1998A1817 — EN — 01.01.2013 — 001.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

Amended by:









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AGREEMENT

on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia







THE EUROPEAN COMMUNITY and the GOVERNMENT OF AUSTRALIA, hereinafter referred to as ‘the Parties’, CONSIDERING the traditional links of friendship that exist between them, CONSIDERING their shared commitment to promoting the enhancement of product quality, with a view to ensuring the health, safety and environment of their citizens, DESIRING to conclude an agreement providing for the mutual recognition of the respective conformity assessment procedures required for market access to the territory of the Parties, TAKING INTO ACCOUNT the improved conditions of trade between the Parties which the mutual recognition of test reports and certificates of conformity will bring about, AWARE of the positive contribution that mutual recognition can have in encouraging greater international harmonisation of standards and regulations, NOTING the close relationship between Australia and New Zealand as confirmed in the Australian and New Zealand Closer Economic Relations Trade Agreement and the Trans-Tasman Mutual Recognition Arrangement as well as the growing level of integration of the Australian and New Zealand conformity assessment infrastructures through the Agreement concerning the establishment of the Council of the Joint Accreditation System of Australia and New Zealand (JAS-ANZ), NOTING the close relationship between the European Community and Iceland, Liechtenstein and Norway through the Agreement on the European Economic Area, which makes it appropriate to consider the conclusion of a parallel mutual recognition agreement between Australia and these countries equivalent to this Agreement, BEARING IN MIND their status as Contracting Parties to the Agreement establishing the World Trade Organisation, and conscious in particular of their obligations under the World Trade Organisation Agreement on Technical Barriers to Trade, HAVE AGREED AS FOLLOWS:







Article 1

Definitions

1. General terms used in this Agreement and its Annexes shall have the meaning given in the definitions contained in ISO/IEC Guide 2 (1991) ‘General terms and their definitions concerning standardisation and related activities’ and in EN 45020 (1993 edition) unless the context requires otherwise. In addition, the following terms and definitions shall apply for the purpose of this Agreement:

‘Conformity assessment’ means systematic examination to determine the extent to which a product, process or service fulfils specified requirements;

‘Conformity assessment body’ means a body whose activities and expertise include performance of all or any stage of the conformity assessment process;

‘Designation’ means the authorisation by a designating authority of a conformity assessment body to perform conformity assessment activities; ‘designated’ has a corresponding meaning;

‘Designating authority’ means a body with the legal power to designate, suspend or withdraw designation of conformity assessment bodies under its jurisdiction.

2. The terms ‘conformity assessment body’ and ‘designating authority’ apply mutatis mutandis to other bodies and authorities with corresponding functions referred to in some Sectoral Annexes.

Article 2

General obligations

1. The Government of Australia shall accept attestations of conformity including test reports, certificates, authorisations and marks of conformity as required by legislation and regulations identified in the Sectoral Annexes issued by designated conformity assessment bodies in the European Community in accordance with this Agreement.

2. The European Community shall accept attestations of conformity including test reports, certificates, authorisations and marks of conformity as required by legislation and regulations identified in the Sectoral Annexes, issued by designated conformity assessment bodies in Australia in accordance with this Agreement.

3. This Agreement shall not entail mutual acceptance of the standards or technical regulations of the Parties or mutual recognition of the equivalence of such standards or technical regulations.

Article 3

Sectoral coverage

1. This Agreement concerns the conformity assessment procedures to satisfy mandatory requirements covered by the Sectoral Annexes.

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2. Each Sectoral Annex shall, in general, contain the following information:

(a) a statement of its scope and coverage;

(b) the legislative, regulatory and administrative requirements pertaining to the conformity assessment procedures;

(c) the designating authorities;

(d) a set of procedures for the designation of conformity assessment bodies, and

(e) additional provisions as required.

Article 4

Scope and coverage

This Agreement shall apply to the conformity assessment of products specified in the statement of scope and coverage in each Sectoral Annex.

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Article 5

Conformity assessment bodies

In accordance with the terms of the Annex and the Sectoral Annexes, each Party recognises that the conformity assessment bodies designated by the other Party fulfil the conditions of eligibility to assess conformity in relation to their requirements as specified in the Sectoral Annexes. In designating such bodies, the Parties shall specify the scope of the conformity assessment activities for which they have been designated.

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Article 6

Designating authorities

1. The Parties shall ensure that the designating authorities responsible for designating conformity assessment bodies have the necessary power and competence to designate, suspend, remove the suspension of, and withdraw the designation of, such bodies.

2. In making such designations, suspensions, removals of suspension and withdrawals, designating authorities shall, unless specified otherwise in the Sectoral Annexes, observe the procedures for designation set out in Article 12 and the Annex.

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Article 7

Verification of designation procedures

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1. The Parties shall exchange information concerning the procedures used to ensure that the designated conformity assessment bodies under their responsibility comply with the legislative, regulatory and administrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex.

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2. The Parties shall compare methods used to verify that the designated conformity assessment bodies comply with the legislative, regulatory and administrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex. Existing systems for the accreditation of conformity assessment bodies in the two Parties may be used for such comparison procedures.

3. Such comparison shall be carried out in accordance with the procedures to be determined by the Joint Committee established under Article 12.

Article 8

Verification of compliance of conformity assessment bodies

1. Each Party shall ensure that conformity assessment bodies designated by a designating authority will be available for verification of their technical competence and compliance with other relevant requirements.

2. Each Party has the right to contest the technical competence and compliance of conformity assessment bodies under the jurisdiction of the other Party. This right will be exercised under exceptional circumstances only.

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3. Such contestation has to be justified in an objective and argued manner and in writing to the other Party and to the Joint Committee.

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4. Where the Joint Committee decides that verification of technical competence or compliance is required, it will be carried out in a timely manner jointly by the Parties with the participation of the relevant designating authorities.

5. The result of this verification will be discussed in the Joint Committee with a view to resolving the issue as soon as possible.

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6. Except when decided otherwise by the Joint Committee, the contested conformity assessment body shall be suspended by the competent designating authority from the time its competence or compliance is challenged until either agreement is reached in the Joint Committee on the status of that body or the challenging Party notifies the other Party and the Joint Committee that it is satisfied as to the competence and compliance of that body.

Article 9

Exchange of information

1. The Parties shall exchange information concerning the implementation of the legislative, regulatory and administrative provisions identified in the Sectoral Annexes and shall maintain an accurate list of conformity assessment bodies designated in accordance with this Agreement.

2. Consistent with their obligations under the World Trade Organization Agreement on Technical Barriers to Trade, each Party shall inform the other Party of the changes it intends to make to the legislative, regulatory and administrative provisions relating to the subject matter of this Agreement and shall, except as provided for in paragraph 3 of this Article, notify the other Party of the new provisions at least 60 calendar days before their entry into force.

3. Where a Party takes urgent measures that it considers warranted by considerations of safety, health or protection of the environment in order to eliminate an immediate risk posed by a product covered by a Sectoral Annex, it shall notify the other Party of the measures and the reasons for their imposition immediately, or as otherwise specified in the Sectoral Annex.

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Article 10

Uniformity of conformity assessment procedures

In the interests of promoting a uniform application of the conformity assessment procedures provided for in the laws and regulations of the Parties, the designated conformity assessment bodies shall take part, as appropriate, in coordination and comparison exercises conducted by each of the Parties in the relevant areas covered by the Sectoral Annexes.

Article 11

Agreements with other countries

The Parties agree that mutual recognition agreements concluded by either Party with a country which is not a party to this Agreement shall in no way entail an obligation upon the other Party to accept test reports, certificates, authorisations and marks of conformity issued by conformity assessment bodies in that third country, save where there is an express agreement between the Parties.

Article 12

Joint Committee

1. A Joint Committee made up of representatives of the two Parties shall be established. It is responsible for the effective functioning of the Agreement.

2. The Joint Committee shall determine its own rules of procedure. It shall take its decisions and adopt its recommendations by consensus. It can decide to delegate specific tasks to subcommittees.

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3. The Joint Committee shall meet at least once a year unless the Joint Committee or the Parties decide otherwise. If required for the effective functioning of this Agreement, or at the request of either Party, an additional meeting or meetings shall be held.

4. The Joint Committee may consider any matter related to the functioning of this Agreement. In particular, it shall be responsible for:

(a) amending the Sectoral Annexes in accordance with this Agreement;

(b) exchanging information concerning the procedures used by either Party to ensure that the conformity assessment bodies maintain the necessary level of competence;

(c) in accordance with Article 8, appointing a joint team or teams of experts to verify the technical competence of a conformity assessment body and its compliance with other relevant requirements;

(d) exchanging information and notifying the Parties of modifications of legislative, regulatory and administrative provisions referred to in the Sectoral Annexes, including those which require modification of the Sectoral Annexes;

(e) resolving any questions relating to the application of this Agreement and its Sectoral Annexes, and

(f) adopting new Sectoral Annexes in accordance with this Agreement.

