by or under Parts 6 and 7) because of concerns for public health and 10 safety.

This section is by way of explanation only.


If any provision of Parts 6 and 7 conflicts with this section, that provision prevails.
(2) 386 Effect of certain instruments issued under this subpart 15 The following instruments have the effect of prohibiting or re- stricting a person from undertaking the activity referred to in the instrument in the limited circumstances described in the in- strument, despite any other authority to undertake that activity given by or under Parts 6 and 7: (a) (b) (c) a prohibition issued under section 387(1): a restriction notice issued under section 389(1): a statement relating to dependency issued under sec- tion 393(1).
Minister may prohibit certain activities 387 Minister may prohibit specific persons prescribing and 20 25 exercising authority The Minister may, by notice in the Gazette,— (a) (b) prohibit any specified prescriber or veterinarian from prescribing a prescription medicine or class or descrip- 30 tion of prescription medicines; and prohibit (either generally or in relation to a specified medicine or class or description of medicines) a speci- fied person from undertaking an activity that the person is otherwise authorised to undertake by or under Parts 35 (1) 250 Therapeutic Products and Medicines Bill Part 7 cl 388 (2) (3) 6 and 7 (whether conferred generally or on a particular class of persons to which the person belongs).
The Minister may not issue a notice under subsection (1)(b) unless he or she believes that there is a risk to public health and safety.

Every person who contravenes a prohibition issued under sub- section (1) commits an offence and is liable, on summary conviction, to a fine not exceeding $40,000.
Compare: 1981 No 118 ss 48, 48A(4) 5 388 Minister must have health authority or Veterinary Council 10 (1) recommendation to prohibit in certain circumstances The Minister must not prohibit— (a) a prescriber under section 387(1) without a recom- mendation from the health authority with which that prescriber is registered; or a veterinarian under section 387(1) without a recom- mendation from the Veterinary Council.
(2) A health authority or the Veterinary Council may, for the pur- poses of determining whether or not to make a recommenda- tion, inquire into the following: (a) (b) in the case of a notice issued under section 387(1)(a), the prescribing of prescription medicines undertaken by the person to whom the prohibition is to relate: in the case of a notice issued under section 387(1)(b), how the person to whom the notice will relate deals with 25 medicines: (b) 15 20 (c) matters incidental to paragraphs (a) and (b).
(3) A health authority and the Veterinary Council have the powers set out in Schedule 5 in relation to an inquiry.

(4) Despite anything in Schedule 5, it is not necessary, unless 30 a health authority or the Veterinary Council requires it, for any other body to conduct an investigation or inquiry or be represented at an inquiry.
Compare: 1981 No 118 s 48A(1)–(3) 251 Part 7 cl 389 Therapeutic Products and Medicines Bill Restriction notice 389 Medical Officer of Health may restrict prescribing and supplying to individual by restriction notice (1) A Medical Officer of Health, who is authorised by the Dir- ector-General under section 510, may issue a restriction no- 5 tice if he or she has reason to believe that an individual— (a) is addicted or habituated to a prescription medicine or pharmacist-only medicine or has obtained a prescrip- tion medicine or pharmacist-only medicine from sev- eral different sources; and is likely to seek further supplies of, or prescriptions for, that medicine.
(2) A restriction notice may include— (b) 10 (a) exceptions to the restrictions in the notice, including an exception allowing certain specified persons to pre- 15 scribe or supply the specified prescription medicine or pharmacist-only medicine to the restricted individual in certain circumstances, specified quantities, or both; and any conditions the Medical Officer of Health chooses.

(b) The Medical Officer of Health may revoke or modify a restric- 20 tion notice by issuing a further notice.
The Medical Officer of Health must serve a copy of a restric- tion notice or further notice on the restricted individual, but a failure to do so does not invalidate the notice.
(3) (4) (5) A restriction notice restricts— (a) (b) prescribers from prescribing the prescription medicine or pharmacist-only medicine specified in the notice, and prescription medicines or pharmacist-only medicines of a similar kind, to the restricted individual named in the notice; and persons from supplying the prescription medicine or pharmacist-only medicine specified in the notice, and prescription medicines or pharmacist-only medicines of a similar kind, to the restricted individual named in the notice.
Compare: 1981 No 118 s 49(1)–(4) 25 30 35 252 Therapeutic Products and Medicines Bill Part 7 cl 392 390 Prescribing or supplying in contravention of restriction notice (2) (1) A person must not prescribe or supply prescription medicines or pharmacist-only medicines to a restricted individual in contravention of a restriction notice.
Every person who knows, or who ought reasonably to have known, that the person prescribed or supplied prescription medicines or pharmacist-only medicines is a restricted indi- vidual commits an offence and is liable, on summary convic- tion,— (a) in the case of an individual, to a term of imprison- ment not exceeding 3 months, or a fine not exceeding $40,000, or both; and in the case of a body corporate, to a fine not exceeding $100,000.
Compare: 1981 No 118 s 49(6) (b) 5 10 15 391 Restricted individual procuring or attempting to procure in contravention of restriction notice (1) A restricted individual must not procure, or attempt to procure, (2) a prescription medicine or pharmacist-only medicine from a 20 person whom the restricted individual knows, or ought reason- ably to have known, is restricted from prescribing or supply- ing the medicine by a restriction notice.
Every restricted individual who contravenes subsection (1) commits an offence and is liable, on summary conviction, to 25 a term of imprisonment not exceeding 3 months, or a fine not exceeding $40,000, or both.

Compare: 1981 No 118 s 49(6) 392 Review or appeal of restriction notice A restricted individual may seek a review of, or appeal against, 30 a restriction notice in the manner set out in Schedule 6.
Compare: 1981 No 118 49(5) 253 Part 7 cl 393 Therapeutic Products and Medicines Bill Statement relating to dependency 393 Statement relating to dependency (1) A Medical Officer of Health, who has been authorised by the Director-General under section 510, may issue a statement relating to dependency if he or she has reason to believe that 5 an individual— (a) is, or is likely to become, dependent on prescription medicines or pharmacist-only medicines; or is acting in a manner that suggests the individual is directly supporting the individual’s own or another 10 individual’s dependency on prescription medicines or pharmacist-only medicines.
(b) (2) A statement of dependency is issued with a view to— (a) (b) assisting in the cure, mitigation, or avoidance of an in- dividual’s dependency; or preventing or restricting the prescribing or supply of certain prescription medicines or pharmacist-only medicines to an individual.
15 20 The statement may be provided to all or any of the following persons: (a) medicines control officers: (b) officers and employees of any district health board es- tablished by or under section 19 of the New Zealand Public Health and Disability Act 2000: persons who provide, or are involved in providing, hos- 25 pital care (as defined in section 4(1) of the Health and Disability Services (Safety) Act 2001): prison managers: (d) (e) managers and superintendents of institutions as defined (c) in section 2 of the Alcoholism and Drug Addiction Act 30 1966: prescribers: (f) (g) members of the police: (h) persons who deal in prescription medicines or pharma- cist-only medicines in the course of business.
35 The Medical Officer of Health must serve a copy of the state- ment relating to dependency on the individual to whom the statement relates, but a failure to comply with that requirement does not invalidate the statement in any way.

(3) (4) 254 Therapeutic Products and Medicines Bill Part 7 cl 396 (5) A statement is privileged unless it is made in malice.

(6) This section does not limit or affect a Medical Officer of Health’s right or duty to publish a statement to an individual.
Compare: 1981 No 118 s 49A(1)–(4) Subpart 3—Licences 5 394 Outline of this subpart (1) (b) (c) (d) This subpart contains provisions about the following types of licences: (a) licences to supply scheduled medicines by wholesale as fixed vendors: licences to supply scheduled medicines by wholesale as mobile vendors: licences to supply pharmacy medicines other than by wholesale: licences to dispense medicines using automated dis- 15 pensing machines: licences to operate pharmacies.
10 (e) Certain additional matters regarding licences to operate phar- macies are set out in subpart 4.

This section is by way of explanation only.

If any provision 20 of Parts 6 and 7 conflicts with this section, that provision prevails.

(2) (3) Applying for licence 395 Who may apply An application for a licence may be made by— (a) an individual who is a resident of New Zealand, on that individual’s own behalf; or a body corporate that is incorporated in New Zealand.
(b) Compare: 1981 No 118 s 50(4) 396 Form of application An application for a licence must— (a) be made to the licensing authority in the prescribed form; and be accompanied by any prescribed particulars, informa- tion, documents, or other materials; and (b) 25 30 35 255 Part 7 cl 397 Therapeutic Products and Medicines Bill be accompanied by any prescribed fee.
(c) Compare: 1981 No 118 s 50(1), (2) Contents of application 397 Application must set out medicines to which it relates (1) An application for a licence must,— 5 (a) (b) (c) (d) than by wholesale, in the case of a licence to supply scheduled medicines by wholesale as a fixed vendor or mobile vendor, spe- cify the scheduled medicines or class or description of scheduled medicines in relation to which the licence is sought; and in the case of a licence to supply pharmacy medicines other specify the pharmacy medicines or class or description of pharmacy medicines in relation to which the licence is sought; and in the case of a licence to dispense medicines by us- 15 ing an automated dispensing machine, specify the medicines or class or description of medicines in rela- tion to which the licence is sought; and in the case of a licence to operate a pharmacy, include the particulars required by section 421.
10 20 (2) Subsection (1) does not restrict an applicant from stating that an application for a licence relates to all medicines of a par- ticular kind (for example, all pharmacy medicines or all pre- scription medicines).

Compare: 1981 No 118 s 50(3) 25 398 Application must contain sufficient information (1) An application for a licence must contain sufficient informa- tion to enable the licensing authority to be satisfied of the mat- ters referred to in section 399.
If an application does not comply with subsection (1), the 30 licensing authority may require the applicant to provide further information for the purpose of being satisfied of the matters referred to in section 399.

(2) (3) An application lapses if the applicant fails to supply the infor- mation requested under subsection (2) within— 30 days of the date of the request; or (a) 35 256 Therapeutic Products and Medicines Bill Part 7 cl 399 any further time allowed by the licensing authority.
(b) Compare: 1981 No 118 s 50(2) Granting of licence 399 Granting of licence (1) The licensing authority must grant a licence if it is satisfied— 5 (a) that the applicant— (i) is eligible to apply for a licence under section 395; and is not currently disqualified from holding a li- cence (of any kind) under Parts 6 and 7; and 10 (ii) (b) (c) (d) (e) (f) (g) that the application has been made in the form required by section 396; and that the application contains all information that is re- quired to be contained in the application under Parts 6 and 7 (including any further information asked for 15 under section 398(2)); and that the application does not contain materially false or misleading information; and in the case of an application made by an individual, that the individual— (i) (ii) is a fit and proper person to hold the licence; and has sufficient knowledge of the obligations of the licence; and has sufficient knowledge of the hazards associ- ated with the medicines to which the licence will, 25 if granted, relate; and (iii) 20 in the case of an application made by a body corporate, that— (i) (ii) the body corporate is of good repute; and every person listed in the application as a pro- 30 posed responsible person has sufficient know- ledge of the obligations of the licence and the hazards associated with the medicines to which the licence will, if granted, relate; and that the premises and equipment the applicant proposes 35 to use for the controlled activity to which the licence will, if granted,
 relate, are adequate and suitable for the controlled activity; and 257 Part 7 cl 400 Therapeutic Products and Medicines Bill (h) (i) in the case of a licence other than a licence to operate a pharmacy, that arrangements have been made, or are to be made, for the safekeeping of adequate records in respect of the medicines to which the licence will, if granted, relate; and in the case of a licence to operate a pharmacy, that— (i) 5 adequate arrangements have been made, or are to be made, for the making, maintaining, and safekeeping of adequate records in respect of the medicines that are to be stored, dispensed, or sup- 10 plied in the premises to which the licence to op- erate is sought; and the additional criteria set out in section 421 have been satisfied.
(ii) (2) A licence granted under subsection (1) must be in the pre- 15 scribed form.
Compare: 1981 No 118 s 51(1), (4) 400 Additional matter when granting licence to supply pharmacy medicines other than by wholesale (1) Despite section 399, the licensing authority must not grant a 20 licence to supply pharmacy medicines other than by wholesale unless the licence relates to particular business premises that are— (a) (b) open to the public; and situated at least 10 kms, by the most practicable route, 25 from the nearest pharmacy.
(2) However, the licensing authority may issue a licence to sup- ply pharmacy medicines other than by wholesale that does not comply with subsection (1)(b) if— (a) the licensing authority considers that doing so is in the 30 interests of the health and safety of members of the pub- lic; or authorised by the regulations.
(b) Compare: 1981 No 118 s 51(2) 258 Therapeutic Products and Medicines Bill Part 7 cl 403 Refusal of licence 401 Refusal of licence (1) (2) The licensing authority must give an applicant a reasonable opportunity to be heard before refusing a licence.

If an applicant asks for the reasons for a refusal of a licence, 5 the licensing authority must, as soon as practicable, provide written reasons.
Compare: 1981 No 118 s 51(3), (7) Authority conferred on licence holder by licence 402 Licence to supply scheduled medicines by wholesale as 10 fixed vendor A licence to supply scheduled medicines by wholesale as a fixed vendor confers authority on the licence holder to supply the scheduled medicines or class or description of scheduled medicines specified in the licence by wholesale— (a) (b) from the premises specified in the licence; and in accordance with any conditions imposed by or under the licence or Parts 6 and 7.
15 Compare: 1981 No 118 s 52(1)(a) 403 Licence to supply scheduled medicines by wholesale as 20 mobile vendor A licence to supply scheduled medicines by wholesale as a mobile vendor confers authority on the licence holder to supply the scheduled medicines or the class or description of scheduled medicines specified in the licence by wholesale— 25 within the geographical area specified in the licence; (a) and in the quantity specified in the licence; and to the persons or classes of persons specified in the li- cence; and in accordance with any conditions imposed by or under the licence or Parts 6 and 7.
(b) (c) (d) 30 Compare: SR1984/143 r 48 259 Part 7 cl 404 Therapeutic Products and Medicines Bill 404 Licence to supply pharmacy medicines other than by wholesale A licence to supply pharmacy medicines other than by whole- sale confers authority on the licence holder to supply the pharmacy medicines or the class or description of pharmacy 5 medicines specified in the licence other than by wholesale— from the premises specified in the licence; and (a) in accordance with any conditions imposed by or under (b) the licence or Parts 6 and 7.
Compare: 1981 No 118 s 52(1)(d) 10 405 Licence to dispense medicines by using automated dispensing machine A licence to dispense medicines by using an automated dis- pensing machine confers authority on the licence holder to dis- pense the medicines or the class or description of medicines 15 specified in the licence by using the automated dispensing ma- chine specified in the licence— (a) (b) (c) in the manner specified in the licence; and from the premises specified in the licence; and in accordance with any conditions imposed by or under 20 the licence or Parts 6 and 7.
406 Licence to operate pharmacy A licence to operate a pharmacy confers authority on the li- cence holder to establish a pharmacy and carry on pharmacy practice in that pharmacy in accordance with any conditions 25 imposed by or under the licence or Parts 6 and 7.
Compare: 1981 No 118 s 52(1)(e) Conditions of licence 407 Conditions of licence (1) Every licence includes the condition that the licence holder 30 must, for the duration of the licence, continue to comply with the matters set out in section 399 to the satisfaction of the licensing authority.

The licensing authority may impose a condition on a licence— (a) when it grants a licence; or 35 (2) 260 Therapeutic Products and Medicines Bill Part 7 cl 409 (3) at any later time.
(b) The regulations may impose a condition on a licence at any time.

(4) A condition may— (a) (b) limit or restrict (in the circumstances specified) an ac- 5 tivity otherwise authorised by the licence; or authorise (in the circumstances specified) an activity otherwise prohibited by the licence.
Compare: 1981 No 118 s 51(4) 408 Reasons for imposing conditions on licence If a licence holder asks the licensing authority for the reasons a condition is imposed on a licence by the licensing authority, the licensing authority must, as soon as practicable, provide written reasons.
Compare: 1981 No 118 s 51(7) 10 15 409 Complying with conditions on licence (1) A licence holder must comply with a condition of a licence (whether imposed by the licensing authority or by or under Parts 6 and 7) on and from the date the condition is imposed.
If the licensing authority is satisfied that a licence holder is 20 failing, or has failed, to comply with a condition imposed on a licence (whether imposed by the licensing authority or by or under Parts 6 and 7), it may— (a) (2) (b) suspend the licence for a reasonable period in order to consider the matter; and do either of the following: (i) if the condition was imposed by the licensing au- thority, revoke the condition and apply another condition the licensing authority considers ap- propriate; or in any case, cancel the licence after— (A) (ii) giving the licence holder a reasonable op- portunity to be heard; and considering any evidence adduced; and considering any submissions made to it by 35 the licence holder.
(B) (C) 25 30 261 Part 7 cl 410 Therapeutic Products and Medicines Bill (3) This section does not limit the powers of the licensing author- ity under section 426 in relation to licences to operate phar- macies.
Compare: 1981 No 118 s 51(6) Suspending, cancelling, and disqualifying holding of licence 5 410 Effect of false or misleading statement made in application (1) for licence If the licensing authority is satisfied, at any time after a licence has been granted, that a licence holder supplied information 10 in the licence holder’s application that is materially false or misleading, the licensing authority may— (a) suspend the licence holder’s licence for a reasonable period in order to consider the matter; and cancel the licence after— (i) giving the licence holder a reasonable opportun- ity to be heard; and considering any evidence adduced; and considering submissions made to it by the licence holder.
(ii) (iii) (b) (2) Nothing in subsection (1) limits section 461.

411 Reasons for cancelling licence If a licence holder asks the licensing authority for the reasons for the cancellation of a licence, the licensing authority must, as soon as practicable, provide written reasons.
Compare: 1981 No 118 s 51(6)–(7) 412 Effect of charge or conviction on licence (1) If a licence holder is charged with an offence under Parts 6 and 7 or the regulations, a court may suspend the person’s licence until the outcome of the charge has been determined.
If a licence holder is convicted of an offence under Parts 6 and 7 or the regulations, a court may, as well as, or instead of, imposing another penalty, do any of the following: (a) cancel the licence to have effect immediately or from a specified date: (2) 262 15 20 25 30 35 Therapeutic Products and Medicines Bill Part 7 cl 414 (b) (c) disqualify the licence holder from holding any kind of licence, or a licence of a particular kind, for any speci- fied period: cause particulars of the conviction and of any order made under paragraphs (a) and (b) to be set out on 5 the licence (an endorsement).
(3) A cancellation, disqualification, or endorsement is deemed to be a sentence or part of a sentence for the purposes of Part 4 of the Summary Proceedings Act 1957.

The registrar of the court in which a licence is cancelled, dis- 10 qualified, or endorsed must notify the Director-General of the cancellation, disqualification, or endorsement.
Compare: 1981 No 118 s 83(1)–(3), (6), (7) (4) 413 Producing licence to court (1) If a court has cancelled or endorsed a licence under section 15 412(2), the licence holder must produce it, in the time and manner directed by the court.
Every person who fails to comply with a direction of the court under subsection (1) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $5,000; and in the case of a body corporate, to a fine not exceeding $40,000.

(b) 20 The registrar of the court must notify the Director-General of 25 the particulars of a conviction under this section.

Section 472 provides that an offence under this section is a strict liability offence.
Compare: 1981 No 118 s 83(4), (5), (7) (2) (3) (4) Duration of licence 414 Duration of licence (1) A licence is in force for 1 year from the date on which it is granted.

(2) Despite subsection (1), a licence may be sooner cancelled under— (a) this subpart; or 30 35 263 Part 7 cl 415 Therapeutic Products and Medicines Bill (b) if the licence is a licence to operate a pharmacy, under subpart 4.
(3) Section 424 (providing for exceptions for mortgagees in pos- session of pharmacies) overrides subsection (1) in certain circumstances.

Compare: 1981 No 118 s 53(1) 5 415 Superseding licence (1) (2) If a licence (licence B) supersedes an existing licence (licence A), and licence B is issued within the period 2 months before licence A expires, then licence B— comes into force on the day that licence A expires; and (a) (b) expires 1 year after the date on which licence A expires.
If a licence holder applies for licence B within the period of not more than 3 months and not less than 1 month before licence A expires, and the application has not been dealt with before 15 the date on which licence A expires, then licence A continues in force until the application for licence B is determined.
Compare: 1981 No 118 s 53(2), (3) 10 416 Surrendering licence on ceasing controlled activity (1) If a licence holder ceases to undertake the controlled activity 20 to which a licence relates, the licence holder must, within 7 days of ceasing to undertake that controlled activity, surrender the licence to the licensing authority.

The licensing authority, on receiving a licence under subsec- tion (1), must retain it for the remainder of the current licence 25 period.
(2) (3) Nothing in this section prevents a licence holder who has sur- rendered a licence from applying to the licensing authority to restore the licence to the licence holder at any time during the current licence period.

30 (4) On receipt of an application of the kind referred to in subsec- tion (3), the licensing authority must restore the licence to the licence holder if satisfied that the licence holder complies with the requirements of Parts 6 and 7 and any regulations.
264 Therapeutic Products and Medicines Bill Part 7 cl 419 (5) It is not necessary for the licence holder to pay a further li- cence fee on an application to have a licence restored under subsection (3).

Compare: SR 1984/143 r 49 Register of licences and records of licensing authority 417 Register of licences and records of licensing authority (1) The licensing authority must keep— a register of licences; and (a) records it is required to keep by the regulations.
(b) (2) A person may access the register of licences for the purpose of inspection— (a) (b) on any day and at any time prescribed; or if no day or time has been prescribed, at all reasonable times.
Compare: 1981 No 118 s 55 5 10 15 Subpart 4—Operating pharmacies 418 Outline of this subpart (1) This subpart— (a) sets out certain requirements relating to licences to op- 20 erate pharmacies that are in addition to the general mat- ters relating to licences set out in subpart 3; and provides for restrictions on who may own and operate and hold interests in pharmacies.

(b) (2) This section is by way of explanation only.
If a provision of 25 Parts 6 and 7 conflicts with this section, that provision pre- vails.

