LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS. Subject to Section III "Operational provisions", general GMP inspections will be carried out against the GMP requirements of the exporting Party. The legislative, regulatory and administrative requirements are listed in the Appendix 1. 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.
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 authori sation 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 — Xxxxxxxxx Xxx, 0000 — 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
