10.

The Sectoral Annex on medicinal products GMP inspection and batch certification, including Appendix 1 and Appendix 2, is replaced by the following: ‘SECTORAL ANNEX ON MEDICINAL PRODUCTS GMP INSPECTION AND BATCH CERTIFICATION TO THE EUROPEAN COMMUNITY – NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT SCOPE AND COVERAGE 1. The provisions of this Sectoral Annex cover all medicinal products which are industrially manufactured in New Zealand 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 New Zealand 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 homoeopathic 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 jointly 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 are 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 to be in conformity with GMP. The batch certificate will be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Union the ‘qualified person’ as referred to in relevant European Union legislation. In New Zealand, the responsible person is named on the licence to manufacture issued under the relevant New Zealand 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 set out in the Table. 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. Applicable legislative, regulatory and administrative provisions for the European Union Applicable legislative, regulatory and administrative provisions for New Zealand — 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 — Medicines Act, 1981 — Medicines Regulations, 1984 — New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Parts 1, 2, 4 and 5 — Agricultural Compounds and Veterinary Medicines Act, 1997 — Agricultural Compounds and Veterinary Medicines Regulations, 2001 — Agricultural Compounds and Veterinary Medicines (ACVM) Standard for Good Manufacturing Practice — Agricultural Compounds and Veterinary Medicines (ACVM) Guideline for Good Manufacturing Practice — and any legislation adopted on the basis of, or that amends, the above legislation SECTION II OFFICIAL INSPECTION SERVICES The lists of official inspection services related to this Sectoral Annex have been jointly determined 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 the 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 the case where 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 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 New Zealand 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 does 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 procedure for medicinal products for human use is published by the European Directorate for the Quality of Medicines & HealthCare. For New Zealand, 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 designated by 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 jointly 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, inspector training sessions, technical requirements, will be: FOR NEW ZEALAND: For medicinal products for human use: Group Manager Medicines and Medical Devices Safety Authority (Medsafe) PO Box 5013 Wellington New Zealand Tel. 64-4-819 6874 Fax 64-4-819 6806 For medicinal products for use in animals: Director, Approvals and ACVM Standards Ministry of Agriculture and Forestry (MAF) PO Box 2526 Wellington 6140 New Zealand Tel. 64-4-894 2541 Fax 64-4-894 2501 FOR THE EUROPEAN UNION: The Director of the European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Tel. 44-171-418 8400 Fax 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 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.’.