419 Meaning of holds an interest in pharmacy (1) For the purposes of this subpart, a person holds an interest in a pharmacy if the person has, or acquires, a direct or indirect 30 estate or interest in the pharmacy (whether by way of shares in a company or by way of charge, loan, guarantee, indemnity, or otherwise) that affects the ownership, management, or control of the pharmacy practice carried on in the pharmacy.
265 Part 7 cl 420 Therapeutic Products and Medicines Bill (2) For the purposes of subsection (1), a person acquires a direct or indirect estate or interest in a pharmacy if the acquisition is made— (a) (b) in the person’s name, or in the name of a nominee; or by the person by means of any device or arrangement.
5 (3) Despite subsections (1) and (2),— (a) (b) a person does not hold an interest in a pharmacy merely by— (i) making, in good faith and in the ordinary course of business in order to facilitate the carrying on 10 of the pharmacy, a loan of money; or holding a security for repayment of that loan: (ii) a person does not hold an interest in a pharmacy that is being carried on by an administrator of the estate of a deceased pharmacist, or by an administrator of the 15 estate of a deceased operator of a pharmacy, merely by holding an interest in that estate.
(4) Despite subsection (3), a covenant, condition, or stipulation expressed or implied in a contract or agreement restricting an operator of a pharmacy in the purchase of pharmaceutical re- 20 quirements or other stock in trade is to be treated, for the pur- poses of this subpart, as a device or arrangement affecting the management and control of the pharmacy practice carried on in that pharmacy.
Compare: 1981 No 118 s 5A 25 Additional information for pharmacy licence 420 Additional matters to be satisfied for pharmacy licence (1) The licensing authority must not grant a licence to operate a pharmacy unless satisfied that— (a) the applicant is a person who is qualified under any of 30 sections 422 to 424 to be granted a licence to operate a pharmacy; and the applicant is a person who is able to satisfy the con- dition set out in section 425.
(b) If the licensing authority has reasonable grounds to believe 35 that a licence holder of a licence to operate a pharmacy has ceased to be a person who satisfies each of the criteria set out (2) 266 Therapeutic Products and Medicines Bill Part 7 cl 422 in subsection (1), the licensing authority may suspend the licence for a reasonable period in order to consider the case.
(3) After considering any evidence adduced or submissions made by the licence holder,— (a) the licensing authority may cancel the licence if the li- 5 censing authority is not satisfied that the licence holder satisfies all of the criteria set out in subsection (1); or the licensing authority must reinstate the licence if the licensing authority is satisfied that the licence holder satisfies all of the criteria set out in subsection (1).
10 (b) Compare: 1981 No 118 s 55A 421 Additional information required for pharmacy licence (1) The licensing authority may, for one or more of the purposes in subsection (2), require an applicant for a licence to operate a pharmacy to supply information additional to that contained 15 in the application under sections 397 and 398.
The purposes referred to in subsection (1) are— (a) (b) (c) determining the nature of an interest held in the phar- macy by any person; and in the case of an applicant who is an individual, the as- 20 sessment under section 399(1)(e) requiring the indi- vidual to be a fit and proper person; and in the case of an applicant that is a body corporate, the assessment under section 399(1)(f) requiring the body corporate to be of good repute; and the assessment in section 420.
25 (d) The application lapses if the applicant fails to supply the in- formation requested under subsection (1) within— (a) (b) Compare: 1981 No 118 s 55B 30 days of the date of the request; or any further time allowed by the licensing authority.
30 (2) (3) Companies 422 Restrictions on companies being granted pharmacy licence (1) A company must not be granted a licence to operate a phar- 35 macy unless— 267 Part 7 cl 422 Therapeutic Products and Medicines Bill (a) (b) (c) (d) (e) at all times more than 50% of the share capital of the company is owned by a pharmacist or pharmacists, and effective control of the company is vested in that pharmacist or those pharmacists; or the company is exempt from the requirements in para- 5 graph (a) by an Order in Council made under section 504 or complies with any modification of those require- ments authorised by an Order in Council made under that section; or the company is deemed to have been issued with a li- 10 cence under section 528; or the pharmacy is in a hospital owned or operated by the company; or the company is a company that, at the commencement of section 55D of the Medicines Act 1981 (as inserted 15 by section 17 of the Medicines Amendment Act 2003), was lawfully operating a pharmacy.
Subsection (1)(e) ceases to apply to a company if there is or has been a change or changes in the ownership of the shares representing 25% of the share capital of the company since 20 the commencement of section 55D of the Medicines Act 1981 (as inserted by section 17 of the Medicines Amendment Act 2003).
For the purposes of subsection (2), if a pharmacist dies or is adjudicated bankrupt the term pharmacist must be read as in- 25 cluding an administrator of the estate of the deceased pharma- cist, or an Assignee (within the meaning of the Insolvency Act 1967) of the estate of a pharmacist, until— (a) the expiry of the period of 1 year after the date of the death of the deceased pharmacist or the date on which 30 the pharmacist was adjudicated bankrupt; or subject to any conditions that the licensing authority proposes, the expiry of any extended period or periods permitted by the licensing authority.
(b) Compare: 1981 No 118 s 55D 35 (2) (3) 268 Therapeutic Products and Medicines Bill Part 7 cl 423 Majority interest in pharmacy 423 Licence and majority interest restrictions for persons (1) A person, either alone or in partnership, must not be granted a licence to operate a pharmacy or hold a majority interest in a pharmacy unless— (a) (b) 5 the person is a pharmacist; or the person is exempt from the requirement in para- graph (a) under an Order in Council made under sec- tion 504 or complies with any modification of those re- quirements authorised by that Order in Council; or the person is deemed to have been issued with a licence under section 528; or the pharmacy is in a hospital owned or operated by the person; or the person was lawfully operating a pharmacy at the 15 commencement of section 55D of the Medicines Act 1981 (as inserted by section 17 of the Medicines Amendment Act 2003).
10 (c) (d) (e) (2) (3) For the purposes of subsection (1), a person does not hold an interest in a pharmacy merely by reason of the person’s 20 membership of a company, or of any other body of persons (whether corporate or un-incorporate) other than a partnership that is lawfully carrying on business in a pharmacy.
For the purposes of subsection (1)— person does not include a company pharmacist includes— (a) 25 an administrator of the estate of a deceased pharmacist, if the pharmacist dies; or an Assignee (within the meaning of the Insolvency Act 1967) carrying on a pharmacy in his or her capacity as 30 Assignee of the estate of a pharmacist, if the pharmacist is adjudicated bankrupt; or a liquidator carrying on a pharmacy under the authority of section 260 and Schedule 6 of the Companies Act 1993, if one is appointed; or a receiver or manager of a property of a company carry- ing on (subject to the Receiverships Act 1993) a phar- macy comprised in that property, if one is appointed.
35 (b) (c) (d) 269 Part 7 cl 424 Therapeutic Products and Medicines Bill (4) Nothing in subsection (3) entitles a person to carry on busi- ness in a pharmacy after— (a) the expiry of the period of 1 year after the date of the death of the deceased pharmacist, or the date on which the pharmacist was adjudicated bankrupt, or the date of 5 the first appointment of a liquidator, receiver, or man- ager, in respect of a company that has carried on a phar- macy; or the expiry of any extended period or periods permitted by the licensing authority, subject to any conditions that 10 the licensing authority imposes.
(b) (5) In this section and in section 428, majority interest, in rela- tion to a pharmacy, means an interest in the pharmacy of more than 50% of the value of the business or businesses undertaken in the pharmacy.
Compare: 1981 No 118 s 55E 15 Mortgagees in possession 424 Exception for mortgagees in possession (1) Despite sections 422 and 423, a mortgagee in possession of a pharmacy may be granted a licence to operate that phar- 20 macy— (a) (b) for a period of 3 months; or subject to any conditions that the licensing authority imposes, for an extended period or periods permitted by that licensing authority.
(2) In this section, mortgagee in possession has the same mean- ing as in section 2 of the Property Law Act 1952.
Compare: 1981 No 118 s 55G Mandatory condition on pharmacy licence 425 Mandatory condition on pharmacy licence Every licence to operate a pharmacy includes the condition that the licence holder must not request or require a pharmacist who is employed or engaged in duties at a pharmacy to act in a way that is inconsistent with the pharmacist’s professional or ethical standards of pharmacy practice.
Compare: 1981 No 118 s 55C 270 25 30 35 Therapeutic Products and Medicines Bill Part 7 cl 427 426 Failure to comply with conditions on pharmacy licence (1) If the licensing authority is satisfied that the licence holder is failing or has failed to comply with any conditions affecting the licence to operate a pharmacy (including, conditions im- posed by the licensing authority or by or under Parts 6 and 5 7), the licensing authority may, instead of, or as well as, exer- cising the powers conferred by section 409(2),— (a) impose a penalty not exceeding $40,000 on the licence holder: forbid the licence holder, or any person with an interest 10 in the pharmacy, from holding any interest in or oper- ating a pharmacy for a period specified by the licensing authority, not exceeding 5 years.
(b) (2) A penalty imposed under subsection (1)(a) may be recov- ered in a court of competent jurisdiction as a debt due to the 15 licensing authority.
Compare: 1981 No 118 s 51(6A), (6B) Restrictions on operating and holding interests in pharmacies 427 Prescriber restricted from holding interest in pharmacy (1) A prescriber must not hold an interest in a pharmacy, other than a pharmacy for which the person holds a licence to operate, unless the prescriber— (a) (b) has the consent of the licensing authority; and holds the interest in accordance with any conditions or 25 restrictions imposed by the licensing authority.
20 (3) (2) A person who has an interest in a pharmacy must not permit or authorise any prescriber to hold or acquire that, or any other, interest in the pharmacy contrary to the requirements in sub- section (1).
The licensing authority must not give consent under subsec- tion (1) unless satisfied that there are sufficient safeguards to prevent the following from being influenced by the commer- cial or financial interests of the prescriber or any other person holding an interest in the pharmacy: (a) (b) the issue of prescriptions: the manner in which prescriptions are issued: 30 35 271 Part 7 cl 428 Therapeutic Products and Medicines Bill any other provision of health care by the prescriber.
(c) Compare: 1981 No 118 s 42C 428 Prohibition on operating or holding of majority interest in more than 5 pharmacies (1) Despite sections 422 and 423, and unless subsection (2) 5 or (3) applies,— (a) (b) a company must not operate more than 5 pharmacies: a person referred to in section 423(3) must not operate or hold a majority interest in more than 5 pharmacies.
Subsection (1) does not apply to any person referred to in 10 section 423(3), to the extent that 1 or more pharmacies, or interests in 1 or more pharmacies, are lawfully included in the estate or property that the person is administering, unless section 423(4) applies.
Subsection (1) does not apply to any person who, while at- 15 tempting to sell 1 pharmacy of which the person is the oper- ator, carries on business in no more than 5 other pharmacies for a period not exceeding 3 months, or, subject to any condi- tions that the licensing authority imposes, any extended period or periods permitted by the authority.

Subsection (3) is subject to sections 422 and 423.


Compare: 1981 No 118 s 55F 20 (2) (3) (4) Fee on prescriptions 429 Offence for persons associated with pharmacies to take fee on prescriptions 25 (2) (1) A pharmacist, a person licensed to operate a pharmacy, or an operator or a manager of a pharmacy must not give, offer, or agree to give to any prescriber or to any other person any money or other consideration as a fee on prescriptions.
Every person who contravenes subsection (1) commits an 30 offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $40,000; and in the case of a body corporate, to a fine not exceeding $100,000.
Compare: 1981 No 118 s 76A (b) 35 272 Therapeutic Products and Medicines Bill Part 7 cl 431 Subpart 5—Certain requirements, restrictions, and offences associated with medicines 430 Outline of this subpart (1) secured and stored; and contained and packaged; and prepared; and delivered; and disposed of.
This subpart deals with how medicines are to be— (a) (b) (c) (d) (e) This subpart also provides for how records relating to the sup- ply of medicines are to be kept and when that information is able to be accessed.

This subpart also contains offences relating to certain activities undertaken with medicines.

This section is by way of explanation only.

If any provision of Parts 6 and 7 conflicts with this section, that provision prevails.
5 10 15 (2) (3) (4) Security, storage, and premises 431 Security of medicines in pharmacy (1) A licence holder of a licence to operate a pharmacy must en- 20 sure that— (a) or prescription medicines all pharmacist-only medicines in the pharmacy are at all times secured in a way that prevents the public gaining ready access to 25 them; and all medicines held in storage for a purpose relating to the operation of the pharmacy are secured in a way that prevents the public gaining ready access to them.
(2) Subsection (1) does not prevent— (a) 30 a pharmacist, or a person employed to work with a pharmacist in a pharmacy, from supplying any sched- uled medicine to a member of the public if he or she is authorised by or under Parts 6 and 7; or a pharmacist engaged at a pharmacy, or a person em- 35 ployed to work with a pharmacist, from supplying a (b) (b) 273 Part 7 cl 432 Therapeutic Products and Medicines Bill non-scheduled medicine to a member of the public if not prohibited by or under Parts 6 and 7.
(3) (4) Every person who contravenes subsection (1)(a) or (b) com- mits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding 5 $5,000; and in the case of a body corporate, to a fine not exceeding $40,000.

(b) Section 472 provides that an offence under this section is a strict liability offence.
Compare: 1981 No 118 s 42B 10 432 Storage of scheduled medicine in person’s possession or charge (1) A person who, in the course of business, has a scheduled (b) medicine in that person’s possession or charge must not put 15 it— (a) in a cupboard, box, shelf, or in any other place of storage in which food or drink is stored or kept for ready use; or in a place where it may be readily accessed by— (i) (ii) children; or persons who are not authorised by or under Parts 6 and 7 to be in possession or charge of that medicine.
Every person who contravenes subsection (1) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $5,000; and in the case of a body corporate, to a fine not exceeding $40,000.

(b) 20 25 Section 472 provides that an offence under this section is a 30 strict liability offence.
Compare: 1981 No 118 s 47(1), (3), (5) (2) (3) 433 Storage of scheduled medicine in unattended building or vehicle Except as provided in the regulations, a person who, in the 35 course of business, has a scheduled medicine in the person’s (1) 274 Therapeutic Products and Medicines Bill Part 7 cl 434 possession must not store that medicine in an unattended building or vehicle, unless the person has secured any of the following against unlawful entry: (a) (b) (c) the building: the vehicle: the specific part of the building or vehicle in which the medicine is left.
5 Every person who contravenes subsection (1) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding 10 $5,000; and in the case of a body corporate, to a fine not exceeding $40,000.
(b) Compare: 1981 No 118 s 47(1), (3), (5) (2) 20 (2) (3) 434 Powers of Medical Officer of Health in respect of premises 15 This section applies to premises that are, in the opinion of the (1) Medical Officer of Health, by reason of their construction or disrepair, or by reason of the use or character of any neighbour- ing premises, in a condition that means any medicine may be at risk of contamination, or may deteriorate or become dirty.
The Medical Officer of Health may (with the Director-Gen- eral’s approval) serve a notice on any owner or occupier of any premises to which this section applies, prohibiting the use of the premises for or in connection with the storage of any medicine.
The notice must specify— (a) (b) (c) If, in the opinion of the Medical Officer of Health, the reason 30 for which the notice was served has ceased to exist, he or she must— (a) (b) the premises to which it relates; and the reasons for the prohibition; and a date on which the prohibition comes into force.

revoke the notice; and notify the owner or occupier of the premises concerned and every other person on whom a copy of the notice 35 has been served.
(5) While a notice remains in force,— (4) 25 275 Part 7 cl 435 Therapeutic Products and Medicines Bill (a) (b) no person on whom it has been served may use or permit the use of the premises specified in the notice for or in connection with the storage of any medicine; and no person on whom a copy of the notice has been served, or who knows the contents of the notice, may use those 5 premises for that purpose.
(6) Every person who contravenes a notice issued under this sec- tion commits an offence and is liable, on summary convic- tion,— (a) in the case of an individual, to a fine not exceeding 10 $5,000; and in the case of a body corporate, to a fine not exceeding $40,000.
Compare: SR 1984/143 r 31 (b) Containers and packages 435 Containers and packages when supplying and 15 20 transporting medicine Except as may be permitted by the regulations, a person must not supply, store, or transport a medicine in the course of busi- ness other than in a container that— (a) ensures liquid does not come into contact with the medicine contained in it; and is resealable after any portion of its contents has been used, unless— (i) (b) the nature of its contents means that it is unlikely 25 that less than the whole would be used on any one occasion; and the container bears a label directing that contents be used immediately on opening; and (ii) (c) complies with any requirements set out in the regula- 30 tions.
If a container of the kind referred to in subsection (1) is en- closed in a package, then a person to whom that subsection ap- plies must not, in the course of business, supply the medicine enclosed in the package, or cause the medicine enclosed in the 35 package to be transported, unless that package complies with any requirements relating to character or labelling set out in the regulations.
(1) (2) 276 Therapeutic Products and Medicines Bill Part 7 cl 437 (3) (4) Every person who contravenes subsection (1) or (2) com- mits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $5,000; and in the case of a body corporate, to a fine not exceeding 5 $40,000.

(b) Section 472 provides that an offence under this section is a strict liability offence.
Compare: 1981 No 118 s 44 436 Container for medicine in person’s possession or charge (1) A person who has a medicine in that person’s possession or charge (whether for supply or any other purpose) must ensure it is in a container that complies with the relevant requirements relating to containers in Parts 6 and 7 and the regulations.
Every person who contravenes subsection (1) commits an 15 offence and is liable, on summary conviction,— (a) (2) 10 in the case of an individual, to a fine not exceeding $5,000; and in the case of a body corporate, to a fine not exceeding $40,000.
(b) (3) (4) (5) It is a defence in a prosecution for an offence under this section if the defendant proves that— (a) the medicine is in the container in which the person acquired it and bears the label that it had when it was acquired; or the medicine was removed from its container for a law- ful purpose.

(b) Section 472 provides that an offence under this section is a strict liability offence.

The defence available under subsection (3) is in addition to 30 the defence available under section 472(3).
Compare: 1981 No 118 s 46 20 25 Packing and preparing medicines 437 Packing and preparing medicines for use (1) A person must not, in the course of business, pack or prepare 35 a medicine for use (including while dispensing a medicine or 277 Part 7 cl 438 Therapeutic Products and Medicines Bill (2) (3) preparing a medicine for administering) in a room, or on a bench, table, or other surface used for the purpose of consum- ing, packing, or preparing food or drink.
Every person who contravenes subsection (1) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $5,000; and in the case of a body corporate, to a fine not exceeding $40,000.

(b) 5 Section 472 provides that an offence under this section is a 10 strict liability offence.
Compare: 1981 No 118 s 47(2), (5) Delivering medicines 438 Delivering medicines (1) A person delivering a medicine for the purposes of supply 15 other than by wholesale must do so in one of the following ways: (a) (b) (c) by handing it, or causing it to be handed, to the indi- vidual to whom it is addressed or for whose use it is in- tended: by post (including, without limitation, by courier) to the individual for whose use it is intended: by posting it, or handing it, or causing it to be handed to an individual whom the person delivering the medicine reasonably believes to be acting on behalf of the indi- 25 vidual referred to in paragraph (a).
20 Every person who contravenes subsection (1) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $5,000; and in the case of a body corporate, to a fine not exceeding $40,000.

(b) Section 472 provides that an offence under this section is a strict liability offence.
Compare: 1981 No 118 s 47(4), (5) 30 35 (2) (3) 278 Therapeutic Products and Medicines Bill Part 7 cl 440 Disposal of medicines 439 Disposal of medicines (1) A person must not dispose of a medicine other than in the (2) manner prescribed by the regulations (if any).
Except as provided in the regulations, every person who 5 contravenes or fails to comply with subsection (1) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $5,000; and in the case of a body corporate, to a fine not exceeding 10 $40,000.

(b) (3) Section 472 provides that an offence under this section is a strict liability offence.
Record keeping 440 Records relating to supplying medicine (1) A person who, in the course of business, supplies any medicine 15 must— (a) (b) keep any records required to be kept by the regulations in a secure place at the person’s place of business in New Zealand; and retain those records in New Zealand (whether or not the business to which the records relate remains in New Zealand) for any period prescribed in the regulations.
20 (2) Every person who contravenes or fails to comply with sub- section (1) commits an offence and is liable, on summary 25 conviction,— (a) in the case of an individual, to a fine not exceeding $5,000; and in the case of a body corporate, to a fine not exceeding $40,000.

(b) 30 (3) Section 472 provides that an offence under this section is a strict liability offence.
Compare: 1981 No 118 s 45(1), (3) 279 Part 7 cl 441 Therapeutic Products and Medicines Bill 441 Providing information about records for supplying medicine (1) A person who, in the course of business, supplies any medicine must— (a) permit a medicines control officer or a member of the 5 police to inspect and make copies of records kept under section 440; and (b) when a demand is made to do so by a medicines control officer or a member of the police, provide the officer or member with any further information in the person’s 10 possession that relates to the person’s dealings with any medicine.
(2) (3) Every person who contravenes or fails to comply with sub- section (1) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $5,000; and in the case of a body corporate, to a fine not exceeding $40,000.
(b) 15 Every person who wilfully obstructs or hinders any inspection 20 under subsection 1(b) commits an offence and is liable, on summary conviction,— (a) in the case of an individual, to a term of imprison- ment not exceeding 3 months, or a fine not exceeding $40,000, or both; and in the case of a body corporate, to a fine not exceeding $100,000.
(b) Compare: 1981 No 118 s 45(2), (3) Knowingly risking public health 442 Offence to knowingly risk public health (1) Every person commits an offence who wilfully acts in contra- vention of, or fails or refuses to comply with, any provision of Parts 6 and 7 or the regulations, knowing that the action, failure, or refusal may create (directly or indirectly) a risk to public health.
Every person who commits an offence against subsection (1) is liable, on conviction on indictment,— (2) 280 25 30 35 Therapeutic Products and Medicines Bill Part 7 cl 444 (a) (b) in the case of an individual, to a term of imprisonment not exceeding 1 year, or a fine not exceeding $100,000, or both; and in the case of a body corporate, to a fine not exceeding $250,000.
5 (3) Despite section 7 of the Summary Proceedings Act 1957, if a person is summarily convicted of an offence under subsec- tion (1), the District Court may sentence the person,— (a) in the case of an individual, to a term of imprison- ment not exceeding 6 months, or a fine not exceeding 10 $40,000, or both; and in the case of a body corporate, to a fine not exceeding $100,000.
Compare: 1981 No 45 s 11AA (b) Subpart 6—Enforcement and certain procedural matters 443 Outline of this subpart (1) This subpart provides for— (a) (b) the appointment and powers of medicines control offi- cers; and that may be exercised by enforcement powers medicines control officers and members of the police under Parts 6 and 7; and (2) 444 (c) matters relating to the procedures associated with of- fences under Parts 6 and 7.

This section is by way of explanation only.


If any provision of Parts 6 and 7 conflicts with this section, that provision prevails.
Interpretation In this subpart, unless the context otherwise requires,— article means— (a) a medicine (including a medicine that is in the form of a substance); or a package or container in which it appears a medicine is contained; or (b) 281 15 20 25 30 35 Part 7 cl 445 Therapeutic Products and Medicines Bill (c) equipment used in connection with the packing or la- belling of medicines as part of dispensing under Parts 6 and 7 document means a document (as defined in section 339) that relates to an activity that is dealt with by or under Parts 6 and 5 7 evidential material means any thing (including an article) for which there are reasonable grounds for believing it is or may be evidence, or may provide or contain evidence, of— (a) (b) occupier, in relation to a place, includes— (a) an offence under Parts 6 and 7; or an attempt to commit an offence under Parts 6 and 7 a person who is present at the place and is in apparent control of it; and any person acting on behalf of the occupier (b) place means anywhere on, under, or over any land or water, and includes all or any part of a building, structure, or con- veyance.
Compare: 1981 No 118 s 63(1) 10 15 20 Medicines control officers 445 Medicines control officers (1) The Director-General must appoint medicines control officers to enforce Parts 6 and 7.

(2) An individual may be appointed under subsection (1) by name, or as the holder for the time being of a particular pos- 25 ition.
The Director-General may— (a) appoint individuals to enforce all or only certain of the provisions of Parts 6 and 7: appoint individuals subject to limitations or restrictions 30 on their exercise of enforcement powers.

(b) Identification cards The Director-General must issue every medicines control officer with an instrument of appointment (an identification card).
35 (3) 446 (1) 282 Therapeutic Products and Medicines Bill Part 7 cl 447 (2) An identification card must state whether the medicines con- trol officer is appointed to enforce— (a) (b) all the provisions of Parts 6 and 7; or only certain provisions of Parts 6 and 7.

(3) An identification card must state any limitations or restrictions 5 (4) imposed on the medicines control officer’s exercise of enforce- ment functions.
Every medicines control officer must produce his or her iden- tification card for inspection— (a) (b) on entering a place under this subpart; and at any later time, on request, during the exercise of any power under this subpart.
10 Powers of entry, search, and seizure 447 Powers of entry to inspect compliance (1) A medicines control officer may, at any reasonable time, enter 15 any place (except a dwellinghouse or marae) for the purpose of an inspection to determine whether or not a person is com- plying with Parts 6 and 7, if the medicines control officer reasonably believes that an activity dealt with under Parts 6 and 7 is being undertaken at that place.
For the purposes of subsection (1), a medicines control offi- cer may— (a) (b) (2) 20 search the place and any thing at the place: inspect, examine, and take measurements of any thing at the place that relates to an article: take samples of things for the purpose of analysis: take photographs and video recordings, and make sketches of the place or any article or thing at the place: inspect, inquire about, and copy any document and for that purpose may also do any of the following: (i) require any person at the place to produce a par- ticular document: require any person at the place who has control or knowledge of a document to reproduce, or assist in reproducing, the document in usable form: operate any equipment at the place: (ii) (iii) 25 30 35 (c) (d) (e) 283 Part 7 cl 448 Therapeutic Products and Medicines Bill (iv) remove a document temporarily to another place in order to copy it: (f) (g) (h) (i) take into or onto the place whatever equipment and materials the medicines control officer requires for the search: request the occupier of the place to— (i) answer any questions put by the medicines con- trol officer; and produce any document medicines control officer: requested by the (ii) seize evidential material: order the occupier, in writing, to identify and hold any article for 5 working days.
(3) If any thing is seized during the inspection, the medicines con- trol officer conducting the inspection must— (a) leave a written inventory of all things seized in a promi- nent place on the place; or send a copy of the inventory to the occupier, within 10 working days after the inspection.

(b) 5 10 15 (4) A medicines control officer may request any individual to as- 20 sist him or her with an inspection under this section.
(5) An individual who assists a medicines control officer must be under the supervision of a medicines control officer.

(6) Nothing in this section limits or affects the privilege against self-incrimination.
448 Entry on serious risk to public health ground (1) A medicines control officer or member of the police may en- ter any place (other than a dwellinghouse or a marae) if the medicines control officer or member of the police has reason- able grounds for believing that— (a) there may be at the place any thing in respect of which the provisions of Parts 6 and 7 have not been complied with; and it is necessary in the interests of public health to exercise powers under this section in order to avoid an imminent 35 risk of death, serious illness, or serious injury; and it is not practicable in the circumstances to obtain a search warrant.
(b) (c) 284 25 30 Therapeutic Products and Medicines Bill Part 7 cl 450 (2) A medicines control officer who enters a place under this sec- tion may exercise the powers listed in section 450(1)(b) to (j).
Search warrant Issue of search warrants 449 (1) Any District Court Judge, Community Magistrate, Justice of the Peace, or Registrar may issue a search warrant if satisfied, on an application in writing made on oath, that— (a) there are reasonable grounds for believing that there is at any place any evidential material; or a search is unable to be undertaken or completed under section 447 or 448 for any reason.
(b) (2) Every search warrant must be in the prescribed form and be directed to— (a) (b) (c) a medicines control officer by name; or a member of the police by name; or every member of the police.

(3) Despite a search warrant being directed to another person under subsection (2), it may be executed by any member of the police.

The Judge, Justice of the Peace, Community Magistrate, or Registrar issuing the search warrant may impose reasonable conditions on its execution.
(4) (5) Any member of the police or any medicines control officer 5 10 15 20 may request any individual to assist him or her in the execution 25 of a search warrant.
450 Powers of entry with search warrant (1) Every search warrant issued under section 449 authorises the medicines control officer or member of the police who is executing it and any person called on by that officer or member 30 to assist to do the following: (a) enter and search the place at any reasonable time, on 1 occasion within 14 days after the date of the warrant being issued: use reasonable force to— (b) 35 285 Part 7 cl 450 Therapeutic Products and Medicines Bill (i) (ii) make entry (for example, by breaking open a door); and open any thing on the place as it is reasonable in the circumstances to open: (c) (d) (e) (f) (g) (h) (i) 5 search the place and any thing at the place: inspect, examine, and take measurements of any thing at the place that relates to an article: take samples of things for the purpose of analysis: take photographs and video recordings, and make sketches of the place or any article or thing at the place: 10 inspect, inquire about, and copy any document and for that purpose may also do any of the following: (i) require any person at the place to produce a par- ticular document: require any person at the place who has control or 15 knowledge of a document to reproduce, or assist in reproducing, the document in usable form: operate any equipment at the place: remove a document temporarily to another place in order to copy it: 20 (ii) (iii) (iv) take into or onto the place whatever equipment and materials the medicines control officer requires for the search: request the occupier of the place to— (i) answer any questions put by the medicines con- 25 trol officer; and any document produce medicines control officer: requested by the (ii) (j) seize evidential material.
(2) A medicines control officer or a member of the police who 30 executes a search warrant must carry it with him or her and produce it for inspection— (a) to the occupier of the place on first entering the place; and at any later time, if required by any other person appear- 35 ing to be in charge of the place or any part of the place.
If the occupier of the place is not present during the search, the medicines control officer or member of the police must leave (b) (3) 286 Therapeutic Products and Medicines Bill Part 7 cl 452 in a prominent place on the place a written statement of the following: (a) (b) the time and date of the search: the name of the medicines control officer or member of the police executing the search: the address of the office or police station to which en- quiries may be made.
(c) If any thing is seized during the search, the medicines control officer or member of the police executing the search warrant must— (a) leave a written inventory of all things seized in a promi- nent place on the place; or send a copy of the inventory to the occupier, within 10 working days after the search.