5. Any amendments to the Sectoral Annexes made in accordance with this Agreement and any new Sectoral Annexes adopted in accordance with this Agreement shall be notified promptly in writing by the Joint Committee to each Party, and shall come into effect for both Parties on the date on which the Joint Committee receives notification from each Party confirming completion of their respective procedures for the amendments or new Sectoral Annex to take effect, unless otherwise mutually determined in writing by the Parties.

6. The following procedure shall apply in relation to the designation of a conformity assessment body:

(a) a Party wishing to designate a conformity assessment body shall forward its proposal to that effect to the other Party in writing, adding supporting documentation as defined by the Joint Committee;

(b) in the event that the other Party consents to the proposal or upon the expiry of 60 calendar days without an objection having been lodged in accordance with the procedures of the Joint Committee, the conformity assessment body shall be considered to be a designated conformity assessment body under the terms of Article 5;

(c) in the event that, under Article 8, the other Party contests the technical competence or compliance of the proposed conformity assessment body within the aforementioned 60-day period, the Joint Committee may decide to carry out a verification of the body concerned, in accordance with Article 8;

(d) in the case of the designation of a new conformity assessment body, conformity assessment carried out by such a body shall be valid from the date on which it becomes a designated conformity assessment body in accordance with this Agreement;

(e) either Party may suspend, remove suspension or withdraw the designation of a conformity assessment body under its jurisdiction. The Party concerned shall immediately notify the other Party and the Joint Committee of its decision in writing, together with the date of such decision. The suspension, removal of suspension or withdrawal shall take effect from the date of the Party’s decision;

(f) in accordance with Article 8, either Party may, in exceptional circumstances, contest the technical competence of a designated conformity assessment body under the jurisdiction of the other Party. In this case the Joint Committee may decide to carry out a verification of the body concerned, in accordance with Article 8.

7. In the event that the designation of a conformity assessment body is suspended or withdrawn, conformity assessment carried out by that body before the date of effect of the suspension or withdrawal shall remain valid unless either the responsible Party has limited or cancelled that validity, or the Joint Committee determines otherwise. The Party under whose jurisdiction the suspended or withdrawn conformity assessment body was operating shall notify the other Party in writing of any such changes relating to a limitation or cancellation of validity.

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8. Where a Party introduces new or additional conformity assessment procedures affecting a sector covered by a Sectoral Annex, the Joint Committee shall, unless the Parties agree otherwise, bring such procedures within the mutual recognition implementing arrangements established by this Agreement.

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9. The Joint Committee shall keep the Sectoral Annexes up-to-date and shall provide these to the Parties upon the amendments taking effect.

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Article 13

Territorial application

This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied and under the conditions laid down in that Treaty and, on the other hand, to the territory of Australia.

Article 14

Entry into force and duration

1. This Agreement shall enter into force on the first day of the second month following the date on which the Parties have exchanged Notes confirming the completion of their respective procedures for the entry into force of this Agreement.

2. Either Party may terminate this Agreement by giving the other Party six months' notice in writing.

Article 15

Final provisions

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1. The Annex to this Agreement forms an integral part thereof. The Sectoral Annexes form the administrative arrangements for the implementation of this Agreement and have less than treaty status.

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2. Any amendment to this Agreement shall be done by mutual agreement.

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3. The Joint Committee may adopt Sectoral Annexes to which Article 2 applies and which will provide the implementing arrangements for this Agreement.

4. Amendments to the Sectoral Annexes, and the adoption of new Sectoral Annexes, shall be determined by the Joint Committee and come into effect in accordance with Article 12(5).

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5. This Agreement and the Sectoral Annexes are drawn up in two originals in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic.

Hecho en Canberra, el veinticuatro de junio de mil novecientos noventa y ocho.

Udfærdiget i Canberra den fireogtyvende juni nitten hundrede og otteoghalvfems.

Geschehen zu Canberra am vierundzwanzigsten Juni neunzehnhundertachtundneunzig.

Έγινε στην Καμπέρα, στις είκοσι τέσσερις Ιουνίου χίλια εννιακόσια ενενήντα οκτώ.

Done at Canberra on the twenty-fourth day of June in the year one thousand nine hundred and ninety-eight.

Fait à Canberra, le vingt-quatre juin mil neuf cent quatre-vingt-dix-huit.

Fatto a Canberra, addì ventiquattro giugno millenovecentonovantotto.

Gedaan te Canberra, de vierentwintigste juni negentienhonderd achtennegentig.

Feito em Camberra, em vinte e quatro de Junho de mil novecentos e noventa e oito.

Tehty Canberrassa kahdentenakymmenentenäneljäntenä päivänä kesäkuuta vuonna tuhat-yhdeksänsataayhdeksänkymmentäkahdeksan.

Som skedde i Canberra den tjugofjärde juni nittonhundranittioåtta.

Por la Comunidad Europea

For Det Europæiske Fællesskab

Für die Europäische Gemeinschaft

Για την Ευρωπαϊκή Κοινότητα

For the European Community

Pour la Communauté européenne

Per la Comunità europea

Voor de Europese Gemeenschap

Pela Comunidade Europeia

Euroopan yhteisön puolesta

På Europeiska gemenskapens vägnar

Por Australia

For Australien

Für Australien

Για την Αυστραλία

For Australia

Pour l'Australie

Per l'Australia

Voor Australië

Pela Austrália

Australian puolesta

För Australien

ANNEX

PROCEDURES FOR THE DESIGNATION AND MONITORING OF CONFORMITY ASSESSMENT BODIES

A. GENERAL REQUIREMENTS AND CONDITIONS

1. Designating authorities shall only designate legally identifiable entities as conformity assessment bodies.

2. Designating authorities shall only designate conformity assessment bodies able to demonstrate that they understand, have experience relevant to, and are competent to apply the conformity assessment requirements and procedures of the legislative, regulatory and administrative provisions of the other Party for which they are designated.

3. Demonstration of technical competence shall be based on: — technological knowledge of the relevant products, processes or services, — understanding of the technical standards and the general risk protection requirements for which designation is sought, — experience relevant to the applicable legislative, regulatory and administrative provisions, — the physical capability to perform the relevant conformity assessment activity, — an adequate management of the conformity assessment activities concerned, and — any other circumstance necessary to give assurance that the conformity assessment activity will be adequately performed on a continuous basis.

4. The technical competence criteria shall be based on internationally-accepted documents supplemented by specific interpretative documents developed as appropriate from time to time.

5. The Parties shall encourage harmonisation of designation and conformity assessment procedures through cooperation between designating authorities and conformity assessment bodies by means of coordination meetings, participation in mutual recognition arrangements, and working group meetings. Where accreditation bodies participate in the designation process they should be encouraged to participate in mutual recognition arrangements.

B. SYSTEM TO DETERMINE CONFORMITY ASSESSMENT BODIES' COMPETENCE

6. The designating authorities may apply the following processes to determine the technical competence of conformity assessment bodies. If necessary, a Party will indicate to the designating authority the possible ways to demonstrate competence. (a) Accreditation Accreditation shall constitute a presumption of technical competence in relation to the requirements of the other Party when: (i) the accreditation process is conducted in conformance with the relevant international documentation (EN 45 000 series or ISO/IEC guides); and either (ii) the accreditation body participates in mutual recognition arrangements where they are subject to peer evaluation which involves evaluation by individuals with recognised expertise in the field of the work being evaluated, of the competence of accreditation bodies and conformity assessment bodies accredited by them; or (iii) the accreditation bodies, operating under the authority of the designating authority, take part in accordance with procedures to be agreed in comparison programmes and exchanges of technical experience in order to ensure the continued confidence in the technical competence of the accreditation bodies and conformity assessment bodies. Such programmes may include joint assessments, special cooperation programmes or peer evaluation. When a conformity assessment body is only accredited to evaluate a product, process or service for compliance with particular technical specifications, designation shall be limited to those technical specifications. When a conformity assessment body seeks designation to evaluate a particular product, process or service for compliance with essential requirements, the accreditation process shall incorporate elements which will permit assessment of the capability (technological knowledge and understanding of the generally stated risk protection requirements of the product, process or service or their use) of the conformity assessment body to evaluate compliance with those essential requirements. (b) Other means When appropriate accreditation is not available or when special circumstances apply, the designating authorities shall require the conformity assessment bodies to demonstrate their competence through other means such as: — participation in regional/international mutual recognition arrangements or certification systems, — regular peer evaluations, — proficiency testing, and — comparisons between conformity assessment bodies.