(b) 5 10 (4) (5) If any action is taken under a warrant at a dwellinghouse or 15 marae, that action must be taken in the presence of a member of the police.
(6) Nothing in this section limits or affects the privilege against self incrimination.

Matters associated with search 20 451 Occupier entitled to be present during search (1) The occupier of a place that is subject to any search under this subpart, and who is present at any time during the search, is entitled to observe the search as it is being carried out.

The right to observe the search ceases if the person observing 25 impedes the search.
This section does not prevent 2 or more parts of the place being searched at the same time.

(2) (3) 452 Use of electronic equipment (1) If a medicines control officer or a member of the police (or 30 any person called on by that officer or member to assist) oper- ates electronic equipment found at a place during a search, the medicines control officer, member of the police, or person as- sisting must take all reasonable care not to damage the equip- ment or corrupt information stored on it.
35 287 Part 7 cl 453 Therapeutic Products and Medicines Bill (2) If, as a result of a failure to take the care required by subsec- tion (1), equipment or information suffers damage, the owner of the equipment or information, or the occupier of the place may seek damages from the Crown in respect of that damage.
(2) (3) 453 Copies of documents seized to be provided (1) 5 If a document that is capable of being copied is seized from a place, it must (if practicable) be copied before the original is removed, and the copy must be left at the place.

If it is not practicable to copy the document before removing it, the document must be copied as soon as practicable after 10 it is removed, and (if practicable) the copy must be promptly delivered to the occupier of the place.
Subsection (1) does not apply— (a) to documents obtained as a result of operating electronic equipment found at the place, if the equipment is not 15 seized and the documents remain stored on it; or to any documents that it is or may be an offence to pos- sess; or if an order under subsection (4) has been made.
(b) (c) (4) A District Court Judge, Community Magistrate, Justice of the 20 Peace, or Registrar may make an order waiving the applica- tion of subsections (1) and (2) if satisfied that the volume of material to be copied is such that copying it will involve substantial cost, and that the cost is not justified.
(5) An order under subsection (4) may be subject to whatever 25 conditions the person making the order thinks are necessary to protect the interests of the person from whom the documents have been seized.

What happens to seized property 454 Disposal of property seized (1) Section 199 of the Summary Proceedings Act 1957 applies— (a) to property seized by a member of the police; and (b) with all necessary modifications, to property seized by 30 a medicines control officer.
(2) Despite subsection (1), if proceedings for an offence relat- 35 ing to the seized property are not brought within a period of 288 Therapeutic Products and Medicines Bill Part 7 cl 455 6 months after the date of seizure, any person claiming to be entitled to the property may, at the expiry of that period, apply to a District Court Judge for an order that the property be de- livered to that person.
(3) On an application under subsection (2), the District Court 5 Judge may— (a) adjourn the application on the terms he or she thinks fit, in order for the proceedings to be brought; or 10 (b) make any order that a court may make under section 199(3)(a) of the Summary Proceedings Act 1957.
If property is seized under this subpart, it must be disposed of as directed by the Director-General if no person— (a) (b) Property may be returned unconditionally or under the terms 15 and conditions that the Director-General thinks fit.

Property may not be returned if it is, or is liable to be, forfeited to the Crown.

is charged with an offence under Parts 6 and 7; or applies to have the article returned.
(4) (5) (6) 455 Order to retain seized property (1) If a medicines control officer wishes to retain any property 20 seized under this subpart for more than 6 months, he or she may apply to a District Court for an order under this section.
(2) A District Court Judge, Community Magistrate, Justice of the Peace, or Registrar may make an order if he or she is satisfied that retaining the property is necessary— (a) 25 for the purpose of investigating an alleged offence under Parts 6 and 7; or as evidence of an alleged offence under Parts 6 and 7; or to secure evidence of an alleged offence under Parts 6 30 and 7.

(b) (c) (3) An order may be for any period of up to 4 years.
(4) Before making an application, the medicines control officer must— (a) take reasonable steps to discover who has an interest in 35 the property; and 289 Part 7 cl 456 Therapeutic Products and Medicines Bill (b) if practicable, notify each person whom the medicines control officer believes to have an interest in the pro- posed application and in any application for a renewal of the order.
(5) If an order is made for a period of less than 4 years, it may be 5 renewed, but the total period of the order (including renewals) may not exceed 4 years.
Analysis of samples 456 Analysis of sample (1) A medicines control officer who obtains a sample for analysis, 10 other than under a search warrant, must— (a) pay the current market value of the sample to the owner of it, or to the person from whom the sample was ob- tained; and either before or immediately after obtaining the sample, 15 inform the person that the sample may be submitted for analysis.
(b) (2) If the medicines control officer fails to comply with subsec- tion (1), the results of any analysis may not be used in any proceedings for an offence under Parts 6 and 7.

(3) A sample taken for the purpose of analysis does not have to be (4) submitted for analysis.

If a sample is not submitted for analysis, it must be treated in the same way as any other thing that is seized.
Compare: 1981 No 118 s 69(1), (5)(a) 457 Analysis of samples and certificate of analyst (1) A certificate of an analyst must be in the prescribed form and be signed by the analyst.

If a method of analysis is prescribed, that method must be used and the certificate must state that the method has been used.

The analysis may be made by a person acting under the direc- tion of the analyst.
The person from whom a sample is obtained, or the owner of a sample, may obtain a copy of the analyst’s certificate or, if (2) (3) (4) 290 20 25 30 Therapeutic Products and Medicines Bill Part 7 cl 459 there is no certificate, the report of the analyst, on payment of the prescribed fee.
Compare: 1981 No 118 ss 2(1), 70 458 Evidence of analysis (1) In any proceedings under Parts 6 and 7, a certificate that is in 5 the prescribed form and purports to be signed by an analyst is, in the absence of evidence to the contrary, sufficient evidence of the authority of the person who signed the certificate and of the facts stated in the certificate.
(2) However, a certificate is admissible in evidence only if,— 10 (a) (b) (c) at least 14 days before the hearing at which the cer- tificate is given in evidence, a copy of the certificate (in addition to any copy served with any summons) is served by the prosecutor; and at the same time, the defendant is informed in writing 15 that the prosecutor does not propose to call the analyst as a witness at the hearing; and the defendant does not, by notice in writing to the pros- ecutor at least 7 days before the hearing, require the ana- lyst to be called by the prosecutor as a witness at the 20 hearing.
(3) A certificate is not admissible in evidence if the Court, of its own motion, directs that the result of the analysis must be dis- regarded unless the result is proved by the oral evidence of the analyst.
25 (4) A certificate of analysis, or other evidence of analysis, may not be ruled inadmissible or be disregarded by reason only of the fact that any provisions of this Act or any regulations made under it that relate to the taking or analysing of samples have not been strictly complied with, if there has been reasonable 30 compliance with those provisions.
Compare: 1981 No 118 s 71 459 Cost of analysis (1) If a person is convicted of an offence under Parts 6 and 7, the Court may order that all fees and other expenses incidental 35 to the analysis of any thing must be paid by the defendant.

291 Part 7 cl 460 Therapeutic Products and Medicines Bill (2) The fees and expenses are part of the costs attending the con- viction and are recoverable accordingly.
Wilfully obstructing 460 Offence of wilfully obstructing (1) A person commits an offence if he or she wilfully obstructs 5 a medicines control officer, a member of the police, or any person assisting a medicines control officer or a member of the police who is exercising powers under this subpart.
(2) Without limiting what else may be treated as obstruction for the purpose of subsection (1), Person A obstructs Person B 10 if Person A— (a) removes, alters, or interferes in any way with a thing that is seized by Person B: tampers with any sample, or any container that holds a sample, that was obtained by person B under or for a 15 purpose associated with this subpart: refuses, either actively or passively, to assist Person B when required under this subpart to do so: (b) (c) (3) (d) misleads Person B as to the whereabouts of any thing, the operation of any equipment, or how to obtain access 20 to any thing.
Every person commits an offence who, without reasonable ex- cuse, refuses to do any of the following when required by a medicines control officer or a member of the police who is ex- ercising a power under section 447 or 450: (a) (b) (c) (d) provide a sample for the purpose of analysis; or produce a document; or reproduce, or assist in reproducing, a document; or answer any questions.
25 (4) A person who commits an offence against this section is liable, 30 on summary conviction, to a fine not exceeding $20,000.
Compare: 1981 No 118 s 75 292 Therapeutic Products and Medicines Bill Part 7 cl 462 False or misleading statement, declaration, or answer 461 False or misleading statement, declaration, or answer (1) Every person commits an offence who, in relation to any re- quirement under Parts 6 and 7,— (a) makes a declaration or statement or answers any ques- tion knowing that the declaration, statement, or answer is false or misleading; or creates, produces, or makes use of a declaration or state- ment, or any document containing a declaration or state- 10 ment, knowing that it is false or misleading; or creates, produces, or makes use of a document knowing that it is not genuine.
(b) (c) 5 (2) Every person who commits an offence against subsection (1) is liable, on summary conviction,— (a) in the case of an individual, to a term of imprison- ment not exceeding 6 months, or a fine not exceeding $40,000, or both; and in the case of a body corporate, to a fine not exceeding $100,000.
Compare: 1981 No 118 s 76 (b) 15 20 Powers of Director-General and Medical Officer of Health 462 Director-General or Medical Officer of Health may (1) (2) 25 require documents or records The Director-General or a Medical Officer of Health may ex- ercise the power in subsection (2) if he or she reasonably suspects that a person, in breach of Parts 6 and 7 or the regu- lations, is in possession of— (a) (b) (c) The Director-General or the Medical Officer of Health may re- quire a person to produce for him or her, or any person specif- ically authorised by him or her, any document or other record 35 that relates or refers to the items mentioned in subsection (1)(a) to (c).
a medicine for supply; or an article relating to the supply of a medicine; or labelling material for use in dispensing a medicine.

30 293 Part 7 cl 463 Therapeutic Products and Medicines Bill (3) If the Director-General or a Medical Officer of Health requires a person to produce a document or record under subsection (2), the Director-General or Medical Officer of Health may make or cause to be made copies of the document or record.
(4) A copy of a document or record made under subsection (3) 5 (5) is to be treated as a true and correct copy, unless the contrary is proved.

The Director-General or a Medical Officer of Health may take possession of a record or document under this section and re- move it from the place where it is kept, for the period of time 10 that is reasonable in the circumstances.
Compare: 1981 No 118 s 66(1), (2), (5) 463 Offence not to comply with requirement in section 462 (1) Every person commits an offence who fails or refuses a re- quirement under section 462(2).

15 (2) A person who commits an offence under subsection (1) is liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $5,000; and in the case of a body corporate, to a fine not exceeding 20 $40,000.
(b) (3) Section 472 provides that an offence under this section is a strict liability offence.
Compare: 1981 No 118 s 66(3) Disclosure of information 25 464 Disclosure of information (1) The purpose of this section is to ensure that government agen- cies and the Authority are able to disclose information to each other that it is desirable or necessary to disclose— (a) to ensure the health and well-being of persons using or 30 dealing with medicines; or for the purposes of maintaining the law, including the prevention, investigation, and detection of offences under Parts 6 and 7 or any of the enactments listed in subsection (4).
35 (b) 294 Therapeutic Products and Medicines Bill Part 7 cl 465 (2) Despite information privacy principles 2 and 11 of the Privacy Act 1993, an approved agency, or an officer or employee of an approved agency, may disclose to any other approved agency, or officer or employee of that agency, any information supplied or obtained under or for the purposes of any of the enactments 5 specified in subsection (4)(b)(i) to (vii), if the disclosure of that information is necessary or desirable for any of the purposes specified in subsection (1).
(3) Nothing in subsection (2) authorises the disclosure of com- (4) mercially sensitive information unless and to the extent that 10 the disclosure is necessary in the particular case to ensure the health or well-being of any individual.
In this section, approved agency means— (a) (b) the Authority; and any government department that is for the time being 15 responsible for administering any of the following: (i) (ii) Agricultural and Veterinary Parts 6 and 7: Compounds Medicines Act 1997: (iii) Animal Products Act 1999: (iv) Biosecurity Act 1993: (v) (vi) (vii) Hazardous Substances and New Organisms Act Customs and Excise Act 1996: Food Act 1981: 1996: (viii) any Act substituted for any of the enactments (ix) listed above: any other person or body having involvement in the monitoring of the use of medicines.
Matters relating to proceedings 465 Matters relating to information and summons (1) Despite section 14 of the Summary Proceedings Act 1957, an information laid under Parts 6 and 7 or the regulations may be laid before the day that is 1 year from the date on which the matter to which the information relates took place.
20 25 30 35 295 Part 7 cl 466 Therapeutic Products and Medicines Bill (2) A certificate of an analyst or a report relating to a prosecution under Parts 6 and 7 or the regulations must be served with any summons issued.
Compare: 1981 No 118 s 77 466 Service of documents (1) 5 (c) If a document is required or authorised by Parts 6 and 7 or the regulations to be served or given to a person, it may be served or given by— (a) (b) delivering it personally; or leaving it at that person’s usual or last known place of 10 residence or business; or posting it by letter addressed to that person at the per- son’s usual or last known place of residence or business.
If a document is posted under subsection (1)(c), it is deemed, in the absence of proof to the contrary, to have been served or 15 given at the time when the letter would have been delivered in the ordinary course of post.

If the person on whom the document is to be served is not in New Zealand, the document may be served on or given to that person’s agent by any of the means referred to in subsection 20 (1).
If the person on whom the document is to be served is de- ceased, the document may be served on or given to that per- son’s personal representative by any of the means referred to in subsection (1).

If a person is unable to serve or give notice by the means re- ferred to in subsection (1), (3), or (4) because the relevant facts for service or giving by those means are not known to that person, that person may ask a District Court Judge in what manner the document might be served or given.
25 30 (2) (3) (4) (5) (6) Despite subsections (1) to (5), a District Court Judge may make an order— (a) directing the manner in which a document is to be served or given; or dispensing with the service or giving of the document.
35 (b) Compare: 1981 No 118 s 103 296 Therapeutic Products and Medicines Bill Part 7 cl 469 467 Contents of container presumed in proceedings In proceedings under Parts 6 and 7 or the regulations, unless the contrary is proved, it is presumed that the contents of a container are the same as the description of its contents set out on the label of the container.
Compare: 1981 No 118 s 73(1) 5 468 Certificate signed by licensing authority (1) In proceedings under Parts 6 and 7 or the regulations, a cer- tificate purporting to be signed by the licensing authority about the matters referred to in subsection (2) is (without proof of 10 the signature of the licensing authority) sufficient evidence, until the contrary is proved, of the facts set out in the certifi- cate.
The matters referred to in subsection (1) are— (a) (b) the contents of the register kept under section 417; or 15 a statement that on a date specified in the certificate— the name of any particular person did not appear (i) on the register as a licence holder; or any particulars specified in the certificate did not appear on the register.
(ii) 20 (2) Compare: 1981 No 118 s 74 469 Copies of documents or records in proceedings (1) In proceedings under Parts 6 and 7 or the regulations, a copy of a document (as defined in section 339) or record must be treated as a true and correct copy of the document or record, 25 unless the contrary is proved.
(2) A copy of a document or a record may be certified by— (a) (b) the medicines control officer who made the copy; or the Director-General or the Medical Officer of Health who made the copy, or any person he or she has caused 30 to make the copy under section 462(3).
297 Part 7 cl 470 Therapeutic Products and Medicines Bill Matters arising from conviction 470 Forfeiture on conviction (1) If a person is convicted of an offence under Parts 6 and 7 or the regulations, the Court may order any of the following to be forfeited to the Crown: (a) (b) any article to which the conviction relates: any medicines similar to any found on the premises of the defendant or in the defendant’s possession at the time of the offence: packages or containers containing medicines of the kind 10 referred to in paragraph (a) or (b).
(c) 5 (2) Any thing forfeited to the Crown under this section must be disposed of as the Minister directs.
471 Notifying health authority or Veterinary Council of conviction If a health practitioner or veterinarian is convicted of an of- fence under Parts 6 and 7 or the regulations, the court must cause particulars of the conviction to be sent to,— (a) in the case of a health practitioner, the health authority with which the health practitioner is registered; and in the case of a veterinarian, the Veterinary Council.
(b) Compare: 1981 No 118 s 87 15 20 Matters effecting liability 472 Strict liability (1) Offences committed under the following sections are strict li- 25 ability offences: (a) section 413 (relating to producing a licence to a court for cancellation or endorsement): section 431 (relating to the security of medicines in pharmacies): section 432 (relating to the storage of scheduled medicines in a person’s possession or charge): section 435 (relating to containers and packages when supplying and transporting medicines): section 436 (relating to containers for medicines in a 35 person’s possession or charge): 30 (b) (c) (d) (e) 298 Therapeutic Products and Medicines Bill Part 7 cl 473 (f) (g) (h) (i) (j) section 437 (relating to packing and preparing medicines for use): section 438 (relating to delivering medicines): section 439 (relating to disposal of medicines): section 440 (relating to keeping records relating to the 5 supply of medicines): section 463 (relating to complying with a direction of the Director-General or a Medical Officer of Health for the provision of information).
By way of explanation, it is not necessary for the prosecu- 10 tion to prove that the defendant intended to commit an offence listed in subsection (1).

It is a defence to an offence listed in subsection (1) if the defendant proves— (a) that the defendant did not intend to commit the offence; 15 and that the defendant took all reasonable steps to ensure— anything required to be done was done; or (i) anything prohibited from being done was not (ii) done.
(b) 20 Compare: 1981 No 118 s 80 (2) (3) (2) 473 Liability of employer for act of employees (1) If an offence is committed under Parts 6 and 7 or the regula- tions by a person acting as an employee, his or her employer is (without prejudice to the liability of the employee) liable by or 25 under Parts 6 and 7 in the same manner and to the same ex- tent as if the employer had personally committed the offence.
If any proceedings are brought against an employer in reliance on subsection (1), it is a defence if the employer proves that— (a) the offence was committed without the employer’s knowledge; and the employer took all reasonable steps to prevent the commission of the offence.
(b) 30 Compare: 1981 No 118 s 79(1), (2) 35 299 Part 7 cl 474 Therapeutic Products and Medicines Bill 474 Liability of executive officers for acts of body corporate (1) An executive officer of a body corporate commits an offence if— (a) (b) (c) (d) the body corporate commits an offence under Parts 6 and 7; and the officer knew that the offence was being or would be committed; and the officer was in a position to influence the conduct of the body corporate in relation to the commission of the offence; and the officer failed to take all reasonable steps to prevent the commission of the offence.
5 10 (2) The maximum penalty for an offence under this section is the maximum penalty that could have been imposed if an indi- vidual had been convicted of the offence that the body corpo- 15 rate committed.

(3) An offence under this section is triable (whether summarily or on indictment) in whatever manner the offence that the body corporate has committed could be tried.
Compare: 1981 No 118 s 79(3) 20 475 Protection of persons acting in performance of functions under Parts 6 and 7 (1) A person who does any act in performance or intended per- formance of any of the functions conferred on him or her by or under Parts 6 and 7 is not under any civil or criminal li- 25 ability for the act, whether done on the ground of want of jur- isdiction, mistake of law or fact, or on any other ground.
Subsection (1) does not apply if the person has acted in bad faith or without reasonable care.

Compare: 1981 No 118 s 102 (2) 30 Subpart 7—Appeals 476 Outline of this subpart (1) This subpart provides for how a person may appeal certain decisions made by— (a) (b) a Medical Officer of Health; or the licensing authority.

35 300 Therapeutic Products and Medicines Bill Part 7 cl 478 (2) This section is by way of explanation only.
If any provision of Parts 6 and 7 conflicts with this section, that provision prevails.

Appeals against decision of Medical Officer of Health in respect of premises 477 Appeal against decision in respect of premises (1) An occupier of premises in respect of which a decision has been made under section 434 by a Medical Officer of Health, may appeal against that decision to a District Court within 14 days after being notified in writing of the decision.
(2) An appeal under this section must— (a) (b) be made by way of originating application in accord- ance with the District Courts Rules 1992; and be filed in the office of the Court nearest to the place of business or employment of the appellant.

(3) On any appeal under this section— (a) the Court may confirm, reverse, or modify the decision appealed against: the decision of the Court is final.
(b) Compare: SR 1984/143 r 65 5 10 15 20 Licensing appeals 478 Appeal against decision of licensing authority (1) A person may appeal to the District Court against any decision of the licensing authority to— refuse to grant the person a licence: (a) impose a condition on the person’s licence: (b) suspend or cancel the person’s licence: (c) (d) impose a penalty under section 426(1)(a) or (b).
The appeal must be made within 28 days after the decision appealed against is given, or within such extended time that 30 the Court may allow.

25 (2) (3) On any appeal under this section, the District Court may, as it thinks fit, confirm, reverse, or modify the decision appealed against.
301 Part 7 cl 479 Therapeutic Products and Medicines Bill 479 Status of decision of licensing authority pending appeal (1) On any appeal under section 478, the District Court may by interim order suspend the operation of the decision appealed against until the final determination of the appeal.
(2) Unless an order is made under section 426(1)(b), every de- 5 cision referred to in section 478(1) takes effect according to its terms even if the time for appealing has not expired or an appeal has not been determined.
Compare: 1981 No 118 s 88 480 Proceedings before District Court (1) At the hearing of an appeal under section 478, the District 10 15 Court— (a) must hear all evidence tendered and representations made by or on behalf of the parties that the Court con- siders relevant to the subject matter of the appeal: (b) may receive as evidence any statement, document, in- formation, or matter that the Court thinks would assist it to deal effectually with the matters before it, whether or not it would be otherwise admissible in a court of law.
For the purpose of modifying any decision of the licensing au- 20 thority or substituting a new decision, the District Court has all the powers and discretions of the licensing authority in re- spect of the same matter.

The District Court may, having regard to the interests of all parties concerned and to the public interest, hold the hearing 25 or any part of it in private.
Compare: 1981 No 118 s 90 (2) (3) 481 Appeal to High Court on question of law (1) A party to an appeal under section 478 may, with the leave of the District Court or the High Court, further appeal to the 30 High Court against any determination of the District Court on a question of law arising in the appeal.

The appeal must be made within 28 days after the decision appealed against is given or within such further time that the Court may allow.
35 (2) 302 Therapeutic Products and Medicines Bill Part 7 cl 484 (3) The Court that grants leave may impose conditions as it thinks fit, whether as to costs or otherwise.

(4) On an appeal under this section, the High Court has the same power to adjudicate on the proceedings as the District Court.

The decision of the High Court on any appeal under this sec- 5 tion is final.
(5) 482 Status of decision of District Court pending appeal (1) Despite section 481, the decision of the District Court takes effect according to its terms, pending the determination of any appeal under section 481, unless— (a) leave to appeal is given by the Court whose decision is appealed against; and that Court, when giving leave, directs that the decision must not take effect pending the determination of the appeal.
(b) (2) If the Court gives a direction under subsection (1)(b),— (a) the Court may make an order as it thinks just regarding the application of the decision of the licensing authority that is appealed against under section 478, pending the determination of an appeal under section 481; and section 483 applies accordingly.
(b) Compare: 1981 No 118 s 93 10 15 20 483 Procedure for appeal Every appeal under section 478 or 481 must be heard and determined in accordance with the rules of Court except to the 25 extent that Parts 6 and 7 provide otherwise.

Compare: 1981 No 118 s 90 484 No person may be deprived of right to appeal No person may be deprived of the right of appeal under sec- tion 478 merely because the person has accepted a licence or 30 complied with a requirement or condition imposed by or under Parts 6 and 7.
Compare: 1981 No 118 s 91 303 Part 7 cl 485 Therapeutic Products and Medicines Bill 485 Licensing authority to implement decision of Court If the District Court or the High Court modifies a decision of the licensing authority, or substitutes a new decision, the li- censing authority must take all necessary measures to imple- ment the decision of the Court.
Compare: 1981 No 118 s 91 5 Subpart 8—Restrictions on xenotransplantation 486 Outline of subpart (1) This subpart provides for general restrictions on, and certain 10 limited circumstances when it is permissible to undertake, xenotransplantation.

This section is by way of explanation only.

If any provision of Parts 6 and 7 conflicts with this section, that provision prevails.
15 (2) 487 the whole or part of an organ, bone, tissue, or cell; or blood or body fluids Interpretation In this subpart, unless the context otherwise requires,— biological material means— (a) (b) xenotransplantation means a medical procedure that in- volves the transplanting, implanting, or infusing of any of the following into a human recipient: (a) live cells, tissues, or organs from an animal source, whether or not that biological material also includes 25 biological material from a human being; or human body fluids, cells, tissues, or organs that have had ex-vivo contact with live non-human cells, tissues, or organs.
Compare: 1981 No 118 s 96A (b) 20 30 488 Restriction on xenotransplantation (1) A person must not conduct a xenotransplantation other than in accordance with an authorisation given under section 489 or 490.

304 Therapeutic Products and Medicines Bill Part 7 cl 490 (2) Every person who contravenes subsection (1) commits an offence and is liable, on summary conviction, to a term of im- prisonment not exceeding 6 months, or to a fine not exceeding $20,000, or both.
Compare: 1981 No 118 s 96B(1), (3) 5 489 Authorisation for particular xenotransplantation given (1) (2) by Minister The Minister may, by notice in writing, authorise a person or a body of persons to conduct a particular xenotransplantation.

The Minister may issue a notice under subsection (1) only if 10 satisfied that the xenotransplantation concerned meets each of the criteria specified in section 491(1).
(4) (3) An authorisation granted under subsection (1) may be granted unconditionally or subject to conditions specified in the notice.

The Minister may, at any time, by written notice, do 1 or more of the following in relation to the authority granted under sub- section (1): vary it: (a) vary or revoke any condition subject to which it was 20 (b) granted: add new conditions: revoke it.
(c) (d) 15 (5) As soon as practicable after giving a notice under subsection (1) or (4), the Minister must publish the notice in the Gazette 25 and present a copy of the notice to the House of Representa- tives.

Compare: 1981 No 118 s 96C 490 Authorisation given for xenotransplantation by Order (1) (2) in Council The Governor-General may, by Order in Council made on the recommendation of the Minister, authorise the conduct of xenotransplantation.
The Minister may make a recommendation only if satisfied that the conduct of the procedure concerned meets each of the 35 criteria specified in section 491(1).

30 305 Part 7 cl 491 Therapeutic Products and Medicines Bill (3) An authorisation granted by an Order in Council under sub- section (1) may be granted unconditionally or subject to any conditions specified in the order.
Compare: 1981 No 118 s 96D 491 Criteria for authority (1) 5 The Minister may grant or recommend an authority sought by an application under section 489 only if satisfied that the application relates to the conduct of a xenotransplantation that meets each of the following criteria: (a) the conduct of the xenotransplantation does not pose an 10 unacceptable risk to the health or safety of the public: any risks posed by the conduct of the xenotransplanta- tion will be appropriately managed.
(b) (2) If the Minister is not satisfied that the conduct of the xeno- transplantation meets any 1 or more of the criteria specified in 15 subsection (1), the Minister— (a) may direct that advice on the question of whether or not the conduct of the xenotransplantation meets that criter- ion (or, as the case may be, those criteria) be obtained from persons who, in the Minister’s opinion, are appro- 20 priately qualified, or have the appropriate expertise, to advise on the question; and after obtaining that advice, may resume his or her con- sideration of the application on the basis of that advice.
(b) Compare: 1981 No 118 s 96E 25 492 Advice on applicability of criteria (1) For the purpose of obtaining advice of the kind referred to in section 491(2)(a), the Minister may do 1 or more of the following: (a) establish an advisory committee to advise on the criteria 30 in question: request a body, committee, or association of persons formed or recognised by or under an enactment to ad- vise on the criteria in question: request the person who made the application under sec- 35 tion 493 (the applicant) to obtain advice on the cri- (b) (c) 306 Therapeutic Products and Medicines Bill Part 7 cl 492 teria in question from a committee consisting of persons nominated by the Minister.
(2) A committee, body, or association of persons that is to provide advice for the purposes of section 491(2)(a) may provide that advice only after it has— (a) 5 (3) (4) (5) (6) given interested parties and members of the public a reasonable opportunity to make submissions in writing or orally, or both; and taken those submissions (if any) into account.
(b) Sections 74 to 86 of the New Zealand Public Health and Dis- 10 ability Act 2000 apply, with all necessary modifications, to the establishment and procedures of an advisory committee that is to be established or that has been established under subsec- tion (1)(a), as if it were an inquiry board under that Act.
The Minister may agree with an applicant whose application 15 relates to the work of a committee, body, or association es- tablished or requested under subsection (1)(a) or (b) that the applicant will pay, or contribute towards the payment of, any costs incurred or to be incurred by the committee or body or association in the examination of aspects of the applicant’s 20 application that, in the Minister’s opinion, could have signifi- cant commercial benefits (whether or not that examination also benefits the public).
The Minister may agree with an applicant whose application relates to the work of a committee of persons nominated by the 25 Minister under subsection (1)(c) that the Minister will pay, or contribute towards the payment of, any costs incurred or to be incurred by the committee in the examination of aspects of the applicant’s application that, in the Minister’s opinion, are likely to benefit the public (whether or not that examination 30 also has commercial benefits).
If the Minister is, under subsection (4), attempting to reach an agreement with the applicant, the Minister may direct the committee, body, or association concerned not to consider any matters relating to the applicant’s application until agreement 35 under subsection (4) has been reached; and the committee or body or association must give effect to that direction.
Compare: 1981 No 118 s 96F 307 Part 7 cl 493 Therapeutic Products and Medicines Bill 493 Applications (1) A person may, by application to the Minister, request the Min- ister to grant an authority under section 489 or to recommend an authorisation under section 490(1).

(2) An application under subsection (1) must be in a form ap- 5 (3) proved by the Director-General and must be accompanied by the prescribed fee.
If the Minister has requested a person to obtain any advice under section 492(1)(c), the Minister may defer consider- ation of the person’s application until the advice is obtained.

Compare: 1981 No 118 s 96G 494 No compensation No compensation is payable by the Crown to any person for any loss or damage arising from the restrictions imposed by section 488.
Compare: 1981 No 118 s 96H 495 Enforcement powers (1) Sections 447 to 461 apply, with all necessary modifications, to an investigation into or, as the case requires, a prosecution of an offence against, section 488.

(2) Nothing in subsection (1) limits the application of any other provision of Parts 6 and 7 (including any provision in sub- part 6) relating to the commission, investigation, or prosecu- tion of an offence, or any matters arising as a result of an of- fence, under section 488.
Compare: 1981 No 118 s 96I 10 15 20 25 (1) 496 Director-General or Medical Officer of Health may require information relating to xenotransplantation The Director-General or a Medical Officer of Health may ex- ercise the power set out in subsection (2) if he or she reason- 30 ably suspects that a person, in breach of Parts 6 and 7, is in possession of an article for use in xenotransplantation.
If this subsection applies, the Director-General or a Medical Officer of Health may require the person to produce for him or her, or any person specifically authorised by him or her, any 35 (2) 308 Therapeutic Products and Medicines Bill Part 7 cl 498 (3) document or other record that relates or refers to the article referred to in subsection (1).
If the Director-General or a Medical Officer of Health requires a person to produce a document or record under subsection (2), the Director-General or the Medical Officer of Health may 5 make or cause to be made copies of the document or record.

(5) (4) A copy of a document or record or an extract from a document or record made under subsection (3) is to be treated as a true and correct copy, unless the contrary is proved.
The Director-General or a Medical Officer of Health may take 10 possession of a record or document under this section and re- move it from the place where it is kept, for the period of time that is reasonable in the circumstances.

Compare: 1981 No 118 ss 66(1), (2), (5), 96I(1) 497 Offence not to comply with requirement to produce under 15 (1) section 496 Every person commits an offence who fails or refuses to pro- duce any document or record required to be produced under section 496.
(2) A person who commits an offence under subsection (1) is 20 liable, on summary conviction,— (a) in the case of an individual, to a fine not exceeding $5,000; and in the case of a body corporate, to a fine not exceeding $40,000.

(b) (3) Section 472 (relating to strict liability) applies to this section as if it were a section listed in section 472(1).

Compare: 1981 No 118 s 66(1), (3) 498 Expiry of subpart (1) (2) This subpart expires on the close of 31 December 2008.
The Governor-General may, by Order in Council, before the date specified in subsection (1), and on the recommendation of the Minister, specify a later date in substitution for that date.

309 25 30 Part 7 cl 499 Therapeutic Products and Medicines Bill (3) An Order in Council made under this section is a regulation for the purposes of the Acts and Regulations Publication Act 1989 and the Regulations (Disallowance) Act 1989.
Compare: 1981 No 118 s 96J Subpart 9—Regulations, Orders in Council, Ministerial notices, and other instruments Regulations 5 499 Regulations (1) The Governor-General may, by Order in Council, make regu- lations for all or any of the purposes listed in subsection (2), 10 on the advice of the Minister tendered after consultation with organisations or bodies that appear to the Minister to represent persons likely to be substantially affected by the regulations.
The purposes referred to in subsection (1) are— (1) (2) (3) (4) (5) Administrative prescribing applications and the manner in which they are to be made, forms, notices, licences, particulars, records, and certificates for any purpose under Parts 6 and 7: prescribing the person or classes of persons to whom 20 any notice must be given: 15 including, without Supplying scheduled medicines by wholesale authorising persons or classes of persons to supply limita- medicines by wholesale, tion, authorising the supply of scheduled medicines by 25 wholesale as fixed vendors or mobile vendors: limiting, restricting, or imposing conditions on— (a) the supply of scheduled medicines by whole- sale (including, without limitation, in relation to supplying scheduled medicines by wholesale as 30 fixed vendors or mobile vendors); and persons or classes of persons supplying sched- uled medicines by wholesale (including, without limitation, in relation to wholesaling scheduled medicines as fixed vendors or mobile vendors): regulating the quantity of scheduled medicines that may be supplied by wholesale as a mobile vendor: (b) 35 (2) 310 Therapeutic Products and Medicines Bill Part 7 cl 499 regulating limits on the size of geographical areas in which persons or classes of persons may supply sched- uled medicines by wholesale as a mobile vendor: Supplying scheduled medicines other than by wholesale authorising persons or classes of persons to supply 5 scheduled medicines other than by wholesale: limiting, restricting, or imposing conditions on— (a) the supply of scheduled medicines other than by wholesale; and persons or classes of persons supplying sched- 10 uled medicines other than by wholesale: (b) Supplying medicines by vending machine authorising persons or classes of persons to supply scheduled medicines by vending machine: (6) (7) (8) (9) (10) prescribing the circumstances in which persons or 15 classes of persons may supply scheduled medicines by vending machine: limiting, restricting, or imposing conditions on— (a) (11) (b)
 the supply of medicines (whether scheduled or non-scheduled) by vending machine; and persons or supplying classes of persons medicines (whether scheduled or non-scheduled) by vending machine: (12) Supplying medicines generally limiting, restricting, or imposing conditions on— (a) the supply of medicines generally, or a particular type of supply; and persons or medicines: classes of persons supplying (b) Dispensing medicines (13) withdrawing a medicine from being able to be dis- pensed: (14) providing for the Director-General to withdraw a medicine from being able to be dispensed and the cir- cumstances in which this may happen: authorising persons or classes of persons to dispense medicines: (15) 311 20 25 30 35 Part 7 cl 499 Therapeutic Products and Medicines Bill (16) (17) (18) (19) (20) (21) regulating the manner and circumstances in which per- sons may dispense medicines and requirements asso- ciated with being able to dispense medicines (for ex- ample, a requirement for a person to have a particular qualification or to be under supervision): regulating the areas or places from which medicines may be dispensed, including limiting dispensing to, or restricting or prohibiting dispensing from, certain areas or places: limiting, restricting, or imposing conditions on— (a) the dispensing of medicines generally, or in rela- tion to a particular manner of dispensing; and persons or medicines: classes of persons dispensing (b) 5 10 regulating how medicines are to be labelled,
 handled, 15 coloured, and compounded as part of dispensing gener- ally or in relation to a particular medicine or specified persons or classes of persons: regulating the conditions in which dispensing may take place, including limiting dispensing to, or restricting or 20 prohibiting dispensing from being undertaken in, cer- tain conditions (for example, requiring dispensing to take place in properly ventilated conditions): regulating appliances associated with dispensing medicines: 25 (22) Automated
 dispensing machines regulating the use of automated dispensing machines (including, without limitation, imposing conditions on the way automated dispensing machines are used): (23) providing for certain persons or classes of persons who 30 (24) (25) may use automated dispensing machines: regulating the areas or places from which medicines may be dispensed from automated dispensing ma- including limiting dispensing by automated chines, dispensing machines to, or restricting or prohibiting 35 dispensing by automated dispensing machines from, certain places or areas: regulating the conditions in which dispensing by auto- mated machine may take place, including limiting dis- 312 Therapeutic Products and Medicines Bill Part 7 cl 499 pensing by automated dispensing machine to, or re- stricting or prohibiting dispensing by automated dis- pensing machine from being undertaken in, certain con- ditions: (26) (27) (28) 5 Prescribers and prescribing requiring prescribers and veterinarians to comply with the qualification, training, and competence require- ments that may be prescribed under section 503: requiring prescribers to provide specified information about the issuing of prescriptions to any specified indi- 10 vidual: limiting, restricting, or imposing conditions on pre- scribers and veterinarians prescribing prescription medicines generally or in relation to a class of pre- scribers or veterinarians: 15 (29) prescribing the circumstances in which prescribers and
 veterinarians may prescribe prescription medicines: (30) Prescriptions regulating or restricting the issuing of prescriptions (generally or in relation to a specific class of prescribers 20 or veterinarians or in specific circumstances): (31) prescribing the form of prescriptions and the manner in which prescriptions may be issued (for example, in electronic form): (32) prohibiting the issuing of prescriptions in a specified 25 manner in certain or all circumstances (for example, prohibiting the issuing of
 prescriptions via the Internet): (33) prescribing the nature of certain matters or particular information which must be contained in prescriptions: (34) prescribing situations or scenarios (including, but not 30 limited to, emergencies) when certain prescription medicines may be supplied without a prescription: imposing conditions on the prescription of medicines generally: (35) (36) waiving the requirement for any person or class of per- 35 sons to comply with requirements relating to prescrib- ing: 313 Part 7 cl 499 Therapeutic Products and Medicines Bill (37) (38) Administering medicines authorising persons or classes of persons to administer prescription medicines: limiting, restricting, or imposing conditions on— (a) (b) administering medicines; and persons or classes of persons administering medicines: 5 (39) prescribing the conditions or circumstances in which medicines may or may not be administered (including, without limitation, limiting administering to, or restrict- 10 ing administering from being undertaken in certain cir- cumstances): (40) (41) Possessing medicines authorising persons or classes of persons to possess pre- scription medicines: limiting, restricting, or imposing conditions on— (a) (b) classes of persons possessing possessing medicines; and persons or medicines: Storing, safekeeping of, transporting, and handling medicines 15 20 (42) providing for the manner of, or limiting, restricting, or imposing conditions on, the storing, handling, and
 safe- keeping of medicines (including, without limitation, in relation to the storage or handling of medicines when 25 undertaking an activity under Parts 6 and 7): regulating appliances and vehicles associated with the supply and storage of medicines: (43) (44) providing for the notification of any suspected contam- (45) (46) ination of medicines sustained in the course of storage 30 or transportation: regulating the construction, sanitation, and use of premises in which medicines are stored or supplied and
 the situations in which premises may be used for stor- ing or supplying medicines: requiring persons or classes of persons authorised to dispense or supply medicines to do or refrain from do- ing certain things when dispensing or supplying (for ex- ample, requiring individuals with open lesions to en- 35 314 Therapeutic Products and Medicines Bill Part 7 cl 499 sure that the lesions are appropriately covered during dispensing or supplying): (47) prescribing requirements relating to sanitation, clean- liness, temperature, humidity, or other factors relating to the risk of a medicine deteriorating or becoming 5 contaminated to be followed in relation to premises in which medicines are stored or supplied: (48) prescribing the accommodation (including, without limitation, the amount of space) that must be provided in order to store or supply a medicine: (49) prohibiting the use of premises or a class of premises 10 (50) (51) (52) for the storage or supply of medicines: exempting certain persons or classes of persons from the storage requirements in section 433: limiting, restricting, or imposing conditions on the ways 15 in which persons may handle medicines: requiring persons or classes of persons authorised to store medicines to do or refrain from doing certain things when storing them (for example, requiring indi- viduals with open lesions to ensure that the lesions are 20 appropriately covered): (53) prohibiting the undertaking of activities undertaken under Parts 6 and 7 in the presence of, or where the medicine is exposed to, specified substances (for ex- ample, toxic or noxious substances): 25 Containers and packaging (55) (54) prescribing the form of containers or packages that medicines are to be kept in during any activity under- taken under Parts 6 and 7: requiring or prohibiting the use of certain containers or 30 packages of a specified kind or description for a speci- fied purpose: exempting persons from the container and package re- quirements in section
 435: (56) (57) providing for ascertaining, assessing, notifying, and 35 correcting damage to, or leakage from, containers or packages of medicine: 315 Part 7 cl 499 Therapeutic Products and Medicines Bill Disposal of medicines (58) prescribing the manner in which medicines must be dis- (59) (60) posed of: limiting, restricting, or imposing conditions on the dis- posal of medicines: exempting a person from any requirements relating to disposal: 5 Record keeping and registers (61) prescribing the form and manner of records to be kept when undertaking any activity under Parts 6 and 7: 10 (62) prescribing the period for which records relating to any activity undertaken under Parts 6 and 7 must be kept: (63) prescribing the method of keeping records or registers for the purposes of Parts 6 and 7 and the persons or classes of persons by whom they must be kept: exempting persons or classes of persons from record- keeping obligations: (64) 15 (65) Supply of information requiring persons or classes of persons engaged in sup- plying, dispensing, using, or administering medicines 20 as part of those persons’ profession, trade, or occupa- tion (whether paid or unpaid) to provide specified in- formation in respect of those activities in any specified form to any specified person in the circumstances the regulations or the specified person requires: 25 (66) Standing orders regulating the issuing, format, and content of standing orders: (67) prescribing obligations or conditions
 with which a per- son issuing a standing order must comply when issuing 30 a standing order or at a later time: (68) prescribing obligations or conditions with which a per- son acting under a standing order must comply when supplying or administering a medicine under a standing order: imposing conditions, limits, requirements, or restric- tions on the contents and use of standing orders: (69) 35 316 Therapeutic Products and Medicines Bill Part 7 cl 499 (70) providing for the nature and extent of any
 review of standing orders: (71) Dependency requiring a prescriber who has an individual under his or her care whom the prescriber considers or has reason- 5 able grounds to suspect is dependent on any medicine to provide such particulars as may be specified: (72) prohibiting, regulating, or restricting the issuing of pre- scriptions and the supply of medicines to dependent per- sons: 10 Licences (73) prescribing the particulars, documents, or other mater- ials that are to accompany an application for a licence: (74) prescribing qualifications and conditions to be imposed on licences, including, without limitation, conditions 15 restricting the licence holder from undertaking speci- fied activities or using any specified process under the licence and a condition allowing (in certain specified circumstances) matters otherwise prohibited by the li- cence: 20 (75) providing for the custody, production, suspension, or revocation of licences: (76) prescribing the days on which persons may inspect registers held by the licensing authority: (77) prescribing, in the case of the register of licences held 25 by the licensing authority, the days and times on which the register may be inspected: (78) prescribing circumstances in which the licensing authority is not required to comply with section 400(1)(b) when issuing a licence to supply pharmacy 30 medicines other than by wholesale: (79) Advisory or technical committees regulating procedures for advisory or technical commit-
 tees appointed under Parts 6 and 7: Analysis 35 (80) prescribing the form of a certificate of analysis and the method of analysis that must be used in analysing a sam- ple: 317 Part 7 cl 499 Therapeutic Products and Medicines Bill Fees (81) prescribing fees payable under Parts 6 and 7 (includ- ing, without limitation, fees for applying for a licence), which may include prescribing fees based on a scale or formula, or at a rate determined on an hourly or other 5 unit basis: (82) providing for the waiver of
 fees payable under Parts 6 and 7, wholly or in part, in a particular case or class of cases, or providing for the Director-General to waive or refund fees, wholly or in part, in a particular case or 10 class of cases and criteria that the Director-General must take into account when considering whether to waive or refund fees: (83) providing for the total or partial refund of fees in a par- ticular case or class of cases: 15 Offences (84) prescribing offences for which a person is liable, on summary conviction, for contravention of, or non-com- pliance with, the regulations: (85) prescribing the level of fine that may be imposed in re- 20 spect of an offence referred to in paragraph (84) that may not exceed $5,000: (86) Exemptions exempting persons or classes of persons or exempting medicines from any limitation, requirement, or condi- 25 tion imposed by the regulations: Enforcement (87) prescribing the form of a search warrant issued under (88) Parts 6 and 7: regulating and controlling the exercise of powers by 30 medicines control officers: General (89) providing for such other matters as are contemplated by, or necessary for giving full effect to, Parts 6 and 7 or their due administration.
35 Regulations made under this section may— (a) apply to medicines generally or to a particular class or description of medicines specified or described in the (3) 318 Therapeutic Products and Medicines Bill Part 7 cl 500 (b) (c) (d) regulations, and may make different provision for dif- ferent classes or descriptions of medicines: apply to an activity generally or to an activity under- taken in specified circumstances: relate to any description or kind of substances or articles 5 specified by their name, or to any class of substances or articles identified: identify any medicine by reference to its name, phar- macological action, or the use or purpose for which it is used or intended to be used.
10 (4) An Order in Council made under subsection (1) is a regula- tion for the purposes of the Acts and Regulations Publication Act 1989 and the Regulations (Disallowance) Act 1989.
Compare: 1981 No 118 s 105(1), (2) Regulations designating designated prescribers 15 500 Regulations designating health practitioners as designated (1) (2) prescribers The Governor-General may, by Order in Council, made on the recommendation of the Minister tendered after consultation with organisations or bodies that appear to the Minister to rep- 20 resent persons likely to be substantially affected, make regu- lations— (a) designating a class of registered health practitioners as designated prescribers: imposing conditions, limits, requirements, and restric- 25 tions on who may be a designated prescriber.
(b) The Minister may recommend that regulations be made under subsection (1)(a) only if, after consultation with any organ- isation that in the Minister’s opinion has an interest in the rec- ommendation, the Minister is satisfied that it is in the public in- 30 terest (including, without limitation, interests in public health and safety) that the group of health practitioners become des- ignated prescribers.
(3) An Order in Council made under subsection (1) is a regula- tion for the purposes of the Acts and Regulations Publication 35 Act 1989 and the Regulations (Disallowance) Act 1989.
319 Part 7 cl 501 Therapeutic Products and Medicines Bill Regulations relating to prescribing notices 501 Regulations relating to prescribing notices and (1) prescription medicines that designated prescribers may prescribe The Governor-General may, by Order in Council, made on the 5 recommendation of the Minister after he or she has undertaken the steps set out in Schedule 4 and established a belief that there is a risk to public health and safety, make regulations doing all or any of the following: (a) revoking a prescribing notice that relates to a particular 10 class of designated prescribers: prescribing the prescription medicine or class or de- scription of prescription medicines that designated pre- scribers registered with the prescribing authority may prescribe: prescribing the circumstances in which those prescrip- tion medicines may be prescribed: prescribing any conditions or restrictions on the circum- stances in which any designated prescriber registered with the prescribing authority may prescribe any pre- 20 scription medicines listed: prohibiting the prescribing of certain prescription medicines in certain circumstances.
15 (b) (c) (d) (e) (2) A prescription medicine included in a regulation made under subsection (1) must relate directly to the scope of practice of 25 the designated prescribers authorised to prescribe it.

(3) An Order in Council made under subsection (1) is a regula- tion for the purposes of the Acts and Regulations Publication Act 1989 and the Regulations (Disallowance) Act 1989.
Regulations designating authorised prescribers 30 502 Regulations designating health practitioners as authorised prescribers The Governor-General may, by Order in Council, made on the recommendation of the Minister tendered after consultation with organisations or bodies that appear to the Minister to rep- 35 resent persons likely to be substantially affected, make regu- (1) 320 Therapeutic Products and Medicines Bill Part 7 cl 503 lations designating a class of health practitioners to be author- ised prescribers for the purposes of Parts 6 and 7.
(3) (2) An Order in Council may only be made under subsection (1) if it relates to a class of health practitioners who, immediately before the Order in Council comes into force, are designated 5 prescribers.
The Minister may recommend that an Order in Council be made under subsection (1) only if, after consultation with any organisation that, in the Minister’s opinion, has an inter- est in the recommendation, the Minister is satisfied of the fol- 10 lowing matters: (a) that it is in the public interest (including, without limita- tion, interests in public health and safety) that the group of health practitioners become authorised prescribers: that the health practitioners are currently designated 15 prescribers.
(b) (4) An Order in Council made under subsection (1) is a regula- tion for the purposes of the Acts and Regulations Publication Act 1989 and the Regulations (Disallowance) Act 1989.
Regulations relating to qualifications, training, and competence of prescribers and veterinarians when prescribing 20 25 (2) (1) 503 Regulations relating to qualifications, training, and competence of prescribers and veterinarians when prescribing For the purposes of this section,— health authority includes the Veterinary Council prescriber includes a veterinarian.
The Governor-General may, by Order in Council, make regu- lations requiring any prescriber or class of prescribers (includ- 30 ing, without limitation, authorised or designated prescribers) to do any of the following in order to be eligible to prescribe prescription medicines, or a class or description of prescrip- tion medicines, for the first time: (a) obtain a specified qualification or a qualification speci- 35 fied by notice in the Gazette by— (i) the Minister; or 321 Part 7 cl 503 Therapeutic Products and Medicines Bill (b) (c) the relevant health authority: the Minister; or the relevant health authority: (ii) undertake specified training or training specified by no- tice in the Gazette by— (i) (ii) demonstrate to the satisfaction of the prescriber’s health authority that he or she is sufficiently knowledgeable to safely prescribe prescription medicines or a specified class of prescription medicines.
5 (3) The Governor-General may, by Order in Council, make regu- 10 lations— (a) 15 (ii) requiring a prescriber, or class of prescribers, to under- take the following at any time: (i) specified training (including training on an on- going basis); or training specified by notice in the Gazette by— (A) (B) the Minister; or the prescriber’s health authority (including training on an ongoing basis); and requiring a prescriber, or class of prescribers, to be 20 assessed (including, without limitation, assessment at regular intervals) in relation to the prescriber’s compe- tence at prescribing prescription medicines of a specific class or description; and requiring a prescriber, or class of prescribers, to pre- 25 scribe prescription medicines under the supervision of a health practitioner or specified class of health practi- tioners; and prohibiting a prescriber who fails to comply with any of the requirements imposed by, or regulations made 30 under, paragraphs (a) to (c) from prescribing pre- scription medicines or prescription medicines of any specified class or description.
(b) (c) (d) (4) An Order in Council made under subsection (2) or (3) is a regulation for the purposes of the Acts and Regulations Publi- 35 cation Act 1989 and the Regulations (Disallowance) Act 1989.
Compare: 1981 No 118 ss 105A, 105B 322 Therapeutic Products and Medicines Bill Part 7 cl 505 Regulations relating to pharmacy ownership and operation 504 Orders in Council providing for exemption from, or (1) (2) modifications of, restrictions on pharmacy ownership and operation The Governor-General may, by Order in Council made on the recommendation of the Minister, make regulations— (a) exempting any person (including a person who is not an individual) or class of person from any of the require- ments of section 422(1)(a) or 423(1)(a): (b) modifying the application of the provisions of section 422(1)(a) or 423(1)(a) in respect of any person or class of person.
5 10 The Minister must not recommend the making of any Order in Council under subsection (1) unless, in the opinion of the 15 Minister,— (a) health services or access to those services will be im- proved by the making of that Order in Council; and the making of that Order in Council is necessary to meet the needs of the community in the particular location of 20 the pharmacy or proposed pharmacy.
(b) (3) The Minister’s reasons for making the recommendation must be included in, or appended to, the Order in Council.

(4) An Order in Council made under subsection (1) is a regula- tion for the purposes of the Acts and Regulations Publication 25 Act 1989 and the Regulations (Disallowance) Act 1989.
Compare: 1981 No 118 s 105C Approval and appointments relating to laboratories and analysts 505 Minister may approve laboratory (1) The Minister may, by notice in the Gazette, approve a labora- tory for any of the purposes of Parts 6 and 7.