C. EVALUATION OF THE DESIGNATION SYSTEM

7. Once the designation systems to evaluate the competence of conformity assessment bodies have been defined by each Party, the other Party may, in consultation with the designating authorities, check that the systems give sufficient assurance that the designation of the conformity assessment bodies satisfies its requirements.

D. FORMAL DESIGNATION

8. Designating authorities shall consult the conformity assessment bodies within their jurisdiction in order to determine their willingness to be designated under the terms of this Agreement. Such consultation should include those conformity assessment bodies who do not operate under the respective legislative, regulatory and administrative requirements of their own Party but which may, nevertheless, be interested and capable of working to the legislative, regulatory and administrative requirements of the other Party.

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9. Designating authorities shall inform their Party’s representatives on the Joint Committee, established under Article 12 of this Agreement, of the conformity assessment bodies to be designated, suspended or withdrawn. Designation, suspension or withdrawal of designation of conformity assessment bodies shall take place in accordance with this Agreement and the rules of procedure of the Joint Committee.

10. When advising their Party’s representative on the Joint Committee established under this Agreement of the conformity assessment bodies to be designated, the designating authority shall provide the following details in respect of each conformity assessment body: (a) the name; (b) the postal address; (c) the facsimile (fax) number and e-mail address; (d) the range of products, processes, standards or services it is authorised to assess; (e) the conformity assessment procedures it is authorised to carry out, and (f) the designation procedure used to determine competence.

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E. MONITORING

11. Designating authorities shall maintain, or cause to maintain, ongoing surveillance over designated conformity assessment bodies by means of regular audit or assessment. The frequency and nature of such activities shall be consistent with international best practices or as agreed by the Joint Committee.

12. Designating authorities shall require designated conformity assessment bodies to participate in proficiency testing or other appropriate comparison exercises where such exercises are technically possible within reasonable cost.

13. Designating authorities shall consult as necessary with their counterparts to ensure the maintenance of confidence in conformity assessment processes and procedures. This consultation may include joint participation in audits related to conformity assessment activities or other assessments of designated conformity assessment bodies, where such participation is appropriate and technically possible within reasonable cost.

14. Designating authorities shall consult, as necessary, with the relevant regulatory authorities of the other Party to ensure that all regulatory requirements are identified and are satisfactorily addressed.

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SECTORAL ANNEX ON MEDICINAL PRODUCTS GMP INSPECTION AND BATCH CERTIFICATION TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS

SCOPE AND COVERAGE

1. The Parties mutually establish that the provisions of this Sectoral Annex will cover all medicinal products which are industrially manufactured in Australia and in the European Union, and to which Good Manufacturing Practice (GMP) requirements apply. For medicinal products covered by this Sectoral Annex, each Party will recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations granted by the competent authorities of the other Party. In addition, the manufacturer’s certification of the conformity of each batch to its specifications will be recognised by the other Party without re-control at import. ‘Medicinal products’ means all products regulated by the pharmaceutical legislation in the European Union and Australia referred to in Section I. The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals, immunologicals, radiopharmaceuticals, stable medicinal products derived from human blood or human plasma, pre-mixes for the preparation of veterinary medicated feedingstuffs, and, where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products. ‘GMP’ is that part of quality assurance which ensures that products are consistently produced and controlled during manufacture to the quality standards appropriate to their intended use and as required by the marketing authorisation granted by the importing Party. For the purpose of this Sectoral Annex it includes the system whereby the manufacturer receives the specification of the product and/or process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification (equivalent to Qualified Person certification in the European Union).

2. With respect to medicinal products covered by the legislation of one Party (‘regulating Party’) but not the other, the manufacturing company may request the authority nominated by the relevant contact point of the regulating Party listed in point 12 of Section III, for the purpose of this Agreement, that an inspection be made by the locally competent inspection service. This provision will apply, inter alia, to the manufacture of active pharmaceutical ingredients and intermediate products and products intended for use in clinical trials, as well as mutually determined pre-marketing inspections. Operational arrangements are detailed under point 3(b) of Section III.

Certification of manufacturers

3. At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products will certify that the manufacturer: — is appropriately authorised to manufacture the relevant medicinal product or to carry out the relevant specified manufacturing operation; — is regularly inspected by the authorities, and — complies with the national GMP requirements recognised as equivalent by the two Parties, referred to in Section I. Where different GMP requirements may be used as a reference (in line with the provisions in point 3(b) of Section III), this is to be mentioned in the certificate. The certificates will also identify the site(s) of manufacture (and contract testing laboratories, if any). The format of the certificate will be decided by the Joint Sectoral Group. Certificates will be issued expeditiously, and the time taken should not exceed 30 calendar days. In exceptional cases, such as when a new inspection has to be carried out, this period may be extended to 60 calendar days.

Batch certification

4. Each batch exported will be accompanied by a batch certificate prepared by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active constituents and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation. This certificate will attest that the batch meets its specifications and will be kept by the importer of the batch. It will be made available upon request of the competent authority. When issuing a certificate, the manufacturer will take account of the provisions of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce. The certificate will detail the agreed specifications of the product, the reference of the analytical methods and the analytical results. It will contain a statement that the batch processing and packaging records were reviewed and found in conformity with GMP. The batch certificate will be signed by the person authorised to release the batch for sale or supply, i.e. in the European Union the ‘qualified person’ as referred to in relevant European Union legislation; in Australia, the persons responsible for manufacturing quality control as specified in the relevant Australian legislation.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS

Subject to Section III, general GMP inspections will be carried out against the GMP requirements of the exporting Party. The applicable legislative, regulatory and administrative provisions related to this Sectoral Annex are listed in the Appendix.

However, the reference quality requirements of products to be exported, including their manufacturing method and product specifications, will be those of the relevant product marketing authorisation granted by the importing Party.

SECTION II

OFFICIAL INSPECTION SERVICES

The lists of official inspection services related to this Sectoral Annex have been mutually established by the Parties and will be maintained by them. If a Party requests from the other Party a copy of its latest lists of official inspection services, the requested Party will provide the requesting Party with a copy of those lists within 30 calendar days of the date of receipt of that request.

SECTION III

OPERATIONAL PROVISIONS

1. Transmission of inspection reports

Upon reasoned request, the relevant inspection services will forward a copy of the last inspection report of the manufacturing or control site, in case analytical operations are contracted out. The request may concern a ‘full inspection report’ or a ‘detailed report’ (see point (2). Each Party will deal with these inspection reports with the degree of confidentiality requested by the Party of origin.

If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when the last inspection dates back to more than two years or a particular need to inspect has been identified, a specific and detailed inspection may be requested. Parties will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 calendar days should a new inspection be carried out.

2. Inspection reports

A ‘full inspection report’ comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A ‘detailed report’ responds to specific queries about a firm by the other Party.

3. Reference GMP

(a) Manufacturers will be inspected against the applicable GMP of the exporting Party (see Section I).

(b) With respect to medicinal products covered by the pharmaceutical legislation of the importing Party but not the exporting one, the locally competent inspection service willing to carry out an inspection of the relevant manufacturing operations will inspect against its own GMP or, in the absence of specific GMP requirements, against the applicable GMP of the importing Party. This will also be the case when the locally applicable GMP are not considered equivalent, in terms of quality assurance of the finished product, to the GMP of the importing Party. Equivalence of GMP requirements for specific products or classes of products (e.g. investigational medicinal products, starting materials) will be determined according to a procedure established by the Joint Sectoral Group.

4. Nature of inspections

(a) Inspections will routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections).

(b) ‘Product- or process-oriented’ inspections (which may be ‘pre-marketing’ inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) will be provided in confidence to the inspectorate.

5. Inspection/establishment fees

The regime of inspection/establishment fees is determined by the manufacturer’s location. Inspection/establishment fees will not be charged to manufacturers located on the territory of the other Party for products covered by this Sectoral Annex.

6. Safeguard clause for inspections

The Parties mutually acknowledge that each Party reserves the right to conduct its own inspection for reasons identified to the other Party. Such inspections are to be notified in advance to the other Party, which has the option of joining the inspection. Recourse to this safeguard clause should be an exception. Should such an inspection take place, inspection costs may be recovered.

7. Exchange of information between authorities and approximation of quality requirements

In accordance with the general provisions of this Agreement, the Parties will exchange any relevant information necessary for the ongoing mutual recognition of inspections. For the purposes of demonstration of capability in cases of significant changes to regulatory systems in either of the Parties, additional specific information may be requested by either Party in relation to an official inspection service. Such specific requests may cover information on training, inspection procedures, general information and document exchange, and transparency of agency audits of official inspection services relevant to the operation of this Sectoral Annex. Such requests should be made through and managed by the Joint Sectoral Group as part of an ongoing maintenance programme.