30 (2) An approval given under subsection (1) may be on any terms and conditions the Minister thinks fit to specify in the notice.
323 Part 7 cl 506 Therapeutic Products and Medicines Bill (3) A notice issued under this section is deemed to be a regulation for the purposes of the Acts and Regulations Publication Act 1989 and the Regulations (Disallowance) Act 1989.

Compare: 1981 No 118 s 2 506 Minister may appoint analyst in charge (1) The Minister may, by notice in the Gazette, appoint an analyst in charge of an approved laboratory.
5 (2) A notice issued under this section is deemed to be a regulation for the purposes of the Acts and Regulations Publication Act 1989 and the Regulations (Disallowance) Act 1989.

Compare: 1981 No 118 s 2 10 507 Analyst in charge may authorise analyst (1) An analyst appointed by the Minister as an analyst in charge of an approved laboratory under section 506(1) may authorise a person to act as an analyst for the purposes of Parts 6 and 7.
15 (2) A person authorised to act as an analyst under subsection (1) may be authorised generally or in relation to a specific matter.

Compare: 1981 No 118 s 2 Appointment of advisory and technical committees 508 Advisory and technical committees (1) The Minister may appoint an advisory or technical committee to advise him or her in relation to any matter dealt with in Parts 6 and 7 or the regulations.
The Minister— (a) may determine the functions of any committee ap- (2) 20 25 pointed under subsection (1); and (b) must provide the committee with staff, accommodation, services, and other facilities that he or she considers ne- cessary or expedient for the performance of those func- 30 tions.

(3) A committee appointed under subsection (1) may determine its own procedure, but must do so in accordance with any rele- vant provisions of Parts 6 and 7 and the regulations.
324 Therapeutic Products and Medicines Bill Part 7 cl 511 (4) Members of a committee appointed under subsection (1) may be paid remuneration by way of fees, salaries, travelling allowances and expenses, and other allowances under the Fees and Travelling Allowances Act 1951, and the provisions of that Act apply as if a member of the committee were a mem- 5 ber of a Statutory Board within the meaning of that Act.
Compare: 1981 No 118 ss 8, 14 Certain powers of Director-General 509 Statement of Director-General (1) The Director-General may, for the purpose of protecting the 10 public, publish statements relating to any activities undertaken with medicines under Parts 6 and 7.

(2) A statement published under this section is protected by qual- ified privilege.
Compare: 1981 No 118 s 98 510 Director-General may authorise Medical Officer of Health to issue notices and statements The Director-General may authorise, by notice in the Gazette, a Medical Officer of Health to issue— (a) (b) restriction notices; or statements relating to dependency.
Subpart 10—Scheduled medicines and referring to medicines Scheduled medicines (1) 511 Standard for Uniform Scheduling of Medicines and Poisons or SUSMP The Standard for the Uniform Scheduling of Medicines and Poisons or SUSMP means the electronic register contain- ing the Managing Director’s listings of scheduled medicines and poisons and includes any additions to that register.

(2) Many of the matters associated with the maintaining of, and access to, the SUSMP are dealt with in the Rules.
325 15 20 25 30 Part 7 cl 512 Therapeutic Products and Medicines Bill (3) To avoid doubt, the SUSMP is not a regulation for the pur- poses of the Acts and Regulations Publication Act 1989 or the Regulations (Disallowance) Act 1989.
512 Scheduled medicines (1) A medicine is a prescription medicine if— 5 (a) (b) it is listed as a prescription medicine in Schedule 4 of the SUSMP and the Minister has not departed from the Managing Director’s listing by notice in the Gazette is- sued under section 514; or the Minister declares the medicine to be a prescription 10 medicine by notice in the Gazette issued under section 513.
(2) A medicine is a pharmacist-only medicine if— (a) (b) it is listed as a pharmacist-only medicine in Schedule 3 of the SUSMP and the Minister has not departed from 15 the Managing Director’s listing by notice in the Gazette issued under section 514; or the Minister declares the medicine to be a pharmacist- only medicine by notice in the Gazette issued under section 513.
20 (3) A medicine is a pharmacy medicine if— (a) (b) it is listed as a pharmacy medicine in Schedule 2 of the SUSMP and the Minister has not departed from the Managing Director’s listing by notice in the Gazette is- sued under section 514; or the Minister declares the medicine to be a pharmacy medicine by notice in the Gazette issued under section 513.
25 513 Ministerial notice declaring scheduled medicine (1) The Minister may, by notice in the Gazette, declare any 30 medicine to be a— (a) (b) (c) The Minister must specify, in the notice, the date on which the 35 declaration takes effect.

prescription medicine; or pharmacist-only medicine; or pharmacy medicine.
(2) 326 Therapeutic Products and Medicines Bill Part 7 cl 516 514 Ministerial notice departing from managing director’s (1) (2) (3) listing The Minister may, by notice in the Gazette, depart from the listing of a scheduled medicine in the SUSMP by declaring that— (a) a specified medicine is not a scheduled medicine of the kind listed by the Managing Director but is a scheduled medicine of another kind; or a specified medicine is not a scheduled medicine of any kind.
(b) 5 10 The Minister must specify, in the notice, the date on which the departure takes effect.

To avoid doubt,— (a) the Minister’s departure overrides the Managing Dir- ector’s listing of a scheduled medicine in the SUSMP; 15 and once the Minister’s departure takes effect, the Man- aging Director’s listing ceases to have any effect for the purposes of Parts 6 and 7.
(b) 515 Director-General to keep Internet register of declarations 20 (1) (2) and departures The Director-General must keep a register of declarations and departures of scheduled medicines made under sections 513 and 514.

The register must— (a) be on the Internet in an electronic form that is publicly accessible at all reasonable times; and list the date on which all declarations and departures have effect.
(b) 516 Evidence of SUSMP (1) The Authority must, on request and on payment of the relevant fee, provide a certified printout of the SUSMP or any extract from it.

It is presumed, unless the contrary is proved, that a certified printout of the SUSMP, or an extract from it, is prima facie 35 evidence of the matters contained within it.
(2) 25 30 327 Part 7 cl 517 Therapeutic Products and Medicines Bill Referring to medicines 517 How to refer to or specify medicines An individual, person, or body required by Parts 6 and 7 to refer to or specify a particular medicine or class of medicines (for example, being required to specify prescription medicines 5 in a prescribing notice, or scheduled medicines in an applica- tion for a licence) may specify the medicine by reference to— (a) (b) its name or trade name; or its pharmacological action.
Subpart 11—Miscellaneous matters Relationship to other enactments 10 518 Relationship with Misuse of Drugs Act 1975 (1) If a medicine is also a controlled drug, the prohibitions, condi- tions, and requirements contained in or imposed under Parts 6 and 7 are in addition to the prohibitions, conditions, and re- 15 quirements contained in or imposed under the Misuse of Drugs Act 1975.
(2) Nothing in section 8 of the Misuse of Drugs Act 1975 (which provides for exemptions from sections 6 and 7 of that Act) authorises any person to undertake any activity in relation to a 20 medicine contrary to Parts 6 and 7.
(3) A person who is authorised by a licence issued under the Mis- use of Drugs Act 1975 to supply a controlled drug by whole- sale, and that controlled drug is also a scheduled medicine, is deemed to be licensed under Parts 6 and 7 to have a licence 25 to supply that scheduled medicine by wholesale as a fixed ven- dor.
(4) A person who is authorised by a licence issued under the Mis- use of Drugs Act 1975 to supply a controlled drug by retail, and that controlled drug is also a scheduled medicine, is deemed 30 to be licensed under Parts 6 and 7 to have a licence to sup- ply that scheduled medicine other than by wholesale.
(5) A person who is deemed to have a licence to carry on an ac- tivity in relation to a controlled drug that is also a prescription medicine is also deemed to have a reasonable excuse to be in 35 328 Therapeutic Products and Medicines Bill Part 7 cl 519 (6) (7) possession of that prescription medicine for the purposes of section 382(1)(a).

Except as specified in subsections (1) to (5), the Misuse of Drugs Act 1975 overrides Parts 6 and 7.
The provisions of the Misuse of Drugs Act 1975 and any regu- 5 lations made under that Act must prevail in the event of any inconsistency between— (a) the provisions of the Misuse of Drugs Act 1975 and the provisions of Parts 6 and 7; and the provisions of any regulations made under the Mis- 10 use of Drugs Act 1975 and the provisions of any regu- lations made under Parts 6 and 7.
(b) Compare: 1981 No 118 s 109 Transitional regime for designated prescribers 519 Designated prescriber under former Act deemed to be 15 (1) designated prescriber Every registered health practitioner who was a designated pre- scriber under the former Act is deemed to be a designated pre- scriber for the purposes of Parts 6 and 7.
(2) On the commencement of this section, the prescribing author- 20 ity with which a designated prescriber of the kind referred to in subsection (1) is registered is deemed until the date that is 12 months from the commencement of this section to have authorised (as if by prescribing notice under section 373) the designated prescribers registered with it to prescribe the pre- 25 scription medicines listed in the schedules of the following en- actments: (a) in the case of nurse practitioners deemed to be desig- nated prescribers under subsection (1), the prescrip- tion medicines listed in the Schedule of the Medicines 30 (Designated Prescriber: Nurse Practitioners) Regula- tions 2005; and in the case of optometrists deemed to be designated prescribers under subsection (1), the prescription medicines listed in the Schedule of the Medicines (Des- 35 ignated Prescriber: Optometrists) Regulations 2005.
(b) 329 Part 7 cl 520 Therapeutic Products and Medicines Bill (3) A prescribing authority of the kind referred to in subsection (2)— (a) may, until the date that is 12 months from the com- mencement of this section, amend the deemed prescrib- ing notice in accordance with Parts 6 and 7; and (b) must, on the date that is 12 months from the commence- ment of this section, comply with section 373 by issu- ing a prescribing notice.
5 (4) To avoid doubt, sections 374 and 375 apply to a deemed prescribing notice under this section.

10 Transitional regime for standing orders 520 Standing orders issued under former Act On the commencement of this section, any standing order is- sued under the former Act that is in force is deemed to be a standing order issued under section 358 or 381.
15 Transitional regime for licences 521 Application for licence to sell medicines by wholesale (1) (2) (3) under former Act Subsection (2) applies to an application for a licence to sell medicines by wholesale made, but not determined or with- 20 drawn, before the commencement of this section.
If this subsection applies, the licensing authority may consider the application and treat it in all respects as if it were an appli- cation for a licence to supply scheduled medicines by whole- sale from fixed premises made under Parts 6 and 7.

The licensing authority may, in considering the application, require the applicant to provide further information necessary to enable the licensing authority to determine whether or not to grant the licence under Parts 6 and 7.
25 (4) Nothing in subsection (1) or (2) applies to the application or 30 any part of the application if it relates to a licence to supply a non-scheduled medicine by wholesale.

If the application or part of the application is for a licence to supply a non-scheduled medicine other than by wholesale, that (5) 330 Therapeutic Products and Medicines Bill Part 7 cl 523 application or that part lapses on the commencement of this section.
522 Licence to sell any medicine by wholesale granted under (1) (2) (3) former Act If, on the commencement of this section, a person holds a li- 5 cence to sell any medicine by wholesale granted under the for- mer Act,— (a) that licence is deemed (until its expiry) to be a licence to supply the scheduled medicines specified in the licence by wholesale from fixed premises granted under Parts 10 6 and 7; and that person need not apply for a superseding licence until the existing licence expires.
(b) If a licence or part of a licence of the kind referred to in sub- section (1) relates to a medicine or matter that is not dealt 15 with by or under Parts 6 and 7, that licence or that part lapses on the commencement of this section.

To avoid doubt, subsection (1) does not apply to a licence or part of a licence to manufacture medicines, or pack or label medicines, granted under the former Act, that does not also 20 relate to the wholesaling of a medicine.
523 Application for licence to sell any medicine by retail (1) (2) (3) under former Act Subsection (2) applies to an application for a licence to sell medicine by retail made, but not determined or withdrawn, 25 before the commencement of this section.

If this subsection applies, the licensing authority may consider the application and treat it in all respects as if it were an appli- cation for a licence to supply pharmacy medicines other than by wholesale made under Parts 6 and 7.
The licensing authority may, in considering the application, require the applicant to provide further information necessary to enable the licensing authority to determine whether or not to grant the licence under Parts 6 and 7.
30 (4) Nothing in subsection (1) or (2) applies to the application or 35 any part of the application if it relates to a licence to sell— 331 Part 7 cl 524 Therapeutic Products and Medicines Bill (a) (b) a non-scheduled medicine by retail; or a scheduled medicine by retail other than a pharmacy medicine.
(5) If the application or part of the application is for a licence to sell a non-scheduled medicine or a scheduled medicine other 5 than a pharmacy medicine by retail, that application or that part lapses on the commencement of this section.
524 Licence to sell medicines by retail granted under former (1) (2) Act If a person holds, on the commencement of this section, a li- 10 cence to sell any medicine by retail granted under the former Act,— (a) that licence is deemed (until its expiry) to be a licence to supply the pharmacy medicines specified in the licence other than by wholesale under Parts 6 and 7; and that person need not apply for a superseding licence until the existing licence expires.
(b) 15 If a licence or part of a licence of the kind referred to in sub- section (1) relates to a medicine or a matter that is not dealt with by or under Parts 6 and 7, that licence or that part lapses 20 on the commencement of this section.

525 Application for licence to hawk medicines under former regulations Subsection (2) applies to an application for a licence to hawk medicines made, but not determined or withdrawn, before the 25 commencement of this section.
If this subsection applies, the licensing authority may con- sider the application and treat the application in all respects as if it were an application for a licence to supply scheduled medicines by wholesale as a mobile vendor made under Parts 30 6 and 7.

The licensing authority may, in considering the application, require the applicant to provide further information necessary to enable the licensing authority to determine whether or not to grant the licence under Parts 6 and 7.
35 (1) (2) (3) 332 Therapeutic Products and Medicines Bill Part 7 cl 527 (4) Nothing in subsection (1) or (2) applies if the application or any part of the application is for a licence to hawk a non- scheduled medicine.

If the application or any part of the application is an application for a licence to hawk a non-scheduled medicine, that applica- 5 tion or that part lapses on the commencement of this section.
(5) 526 Licence to hawk medicines granted under former (1) regulations If a person holds, on the commencement of this section, a licence to hawk medicines granted under the former regula- 10 tions,— (a) that licence is deemed (until its expiry) to be a licence to supply by wholesale as a mobile vendor the scheduled medicines specified in the licence granted under Parts 6 and 7; and that person need not apply for a superseding licence until the existing licence expires.
(b) 15 (2) If the licence or a part of the licence of the kind referred to in subsection (1) relates to a medicine or a matter that is not dealt with by or under Parts 6 and 7, the licence or that part 20 of the licence lapses on the commencement of this section.

527 Application for licence to operate pharmacy under (1) (2) (3) former Act Subsection (2) applies to an application for a licence to op- erate a pharmacy made, but not determined or withdrawn, be- 25 fore the commencement of this section.
If this subsection applies, the licensing authority may consider the application and treat it in all respects as if it were an appli- cation to operate a pharmacy made under Parts 6 and 7.

The licensing authority may, in considering the application, 30 require the applicant to provide further information necessary to enable the licensing authority to determine whether or not to grant a licence to operate a pharmacy under Parts 6 and 7.
333 Part 7 cl 528 Therapeutic Products and Medicines Bill 528 Licence to operate pharmacy granted under former Act (1) If a person holds, on the commencement of this section, a li- cence to operate a pharmacy granted under the former Act,— the licence is deemed (until its expiry) to be a licence to (a) operate a pharmacy granted under Parts 6 and 7; and that person need not apply for a superseding licence until the existing licence expires.
(b) 5 (2) If a licence or a part of a licence of the kind referred to in subsection (1) relates to a medicine or a matter that is not dealt with by or under Parts 6 and 7, the licence or that part 10 of the licence lapses on the commencement of this section.

529 Other licences granted under former Act (1) A licence granted under the former Act of a kind other than a kind provided for in sections 521 to 528 is not deemed to be a licence for the purposes of Parts 6 and 7.
(2) However, it may be deemed to be a licence under Parts 1 to 5.

(3) This section is by way of explanation only.

530 Condition on deemed licence (1) Every licence deemed to be a licence for the purposes of Parts 6 and 7 under any of sections 521 to 528— (a) remains subject to any condition imposed on the licence by or under the former Act or former regulations; and becomes subject to the condition in section 407(1); and all provisions of Parts 6 and 7 and the regulations 25 apply to the licence.
(b) (c) (2) The licensing authority must, within a reasonable time after the commencement of this section, provide to each holder of a deemed licence under Parts 6 and 7 written notice of the condition in section 407(1).

30 (3) Despite subsection (2), a person is subject to the condition in section 407(1) on the commencement of this section.
334 15 20 Therapeutic Products and Medicines Bill Part 7 cl 533 Transitional regime for proceedings and appeals under former Act 531 Proceedings commenced under former Act Any proceedings that, on the commencement of this section, have commenced but have not been completed under the for- 5 mer Act or former regulations must be continued and com- pleted in all respects as if the former Act or former regulations had not been repealed.
532 Appeal from decision under former Act Any appeal from a decision made under the former Act 10 (whether lodged before, on, or after the commencement of this section) that relates to a matter dealt with under Parts 6 and 7 must be dealt with in all respects under the former Act as if the former Act had not been repealed.
Transitional regime for officers under former Act 15 533 Officers appointed under former Act (1) On the commencement of this section, any person appointed under section 15(1) of the former Act remains an employee of the Ministry for the time being responsible for the administra- tion of Parts 6 and 7.
For the purposes of every enactment, law, contract, and agree- ment relating to the employment of the employee,— (a) (2) (b) the contract of employment of that officer is taken to be unbroken; and the officer’s period of service and every other period of 25 service of that officer that is recognised as continuous service is taken to have been a period of service.
20 (4) (3) A person to whom subsection (1) applies is not entitled to any compensation just because the person has ceased to be an officer under the former Act.

To avoid doubt, a person deemed under subsection (1) to be an employee of the Ministry for the time being responsible for the administration of Parts 6 and 7 is not a medicines control officer for the purposes of Parts 6 and 7, unless he or she is appointed as a medicines control officer under section 445.
30 35 335 Part 7 cl 534 Therapeutic Products and Medicines Bill 534 No compensation for loss of office or appointment The Crown is not liable to make payment to, or otherwise com- pensate, any person who ceases to hold an office or appoint- ment (including, without limitation, an appointment to a com- mittee) under the former Act.
5 Transitional regime for xenotransplantation 535 Xenotransplantation An authorisation issued by the Minister under section 96C of the former Act is to be treated as if it is an authorisation issued under section 489 and may be amended accordingly.
10 Transitional regime for approved laboratory and analyst under former Act 536 Approved laboratory under former Act On the commencement of this section, any laboratory ap- proved under the former Act is deemed to be an approved 15 laboratory for the purposes of Parts 6 and 7.

537 Analyst in charge under former Act (1) On the commencement of this section, any person who is an analyst in charge under the former Act is deemed to be an analyst in charge for the purposes of Parts 6 and 7.
(2) On the commencement of this section, any person who is au- thorised by an analyst in charge to be an analyst under the for- mer Act is deemed to be an analyst under Parts 6 and 7.

Repeal 538 Repeal The Medicines Act 1981 (1981 No 118) is repealed.
20 25 539 Transitional and savings regulations Despite section 538, the Governor-General may from time to time, by Order in Council, make regulations— (a) prescribing transitional and savings provisions concern- 30 ing the coming into force of Parts 6 and 7, which may 336 Therapeutic Products and Medicines Bill Part 7 cl 543 (b) be in addition to, or in place of, the transitional and sav- ings provisions in this subpart: providing that, subject to such conditions as may be spe- cified in the regulations, during a specified transitional period,— (i) 5 specified provisions of Parts 6 and 7 (including definitions) do not apply: specified terms have the meanings given to them by the regulations: specified provisions of the former Act or former 10 regulations that have been repealed or revoked by Parts 6 and 7 are to continue to apply.
(ii) (iii) 540 Expiry of section 539 Section 539 expires on the date that is 2 years from the date of the commencement of that section.

15 541 Revocations Revocations The regulations and orders specified in Schedule 7 are re- voked.

Savings 542 Validity of actions under former Act and regulations not affected The repeal of the former Act and the revocation of the regula- tions listed in Schedule 7 do not affect the validity or effect of anything done under the former Act or those regulations.
20 25 543 Medicines (Approved Laboratories and Analysts in Charge) Notice 2000 saved Despite the repeal of the former Act under section 538, the Medicines (Approved Laboratories and Analysts in Charge) Notice 2000 (SR 2000/173) continues until revoked as if it had 30 been made under sections 505 and 506 and may be amended accordingly.
337 Part 7 cl 544 Therapeutic Products and Medicines Bill 544 Medicines (Standing Order) Regulations 2002 saved Despite the repeal of the former Act under section 538, the Medicines (Standing Order) Regulations 2002 (SR 2002/373) continue until revoked as if they had been made under Parts 6 and 7 and may be amended accordingly.
5 545 Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 saved Despite the repeal of the former Act under section 538, the Medicines (Designated Prescriber: Nurse Practitioners) Regu- lations 2005 (SR 2005/266) are saved and deemed until re- 10 voked to be regulations made under section 503 and may be amended accordingly.
546 Medicines (Designated Prescriber: Optometrists) Regulations 2005 saved Despite the repeal of the former Act under section 538, the 15 Medicines (Designated Prescriber: Optometrists) Regulations 2005 (SR 2005/256) are saved and deemed until revoked to be regulations made under section 503 and may be amended accordingly.
547 Orders in Council made under section 96D(1) of former 20 Act saved Despite the repeal of the former Act under section 538, any Order in Council made under section 96D(1) of the former Act continues in force as if it has been made under section 490 and may be amended accordingly.

25 Consequential amendments 548 Consequential amendments The enactments specified in Schedule 8 are amended in the manner indicated in that schedule.
338 Therapeutic Products and Medicines Bill Schedule 1 Schedule 1 Text of Agreement s 5 5 Agreement between the Government of New Zealand and the Government of Australia for the establishment of a joint scheme for the regulation of therapeutic products The Government of New Zealand and the Government of Australia (referred to in this Agreement as “the Parties”): CONSCIOUS of their geographic proximity, long-standing friend- ship, and close historic, political, and economic relationship; RECOGNISING the development of that relationship through the 10 Australia New Zealand Closer Economic Relations Trade Agreement done at Canberra on 28 March 1983, and subsequent arrangements and agreements developed within that framework; NOTING in particular the Arrangement relating to Trans-Tasman Mutual Recognition signed by the Australian Prime Minister, Pre- 15 miers and Chief Ministers on 14 June 1996 and by the New Zealand Prime Minister on 9 July 1996, and the cooperation programme in relation to regulatory requirements for therapeutic products pursued under the auspices of that Arrangement; AWARE that this relationship will be significantly strengthened and 20 that both countries will benefit through the development of a joint Trans-Tasman scheme for the regulation of therapeutic products; ACKNOWLEDGING their commitment to securing trade liberalisa- tion and an outward-looking approach to trade; CONSCIOUS of their obligations under the Agreement establishing 25 the World Trade Organization done at Marrakesh on 15 April 1994; AFFIRMING their shared commitment to safeguarding public health and safety through a regulatory regime consistent with international best practice for the regulation of the quality, safety, and efficacy or performance of therapeutic products; and DESIRING therefore to establish a joint scheme for the regulation of therapeutic products in both New Zealand and Australia, to be ad- ministered by a single world class agency responsible to both Parties; HAVE agreed as follows: 30 ARTICLE 1 Definitions 35
 339 Schedule 1 Therapeutic Products and Medicines Bill For the purposes of this Agreement, unless the context otherwise re- quires: Agency means the agency to be established in accordance with Art- icle 5; Approval means an approval or other authorisation (however de- 5 scribed) granted by the Agency under Article 11; Australian Implementing Legislation means the Acts of the Par- liament of Australia, and any regulations made under them, that give effect to the Scheme; Australian Minister means the Minister of the Government of Aus- 10 tralia who is responsible for the health portfolio or any other Minister acting for or on behalf of such Minister; Board means the board established under Article 6; commencement date means the date on which the Scheme comes into force; Managing Director means the managing director of the Agency ap- pointed under Article 6, and includes an acting managing director; manufacture, in relation to therapeutic products, means: (a) (b) to produce the products; or to engage in any part of the process of producing the prod- 20 ucts or of bringing the products to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the prod- ucts or of any component or ingredient of the products as part of that process; 15 25 merits review means a review of certain decisions taken by the Agency, as provided for in Article 13; Merits Review Panel means the panel referred to in Article 13; Ministerial Council means the council established under Article 4; New Zealand Implementing Legislation means the Acts of the Par- 30 liament of New Zealand, and any regulations made under them, that give effect to the Scheme; New Zealand Minister means the Minister of the Government of New Zealand who is responsible for the health portfolio or any other Minister acting for or on behalf of such Minister; Order means an order made by the Agency under Article 10; 35 340 Therapeutic
 Products and Medicines Bill Schedule 1 Principal Member means a person designated as a Principal Mem- ber of a Review Tribunal under Article 13; promotion includes advertising; regulatory function means: (a) a function of the Agency referred to in any of subparagraphs 5 (a) to (e) of paragraph 2 of Article 5, and any function inci- dental to those functions; any other function of the Agency that the Rules declare to be a regulatory function; and a power exercised in the course of performing a function re- 10 ferred to in paragraphs (a) or (b) of this definition; and a ref- erence to the performance of a regulatory function includes a reference to the exercise of such a power; (b) (c) 15 Review Tribunal means a Trans-Tasman merits review tribunal pro- vided for under Article 13; Rule means a rule made by the Ministerial Council under Article 9; Scheme means the joint scheme described in paragraph 1 of Article 3; supply, in relation to therapeutic products, includes: (a) supply by way of sale, exchange, gift, lease, loan, hire or hire 20 purchase; supply, whether free of charge or otherwise, by way of sample or promotion; supply, whether free of charge or otherwise, in the course of testing for safety, efficacy or performance, of therapeutic prod- 25 ucts in a human; and supply by way of administration to, or application in the treat- ment of, a human; territory means: (a) in relation to Australia, the territory of Australia including the 30 territory of Christmas
 Island and the territory of the Cocos (Keeling) Islands, but does not include any other external ter- ritory of Australia, unless the Parties have exchanged notes agreeing the terms on which this Agreement shall so apply; and in relation to New Zealand, the territory of New Zealand, but does not include Tokelau; 35 (b) (c) (d) (b) 341 Schedule 1 Therapeutic Products and Medicines Bill therapeutic product: (a) means: (i) (ii) (iii) (iv) (ii) (ii) includes: (i) (b) (c) product that is represented in any way
 to be, or that is, whether because of the way in which the product is presented or for any other reason, likely to be taken to 5 be for therapeutic use; an ingredient or component in the manufacture of a product referred to in subsubparagraph (i); a container or part of a container for a product, ingredi- ent or component referred to in subsubparagraphs (i) or 10 (ii); or a product falling within a class of products the sole or principal use of which is, or ordinarily is, a therapeutic use; and a product which the Rules provide shall be treated as a therapeutic product for the purposes of this Agreement; and a product which is declared to be a therapeutic product in an Order made under paragraph 2 of Article 10; but 15 20 does not include: (i) a product which the Rules provide shall not be treated as a therapeutic product for the purposes of this Agree- ment; or a product which is declared not to be a therapeutic prod- 25 uct in an Order made under paragraph 2 of Article 10. therapeutic use: (a) means use in or in connection with: (i) (ii) (iii) (iv) (v) (vi) 30 preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in humans; influencing, inhibiting or modifying a physiological process in humans; testing the susceptibility of humans to a disease or ail- ment; influencing, controlling or preventing conception in hu- 35 mans; testing for pregnancy in humans; or the replacement or modification of parts of the anatomy in humans; and 342 Therapeutic Products and Medicines Bill Schedule 1 (b) (c) includes any other use which the Rules provide shall be treated as a therapeutic use for the purposes of this Agreement; but does not include any use which the Rules provide shall not be treated as a therapeutic use for the purposes of this Agreement.
ARTICLE 2 Objectives of this Agreement 5 1 2 The primary objective of the Parties in concluding this Agree- ment is to safeguard public health and safety in Australia and New Zealand by establishing and maintaining a joint scheme consistent with international best practice for the regulation of 10 the quality, safety, and efficacy or performance of therapeutic products, and of their manufacture, supply, import, export and promotion.
The other objectives of the Parties in concluding this Agree- ment are: (a) 15 to establish a world-class regulatory agency to be re- sponsible for the effective and efficient administration of the Scheme and to be accountable to both Parties; to establish a Ministerial Council to oversee the im- plementation of the Scheme and the operation of the 20 Agency and to perform certain functions to give effect to the Scheme; and to avoid barriers to trade except where such barriers are necessary to safeguard public health or safety, or to fulfil other legitimate objectives consistent with the Parties’ 25 international obligations.
(b) (c) ARTICLE 3 The Scheme 1 The Parties shall adopt a joint scheme for the regulation of the quality, safety, and efficacy or performance of therapeutic 30 products, and in particular for: (a) the regulation of the manufacture, supply, import, ex- port and promotion of therapeutic products; the setting of standards in relation to the quality, safety, and efficacy or performance of therapeutic products and 35 (b) 343 Schedule 1 Therapeutic Products and Medicines Bill their manufacture, supply, import, export and promo- tion; the post-market monitoring of therapeutic products; and the enforcement of the Scheme’s requirements.
(c) (d) Where a Rule requires an Approval in relation to the manu- 5 facture, supply, import, export or promotion of a therapeutic product, each Party shall prohibit the manufacture, supply, im- port, export or promotion of the therapeutic product otherwise than under and in accordance with the required Approval.
Where a Rule prescribes the manner or circumstances in which 10 a therapeutic product is not to be manufactured, supplied, im- ported, exported or promoted, each Party shall prohibit the manufacture, supply, import, export or promotion of the ther- apeutic product in that manner or those circumstances.
Where a Rule or Order prescribes requirements relating to the 15 manufacture, supply, import, export or promotion of a ther- apeutic product, each Party shall prohibit such manufacture, supply, import, export or promotion unless it is carried out in accordance with the Rule or Order.
Each Party shall ensure the effective implementation, oper- 20 ation, maintenance and enforcement of the Scheme in accord- ance with the objectives of this Agreement and, subject to paragraph 4 of Article 11 and to Article 12, shall ensure that its joint nature is maintained.
The Parties shall conduct effective consultation together in re- 25 lation to the legislation to be enacted by each Party to imple- ment the Scheme, and in relation to any amendments to that legislation, with a view to ensuring that it is consistent with and gives effect to the objectives of this Agreement.
Each Party shall ensure that its legislation implementing the 30 Scheme is not amended or repealed in a manner that is incon- 344 Therapeutic Products and Medicines Bill Schedule 1 sistent with this Agreement, or would prejudice the joint na- ture of the Scheme or its effectiveness.
8 9 10 A Party shall not: (a) (b) introduce Government legislation giving effect to para- graphs 4 or 5 of Article 5; or introduce Government amendments to the legislation giving effect to paragraphs 4 or 5 of Article 5; without the written consent of the other Party, which may be withheld only if the other Party: (c) is of the view that the legislation is inconsistent with the 10 requirements of paragraphs 4 or 5 of Article 5; and outlines the nature of its concerns in a diplomatic note.
(d) 5 Each Party shall use its best endeavours to reach agreement with the other Party in relation to any other amendments to the legislation that gives effect to Article 5, including, where 15 relevant, reflecting the position of the other Party in any papers for the Government of that Party.
The Parties shall cooperate closely in relation to mutual recog- nition or other arrangements with third countries that may af- fect the regulation of therapeutic products within their respect- 20 ive territories, with a view to securing outcomes consistent with the Scheme.

ARTICLE 4 The Ministerial Council 1 2 A Ministerial Council comprising the Australian Minister and 25 the New Zealand Minister is hereby established.
The functions of the Ministerial Council are: to oversee the Agency and the Scheme; (a) to ensure accountability in respect of the Agency, and (b) in respect of the operation of the Scheme, to each of the 30 Parties; to make, amend and revoke Rules in accordance with this Agreement to give effect to the Scheme; (c) 345 Schedule 1 Therapeutic Products and Medicines Bill (d) (e) (f) to appoint and remove the members of the Board, in- cluding the Managing Director; to establish expert advisory committees to advise the Managing Director on matters specified in the Rules, and to appoint and remove the members of those com- 5 mittees; and to appoint and remove members of the Merits Review Panel and to designate the Principal Members of the Review Tribunals.
3 4 All decisions of the Ministerial Council shall be made with the 10 agreement of both members of the Council.

Subject to this Agreement, the Ministerial Council shall regu- late its own procedure.

ARTICLE 5 The Agency 15 20 25 The Agency shall be established, and shall be responsible for the administration of the Scheme in the territory of both Par- ties, in accordance with this Agreement.
The function of the Agency shall be to administer the Scheme in the territory of both Parties, and includes: (a) setting standards in relation to the manufacture, supply, import, export and promotion of therapeutic products; considering and determining applications for Ap- provals, and granting, amending, suspending and re- voking Approvals; (b) (c) monitoring, auditing and enforcing compliance with the requirements of the Scheme; (d) monitoring the quality, safety, and efficacy or perform- ance of therapeutic products; (e) making, amending and revoking Orders to give effect 30 (f) to the Scheme; providing information to the public in relation to thera- peutic products; 1 2 346 Therapeutic Products and Medicines Bill Schedule 1 (g) (h) (i) (j) undertaking or commissioning research in relation to the quality, safety, and efficacy or performance of ther- apeutic products; advising the Ministerial Council on matters relating to the administration of the Scheme; monitoring international developments in regulatory excellence regarding therapeutic products and recom- mending enhancements to the Scheme to the Minister- ial Council; and any function incidental to the functions referred to in 10 subparagraphs (a) to (i).
5 The Agency may engage in activities (including performing functions and providing services) that fall outside the scope of the Scheme at the request of either Party on such terms and conditions as may be approved by the Ministerial Council in 15 writing.
The Australian Implementing Legislation shall: (a) establish the Agency as a body corporate, the members of which are the members of the Board; provide that the Agency has the functions specified in 20 paragraph 2; and provide that the Agency may engage in activities speci- fied in accordance with paragraph 3.
(b) (c) The Australian Implementing Legislation and the New Zealand Implementing Legislation shall confer such rights, 25 powers and privileges on the Agency as are required to enable the Agency to perform its regulatory functions.

To avoid doubt, the Agency shall not have international legal personality.
3 4 5 6 ARTICLE 6 The Board 1 A Board is hereby established comprising: (a) the Chair of the Board; 30 347 Schedule 1 Therapeutic Products and Medicines Bill (b) (c) (d) (e) the Managing Director of the Agency; a person with broad experience in relation to public health and regulatory matters in New Zealand; a person with broad experience in relation to public health and regulatory matters in Australia; and a person with broad experience in commercial matters.
5 The Ministerial Council shall appoint the members of the Board.

The Chair of the Board and the Managing Director may only be appointed with the written agreement of both members of the Ministerial Council.

The Ministerial Coun- 10 cil shall seek to reach consensus on the appointment of the other members of the Board.
Notwithstanding paragraph 3 of Article 4, in the event that consensus is not reached, the Ministerial Council: (a) shall appoint the Board member referred to in subpara- 15 graph (c) of paragraph 1 on the recommendation of the New Zealand Minister; shall appoint the Board member referred to in subpara- graph (d) of paragraph 1 on the recommendation of the Australian Minister; and shall appoint the Board member referred to in subpara- graph (e) of paragraph 1 in the manner provided for in the Rules.
20 (b) (c) The appointments to the Board shall be made in accordance with the Rules.

25 The Ministerial Council may remove a member of the Board in the same manner in which that member may be appointed, in accordance with the Rules.
Subject to paragraph 6, the Board shall be responsible to the Ministerial Council for the governance of the Agency, and in 30 particular for: (a) (b) (c) financial matters concerning the Agency; the administration of the Agency; the efficiency and effectiveness with which the Agency performs its functions; 35 2 3 4 5 348 Therapeutic Products and Medicines Bill Schedule 1 (d) (e) the strategic direction of the Agency; and reporting to the Ministerial Council regarding the mat- ters referred to in subparagraphs (a) to (d).
6 The Board shall not be responsible to the Ministerial Council for decisions made by the Managing Director in the perform- 5 ance of the Agency’s regulatory functions.

ARTICLE 7 The Managing Director 1 2 3 The Managing Director shall be the chief executive of the Agency, and as such shall be responsible to the Board for 10 the management of the Agency.
The Managing Director shall manage the Agency under the direction of the Board in rela- tion to the matters for which the Board is responsible under paragraph 5 of Article 6.

The regulatory functions of the Agency shall be performed by 15 the Managing Director on behalf of and in the name of the Agency.
The Managing Director shall not be responsible to the Board for decisions made by the Managing Director in the perform- ance of the Agency’s regulatory functions, and in particular 20 the Board may not give the Managing Director a direction in relation to a particular decision required to perform a regula- tory function.
ARTICLE 8 Accountability of the Agency 25 1 The Parties agree to the following principles: (a) (b) the Agency shall be accountable to the Parties for the performance of its functions; the appropriate level and type of accountability for the Agency is that which would normally apply to a regula- 30 tory agency established by the legislation of each Party; and 349 Schedule 1 Therapeutic Products and Medicines Bill (c) there shall be no unnecessary duplication in account- ability requirements that apply to the Agency.
Accountability requirements that apply to the Agency may be set out in Rules, or in the Parties’ domestic legislation that is applied to the Agency, or in both Rules and the Parties’ 5 domestic legislation that is applied to the Agency.

The Board shall, in respect of each financial year, provide to the Ministerial Council an annual report on the activities of the Agency and financial statements for the Agency, prepared in accordance with the Rules.
10 The Agency shall prepare and provide to the Ministerial Coun- cil planning documents, reports and information as specified in the Rules.

The financial statements of the Agency shall be audited.

The Auditor-General of Australia and the Auditor-General of New 15 Zealand shall be appointed as the joint auditors of the Agency with responsibility for the audit of the financial statements of the Agency.
Each Party may provide for the application to the Agency of statutory accountability regimes that apply in the territory of 20 that Party to similar regulatory agencies to the extent and in a manner that is consistent with this Agreement, and in particu- lar with the principles in paragraph 1.

The Parties shall consult each other in relation to the application of statutory account- ability regimes to the Agency, and in relation to such modifi- 25 cations of those regimes as may be appropriate.
ARTICLE 9 Ministerial Council Rules The Ministerial Council may make Rules for the following purposes: (a) providing for the governance and accountability of the Agency; 30 1 350 Therapeutic Products and Medicines Bill Schedule 1 (c) (d) (b) without limiting subparagraph (a), providing for finan- cial matters concerning the Agency, including (without limitation) borrowing and other raising of finance by the Agency; providing for aspects of the employment arrangements 5 for the Agency; prescribing standards of good regulatory practice to be complied with by the Agency; providing for the fees and charges that may be levied by the Agency in connection with the performance of 10 its functions, and the payment of such fees and charges; prescribing principles or requirements to be complied with in setting fees and charges; providing for: (i) (g) (e) (f) (ii) the delegation by the Managing Director of any 15 of the Managing Director’s functions or powers, including regulatory functions that the Managing Director exercises on behalf of and in the name of the Agency; the subdelegation of those functions or powers; 20 and the effect of the delegation or subdelegation; (iii) prescribing the procedure to be followed in connection with the making, amending or revoking of Orders; providing for internal review of specified decisions of 25 the Agency in connection with the grant, amendment, suspension or revocation of Approvals, and any other specified classes of decisions of the Agency; prescribing, for the purposes of subparagraph (c) of paragraph 1 of Article 13, further classes of decision of 30 the Agency that are subject to merits review; prescribing the procedure to be followed in connection with the appointment and removal of Board members, except in so far as it is provided for in this Agreement; prescribing the terms and conditions on which Board 35 members hold office, including their term of office and remuneration; providing for acting appointments to the Board; prescribing Board procedure; (h) (i) (j) (k) (l) (m)
 (n) 351 Schedule 1 Therapeutic Products and Medicines Bill providing for: (i) 5 (ii) the delegation by the Board of any of the Board’s functions or powers; the subdelegation of those functions or powers; and the effect of the delegation or subdelegation; (iii) providing that certain products or classes of products are or are not to be treated as therapeutic products for the purposes of this Agreement; providing that certain uses of products are or are not to 10 be treated as a therapeutic use for the purposes of this Agreement; providing for a framework for the classification of ther- apeutic products to enable a system or systems of ac- cess controls for therapeutic products to be applied in 15 the territory of each Party; prescribing the circumstances in which a therapeutic product is not to be manufactured, supplied, imported, exported or promoted; prescribing the circumstances in which an Approval is 20 required under the Scheme, whether by reference to an activity, the person engaging in the activity, the thera- peutic product involved in the activity or otherwise; prescribing requirements to be complied with in relation to the manufacture, supply, import, export or promotion 25 of therapeutic products; prescribing requirements that must be satisfied before an Approval is granted by the Agency; prescribing the procedure to be followed in connection with applications for Approvals and the determination 30 of such applications; prescribing terms and conditions on
 which any class or classes of Approval may or shall be granted by the Agency; prescribing the circumstances in which Approvals may 35 be amended, suspended or revoked and prescribing the procedure to be followed in connection with such mat- ters; (o) (p) (q) (r) (s) (t) (u) (v) (w) (x) (y) 352 Therapeutic Products and Medicines Bill Schedule 1 (z) (aa) providing for regulatory approvals in respect of speci- fied therapeutic products or classes of therapeutic prod- ucts granted by regulators in specified
 countries to be recognised by the Agency as establishing that those products meet appropriate standards of quality, safety, 5 and efficacy or performance, and providing for simpli- fied procedures for applying for an Approval in respect of such products; providing for authoritative standards or principles such as those provided in the British Pharmacopoeia, the 10 European Pharmacopoeia, or other relevant authori- tative standards or principles (as in force or existing from time to time) to apply in relation to all therapeu- tic products, specified therapeutic products or specified classes of therapeutic products, in circumstances where 15 no other applicable standard or principle is prescribed by Rules or Orders; (bb) prescribing requirements in relation to the promotion of (cc) therapeutic products; prescribing the kinds of representations that are not to 20 be made in relation to therapeutic products; (ff) (ee) (dd) prescribing requirements for providing information to the Agency regarding therapeutic products and their manufacture, supply, import, export or promotion; prescribing requirements for providing information to 25 the public or specified classes of persons regarding ther- apeutic products and their manufacture, supply, import, export or promotion; prescribing record-keeping and notification require- ments in respect of the manufacture, supply, import, 30 export or promotion of therapeutic products; identifying matters that may be dealt with by way of Orders rather than by Rules; setting out rules of interpretation for Rules and Orders (including rules dealing with the effect of the amend- 35 ment, Orders); revocation and disallowance of Rules and (hh) (gg) 353 Schedule 1 Therapeutic Products and Medicines Bill (ii) (jj) prescribing a method by which Rules or Orders shall be published for the purposes of paragraph 6 of this Article or paragraph 6 of Article 10; providing, in accordance with Article 21, for the tran- sition from the separate regimes
 operated by the Par- 5 ties before the commencement date to the Scheme es- tablished by this Agreement; (kk) providing for the establishment, terms of reference, composition and operation of expert advisory com- mittees, and for the terms and conditions that apply to 10 membership of such committees, including the term of office and remuneration of members; providing for the appointment and removal of members of the Merits Review Panel and for the terms and con- ditions that apply to such appointments; (ll) 15 (mm) prescribing the procedure to be followed in connection with an application for merits review, and in conducting a merits review, in accordance with Article 13; (nn) providing for an Approval to be given that applies in the territory of one Party only, or that applies differently in 20 the territory of each Party, for the purposes of subpara- graph (c) of paragraph 4 of Article 11; (oo) providing for the retention of materials and documents provided in relation to applications for Approvals that are made to the Agency; (pp) declaring that a function of the Agency is a regulatory function; and (qq) providing for any other matters that are necessary or convenient to be dealt with under Rules in order to give effect to the objectives of this Agreement.
25 30 In exercising its powers to make, amend or revoke Rules, the Ministerial Council shall give effect to the objectives of this Agreement.

Rules may be amended or revoked by the Ministerial Council in the same manner in which Rules may be made.
35 2 3 354 4 5 6 7 Therapeutic Products and Medicines Bill Schedule 1 Each Party shall legislate to provide for Rules to be tabled in the Parliament of that Party and to be subject to disallowance in whole (and not in part) by that Parliament within a reason- able time from tabling.

If any Rules are disallowed by the Parliament of one Party, they shall cease to have effect for the 5 purposes of this Agreement and the Australian Implementing Legislation and the New Zealand Implementing Legislation.
A Rule shall have effect under this Agreement and the Aus- tralian Implementing Legislation and the New Zealand Imple- menting Legislation on the later of the following dates: (a) any date specified in the Rule as the date on which the Rule is to have effect; the date on which the requirements of paragraph 7 have been satisfied.

(b) 10 The Agency shall ensure that Rules are published, as soon as 15 practicable after they are made, on the Internet or by such other method as may be specified in Rules.
Rules must be published, or the making of the Rules must be notified, as soon as practicable after they are made: (a) in the official Gazette of New Zealand, or in such other 20 manner as may be specified for this purpose in the New Zealand Implementing Legislation; and in the official Gazette of the Commonwealth of Aus- tralia, or in such other manner as may be specified for this purpose in the Australian Implementing Legisla- 25 tion.
(b) ARTICLE 10 Therapeutic Product Orders 1 The Agency may make the following Orders: (a) Orders dealing with matters identified in Rules made 30 under subparagraph (gg) of paragraph 1 of Article 9; (b) Orders made in accordance with the provisions of any other Rule made under paragraph 1 of Article 9.
355 Schedule 1 Therapeutic Products and Medicines Bill Where the Managing Director is satisfied that particular prod- ucts or classes of products: (a) are or are not therapeutic products within the meaning of this Agreement; or (b) when used, promoted or presented in a particular way, 5 are or are not therapeutic products within the meaning of this Agreement; the Agency may make an Order declaring that the products, or the products when used, promoted or presented in that way, are or are not, for the purposes of this Agreement, therapeutic 10 products.
Orders may be amended or revoked by the Agency in the same manner in which Orders may be made.

Each Party shall legislate to provide for Orders to be tabled in the Parliament of that Party and to be subject to disallowance 15 in whole (and not in part) by that Parliament within a reason- able time from tabling.
If any Orders are disallowed by the Parliament of one Party, they shall cease to have effect for the purposes of this Agreement and the Australian Implementing Legislation and the New Zealand Implementing Legislation.
20 An Order shall have effect under this Agreement and the Aus- tralian Implementing Legislation and the New Zealand Imple- menting Legislation on the later of the following dates: (a) any date specified in the Orders as the date on which the Order is to have effect; the date on which the requirements of paragraph 7 have been satisfied.

(b) 25 The Agency shall ensure that Orders are published, as soon as practicable after they are made, on the Internet or by such other method as may be specified in Rules.
30 Orders must be published, or the making of the Orders must be notified, as soon as practicable after they are made: 356 Therapeutic Products and Medicines Bill Schedule 1 (a) (b) in the official Gazette of New Zealand, or in such other manner as may be specified for this purpose in the New Zealand Implementing Legislation; and in the official Gazette of the Commonwealth of Aus- tralia, or in such other manner as may be specified for 5 this purpose in the Australian Implementing Legisla- tion.
ARTICLE 11 Approvals 1 2 3 4 Any person may apply to the Agency for an Approval in rela- 10 tion to the manufacture, supply, import, export or promotion of a therapeutic product in accordance with the Rules.

The Agency shall consider and determine the application in ac- cordance with the Rules.

The Agency may grant, amend, suspend or revoke an Ap- 15 proval in accordance with the Rules.
An Approval shall apply in the territory of both Parties, and shall be given effect under the Australian Implementing Le- gislation and the New Zealand Implementing Legislation, un- less the Approval expressly provides that it applies only in the 20 territory of one Party, or expressly provides for differences in its application in the territories of the Parties (in this Article referred to as a regulatory difference).
An Approval may provide that it applies in the territory of one Party only, or provide for differences in its application in the 25 territories of the Parties, where: (a) the Approval relates to a therapeutic product or a class of therapeutic products in respect of which a Party has notified a departure under Article 12, and the terms of the Approval give effect to that departure; the Agency considers that it is desirable for the ther- apeutic product to be supplied in a different manner or subject to different requirements in the territory of the two Parties, having regard to differences in public (b) 30 357 Schedule 1 Therapeutic Products and Medicines Bill health, safety, environmental or cultural circumstances of the Parties; or the Rules provide for such differences.
(c) 5 6 The Ministerial Council shall, at least once a year, review Ap- provals that are subject to a regulatory difference, and consider 5 whether there is a continuing need for each regulatory differ- ence.

The Agency shall, at least once a year, review Approvals that are subject to a regulatory difference under subparagraph (b) of paragraph 4, and consider whether there is a continuing need 10 for each regulatory difference.
ARTICLE 12 Departures from the Scheme by one Party in Exceptional Circumstances Either Party may, by regulations made under that Party’s Im- 15 plementing Legislation: (a) specify a therapeutic product, or class of therapeutic products, to which this Article applies; and exclude or modify the application of the Scheme in re- spect of that therapeutic product or class of therapeutic 20 products.
(b) A Party may make regulations in accordance with this Article only if satisfied that: (a) it is necessary for it to do so having regard to excep- tional public health, safety, third country trade, envir- 25 onmental or cultural factors that affect that Party; and the proposed action will not compromise public health or safety in the territory of that Party.
(b) Where a Party takes action under paragraph 1: (a) The Scheme shall apply in the territory of that Party 30 subject to the regulations made under paragraph 1; (b) Nothing in this Agreement prevents the other Party from taking measures to prevent the importation of any 1 2 3 358 Therapeutic Products and Medicines Bill Schedule 1 therapeutic product or class of therapeutic products to which that action relates, if that therapeutic product or class of therapeutic products does not meet the require- ments of the Scheme.
Before taking action under paragraph 1, a Party shall notify the 5 other Party of the proposed departure from the Scheme and of the reasons for that departure, and shall afford the other Party a reasonable opportunity to comment on the proposed departure.
Where a Party has taken action under paragraph 1, that Party: (a) shall keep the matter under review with a view to deter- 10 mining whether the exceptional factors that affect that Party continue to apply; and shall, at the request of the other Party, enter into consult- ations to discuss the continuing need for that departure.
(b) The Ministerial Council shall, at least once a year, consider 15 any departures in force under paragraph 1, and may make rec- ommendations to the Parties in relation to those departures.
Action taken under this Article shall not be more trade restrict- ive than is necessary to take account of the factors referred to in paragraph 2, and shall not result in therapeutic products 20 imported from the other Party being accorded treatment less favourable than that accorded to: (a) such products originating in the territory of the Party which implemented the departure; or such products originating in any other country.
(b) 25 A Party that has taken action under this Article may consult with the Agency in relation to any alternative regulatory meas- ures to be adopted pursuant to the departure, and the Agency shall if so consulted assist with the development and imple- mentation of such measures on terms (including terms relating 30 to the funding of the Agency’s work) determined by the Min- isterial Council.
359 Schedule 1 Therapeutic Products and Medicines Bill 9 In the context of the review provided for in Article 17, the Parties shall specifically review the operation of this Article, taking into account experience gained since the inception of the Scheme.
ARTICLE 13 Merits Review of the Agency’s Regulatory Decisions Each Party shall legislate to provide for the review before a Review Tribunal, in accordance with this Article, of decisions made by the Agency in relation to: (a) (b) an application for an Approval; the amendment, suspension or revocation of an Ap- proval; or any other matter specified in the Rules.
(c) In determining a merits review, a Review Tribunal shall recon- sider the matter decided by the Agency, and may exercise all 15 the powers and discretions conferred on the Agency under this Agreement and the Rules.