In addition, the relevant authorities in Australia and in the European Union will keep each other informed of any new technical guidance or changes to inspection procedures. Each Party will consult the other before their adoption.

8. Official batch release

The official batch release procedure is an additional verification of safety and efficacy of immunological medicinal products (vaccines) and blood derivatives, carried out by the competent authorities before the distribution of each batch of product. This Agreement will not encompass this mutual recognition of official batch releases. However, when an official batch release procedure applies, the manufacturer will provide, at the request of the importing Party, the official batch release certificate if the batch in question has been tested by the control authorities of the exporting Party.

For the European Union, the official batch release procedures for medicinal products for human use are published by the European Directorate for the Quality of Medicines & HealthCare. For Australia, the official batch release procedure is specified in document ‘WHO Technical Report Series, No 822, 1992’.

9. Inspectors’ training

In accordance with the general provisions of this Agreement, training sessions for inspectors, organised by the authorities, will be accessible to inspectors of the other Party. The Parties will keep each other informed of these sessions.

10. Joint inspections

In accordance with the general provisions of this Agreement, and by mutual arrangement between the Parties, joint inspections may be authorised. These inspections are intended to develop common understanding and interpretation of practice and requirements. The setting up of these inspections and their form will be established through procedures approved by the Joint Sectoral Group.

11. Alert system

Contact points will be agreed between the Parties to permit competent authorities and manufacturers to inform the authorities of the other Party with the appropriate speed in case of quality defects, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch. A detailed alert procedure will be mutually established.

The Parties will ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could affect the protection of public health, is communicated to the other Party with the appropriate degree of urgency.

12. Contact points

For the purpose of this Sectoral Annex, the contact points for any technical question, such as exchange of inspection reports, inspectors training sessions, technical requirements, will be:







FOR AUSTRALIA: For medicinal products for human use: The Head of OfficeTherapeutic Goods AdministrationDepartment of Health and AgeingPO Box 100Woden ACT 2606AustraliaTel. 61-6-232-8622Fax 61-6-232-8426 For medicinal products for use in animals: The Manager, Manufacturing Quality and Licensing SectionAustralian Pesticides and Veterinary Medicines AuthorityPO Box 6182Kingston ACT 2604AustraliaTel. 61-6210-4803Fax 61-6210-4741 FOR THE EUROPEAN UNION: The Director of the European Medicines Agency7 Westferry CircusCanary WharfLondon E14 4HBUnited KingdomTel. 44-171-418 8400Fax 44-171-418 8416

13. Joint Sectoral Group

A Joint Sectoral Group made up of representatives of the Parties will be established under this Sectoral Annex. It will be responsible for the effective functioning of this Sectoral Annex. It will report to the Joint Committee as the Joint Committee will determine.

The Joint Sectoral Group will determine its own rules of procedure. It will take its decisions and adopt its recommendations by consensus. It may decide to delegate its tasks to subgroups.

14. Divergence of views

Both Parties will use their best endeavours to resolve any divergence of views concerning, inter alia, compliance of manufacturers and conclusions of inspection reports. Unresolved divergences of view will be referred to the Joint Sectoral Group.

SECTION IV

CHANGES TO THE LIST OF OFFICIAL INSPECTION SERVICES

The Parties mutually recognise the need for this Sectoral Annex to accommodate change, particularly with regard to the entry of new official inspection services or changes in the nature or role of established competent authorities. Where significant changes have occurred with regard to official inspection services, the Joint Sectoral Group will consider what, if any, additional information is required to verify programmes and establish or maintain mutual recognition of inspections, in accordance with point 7 of Section III.

In accordance with this Agreement, the Australian veterinary medicinal product manufacturers will be inspected by the Therapeutic Goods Administration (TGA) on behalf of the Australian Pesticides and Veterinary Medicines Authority (APVMA), according to the current Australian code of GMP and the European Union GMP Guide for veterinary medicinal products. The European Union will recognise the conclusions of inspections carried out by the TGA and Australian manufacturers’ certifications of batch conformity. Should APVMA begin to carry out inspections itself, inspection reports will also be routinely transmitted to the importing Party until there has been a satisfactory verification of the APVMA GMP inspection programme.

Appendix

LIST OF APPLICABLE LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS

For the European Union:

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products, as amended;

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended;

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended;

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, as amended;

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended;

Guide to Good Distribution Practice (94/C 63/03);

Volume 4 — Guidelines for good manufacturing practices for medicinal products for human and veterinary use.

For Australia:

For products for human use:

Therapeutic Goods Act 1989, and Regulations, Orders and Determinations thereunder, including Orders setting standards such as labelling, the Determination establishing Manufacturing Principles and Australian Codes of Good Manufacturing Practice.

For products for veterinary use:

Legislation — Commonwealth: — Agricultural and Veterinary Chemicals (Administration) Act, 1992 — Agricultural and Veterinary Chemicals Act, 1994 — Agricultural and Veterinary Chemicals Code Act, 1994 — Agricultural and Veterinary Chemicals (Administration) Regulations, 1995 — Agricultural and Veterinary Chemicals Instrument No 1 (Manufacturing Principles), 2007 — Agricultural and Veterinary Chemicals Code Regulations, 1995

Legislation — New South Wales: — Stock Foods Act, 1940 — Stock Medicines Act, 1989 — Public Health Act, 1991 — Poisons and Therapeutic Goods Act, 1966 — Pesticides Act, 1979 — Agricultural and Veterinary Chemicals (NSW) Act, 1994 including any regulations, orders or instruments made under the above legislation

Legislation — Victoria: — Animal Preparations Act, 1987 — Health Act, 1958 — Drugs, Poisons and Controlled Substances Act, 1981 — Agricultural and Veterinary Chemicals (Victoria) Act, 1994 including any regulations, orders or instruments made under the above legislation

Legislation — Queensland: — Agricultural Standards Act, 1994 — Stock Act, 1915 — Health Act, 1937 — Agricultural and Veterinary Chemicals (Queensland) Act, 1994 including any regulations, orders or instruments made under the above legislation

Legislation — South Australia: — Stock Medicines Act, 1939-1978 — Stock Foods Act, 1941 — Dangerous Substances Act, 1986 — Controlled Substances Act, 1984 — Stock Diseases Act, 1934 — Agricultural and Veterinary Chemicals (SA) Act, 1994 including any regulations, orders or instruments made under the above legislation

Legislation — Western Australia: — Veterinary Preparations and Animal Feeding Stuffs Act, 1976–1982 — Poisons Act, 1964-1981 — Health Act, 1911 — Agricultural and Veterinary Chemicals (WA) Act, 1995 — Health (Pesticides) Regulations, 1956 including any regulations, orders or instruments made under the above legislation

Legislation — Tasmania: — Veterinary Medicines Act, 1987 — Poisons Act, 1971 — Public Health Act, 1997 — Agricultural and Veterinary Chemicals (Tasmania) Act, 1994 — Pesticides Act, 1968 including any regulations, orders or instruments made under the above legislation

Legislation — Northern Territory: — Poisons and Dangerous Drugs Act, 1983 — Therapeutic Goods and Cosmetics Act, 1986 — Stock Diseases Act, 1954 — Agricultural and Veterinary Chemicals (NT) Act, 1994 including any regulations, orders or instruments made under the above legislation

Legislation — Australian Capital Territory — Environment Protection Act, 1997 including any regulations, orders or instruments made under the above legislation.

SECTORAL ANNEX ON MEDICAL DEVICES TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS

SCOPE AND COVERAGE

The Parties mutually establish that the provisions of this Sectoral Annex will apply to the following products:







Products for export to the European Union Products for export to Australia (1) All medical devices: (a) manufactured in Australia; and (b) subject to third party conformity assessment procedures, both product- and quality systems-related; and (c) provided for in Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; and (d) provided for in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended. (1) All medical devices: (a) manufactured in the European Union; and (b) subject to conformity assessment procedures, both product- and quality systems-related, under the Australian Therapeutic Goods Act 1989 and Therapeutic Goods Regulations, as amended. (2) For the purposes of paragraph 1: (a) medical devices provided for in the Appendix are excluded; and (b) unless otherwise provided for or by mutual arrangement by the Parties, ‘manufacture’ of a medical device does not include: (i) restoration or renovation processes such as repairing, re-conditioning, overhauling or refurbishing; or (ii) operations such as pressing, labelling, ticketing, packaging and preparation for sale, conducted alone or in combination with each other; or (iii) quality control inspections alone; or (iv) sterilisation alone. (2) For the purposes of paragraph 1: (a) medical devices provided for in the Appendix are excluded; and (b) unless otherwise provided for or by mutual arrangement by the Parties, ‘manufacture’ of a medical device does not include: (i) restoration or renovation processes such as repairing, re-conditioning, overhauling or refurbishing; or (ii) operations such as pressing, labelling, ticketing, packaging and preparation for sale, conducted alone or in combination with each other; or (iii) quality control inspections alone; or (iv) sterilisation alone.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS







Legislative, regulatory and administrative requirements of the European Union with which Australian-designated conformity assessment bodies will assess compliance Legislative, regulatory and administrative requirements of Australia with which European Union-designated conformity assessment bodies will assess compliance — Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as amended — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended — and any legislation adopted on the basis of these Directives — Therapeutic Goods Act 1989, as amended — Therapeutic Goods Regulations 1990, as amended — Therapeutic Goods (Medical Devices) Regulations 2002, as amended — and any subordinate legislation referred to in the above Acts or Regulations, as amended (1) (1) General reference to Australia’s subordinate legislation referred to in the Therapeutic Goods Act and Regulations and to anticipate any legislative changes.

SECTION II

DESIGNATED CONFORMITY ASSESSMENT BODIES







Conformity assessment bodies designated by Australia to assess products against the European Union’s legislative, regulatory and administrative requirements Conformity assessment bodies designated by the European Union to assess products against Australia’s legislative, regulatory and administrative requirements The lists of designated conformity assessment bodies have been mutually established by the Parties and will be maintained by them. The lists of designated conformity assessment bodies have been mutually established by the Parties and will be maintained by them.

SECTION III

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES FOR THE PURPOSES OF THIS AGREEMENT







For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the Member States of the European Union — Department of Health and Ageing for the Therapeutic Goods Administration — Belgium — Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie Agence Fédérale des Médicaments et des Produits de Santé – Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten — Bulgaria — Държавна агенция за метрологичен и технически надзор — Czech Republic — Úřad pro technickou normalizaci, metrologii a státní zkušebnictví — Denmark — Indenrigs- og Sundhedsministeriet Lægemiddelstyrelsen — Germany — ZLG — Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, Bonn ZLS — Zentralstelle der Länder für Sicherheitstechnik, München — Estonia — Majandus- ja Kommunikatsiooniministeerium — Ireland — Department of Health Irish Medicines Board — Greece — Υπουργείο Υγείας και Κοινωνικής Αλληλεγγύης Εθνικός Οργανισμός Φαρμάκων — Spain — Ministerio de Sanidad, Política Social e Igualdad Agencia Española de Medicamentos y Productos Sanitarios — France — Ministère de la Santé Agence Française de Sécurité Sanitaire des produits de Santé Agence Nationale du Médicament Vétérinaire — Italy — Ministero della Salute – Dipartimento dell’ Innovazione – Direzione Generale Farmaci e Dispositivi Medici — Cyprus — The Drugs Council, Pharmaceutical Services (Ministry of Health) Veterinary Services (Ministry of Agriculture) — Latvia — Zāļu valsts aģentūra Veselības ministrija — Lithuania — Lietuvos Respublikos sveikatos apsaugos ministerija — Luxembourg — Ministère de la Santé Division de la Pharmacie et des Médicaments — Hungary — Országos Gyógyszerészeti Intézet — Malta — Direttorat tal-Affarijiet Regolatorji, Awtorità Maltija dwar l-iStandards — Netherlands — Ministerie van Volksgezondheid, Welzijn en Sport Inspectie voor de Gezondheidszorg — Austria — Bundesministerium für Gesundheit Bundesamt für Sicherheit im Gesundheitswesen — Poland — Ministerstwo Zdrowia Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych — Portugal — INFARMED:I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.) — Romania — Ministerul Sănătății – Departament Dispozitive Medicale — Slovenia — Ministrstvo za zdravje Javna agencija Republike Slovenije za zdravila in medicinske pripomočke — Slovakia — Úrad pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republiky — Finland — Sosiaali- ja terveysministeriö Sosiaali- ja terveysalan lupa- ja valvontavirasto (Valvira) — Sweden — Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom — Medicines and Healthcare products Regulatory Agency

SECTION IV

PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES







Procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Union’s requirements Procedures to be followed by the European Union in designating conformity assessment bodies to assess products against Australia’s requirements The Therapeutic Goods Administration of the Department of Health and Ageing will meet the requirements of the Directives listed in Section I, taking into account Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, as amended, insofar as it refers to the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, and be designated for specific categories or classes of devices and conformity assessment procedures. For products covered by Section V, designation will occur on the basis of a confidence-building programme as referred to in point 1.2 of Section V. (1) Conformity assessment bodies will meet the requirements mentioned in the Directives listed in Section I, taking into account Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, as amended, insofar as it refers to the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, and be designated for specific categories or classes of devices and conformity assessment procedures. For products covered by Section V, designation will occur on the basis of a confidence-building programme as referred to in point 1.2 of Section V. (2) (1) Presumption of competence is following successful completion of confidence-building for Section V devices. (2) Presumption of competence is following successful completion of confidence-building for Section V devices.

SECTION V

ADDITIONAL PROVISIONS

1. Confidence-building with respect to high-risk devices

1.1. A confidence-building process for the purpose of strengthening confidence in the designating systems of each of the Parties will apply for the following medical devices: — active implantable devices as defined in the legislation referred to in Section I; — devices that are classified as class III devices under the legislation referred to in Section I; — medical devices that are implantable intra-ocular lenses; — medical devices that are intra-ocular visco-elastic fluids, and — medical devices that are a barrier indicated for contraception or prevention of the sexual transmission of disease.

1.2. The Parties will establish a detailed programme to this effect involving the Therapeutic Goods Administration and the European Union’s competent authorities.

1.3. The confidence-building period will be reviewed after two years commencing from the date this Sectoral Annex, as amended, becomes effective.

1.4. Additional specific requirements for regulatory progress: 1.4.1. In pursuance of Articles 2, 7(1), 8(1) and 9(1) of this Agreement, either Party may request additional specific requirements in relation to the conformity assessment bodies for the purposes of demonstration of experience in the evolving regulatory systems. 1.4.2. These specific requirements may include training, observed conformity assessment body audits, visits and information and document exchange, including audit reports. 1.4.3. These requirements may likewise be applicable in relation to the designation of a conformity assessment body in accordance with this Agreement.

2. Registration, listing and inclusion procedures for the Australian Register of Therapeutic Goods (ARTG)

2.1. The Parties recognise that Australian procedures under the Therapeutic Goods Act 1989 for the registration, listing or inclusion of products for market surveillance purposes, and corresponding European Union procedures, are unaffected by this Agreement.

2.2. Within the framework of this Agreement, the Australian Regulatory Authority will without delay enter a product from the European Union on the ARTG without further assessment of the product. This is contingent upon receipt of a product application accompanied by the prescribed fee and the conformity assessment body’s certification to Australia’s requirements.

2.3. Any fees attached to registration by either Party will be related only to the costs of the medical device registration, enforcement and post-market surveillance activities of the Parties in this sector.

3. Exchange of information

The Parties agree to inform each other of:

— certificates withdrawn, suspended, restricted or revoked;

— adverse events in the context of the GHTF medical device vigilance procedure;

— matters concerning product safety; and

— any legislation or amendment to existing legislation adopted on the basis of the legal texts listed in Section I.

The Parties will establish contact points for each of these purposes.

The Parties will consider the consequences of the establishment of European Database on Medical Devices (Eudamed).

In addition, the Therapeutic Goods Administration will advise of any certificates issued.

4. New legislation

The Parties jointly note that Australia is to introduce new legislation concerning in vitro diagnostics (IVDs), and that any new arrangements will respect the principles on which this Agreement is based.

The Parties mutually declare their plan to extend the scope of this Agreement to IVDs as soon as the Australian legislation on IVDs is in place.

5. Measures to protect public health and safety

Implementation of this Sectoral Annex will not constrain a Party from taking measures necessary to protect public health and safety, in accordance with the legislation referred to in Section I. Each Party will duly inform the other Party of such measures.

6. Joint Sectoral Group

A Joint Sectoral Group made up of representatives of the Parties will be established under this Sectoral Annex. It will be responsible for the effective functioning of this Sectoral Annex. It will report to the Joint Committee as the latter will determine.

The Joint Sectoral Group will determine its own rules of procedure. It will take its decisions and adopt its recommendations by consensus. It may decide to delegate its tasks to subgroups.

7. Divergence of views

Both Parties will use their best endeavours to resolve any divergence of views. Unresolved divergences of view will be referred to the Joint Sectoral Group.