Each Party shall provide a Review Tribunal with the functions and powers that are necessary to conduct reviews of decisions of the Agency.
The Parties shall provide that a Review Tribunal may: (a) (b) (c) affirm the decision under review; vary the decision under review; or set aside the decision under review and: (i) (ii) make a decision in substitution for the decision so set aside; or remit the matter for reconsideration by the Agency in accordance with any directions or recommendations of the Review Tribunal.

The members of a Review Tribunal shall be drawn from the Merits Review Panel.
30 The Ministerial Council may from time to time appoint per- sons as members of the Merits Review Panel in accordance with the Rules.
The Ministerial Council shall only appoint a 5 10 20 25 360 Therapeutic Products and Medicines Bill Schedule 1 person to the Merits Review Panel if it is satisfied the person is appropriately qualified to serve as a member of a Review Tribunal, having regard to that person’s knowledge of and ex- perience in medicine, therapeutic products, public administra- tion or law.

The term of each appointment shall be specified 5 by the Ministerial Council.
The Ministerial Council shall designate: (a) one member of the Merits Review Panel as the Princi- pal Member in respect of merits reviews conducted in Australia; one member of the Merits Review Panel as the Principal Member in respect of merits reviews conducted in New Zealand.
(b) Without limiting paragraphs 5 and 6, the Ministerial Council may from time to time: (a) appoint as a member of the Merits Review Panel the holder from time to time of an office established by either Party; and designate as the Principal Member of a Review Tribunal the holder from time to time of an office established by 20 either Party.
(b) The composition of a Review Tribunal to consider and deter- mine a merits review shall be decided by the relevant Principal Member, having regard to the expertise required for the pur- poses of that merits review.

25 Each Party shall provide for the transfer of merits review pro- ceedings between jurisdictions where a Review Tribunal con- siders that it is in the interests of justice to do so.
10 15 Each Party may legislate to provide for a right of appeal to a superior court on questions of law in respect of a determin- 30 ation by a Review Tribunal of a merits review conducted in the territory of that Party.
361 Schedule 1 Therapeutic Products and Medicines Bill 11 12 13 The Parties shall consult together in relation to the procedure to be followed in connection with applying for merits review and conducting merits reviews, to ensure the effective, just and efficient determination of merits reviews.
These matters shall be provided for in the Australian Implementing Legisla- 5 tion and the New Zealand Implementing Legislation or, if and to the extent that the Parties so agree, in Rules made by the Ministerial Council for the purposes of this Article.

Except as otherwise provided in this Agreement, Rules or ap- plicable legislation, a Review Tribunal may determine its own 10 procedure.
A decision by the Agency in relation to matters referred to in paragraph 1 shall have effect for the purposes of this Agree- ment, and shall be given effect under the Australian Imple- menting Legislation and the New Zealand Implementing Le- 15 gislation, subject to any orders made by a Review Tribunal, or by a court of either Party on appeal from a Review Tribunal, that vary, set aside, suspend, or otherwise affect that decision.
ARTICLE 14 Judicial Review of Agency Decisions and Rules 20 Each Party may legislate to provide for judicial review before the courts of that Party of decisions and Orders made by the Agency, in the same manner as if the Agency were exercising a statutory power of decision under the laws of that Party.
Each Party may legislate to provide for judicial review be- 25 fore the courts of that Party of a Rule made by the Ministerial Council, in the same manner as if the Rules were made under a statute of that Party.
Legislation of a Party which provides for judicial review in accordance with this Article shall provide for the court before 30 which judicial review proceedings have been commenced to grant a stay of those proceedings, on the application of a party to those proceedings, if the court considers that, taking into ac- 1 2 3 362 Therapeutic Products and Medicines Bill Schedule 1 count relevant factors such as the residence of the applicant, it would be more appropriate for the proceedings to be heard and determined in the courts of the other Party, in the interests of the effective, just, and efficient determination of those pro- ceedings.
5 4 A decision by the Agency, an Order or a Rule shall have ef- fect for the purposes of this Agreement, and shall be given effect under the Australian Implementing Legislation and the New Zealand Implementing Legislation, subject to any orders, made in the course of proceedings before a court in either Party 10 in which judicial review has been sought as provided for in this Article, that vary, suspend, set aside or otherwise affect that decision, Order or Rule.
ARTICLE 15 Funding 15 1 2 The Parties shall provide initial funding to the Agency, and transfer to the Agency certain assets employed by each of them in connection with the regulation of therapeutic products prior to the commencement of the Scheme, on such terms as may be agreed between them prior to the establishment of the Agency.

20 The Parties shall not be required to provide any further funding to the Agency except in accordance with paragraph 4, or as may be agreed by both Parties.
The fees and charges that may be levied by the Agency in connection with the performance of its functions shall be pre- 25 scribed in Rules.
The fees and charges shall: (a) be designed to recover the full costs of the Agency’s op- erations under the Scheme in an efficient and equitable manner; provide such incentives for the timely and efficient de- 30 termination of applications by the Agency as the Min- isterial Council thinks fit; and comply with such other principles or requirements as may be prescribed in the Rules.
(b) (c) 363 Schedule 1 Therapeutic Products and Medicines Bill 3 4 5 Before setting fees and charges, the Ministerial Council shall: seek recommendations from the Board in respect of (a) those fees and charges; and ensure stakeholder representatives are consulted where appropriate.
(b) 5 The Ministerial Council shall determine terms and conditions as to funding where the Agency is to engage in activities (in- cluding performing functions and providing services) that fall outside the scope of the Scheme in accordance with paragraph 3 of Article 5.

Without limiting the generality of this provi- 10 sion, a Party may agree to provide funding to the Agency in connection with such activities, or the Agency may be empow- ered to levy fees or charges in respect of such activities.
The Agency shall not be subject to income tax in the territory of either Party.
15 ARTICLE 16 Consultations The Parties shall, at the written request of either, promptly enter into consultations with a view to seeking an early, equitable and mutually satisfactory solution, if the Party which requested the consultations 20 considers that: (a) The Parties shall, at the written request of either, promptly en- ter into consultations with a view to seeking an early, equit- able and mutually satisfactory solution, if the Party which re- quested the consultations considers that: the achievement of any of the objectives of this Agreement is being or may be frustrated.
(b) 25 ARTICLE 17 Review The Parties agree to conduct and conclude, no later than five years 30 after the date of entry into force of this Agreement, a review of the 364 Therapeutic Products and Medicines Bill Schedule 1 effectiveness of the Scheme and of the Agency, with a view to agree- ing to and implementing any necessary improvements.
ARTICLE 18 Amendment If either of the Parties considers that an amendment to this Agreement 5 would be desirable, it may request consultations with the other Party to this end.

Such consultations shall be entered into promptly by the Parties, unless they agree otherwise.

Any agreed amendments shall enter into force when they have been confirmed by an exchange of diplomatic notes.
10 ARTICLE 19 Participation of Third Parties 1 2 The Parties may agree to the association of any other State with this Agreement.

The terms of such association shall be negotiated between the 15 Parties and that other State.

ARTICLE 20 Termination 1 2 Either Party may at any time give notice in writing through diplomatic channels to the other Party of its decision to ter- 20 minate this Agreement.
Upon such notice being given, the Agreement shall termin- ate on a date to be agreed by the Parties in writing.

The Par- ties may agree that the Agreement shall terminate on different dates in respect of different classes of therapeutic product.

In 25 the absence of such agreement, this Agreement shall termin- ate on the later of: (a) any date specified in the notice as the date on which the termination is to be effective; or the date 3 years after the date on which the notice was 30 received.
(b) 365 Schedule 1 Therapeutic Products and Medicines Bill 3 4 5 Upon termination of this Agreement: (a) the Agency shall cease to be governed in accordance with this Agreement, and shall be governed in such manner as may be specified in Australian legislation; (b) New Zealand shall have no interest in the Agency or its 5 assets, except as may be determined in accordance with paragraphs 4 and 5.
Prior to the termination of this Agreement the Parties shall use their best endeavours to reach agreement in relation to matters arising out of that termination, including: (a) 10 arrangements for use by New Zealand of the intellec- tual property of the Agency and information held by the Agency, as at the date of termination; assistance to be provided by the Agency in connection with new arrangements for the regulation of therapeutic 15 products in New Zealand; and financial arrangements in connection with the termin- ation of this Agreement, having regard to paragraph 3 and to the financial contributions that the Parties have made in connection with the establishment and imple- 20 mentation of the Scheme.
(b) (c) If agreement is not reached on the matters referred to in para- graph 4, either Party may make a written request to the other Party for the difference between them to be referred to arbitra- tion in accordance with the Annex.

25 ARTICLE 21 Transitional Provisions Each Party shall legislate to give effect to the transitional ar- rangements set out in this Article.
On and after the commencement date, the manufacture, sup- 30 ply, import, export or promotion of a therapeutic product that was lawful in the territory of one Party immediately before the commencement date continues to be lawful in the territory of that Party for a specified period by virtue of the deemed grant 1 2 366 3 4 5 Therapeutic Products and Medicines Bill Schedule 1 of a transitional approval under the Scheme on the terms and conditions (if any) that applied in respect of the manufacture, supply, import, export or promotion of that therapeutic prod- uct before the commencement date, subject to any Rules that apply under paragraph 3.
5 Every transitional approval shall be subject to the relevant ap- plicable Rules.
Without limiting subparagraph (jj) of para- graph 1 of Article 9, Rules made under that subparagraph may: apply some or all of the provisions of the superseded (a) legislation, with or without modification, to therapeutic 10 products or activities that are subject to a transitional approval; apply different specified periods to different transitional approvals for therapeutic products or activities; and provide for the temporary extension of a transitional 15 approval, at the discretion of the Agency or as otherwise set out in Rules.
(b) (c) Each Party shall establish a transitional system (which may include the establishment, appointment or continuation of a body) for dealing with applications received under the super- 20 seded legislation but not determined by the commencement date.

Applications that are received under the superseded legislation but not determined by the commencement date shall be deter- mined in accordance with the transitional system established 25 by the Party in whose territory the application was lodged.
The transitional system: (a) shall ensure that the application is determined on the same basis as applied to the application before the com- mencement date; shall provide for the grant of transitional approvals under the Scheme for a specified period as provided for in the Rules; and shall grant transitional approvals only in relation to the territory of the Party that operates the transitional sys- 35 tem.
30 (b) (c) 367 Schedule 1 Therapeutic Products and Medicines Bill 6 7 8 Each Party may provide that applicants whose applications were lodged under the superseded legislation but which are not, or are unlikely to be, determined by the commencement date may elect to have their applications determined by the Agency under the Scheme rather than under the transitional 5 system established by the Party.
All post-market activities, appeals and reviews that were com- menced under the superseded legislation but not completed by the commencement date shall be completed on the same basis as if the activity, appeal or review were continuing under 10 that legislation.
However, the Parties may provide that per- sons other than those provided for under the superseded legis- lation may conduct post-market activities, appeals or reviews, as long as the Parties ensure that, to the fullest extent prac- ticable, the substantive effect of the superseded legislation is 15 maintained.
The Parties agree that, where a therapeutic product had been approved in the territory of either Party under the superseded legislation before the commencement date, the requirements for applying for and obtaining an Approval under the Scheme 20 shall take into account, among other relevant factors, that ap- proval and the history of use of the product.
ARTICLE 22 Compliance with Other Laws and Regulations This Agreement is not intended to affect the operation of laws 25 affecting therapeutic products in force in the territory of either Party, except to the extent that such laws are superseded by the Australian Implementing Legislation or the New Zealand Implementing Legislation.

Examples of such laws that this Agreement is not intended to affect are laws relating to bio- 30 security, customs controls, intellectual property and consumer protection.
The Parties confirm that therapeutic products in their territor- ies shall continue to be subject to such additional requirements, 1 2 368 Therapeutic Products and Medicines Bill Schedule 1 whether in force before or after the Scheme commences, as well as to the requirements imposed under the Scheme.
ARTICLE 23 Entry into Force This Agreement shall enter into force on the date on which the Par- 5 ties have exchanged diplomatic notes confirming the completion of their respective domestic procedures for the entry into force of this Agreement.

IN WITNESS WHEREOF the undersigned, being duly authorised by their respective Governments, have signed this Agreement.
DONE in duplicate at December 2003. on this day of FOR THE GOVERNMENT OF NEW ZEALAND FOR THE GOVERNMENT OF AUSTRALIA 369 Schedule 1 Therapeutic Products and Medicines Bill ANNEX—ARBITRATION MECHANISM FOLLOWING TERMINATION Where either Party has made a written request in accordance with paragraph 5 of Article 20, and subject to any modifications that may 5 be agreed in writing between the Parties, the arbitration shall be car- ried out in accordance with the procedures set out in this Annex.
Each Party shall within 30 days of the receipt of the written request referred to above set out in writing the matters arising out of termination where agreement has not been reached and 10 communicate this to the other Party.

Taking into account the matters which are the subject of the arbitration, the Parties shall appoint an arbitral tribunal con- sisting of three members.
Each Party shall appoint an arbitra- tor within 30 days of the receipt of the second communication 15 referred to in paragraph 1 and the two arbitrators appointed shall seek to designate by common agreement the third arbi- trator, who shall chair the tribunal.
Each arbitrator, including the chair of the tribunal, shall have international commercial arbitration experience and shall not be a national of either of 20 the Parties, nor have his or her usual place of residence in the territory of one of the Parties, nor be employed by either of them, nor have dealt with any matters in relation to the Scheme in any capacity.
If the chair of the tribunal has not been designated within 30 25 days of the appointment of the second arbitrator, the Secre- tary-General of the Permanent Court of Arbitration shall at the request of either Party appoint the chair of the arbitral tribunal within a further 30-day period.
If one of the Parties does not appoint an arbitrator within the 30 time specified in paragraph 2 of this Annex, the other Party may inform the Secretary-General of the Permanent Court of Arbitration who shall appoint the chair of the arbitral tribunal within a further 30 day period and the chair shall, upon ap- 1 2 3 4 370 Therapeutic Products and Medicines Bill Schedule 1 pointment, request the Party which has not appointed an arbi- trator to do so within 14 days.
If after such period that Party has still not appointed an arbitrator, the chair shall inform the Secretary-General of the Permanent Court of Arbitration who shall make this appointment within a further 30 day period.

5 Before any appointments to the arbitral tribunal are made by the Secretary-General of the Permanent Court of Arbitration, the Parties shall notify him or her of the matters which form the subject of the arbitration.
The Secretary-General of the Permanent Court of Arbitration shall take this information into 10 account in making any appointments to the tribunal.

The function of an arbitral tribunal is to make an objective as- sessment of the matters which are the subject of the arbitra- tion and to make such findings and rulings necessary for the resolution of the matters referred to it as it thinks fit.
The arbi- 15 tral tribunal shall release to the Parties its findings and rulings in a report on the matters referred to it within 180 days of its formation or such other period as the Parties may agree.

The findings and rulings of the arbitral tribunal shall be binding on the Parties and the Parties shall take all necessary action to im- 20 plement the rulings.
Unless the arbitral tribunal determines otherwise and subject to the provisions of this Annex, the arbitral tribunal shall be guided by the procedures in the UNCITRAL Arbitration Rules adopted by the United Nations Commission on International 25 Trade Law on 28 April 1976 as approved by the General As- sembly of the United Nations on 15 December 1976.
Unless the arbitral tribunal decides otherwise, the expenses of the tribunal, including the remuneration of its members, shall be borne by the Parties in equal shares.

30 The arbitral tribunal may at any stage of the proceedings make proposals to the Parties with a view to achieving a mutually satisfactory solution of the dispute.
The Parties may agree to 371 Schedule 1 Therapeutic Products and Medicines Bill terminate the proceedings of the arbitral tribunal in the event that a mutually satisfactory solution to the dispute has been found.
372 1 Therapeutic Products and Medicines Bill Schedule 2 Schedule 2 Provisions applying to Review Tribunal s 139 Rules prevail over certain clauses If a Rule conflicts with any of the following clauses, the Rule prevails: (a) (b) clause 2 (sitting of Review Tribunal): clause 3 (evidence in proceedings before Review Tri- bunal): clause 5 (witness summons): clause 6 (service of summons): clause 7 (witness’s allowances): clause 11 (costs).
(c) (d) (e) (f) 5 10 2 (1) Sittings of Review Tribunal The Review Tribunal must fix a time and place for the hearing of proceedings and give notice to the parties of the time and 15 place so fixed.

(2) No sitting of the Review Tribunal may take place, except for the purposes of interlocutory or other ancillary matters, unless all members are present.

(3) A sitting of the Review Tribunal may be held in whatever place 20 the Review Tribunal considers is convenient.
(4) A sitting of the Review Tribunal must be held in public unless the Review Tribunal in any particular case, having regard to the interests of the parties and of all other persons concerned, considers that the sitting or any part of it should be held in 25 private.

(5) Any sitting of the Review Tribunal may be adjourned from time to time and from place to place.
3 (1) (2) Evidence in proceedings before Review Tribunal The Evidence Act 1908 applies to the Review Tribunal, sub- 30 ject to subsections (2) to (4).

The Review Tribunal may receive as evidence any statement, document, information, or matter that may in its opinion assist it to deal effectively with the matters before it, whether or not it would be admissible in a court of law.
35 373 Schedule 2 Therapeutic Products and Medicines Bill (3) (4) 4 (1) (2) 5 (1) (2) (3) The Review Tribunal may take evidence on oath, and for that purpose any member or officer of the Review Tribunal may administer an oath.

The Review Tribunal may permit a person appearing as a wit- ness before it to give evidence by tendering a written statement 5 and, if the Review Tribunal thinks fit, verifying it by oath.
Restrictions on publication The Review Tribunal may make an order prohibiting the pub- lication of any report or description of the proceedings or of any part of the proceedings.

Every person commits an offence and is liable, on summary conviction, to a fine not exceeding $3,000 who contravenes any order made by the Review Tribunal under subsection (1) of this section.
Witness summons The Review Tribunal may of its own motion, or on the applica- tion of any party to the proceedings, issue a witness summons to any person requiring that person to attend before the Review Tribunal to give evidence at the hearing of the proceedings.
The witness summons must state— (a) (b) (c) the place where the witness is to attend; and the date and time when the witness is to attend; and the papers, documents, records, or things that that wit- ness is required to bring and produce to the Review Tri- bunal; and the witness’s entitlement to be paid a sum in respect of allowances and travelling expenses; and the penalty for failing to attend.
(d) (e) The power to issue a witness summons may be exercised by the Review Tribunal or its chairperson, or by any officer of the 30 Review Tribunal purporting to act by the direction or with the authority of the Review Tribunal or the chairperson.
10 15 20 25 Service of summons 6 (1) A witness summons may be served— (a) by delivering it personally to the person summoned; or 35 374 (2) (3) 7 (1) Therapeutic Products and Medicines Bill Schedule 2 (b) by posting it by registered letter addressed to the person summoned at that person’s usual place of residence.
The summons must,— (a) if it is served under subclause (1)(a), be served at least 24 hours before the attendance of the witness is re- 5 quired; or if it is served under subclause (1)(b), be served at least 10 days before the date on which the attendance of the witness is required.

(b) If the summons is posted by registered letter, it is deemed for 10 the purposes of subclause (2)(b) to have been served at the time when the letter would be delivered in the ordinary course of post.
Witnesses’ allowances Every witness attending before the Review Tribunal to give 15 evidence under a summons is entitled to be paid witnesses’ fees, allowances, and travelling expenses according to the scales for the time being prescribed by regulations made under the Summary Proceedings Act 1957, and those regula- tions apply accordingly.
20 (3) (2) On each occasion on which the Review Tribunal issues a sum- mons under clause 5, the Review Tribunal, or the person ex- ercising the power of the Review Tribunal under subclause (3) of that clause, must fix an amount that, on the service of the summons, or at some other reasonable time before the date 25 on which the witness is required to attend, must be paid to the witness.
The amount fixed under subclause (2) must be the estimated amount of the allowances and travelling expenses to which, in the opinion of the Review Tribunal or person, the witness will 30 be entitled according to the prescribed scales if the witness attends at the time and place specified in the summons.

(4) Where a party to the proceedings has requested the issue of the witness summons, the fees, allowances, and travelling ex- penses payable to the witness must be paid by that party.
35 375 Schedule 2 Therapeutic Products and Medicines Bill (5) Where the Review Tribunal has of its own motion issued the witness summons, the Review Tribunal may direct that the amount of those fees, allowances, and travelling expenses— (a) (b) form part of the costs of the proceedings; or be paid from money appropriated by Parliament for the 5 purpose.
Privileges and immunities 8 (1) Witnesses appearing before the Review Tribunal have the same privileges and immunities as witnesses have in proceed- ings in a District Court.

Counsel appearing before the Review Tribunal have the same privileges and immunities as counsel have in proceedings in a District Court.
(2) 10 9 (1) Non-attendance or refusal to co-operate Every person commits an offence who, after being summoned 15 to attend to give evidence before the Review Tribunal or to produce to the Review Tribunal any papers, documents, records, or things, without sufficient cause,— (a) (b) fails to attend in accordance with the summons; or refuses to be sworn or to give evidence, or, having been 20 sworn, refuses to answer any question that the person is lawfully required by the Review Tribunal or any mem- ber of it to answer concerning the proceedings; or fails to produce any such paper, document, record, or thing.
(c) 25 (2) Every person who commits an offence against subclause (1) is liable, on summary conviction, to a fine not exceeding $1,500.

(3) No person summoned to attend before the Review Tribunal may be convicted of an offence against subclause (1) unless 30 there was paid to that person travelling expenses in accordance with clause 7.
Contempt of Review Tribunal Every person commits an offence, and is liable, on summary conviction, to a fine not exceeding $1,000, who— 35 10 (1) 376 Therapeutic Products and Medicines Bill Schedule 2 (a) (b) (c) assaults, threatens, or intimidates, or intentionally in- sults, the Review Tribunal or any member of it, or any special adviser to or officer of the Review Tribunal, dur- ing a sitting of the Review Tribunal, or in going to, or returning from, any sitting; or intentionally interrupts the proceedings of the Review Tribunal or otherwise misbehaves while the Review Tri- bunal is sitting; or intentionally and without lawful excuse disobeys an order or direction of a member of the Review Tribunal 10 in the course of any proceedings before the Review Tribunal.
5 (2) A member of the Review Tribunal may order the exclusion from a sitting of the Review Tribunal of any person whose behaviour, in that member’s opinion, constitutes an offence 15 against subclause (1), whether or not such person is charged with the offence; and any member of the police may take such steps as are reasonably necessary to enforce such an exclusion.

11 (1) (2) Costs Except as provided in subclause (2), costs may not be 20 awarded against a party to proceedings before the Review Tribunal.
The Review Tribunal may, subject to the Rules, order one party (Party A) to pay to another (Party B) the costs, or part of the costs, of Party B in connection with the proceedings if, in the 25 opinion of the Review Tribunal,— (a) (b) a claim by Party A is frivolous or vexatious; or Party A has unnecessarily prolonged the proceedings by engaging in conduct intended to impede the prompt resolution of the proceedings.
30 377 Schedule 3 Therapeutic Products and Medicines Bill Schedule 3 Consequential amendments relating to establishment of Authority s 335 Crown Organisations (Criminal Liability) Act 2002 (2002 No 37) Definition of government-related organisation in section 4: insert 5 after paragraph (a): “(aa) the Authority defined in section 6(1) of the Therapeu- tic Products Act 2006:” Ombudsmen Act 1975 (1975 No 9) Part 2 of Schedule 1: insert “the Authority defined in section 6(1) 10 of the Therapeutic Products Act 2006” in its appropriate alphabetical order.
Public Records Act 2005 (2005 No 40) Definition of public office in section 4: insert after paragraph (c)(x): “(xa) the Authority defined in section 6(1) of the 15 Therapeutic Products Act 2006; and”.
Section 11(1): insert after paragraph (g): “(ga) to enter into memorandums of understanding with the Director-General of the National Archives of Australia about the management and disposal of public records of 20 the Authority defined in section 6(1) of the Therapeu- tic Products Act 2006; and” 378 1 (1) Therapeutic Products and Medicines Bill Schedule 4 s 376 Schedule 4 Powers of Minister in relation to prescribing authorities’ obligations Requesting information relating to prescribing Authorities’ prescribing notices and reviews The Minister may, by written notice, require a prescribing au- thority to supply him or her with specified information relating to— (a) 5 any prescribing notice issued by the prescribing author- ity (including, without limitation, information as to how 10 a prescription medicine included in a prescribing notice relates directly to the scope of practice of the designated prescriber registered with the prescribing authority); or any review undertaken under section 374 (including, without limitation, information as to how the prescrib- 15 ing authority determined whether any prescription medicine should be or should not be prescribed by des- ignated prescribers registered with it).
(b) (2) Any information the Minister requires must be supplied by the prescribing authority— (a) within the time specified in the Minister’s written notice or within any extended time the Minister allows; and in the manner and form notified by the Minister (if any).

(3) A prescribing authority is not required to supply information (b) 20 (4) (5) 2 (1) that is not already in its possession.
If the Minister is satisfied that complying with a requirement would cost a prescribing authority monetary expense, the Min- ister must make a grant to meet that cost, out of money appro- priated by Parliament.

In this clause, information does not include information about 30 an identifiable individual.
Compare: 2003 No 48 s 123 25 Minister may audit prescribing Authorities’ compliance with obligations For the purpose of ascertaining whether a prescribing authority 35 is or has been complying with its obligations under sections 379 Schedule 4 Therapeutic Products and Medicines Bill (2) (3) (4) 373 to 375, the Minister may appoint an auditor to audit the relevant records of the prescribing authority.

The auditor must report to the Minister on the matters to be ascertained by the audit.
The auditor must be given access at all reasonable times to all 5 records of the prescribing authority that relate to its obligations under sections 373 to 375.