Appendix

The provisions of this Sectoral Annex will not apply to the following devices:

— medical devices that contain or are manufactured using cells, tissues or tissue derivatives of animal origin that have been rendered non-viable, where the safety with regard to viruses or other transferable agents requires validated methods for elimination or viral inactivation in the course of the manufacturing process;

— medical devices that contain tissues, cells or substances of microbial, bacterial or recombinant origin and are intended for use in or on the human body;

— medical devices incorporating tissues or tissue derivatives of human origin;

— medical devices incorporating stable derivatives of human blood or human plasma that are liable to act on the human body in a way that is ancillary to the device;

— medical devices that incorporate, or intend to incorporate, as an integral part, a substance that, if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device, and

— medical devices that are intended by the manufacturer specifically to be used for chemical disinfection of other medical devices, except for sterilisers using dry heat, moist heat or ethylene oxide.

Both Parties may decide by mutual arrangement to extend the application of this Sectoral Annex to the aforementioned medical devices.

▼B

SECTORAL ANNEX ON TELECOMMUNICATIONS TERMINAL EQUIPMENT TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS

SCOPE AND COVERAGE

The provisions of this Sectoral Annex shall apply to the following:







Products for export to the European Community Products for export to Australia Any product falling under the scope of Directive 98/13/EC of the European Parliament and of the Council of 12 February 1998 relating to telecommunications terminal equipment and satellite earth station equipment, including the mutual recognition of their conformity. In general terms, that Council Directive covers: (a) terminal equipment intended to be connected to the public telecommunications networks. The terminal equipment may be connected directly or indirectly to the termination of the public telecommunications network, and (b) satellite earth station equipment, which is capable of being used either for transmission only, or for transmission and reception, or for reception only, of radio communications signals by means of satellites or other space-based systems. Purpose-built satellite earth station equipment used as part of the public switched telecommunications network is excluded. This list of product groups may be extended to include other European Community common technical regulations in this sector as they become available. Any product defined as customer equipment in the Telecommunications Act 1997. In general this is equipment whose parameters are defined in the Australian Communications Authority Technical Standards as determined under the above Act. These requirements are set out in the Telecommunications Labelling (Customer Equipment and Customer Cabling) Notice No 2 of 1997.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS







The legislative, regulatory and administrative requirements of the European Community with which Australian designated conformity assessment bodies shall assess compliance The legislative, regulatory and administrative requirements of Australia with which European Community designated conformity assessment bodies shall assess compliance — Directive 98/13/EC of the European Parliament and of the Council of 12 February 1998 relating to telecommunications terminal equipment and satellite earth station equipment, including the mutual recognition of their conformity — Commission Decision 95/290/EC of 17 July 1995 on a common technical regulation for public land-based European radio message system (ERMES) receiver requirement — Commission Decision 95/525/EC of 28 November 1995 on a common technical regulation for attachment requirements for terminal equipment for digital European cordless telecommunications (DECT), public access profile (PAP) applications — Commission Decision 96/629/EC of 23 October 1996 on a common technical regulation for telephony application requirements for public pan-European cellular digital land-based mobile communications, Phase II — Commission Decision 96/630/EC of 23 October 1996 on a common technical regulation for the general attachment requirements for public pan-European cellular digital land-based mobile communications, Phase II — Commission Decision 97/346/EC of 20 May 1997 on a common technical regulation for the pan-European integrated services digital network (ISDN) basic access — Commission Decision 97/347/EC of 20 May 1997 on a common technical regulation for the pan-European integrated services digital network (ISDN) primary rate access — Commission Decision 97/486/EC of 9 July 1997 on a common technical regulation for the general attachment requirements for terminal equipment to interface to open network provision (ONP) two-wire analogue leased lines — Commission Decision 97/487/EC of 9 July 1997 on a common technical regulation for the attachment requirements for terminal equipment to interface to open network provision (ONP) four-wire analogue leased lines — Commission Decision 97/520/EC of 9 July 1997 on a common technical regulation for the attachment requirements for the terminal equipment interface for connection to 2 048 kbit/s digital unstructured ONP leased lines (Amendment 1) — Commission Decision 97/521/EC of 9 July 1997 on a common technical regulation for the attachment requirements for the terminal equipment interface for connection to 2 048 kbit/s digital structured ONP leased lines — Commission Decision 97/522/EC of 9 July 1997 on a common technical regulation for the attachment requirements for the terminal equipment interface for connection to 64 kbit/s digital unrestricted ONP leased lines (Amendment 1) — Commission Decision 97/523/EC of 9 July 1997 on a common technical regulation for the general terminal attachment requirements for digital enhanced cordless telecommunications (DECT) (edition 2) — Commission Decision 97/524/EC of 9 July 1997 on a common technical regulation for the telephony application requirements for digital enhanced cordless telecommunications (DECT) (edition 2) — Commission Decision 97/525/EC of 9 July 1997 on a common technical regulation for the attachment requirements for terminal equipment for digital enhanced cordless telecommunications (DECT) generic access profile (GAP) applications — Commission Decision 97/526/EC of 9 July 1997 on a common technical regulation for the general attachment requirements for public pan-European cellular digital land-based mobile communications (edition 2) — Commission Decision 97/527/EC of 9 July 1997 on a common technical regulation for the telephony application requirements for public pan-European cellular digital land-based mobile communications (edition 2) — Commission Decision 97/528/EC of 9 July 1997 on a common technical regulation for the general attachment requirements for mobile stations intended to be used with Phase II public digital cellular telecommunications networks operating in the DCS 1800 band — Commission Decision 97/529/EC of 9 July 1997 on a common technical regulation for the telephony application requirements for mobile stations intended to be used with Phase II public digital cellular telecommunications networks operating in the DCS 1800 band — Commission Decision 97/544/EC of 9 July 1997 on a common technical regulation for terminal equipment to be connected to public circuit switched data networks and ONP leased circuits using a CCITT Recommendation X.21 type interface — Commission Decision 97/545/EC of 9 July 1997 on a common technical regulation for the general attachment requirements for data terminal equipment (DTE) to connect to packet switched public data networks (PSPDNs) offering CCITT Recommendation X.25 interfaces — Commission Decision 97/639/EC of 19 September 1997 on a common technical regulation for the attachment requirements for the terminal equipment interface for connection to 34 Mbit/s digital unstructured and structured leased lines — Commission Decision 97/751/EC of 31 October 1997 on a common technical regulation for the attachment requirements for the terminal equipment interface for connection to 140 Mbit/s digital unstructured and structured leased lines — Telecommunications Act 1997 — Radiocommunications Act 1992

SECTION II

DESIGNATED CONFORMITY ASSESSMENT BODIES







The conformity assessment bodies designated by Australia to assess products against the European Community's legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against Australia's legislative, regulatory and administrative requirements The designated conformity assessment bodies are: [Name and details to be inserted] [Note: Further names to be added as required] The designated conformity assessment bodies are: [Name and details to be inserted] [Note: Further names to be added as required]

SECTION III

THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II







For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the European Community Under the authority of the Government of Australia: (a) For certification bodies: — The Joint Accreditation System of Australia and New Zealand (JAS-ANZ), and (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA). — Belgium — Institut belge des services postaux et des telecommunications — Belgisch instituut voor postdiensten en telecommunicatie — Denmark — Telestyrelsen — Germany — Bundesministerium für Wirtschaft — Greece — Υποζϱγείο Μειαφοϱών ϰαί Επιϰοινωνιών — Ministry of Transport and Communications — Spain — Ministerio de Fomento — France — Ministère de l'économie, des finances et de l'industrie — Secrétariat d'État à l'industrie — Direction des postes et télécommunications — Service des télécommunications — Ministère de l'économie, des finances et de l'industrie — Secrétariat d'État à l'industrie — Direction générale des stratégies industrielles — Sous direction de la qualité et de la normalisation — Ireland — Department of Transport, Energy and Communications — Italy — Ispettorato Generale TLC — Luxembourg — Administration des postes et télécommunications — Netherlands — De Minister van Verkeer en Waterstaat — Austria — Bundesministerium für Wissenschaft und Verkehr — Portugal — Instituto das Comunicações de Portugal — Finland — Liikenneministeriö/Trafikministeriet — Telehallintokeskus/Teleförvaltningscentralen — Sweden — Under the authority of the Government of Sweden: — Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — UK — Department of Trade and Industry

SECTION IV

PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES







The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community's requirements The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia's requirements The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives and be designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through: (a) Product Certification Bodies operating according to the requirements of EN 45011 or ISO Guides 28 and 40, and either: — accredited by JAS-ANZ, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. The procedures for designating conformity assessment bodies will be consistent with the principles and procedures set out in the Annex to the Agreement. (a) Testing laboratories: The following procedures are deemed to be consistent with those set out in the Annex to the Agreement: — accreditation by an accreditation body which is a signatory to the European cooperation for Accreditation (EA) Multilateral Agreement on Calibration and Testing, or — ability to demonstrate competence under an equivalent accreditation scheme. (b) Quality System Certification Bodies operating according to the requirements of EN 45012 or ISO Guide 62, and either: — accredited by JAS-ANZ, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. (c) Testing laboratories operating according to the requirements of EN 45001 or ISO Guide 25, and either: — accredited by NATA, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. (b) Certification Bodies: The following procedures are deemed to be consistent with those set out in the Annex to the Agreement: — accreditation by an accreditation body which is a signatory to the European cooperation for Accreditation (EA) Multilateral Agreement on Certification; — accreditation by an accreditation body with which JAS-ANZ has a mutual recognition agreement, or — ability to demonstrate competence under an equivalent accreditation scheme.

SECTION V

ADDITIONAL PROVISIONS

1. In accordance with Part 21 of the Telecommunications Act 1997, the Australian Communications Authority (ACA) is required to authorise a manufacturer or importer to apply a label to customer equipment prior to placing that customer equipment on the Australian market. Within the framework of this Agreement, the ACA will use its best endeavours, within five (5) working days and in any case no longer than 10 days, to issue such an authorisation in accordance with procedures set out in the Telecommunications Labelling (Customer Equipment and Customer Cabling) Notice No 2 of 1997.

2. It is agreed by both Parties that the relevant Council Directives and Australian legislative and regulatory requirements allow mutual recognition of separate elements of the conformity assessment process. Accordingly each Party shall accept test reports issued by conformity assessment bodies designated by the other Party as meeting its requirements in this regard.

3. Where the legislative, regulatory or administrative provisions of either Party require it, conformity assessment bodies subcontracting all or part of the testing must subcontract only to testing laboratories accredited in accordance with clause (a) in Section IV above.

4. In respect of telecommunications terminal equipment which is subject to the provisions of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits and Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, the relevant provisions of the Sectoral Annexes on, respectively, Low Voltage Equipment and Electromagnetic Compatibility shall apply.







ACA technical standards TS 001 TS 0014 TS 002 TS 0015 TS 003 TS 0016 TS 004 TS 0018 TS 005 TS 0019 TS 006 TS 0020 TS 007 TS 0021.1 TS 008 TS 0021.2 TS 009 TS 0021.3 TS 0012 TS 0023 TS 0013.1 TS 0024 TS 0013.2 TS 0028

SECTORAL ANNEX ON LOW VOLTAGE EQUIPMENT TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS

SCOPE AND COVERAGE

The provisions of this Sectoral Annex shall apply to the following types of low voltage equipment:

— All products falling within the scope of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits.

— Electrical products which are within the scope of Australian State and Territory legislation for the safety of low voltage electrical equipment.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS







The legislative, regulatory and administrative requirements of the European Community with which Australian designated conformity assessment bodies shall assess compliance The legislative, regulatory and administrative requirements of Australia with which European Community designated conformity assessment bodies shall assess compliance Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits, as amended New South Wales — Electricity Act 1945 — Electricity (Equipment Safety) Regulation 1994 Victoria — State Electricity Commission Act 1958 — Electricity Industry Act 1993 Queensland — Electricity Act 1994 — Electricity Regulation 1994 Western Australia — Electricity Act 1945 — Electricity Act Regulations 1947 South Australia — Electrical Products Act 1988 Tasmania — Hydro Electric Commission Act 1944 Australian Capital Territory — Electricity Act 1971 Northern Territory — Power and Water Authority Act 1987 — Electricity By-Laws

SECTION II

DESIGNATED CONFORMITY ASSESSMENT BODIES







The conformity assessment bodies designated by Australia to assess products against the European Community's legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against Australia's legislative, regulatory and administrative requirements The designated conformity assessment bodies are: [Name and details to be inserted] [Note: Further names to be added as required] The designated conformity assessment bodies are: [Name and details to be inserted] [Note: Further names to be added as required]

SECTION III

THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II







For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the European Community Under the authority of the Government of Australia: (a) For certification bodies: — The Joint Accreditation System of Australia and New Zealand (JAS-ANZ), and (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA) — Belgium — Ministère des affaires économiques — Ministerie van Economische Zaken — Denmark — Boligministeriet — Germany — Bundesministerium für Arbeit und Sozialordnung — Greece — Ζπονϱγείο Ανáπινξηϛ — Ministry of Development — Spain — Ministerio de Industria y Energía — France — Ministère de l'économie, des finances et de l'industrie — Secrétariat d'État à l'industrie — Direction générale des stratégies industrielles — Sous direction de la qualité et de la normalization — Ireland — Department of Enterprise and Employment — Italy — Ministero dell'Industria, del Commercio e dell'Artigianato — Luxembourg — Ministère des transports — Netherlands — Staat der Nederlanden — Austria — Bundesministerium für wirtschaftliche Angelegenheiten — Portugal — Under the authority of the Government of Portugal: — Instituto Português da Qualidade — Finland — Kauppa- ja teollisuusministeriö/ Handels- och industriministeriet — Sweden — Under the authority of the Government of Sweden: — Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — UK — Department of Trade and Industry

SECTION IV

PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES







The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community's requirements The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia's requirements The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives and be designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through: (a) Inspection bodies operating in accordance with the requirements of EN 45004 or ISO Guide 39, and either: — accredited by NATA, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. (b) Testing laboratories operating according to the requirements of EN 45001 or ISO Guide 25, and either: — accredited by NATA, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. The following procedures are deemed to be consistent with the procedures set out in the Annex to the Agreement: (a) Testing laboratories: — accredited by accreditation bodies which are signatories to the European cooperation for Accreditation (EA) Multilateral Agreement on Calibration and Testing, or — recognised within the IECE CB scheme, or — able to demonstrate competence under an equivalent accreditation scheme. (b) Certification bodies — accredited by accreditation bodies which are signatories to the European cooperation for Accreditation (EA) Multilateral Agreement on Certification — membership of the IECEE CB scheme — accredited by an accreditation body with which JAS-ANZ has a mutual recognition agreement, or — able to demonstrate competence under an equivalent accreditation scheme.

SECTION V

ADDITIONAL PROVISIONS

1. In accordance with Australian legislation set out in Section I of this Annex, certain types of electrical equipment (the Declared Articles list) are required to be registered before they can be placed on the market. Within the framework of this Agreement, the Australian State and Territory Regulatory Authorities will within five (5) working days register a product from the European Community upon receipt of an application accompanied by the designated fee without further assessment of the product. The designated fee will be related to the costs of the electrical equipment registration, enforcement and post-market surveillance activities of the Australian regulatory authorities.

2. The Parties note that a Regulatory Compliance Mark (RCM) is to be introduced in Australia in August 1996. The adoption of the RCM, together with changes to Australian regulatory requirements, may result in due course in the removal of the arrangements described in paragraph 1 above. Any conditions for use of the RCM will respect the principles of the Mutual Recognition Agreement, notably Article 2 of the Agreement.

3. Where the legislative, regulatory or administrative provisions of either Party require it, conformity assessment bodies subcontracting all or part of the testing must subcontract only to testing laboratories accredited in accordance with clause (a) in Section IV above.

4. In the event of a challenge within the European Community under Article 8(2) of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits, test reports issued by designated conformity assessment bodies in Australia will be accepted by European Community authorities in the same way that reports from European Community notified bodies are accepted. That is, conformity assessment bodies in Australia will be recognised under Article 11 of that Council Directive as ‘bodies which may make a report in accordance with Article 8’.