The auditor may require the registrar of the prescribing au- thority to provide any information and explanations that, in the auditor’s opinion, may be necessary to enable the auditor 10 to prepare the report.
(5) Within 12 sitting days of receiving the auditor’s report, the Minister must— (a) (b) Compare: 2003 No 48 s 124 present a copy of the report to the House of Represen- tatives; and give a copy to the prescribing authority.
15 Minister may require prescribing authority to respond to concerns following audit If, after consideration of an auditor’s report, the Minister has 20 concerns about a prescribing authority’s compliance with its obligations under sections 373 to 375 or the manner in which it is complying with its obligations under those sections, the Minister may, by written notice to the prescribing author- ity,— (a) (b) set out the concerns and the reasons for them; and require the prescribing authority to give the Minister a written response within the time specified in the notice or within any extended time the Minister allows.
25 The response must state, in respect of each concern set out in 30 the Minister’s notice, whether the prescribing authority con- siders that the concern— is justified; or (a) is justified in part; or (b) is not justified.
(c) 35 3 (1) (2) 380 (3) (4) 4 (1) (2) (3) (4) Therapeutic Products and Medicines Bill Schedule 4 If the response states that the prescribing authority considers that the concern is justified or is justified in part, the response must also provide information on— (a) the steps that the prescribing authority has taken, is tak- ing, or proposes to take to address the concern or part 5 of the concern; and the time within which those steps have been, are being, or are to be taken.
(b) If the response states that the prescribing authority considers that the concern is not justified or is not justified in part, the 10 response must set out the prescribing authority’s reasons for the statement.
Compare: 2003 No 48 s 125 Conciliation conference If it appears from a prescribing authority’s response under 15 clause 3 that there is a significant difference of opinion be- tween the Minister and the prescribing authority, the Minister may convene a conciliation conference by written notice to the prescribing authority.

Before giving written notice of a conciliation conference, the 20 Minister must consult with the prescribing authority about the proposed notice.
The notice must— (a) (b) appoint a time and place for the conference; and invite the chairperson of the prescribing authority to 25 take part in the conference; and invite the chairperson to nominate 2 persons registered with the prescribing authority to take part in the confer- ence.
(c) The conference may be attended— (a) by a person (the conciliator) appointed by the Attorney- General to preside over the conference; and by either— the Minister with up to 2 assistants; or (i) (ii) up to 3 representatives of the Minister; and by the chairperson of the prescribing authority and the nominated persons.
(b) (c) 30 35 381 Schedule 4 Therapeutic Products and Medicines Bill (5) The aim of the conference is to— (a) (b) clarify the nature of the difference of opinion; and resolve that difference.

(6) As soon as practicable after the conference, the conciliator must report to the Minister and to all the persons registered 5 with the prescribing authority on the matters that the parties to the conference resolved and on the matters on which their opinions still differ.
Compare: 2003 No 48 s 126 382 Therapeutic Products and Medicines Bill Schedule 5 Schedule 5 Powers of health authority or Veterinary Council when making inquiries s 388(3) 1 Procedure Subject to Parts 6 and 7 and the regulations, a health author- 5 ity or the Veterinary Council making an inquiry under section 388(2) may regulate its procedure in any manner it thinks fit.
Evidence 2 (1) A health authority or the Veterinary Council making an inquiry under section 388(2) may receive as evidence any statement, 10 document, information, or matter that may, in its opinion, as- sist it to deal effectively with the matters before it.

(2) A health authority or the Veterinary Council making an inquiry under section 388(2) may take evidence on oath.
(3) A health authority or the Veterinary Council making an in- 15 quiry under section 388(2) may permit a person appearing as a witness before it to give evidence by tendering a written statement and, if the health authority or the Veterinary Coun- cil thinks fit, verifying it by oath.
20 Witness summons 3 (1) A health authority or the Veterinary Council making an in- quiry under section 388(2) may, on its own initiative or on the application of the prescriber or veterinarian to whom the inquiry relates, issue a witness summons to any person requir- ing that person to attend before the health authority or Veter- 25 inary Council to give evidence.
The witness summons must state— (a) (b) (c) the place where the person is to attend; and the date and time when the person is to attend; and the papers, documents, records, or things that the person 30 is required to bring and produce; and the penalty for failing to attend.

(d) The power to issue a witness summons may be exercised by any officer of a health authority or the Veterinary Council.
(3) (2) 383 Schedule 5 Therapeutic Products and Medicines Bill 4 Witnesses’ allowances Every witness attending before a health authority or the Veter- inary Council to give evidence under a summons is entitled to be paid witnesses’ fees, allowances, and travelling expenses according to the scales for the time being prescribed by regu- 5 lations made under the Summary Proceedings Act 1957, and those regulations apply accordingly.
Service of summons 5 (1) A witness summons may be served— (a) (b) by delivering it personally to the person summoned; or 10 by posting it by registered letter addressed to the person summoned at that person’s usual place of residence or business.
The summons must,— (a) if it is served under subclause (1)(a), be served at 15 least 24 hours before the attendance of the witness is re- quired; or if it is served under subclause (1)(b), be served at least 10 days before the date on which the attendance of the witness is required.

(b) 20 If the summons is posted by registered letter, it must be re- garded for the purposes of subclause (2)(b) to have been served at the time when the letter would be delivered in the ordinary course of post.
25 Non-attendance or refusal to co-operate Every person commits an offence who, after being summoned to attend to give evidence before a health authority or the Vet- erinary Council making inquiries under section 388(2) or to produce to the health authority or the Veterinary Council any papers, documents, records, or things, without sufficient 30 cause,— (a) (b) fails to attend in accordance with the summons; or refuses to be sworn or to give evidence, or, having been sworn, refuses to answer any question that the person is lawfully required by the health authority or the Veterin- 35 ary Council to answer; or (2) (3) 6 (1) 384 Therapeutic Products and Medicines Bill Schedule 5 (c) fails to produce any such paper, document, record, or thing.
(2) Every person who commits an offence against subclause (1) is liable, on summary conviction, to a fine not exceeding $1,500.

5 (3) No person summoned to attend before a health authority or the Veterinary Council may be convicted of an offence against subclause (1) unless there was tendered or paid to that person travelling expenses in accordance with clause 4.
385 Schedule 6 Therapeutic Products and Medicines Bill Schedule 6 Review or appeal of restriction notice s 392 Review of restriction notice 1 (1) A restricted individual may (at any time during a restriction notice’s duration) apply to the Medical Officer of Health to— 5 (a) (b) modify any restriction, exception, or condition in the revoke the restriction notice; or restriction notice.
(2) A restricted individual making an application must include the following information: (a) 10 in a case where a prescriber is able to prescribe to the restricted person as a consequence of an exception at- tached to the notice under section 389(2)(a), a writ- ten statement from that prescriber of the reason why the restriction notice should be revoked or any prohibition, 15 condition, or exception attached to it modified; or in any other case, a written statement from an author- ised prescriber whose care the restricted person is under, as to the reason why the restriction notice should be re- voked or any restriction, exception, or condition in it 20 modified.
(b) Appeal against restriction notice 2 (1) A restricted individual may appeal against (at any time dur- ing a restriction notice’s duration) the following matters to the Minister: (a) the issuing of a restriction notice to which he or she is subject: a refusal by a Medical Officer of Health to revoke or modify a restriction notice.

(b) 25 (2) (3) The Minister may on appeal, confirm, vary, or revoke a restric- 30 tion notice or the decision of a Medical Officer of Health.
The decision of the Minister on appeal is final.
Compare: 1981 No 118 s 49(5) 386 Therapeutic Products and Medicines Bill Schedule 7 Schedule 7 Regulations and orders revoked s 541 Medicines Act Commencement Order 1984 (SR 1984/142) Medicines Amendment Act Commencement Order 1994 (SR1994/298) 5 Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325) Medicines Regulations 1984 (SR 1984/143) Medicines (Related Products (Exempted Foods)) Regulations 2003 (SR 2003/371) 10 387 Schedule 8 Therapeutic Products and Medicines Bill s 548 Schedule 8 Consequential amendments to enactments Part 1 Acts amended Agricultural Compounds and Veterinary Medicines Act 1997 (1997 No 87) Section 21(4): omit “section 3 of the Medicines Act 1981” and sub- stitute “section 339 of the Medicines Act 2006”.
Section 79: omit “the Medicines Act 1981” and substitute “the Medicines Act 2006, the Therapeutic Products Act 2006”.

5 10 Animal Products Act 1999 (1999 No 93) Section 161(5)(a)(vii): repeal and substitute: “(vii) the Medicines Act 2006: “(viia) the Therapeutic Products Act 2006”.

Carriage of Goods Act 1979 (1979 No 43) Section 30: omit “the Medicines Act 1981” and substitute “the Medicines Act 2006, the Therapeutic Products Act 2006”.

15 Copyright Act 1994 (1994 No 143) Section12(6)(a): repeal.
Section 76(a): repeal.

20 Corrections Act 2004 (2004 No 50) Paragraph (b) of the definition of drug in section 3(1): repeal and substitute: “(b) a prescription medicine or pharmacist-only medicine within the meaning of section 339 of the Medicines 25 Act 2006”.

Definition of medicine in section 3(1): repeal and substitute: “medicine has the same meaning as in section 339 of the Medicines Act 2006”.
388 Therapeutic Products and Medicines Bill Schedule 8 Part 1—continued Fair Trading Act 1986 (1986 No 121) Section 27(5): repeal and substitute: “(5) No Order in Council may be made under this section in re- spect of any medicine (within the meaning of the Medicines Act 2006) or therapeutic product (within the meaning of the 5 Therapeutic Products Act 2006) except in relation to the price of the medicine or therapeutic product.” Finance Act 1994 (1994 No 73) Definition of pharmaceuticals in section 2(1): omit “medicines, therapeutic medical devices” and substitute “medicines (as defined 10 in the Medicines Act 2006, therapeutic products (as defined in the Therapeutic Products Act 2006)”.
Hazardous Substances and New Organisms Act 1996 (1996 No 30) Definition of qualifying medicine and qualifying organism in sec- 15 tion 2(1): repeal and substitute: “qualifying organism means a new organism that is or is con- tained in a qualifying therapeutic product or a qualifying vet- erinary medicine “qualifying therapeutic product means a therapeutic product 20 that— “(a) “(b) meets the criteria in section 38I(3).” is or contains a new organism; or Definition of responsible chief executive in section 2: omit “the Medicines Act 1981” and substitute “the Medicines Act 2006”.
Section 2(1): insert in their appropriate alphabetical order: 25 “therapeutic product means a therapeutic product as defined in section 6(1) of the Therapeutic Products Act 2006 “Therapeutic Products Authority means the Authority as defined in section 6(1) of the Therapeutic Products Act 30 2006”.

Section 19(2)(ba): add “or to the Therapeutic Products Authority”.
389 Schedule 8 Therapeutic Products and Medicines Bill Part 1—continued Hazardous Substances and New Organisms Act 1996 (1996 No 30)—continued Section 19(2): repeal paragraphs (bb) and (bc) and substitute: “(bb) the power to determine whether a therapeutic product or veterinary medicine is a qualifying therapeutic prod- uct or qualifying veterinary medicine to the responsible chief executive or to the Therapeutic Products Author- 5 ity: “(bc) the power to review and amend controls under section 38L in relation to qualifying therapeutic products or qualifying veterinary medicines to the responsible chief executive or to the Therapeutic Products Authority:” 10 Section 19(2)(ca)(i): repeal and substitute: “(i) an employee of the Therapeutic Products Author- ity, or of any person specified in section 97, with relevant experience; or”.
Section 19(2)(h)(i): insert “or of the Therapeutic Products Authority” 15 after “Forestry”.

Section 25(6): omit “innovative medicine application” and substitute “innovative therapeutic product application”.
Definition of innovative medicine application in section 25(8): re- peal and substitute: 20 “innovative therapeutic product application means an ap- plication that— “(a) is made to the Therapeutic Products Authority for a product licence for a therapeutic product; and includes protected active ingredient information (as that 25 term is defined in section 181 of the Therapeutic Prod- ucts Act 2006).” “(b) Section 27(f): omit “medicine” wherever it appears and substitute in each case “therapeutic product”.
Section 38I(3): insert “, the Therapeutic Products Authority,” after 30 “The Authority”.

Section 38I(3): omit “qualifying medicine” and substitute “qualify- ing therapeutic product”.

390 Therapeutic Products and Medicines Bill Schedule 8 Part 1—continued Hazardous Substances and New Organisms Act 1996 (1996 No 30)—continued Section 38I(3)(a): omit “the medicine” and substitute “the therapeu- tic product”.

Section 38I(4): omit “qualifying medicine” and substitute “qualify- ing therapeutic product”.
Section 38I(4)(a): omit “the medicine” wherever it appears and sub- 5 stitute in each case “therapeutic product”.

Section 38I(5): repeal and substitute: “(5) To avoid doubt, an approval under this section does not, in itself, authorise anything for which an approval is required under the Medicines Act 2006, Act 2006, or the Agricultural Compounds and Veterinary Medicines Act 1997.”.
the Therapeutic Products 10 Section 38J: omit “qualifying medicine” wherever it appears and sub- stitute in each case “qualifying therapeutic product”.

Section 38J: omit “the medicine” wherever it appears and substitute 15 in each case “the therapeutic product”.

Section 38K(1): omit “qualifying medicine” wherever it appears and substitute in each case “qualifying therapeutic product”.

Cross heading above section 49A: omit “medicines” and substitute “therapeutic products”.
Definition of government agency in section 49A: add the following paragraph: “(c) the Therapeutic Products Authority” 20 Definition of interested government agency in section 49A: omit “medicine” and substitute “therapeutic product”.

Definition of medicine in section 49A: repeal.
Paragraph (g) of the definition of responsible minister in section 49A: repeal and substitute: 25 “(g) the Therapeutic Products Act 2006” 391 Schedule 8 Therapeutic Products and Medicines Bill Part 1—continued Hazardous Substances and New Organisms Act 1996 (1996 No 30)—continued Section 49A: insert the following definition of therapeutic product in its appropriate alphabetical order: “therapeutic product means a therapeutic product (as defined in section 6 of the Therapeutic Products Act 2006) that is or contains a hazardous substance or a new organism”.
5 15 Section 49C(b): omit “medicine” and substitute “therapeutic prod- uct”.

Section 49D: omit from the heading “medicine” and substitute “ther- apeutic product”.

Section 49D: omit “medicine” wherever it appears and substitute in 10 each case “therapeutic product”.

Section 49E(2): omit “medicine” wherever it appears and substitute in each case “therapeutic product”.

Section 49F(3)(a): omit “medicine” wherever it appears and substi- tute in each case “therapeutic product”.
Section 49G: omit “medicine” wherever it appears and substitute “therapeutic product”.

Section 49H(2)(b): omit “medicine” and substitute “therapeutic product”.

Section 49I: omit “medicine” wherever it appears and substitute in 20 each case “therapeutic product”.

Section 49L(2): omit “medicine” and substitute “therapeutic prod- uct”.
Sections 55(3) and (4): repeal and substitute: “(3) Sections 182 and 183 of the Therapeutic Products Act 2006 25 (which relate to the protection of protected active ingredient information, as defined in section 181 of that Act) apply to any protected active ingredient information held by the Au- thority if— “(a) the information relates to an application made under this 30 Act relating to a hazardous substance or new organism; and 392 Therapeutic Products and Medicines Bill Schedule 8 Part 1—continued Hazardous Substances and New Organisms Act 1996 (1996 No 30)—continued “(b) the substance or organism is the subject of an innovative therapeutic product application (as defined in section 25(8) of this Act).
“(4) Despite subsection (3),— “(a) “(b) the Authority may disclose any protected active ingre- 5 dient information to any prescribed person or class of person, or to any prescribed organisation or class of or- ganisation; and if the application for approval is required to be publicly notified under section 53, the Authority must provide a 10 summary of the effects of the hazardous substance or new organism.” Health Practitioners Competence Assurance Act 2003 (2003 No 48) Section 67(b): insert after subparagraph (ix): “(ixa) the Medicines Act 2006; or”.
Section 67(b): add the following subparagraph: “(xiii) the Therapeutic Products Act 2006.”.

Section 100(2)(a): insert after subparagraph (ix): “(ixa) the Medicines Act 2006; or”.

Section 100(2)(a): insert after subparagraph (xii): “(xiia) the Therapeutic Products Act 2006; or”.
15 20 Injury Prevention, Rehabilitation, and Compensation Act 2001 (2001 No 49) Paragraph (a) of the definition of pharmaceutical in section 6(1): 25 repeal and substitute: “(a) a prescription medicine, pharmacist-only medicine, or pharmacy medicine (as defined in section 339 of the Medicines Act 2006); or”.
393 Schedule 8 Therapeutic Products and Medicines Bill Part 1—continued Maritime Transport Act 1994 (1994 No 104) Section 20(1): omit “(as defined in the Medicines Act 1981)” and substitute “(as defined in the Medicines Act 2006)”.

Section 50(1)(e): omit “(as defined in the Medicines Act 1981)” and substitute “(as defined in the Medicines Act 2006)”.

Section 52(1)(b)(i)(A): omit “(as defined in the Medicines Act 1981)” and substitute “(as defined in the Medicines Act 2006)”.
Section 52(1)(b)(ii): omit “(as defined in the Medicines Act 1981)” and substitute “(as defined in the Medicines Act 2006)”.

Misuse of Drugs Act 1975 (1975 No 116) Paragraph (b) of the definition of controlled drug analogue in sec- tion 2(1): repeal and substitute: “(b) any prescription medicine, pharmacist-only medicine, or pharmacy medicine within the meaning of the Medicines Act 2006”.
5 10 15 Definition of designated prescriber in section 2(1): omit “section 2(1) of the Medicines Act 1981” and substitute “section 339 of the Medicines Act 2006”.

Definition of standing order in section 2(1): omit “section 2(1) of the Medicines Act 1981” and substitute “section 339 of the 20 Medicines Act 2006”.

Section 8(2)(l)(i): omit “(as defined in section 2(1) of the Medicines Act 1981)” and substitute “(as defined in section 339 of the Medicines Act 2006)”.
Section 8(2)(l)(ii): omit “(as defined in section 2(1) of the Medicines 25 Act 1981)” and substitute “(as defined in section 339 of the Medicines Act 2006)”.

New Zealand Public Health and Disability Act 2000 (2000 No 91) Definition of pharmaceutical in section 6(1): omit “medicine, ther- apeutic medical device” and substitute “medicine (as defined in the 30 Medicines Act 2006), therapeutic product (as defined in the Thera- peutic Products Act 2006)”.
394 Therapeutic Products and Medicines Bill Schedule 8 Part 1—continued Ombudsmen Act 1975 (1975 No 9) Part 2 of Schedule 1: omit the items relating to “The Medicines Clas- sification Committee” and “The Medicines Review Committee”.
Smoke-Free Environments Act 1990 (1990 No 108) Definition of tobacco product in section 2(1): omit “(being a 5 medicine in respect of which there is in force a consent or provi- sional consent given under section 20 or section 23 of the Medicines Act 1981)” and substitute “(being a therapeutic product (as defined in section 6(1) of the Therapeutic Products Act 2006) that has been granted a product licence or other approval in accordance with 10 the Rules (as defined section 6(1) of that Act))”.
Summary Proceedings Act 1957 (1957 No 87) Part 2 of Schedule 1: insert the following item in its appropriate al- phabetical order: Medicines Act 2006 Offence to knowingly risk public health s 442 Therapeutic Products Act 2006 s50(6) s51(5) s52(7) s53(5) s54(6) s55(6) s56(6) s58(6) s59(5) s68(4) s74(4) Manufacturing without manufacturing licence or correct manufacturing licence Breaching conditions of manufacturing licence Manufacture, import, export, or supply without product licence or correct product licence Breaching conditions of product licence Breaching conditions of special purpose approval or requirements of exemption Import, export, or supply of product that does not conform to applicable standards Breaching conditions of authorisation not to conform to applicable standards Manufacturer supplying or exporting therapeutic product to which conformity assessment procedures not applied Other persons supplying or exporting products to which conformity assessment procedures not applied Dealing with counterfeit products False or misleading statements in applications 395 Schedule 8 Therapeutic Products and Medicines Bill Summary Proceedings Act 1957 (1957 No 87)—continued Part 1—continued s79(4) s85(6) Applicants, holders, and former holders giving false or misleading information Failing to comply with recovery notice Trade Marks Act 2002 (2002 No 49) Section 98: Repeal.
Trans-Tasman Mutual Recognition Act 1997 (1997 No 60) Schedule 3: omit the item relating to “Medicines Act 1981” and sub- stitute “Therapeutic Products Act 2006”.

5 Part 2 Regulations amended Agricultural Compounds and Veterinary Medicines Regulations 2001 (SR 2001/101) Clause 1 in Schedule 1: omit “or restricted medicines (as those terms 10 are defined in the Medicines Act 1981)” and substitute “pharma- cist-only medicine (as those terms are defined in the Medicines Act 2006)”.
Column 1 of Schedule 2: omit the item that reads as “Preparations scheduled as pharmacy only, prescription, or restricted medicines 15 under the Medicines Act 1981, used as veterinary medicines”, and substitute the following item: Preparations that are scheduled medicines under the Medicines Act 2006, used as veterinary medicines Animal Products (Exemptions and Inclusions) Order 2000 (2000/209) Clause 5: revoke and substitute: “5 Medicines and therapeutic products “(1) Parts 2 to 4 of the Act do not apply to the secondary processing of animal products or the processing of dairy material, being products or material that are, or are being processed to become or form part of, a medicine (as defined in the Medicines Act 25 20 396 Therapeutic Products and Medicines Bill Schedule 8 Animal Products (Exemptions and Inclusions) Order 2000 (2000/209)—continued Part 2—continued 2006) or a therapeutic product (as defined in the Therapeutic Products Act 2006).
5 “(2) The exemption under subclause (1) includes the secondary processing of animal products or the processing of dairy ma- terial for the purpose or in the course of— “(a) manufacturing, packing or labelling, or supplying ther- apeutic products that consist of or contain those ani- mal products or that dairy material, by a person who has been granted a manufacturing licence, a product li- cence, or other approval in accordance with the Rules 10 (as defined in the Therapeutic Products Act 2006); or supplying any medicine that consists of or contains those animal products or that dairy material, by a person who is authorised to do so by or under the Medicines Act 2006.
“(b) 15 “(3) The exemption in this clause does not obviate the need for compliance with provisions of Parts 2 to 4 of the Act if the medicine or related product is intended for export in circum- stances that would require an official assurance to be issued, and the official assurance may only be issued on the basis of 20 compliance with those provisions.” Children, Young Persons, and Their Families (Residential Care) Regulations 1996 (SR 1996/354) Regulation 14(5): “pharmacist-only medicine”.
Regulation 14(6): revoke and substitute: “(6) omit “restricted medicine” and substitute In this regulation, the terms administer, prescription medicine, pharmacist-only medicine, and medicine have the meanings given to them by section 339 of the Medicines Act 2006.”.
25 30 397 Schedule 8 Therapeutic Products and Medicines Bill Part 2—continued Dangerous Goods (Labelling) Regulations 1978 (SR 1978/305) Regulation 9(1)(d): omit “ the Medicines Act 1981” and substitute “the Rules and Orders (as defined in section 6(1) of the Therapeutic Products Act 2006)”.
Dietary Supplements Regulations 1985 (SR 1985/208) Regulation 11: omit “by the Medicines Act 1981 and any regulations made under that Act” and substitute “by Rules and Orders (as defined in section 6(1) of the Therapeutic Products Act 2006)”.
5 Food (Safety) Regulations 2002 (SR 2002/396) Regulation 5: revoke and substitute: “5 Application Nothing in these regulations applies in respect of any food that is a therapeutic product within the meaning of the Therapeutic Products Act 2006.” Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001 (SR 2001/112) Regulation 5: revoke and substitute: “5 Therapeutic products “(1) A therapeutic products is not hazardous for the purposes of the Act unless Parts 13, 14, or 15 of the Act apply.
10 15 20 “(3) “(2) Despite subclause (1), a new therapeutic product must be treated as hazardous if it meets any of the minimum degrees of hazard prescribed in these regulations and an application is made to register that therapeutic product as a trade name product under the Agricultural Compounds and Veterinary 25 Medicines Act 1997.
In this regulation,— “new therapeutic product means a therapeutic product that has not been granted a product licence or other approval under the Rules (as defined in section 6(1) of the Therapeutic Prod- 30 ucts Act 2006) “therapeutic product has the same meaning as in section 6(1) of the Therapeutic Products Act 2006, except that it does 398 Therapeutic Products and Medicines Bill Schedule 8 Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001 (SR 2001/112)—continued Part 2—continued not include a gas contained at a pressure greater than 170 kPa in a container larger than 100 mL, at any time after that gas becomes so contained and before the time the gas is first ad- ministered to a person for a therapeutic purpose.” Health Entitlement Cards Regulations 1993 (SR 1993/169) Definition of pharmaceutical in regulation 22(1): omit “or related product” and substitute “or therapeutic product .” 5 Health (Needles and Syringes) Regulations 1998 (SR 1998/254) Definition of registered pharmacy in regulation 2: omit “Medicines Act 1981” and substitute “Medicines Act 2006”.
Regulation 12(7)(a): revoke and substitute: 10 “(a) for a therapeutic use as defined in the Therapeutic Prod- ucts Act 2006; or”.

Regulation 13(3)(a): revoke and substitute: “(a) for a therapeutic use as defined in the Therapeutic Prod- 15 ucts Act 2006; or”.

Misuse of Drugs Regulations 1977 (SR 1977/37) Definition of designated prescriber nurse in regulation 2(1): omit “the Medicines Act 1981” and substitute “the Medicines Act 2006”.
Definition of pharmacy practice in regulation 2(1): “Medicines Act 1981” and substitute “Medicines Act 2006”.

Regulation 21(1): omit “of section 20 or section 24 of the Medicines Act 1981” and substitute “of the Rules and Orders (as defined in sec- tion 6 of the Therapeutic Products Act 2006)”.
Regulation 25(3): revoke and substitute: “(3) Subclause (1) does not apply,— omit 20 25 “(a) in respect of ephedrine or pseudoephedrine, if— “(i) the drug is enclosed in a primary container theat complies with packaging requirements in any Rules and Orders (as defined in section 6(1) of 30 the Therapeutic Products Act 2006); and 399 Schedule 8 Therapeutic Products and Medicines Bill Misuse of Drugs Regulations 1977 (SR 1977/37)—continued Part 2—continued “(ii) the larger container in which the strips of primary containers are contained complies with subclause (1) of this regulation; and in respect of all other controlled drugs, if— “(i) the drug is contained in a safety container that 5 complies with the relevant safety container re- quirements in any Rules and Orders (as defined in section 6(1) of the Therapeutic Products Act 2006); and the labelling of the safety container complies 10 with requirements in those Rules and Orders.” “(ii) “(b) 400