SECTORAL ANNEX ON ELECTROMAGNETIC COMPATIBILITY TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS

SCOPE AND COVERAGE

The provisions of this Sectoral Annex shall apply to the following:

— Electromagnetic compatibility of equipment as defined in Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, but excluding radiocommunications equipment which is not connected to the public switched telecommunication networks, and

— Electromagnetic compatibility of equipment regulated under the Australian Radiocommunications Act 1992.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS







The legislative, regulatory and administrative requirements of the European Community with which Australian designated conformity assessment bodies shall assess compliance The legislative, regulatory and administrative requirements of Australia with which European Community designated conformity assessment bodies shall assess compliance Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, as amended Radiocommunications Act 1992

SECTION II

DESIGNATED CONFORMITY ASSESSMENT BODIES







The conformity assessment bodies designated by Australia to assess products against the European Community's legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against Australia's legislative, regulatory and administrative requirements The designated conformity assessment bodies are: [Name and details to be inserted] [Further names to be added as required] The designated conformity assessment bodies are: ►M2 — Finland — Nordic Accredited Testing Laboratories Oy NATLABS PO box 677 (Koneenkatu 12) FIN-05801 HYVINKÄÄ, Tel. (358-20) 475 2600 Fax (358-20) 475 2719 ◄

SECTION III

THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II







For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the European Community Under the authority of the Government of Australia: (a) For certification bodies: — The Joint Accreditation System of Australia and New Zealand (JAS-ANZ) (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA) — Belgium — Ministère des affaires economiques — Ministerie von Economische Zaken — Denmark — For telecommunication equipment: — Telestyrelsen — For other equipment: — Danmarks Elektriske Materielkontrol (DEMKO) — Germany — Bundesministerium für Wirtschaft — Greece — Υποζϱγείο Μειαφοϱών ϰαι Επιϰοινωνιών — Ministry of Transport and Communications — Spain — For telecommunication equipment: — Ministerio de Fomento — for other equipment: — Ministerio de Industria y Energía — France — Ministère de l'économie, des finances et de l'industrie — Secrétariat d'État à l'industrie — Direction générale des stratégies industrielles — Sous direction de la qualité et de la Normalization — Ireland — Department of Transport, Energy and Communications — Italy — Ministero dell'Industria, del Commercio e dell'Artigianato — Luxembourg — Ministère des transports — Netherlands — De Minister van Verkeer en Waterstaat — Austria — For telecommunication equipment: — Bundesministerium für Wissenschaft und Verkehr — For other equipment: — Bundesministerium für wirtschaftliche Angelegenheiten — Portugal — Under the authority of the Government of Portugal: — Instituto das Comunicações de Portugal — Finland — For telecommunication equipment: — Liikenneministeriö/Trafikministeriet — For other equipment: — Kauppa- ja teollisuusministeriö/Handels- och industriministeriet — Sweden — Under the authority of the Government of Sweden: — Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — UK — Department of Trade and Industry

SECTION IV

PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES







The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community's requirements The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia's requirements The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives, and are designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through: (a) For the purposes of Article 10(5) of Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, inspection bodies operating according to the requirements of EN 45004 or ISO Guide 39, and either: — accredited by NATA, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. (b) For competent bodies according to Article 10(2) of Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, testing laboratories operating according to the requirements of EN 45001 or ISO Guide 25, and either: — accredited by NATA, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. The following procedures are deemed to be consistent with the procedures set out in the Annex to the Agreement: (a) Testing laboratories operating according to the requirements of ISO Guide 25 or EN 45001, and either: — accredited by accreditation bodies which are signatories to the European cooperation for Accreditation (EA) Multilateral Agreement on Calibration and Testing, or — able to demonstrate competence under an equivalent accreditation scheme. (b) Inspection bodies operating according to the requirements of ISO Guide 39 or EN 45004, and either: — accredited by accreditation bodies which are signatories to a European Multilateral Agreement, or — able to demonstrate competence under an equivalent accreditation scheme.

SECTION V

ADDITIONAL PROVISIONS

The European Community and Australia agree that

1. Reports and certificates prepared by European Community competent bodies will be accepted by Australian regulatory authorities.

2. Reports and certificates prepared by designated conformity assessment bodies in Australia will also be accepted by European Community authorities on the same basis as reports and certificates prepared by European Community competent bodies.

3. Where the legislative, regulatory or administrative provisions in either Party require it, conformity assessment bodies subcontracting all or part of the testing must subcontract only to testing laboratories accredited in accordance with clause (a) in Section IV above.

4. The Parties note the Australian requirement for its competent bodies to be members of the Australian Association of Competent Bodies and the Commission's current consideration of a proposal to establish a Technical Secretariat for Notified Bodies and Competent Bodies under Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility to promote the coordination activities of these Bodies under this Directive. The Parties also note the European Commission's intention to encourage competent bodies to participate in coordination activities.

SECTORAL ANNEX ON MACHINERY TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS

SCOPE AND COVERAGE

The provisions of this Sectoral Annex shall apply to the products listed in Annex IV to Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery and to tower cranes and mobile cranes.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS







The legislative, regulatory and administrative requirements of the European Community with which Australian designated conformity assessment bodies shall assess compliance The legislative, regulatory and administrative requirements of Australia with which European Community designated conformity assessment bodies shall assess compliance — Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery, as amended — Directives setting out noise limitation requirements for tower cranes as follows: — — Council Directive 79/113/EEC of 19 December 1978 on the approximation of the laws of the Member States relating to the determination of the noise emission of construction plant and equipment, as amended — Council Directive 84/532/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to common provisions for construction plant and equipment, as amended — Council Directive 84/534/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of tower cranes, as amended The following legislative, regulatory and administrative requirements cover the conformity assessment procedures for the use of products covered by this Annex. New South Wales Victoria — Occupational Health and Safety Act 1985 (1) — Occupational Health and Safety (Plant) Regulations 1995 (1) — Code of Practice for Plant 1995 (1) — Equipment (Public Safety) Act 1994 (1) — Equipment (Public Safety) (General) Regulations 1995 (1) Queensland — Workplace Health & Safety Act 1995 — Workplace Health & Safety Regulation 1995 — Workplace Health & Safety (Plant) — Code of Practical Approval Notice 1993 Western Australia — Occupational Safety & Health Regulations 1996 South Australia — Occupational Health, Safety & Welfare Act 1986 — Occupational Health, Safety & Welfare Regulations 1995 Tasmania — Workplace Health & Safety Act 1995 Australian Capital Territory Northern Territory — Work Health Act — Work Health (Occupational Health and Safety) Regulations (1) There are no mandatory conformity assessment requirements under this legislation.

SECTION II

DESIGNATED CONFORMITY ASSESSMENT BODIES







The conformity assessment bodies designated by Australia to assess products against the European Community's legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against Australia's legislative, regulatory and administrative requirements The designated conformity assessment bodies are: [Name and details to be inserted] [Further names and details to be added as required] The designated conformity assessment bodies are: [Name and details to be inserted] [Further names and details to be added as required]

SECTION III

THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II







For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the European Commission Under the authority of the Government of Australia: (a) For certification bodies: — the Joint Accreditation System of Australia and New Zealand (JAS-ANZ) (b) For testing laboratories and inspection bodies: — The National Association of Testing Authorities, Australia (NATA) — Belgium — Ministère de l'économie — Ministerie van Economie — Denmark — Direktoratet fur Arbejdstilsynet — Germany — Bundesministerium für Arbeit und Sozialordnung — Greece — Υπονϱγείο Ανáπινξηϛ — Ministry of Development — Spain — Ministerio de Industria y Energía — France — Ministère de l'économie, des finances et de l'industrie — Secrétariat d'Etat à l'industrie — Direction de l’action régionale de de la petite et moyenne industrie — Sous direction de la Sécurité industrielle — Ministère de l'économie, des finances et de l'industrie — Secrétariat d'Etat à l'industrie — Direction générale des stratégies industrielles — Sous direction de la qualité et de la normalisation — Ireland — Department of Enterprise and Employment — Italy — Ministero dell'Industria, del Commercio e dell'Artigianato — Luxembourg — Ministère des transports — Netherlands — Staat der Nederlanden — Austria — Bundesministerium für wirtschaftliche Angelegenheiten — Portugal — Under the authority of the Government of Portugal: — Instituto Português da Qualidade — Finland — Sosiaali- ja terveysministeriö/ Social- och hälsovardsministeriet — Sweden — Under the authority of the Government of Sweden: — Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — UK — Department of Trade and Industry

SECTION IV

PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES







The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community's requirements The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia's requirements The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives, and are designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through: (a) For the purpose of Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery: Inspection bodies operating to the requirements of EN 45004 or ISO Guide 39, and either: — accredited by NATA, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. (b) For the purpose of Council Directives setting out noise limitation requirements for tower cranes: Product certification bodies operating according to the requirements of EN 45011 or ISO Guides 28 and 40, and either: — accredited by JAS-ANZ, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. In accordance with the specific requirements set out in the legislation, regulations and administrative provisions listed in Section I, and where these make compliance with Australian standards for plant mandatory, the conformity assessment bodies listed in Section II are designated by the designating authorities specified in Section III in accordance with the following criteria: — Design verification for compliance with technical standards may not be required under all legislation listed in Section I. — If design verification is required it must be conducted by a design verifier who has not been involved in the machinery design and who has acquired through training, qualification, or experience, or a combination of these, the knowledge and skills enabling that person to perform this task. Where the designer and design verifier are employed or engaged by the same person the whole of the design process must, if the legislation requires, operate: (a) within a quality system meeting requirements of ISO 9001 and be certified by a quality systems certification body operating according to the requirements of ISO Guide 62 or EN 45012, and either: — accredited by an accreditation body which is a signatory