Done at Brussels, 6 November 2001.
For the European Parliament
The President
N. Fontaine
For the Council
The President
D. Reynders
(1) OJ C 368, 20.12.1999, p. 3.
(2) Opinion of the European Parliament of 3 July 2001 (not yet published in the Official Journal) and Council Decision of 27 September 2001.
(3) OJ 22, 9.2.1965, p. 369/65. Directive as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).
(4) OJ L 147, 9.6.1975, p. 1. Directive as last amended by Commission Directive 1999/83/EC (OJ L 243, 15.9.1999, p. 9).
(5) OJ L 147, 9.6.1975, p. 13. Directive as last amended by Commission Directive 2000/38/EC (OJ L 139, 10.6.2000, p. 28).
(6) OJ L 142, 25.5.1989, p. 14.
(7) OJ L 142, 25.5.1989, p. 16.
(8) OJ L 181, 28.6.1989, p. 44.
(9) OJ L 113, 30.4.1992, p. 1.
(10) OJ L 113, 30.4.1992, p. 5.
(11) OJ L 113, 30.4.1992, p. 8.
(12) OJ L 113, 30.4.1992, p. 13.
(13) OJ L 297, 13.10.1992, p. 8.
(14) OJ L 214, 24.8.1993, p. 1. Regulation as amended by Commission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).
(15) OJ L 265, 5.10.1984, p. 1. Directive repealed with effect from 13 May 2000 by Directive 97/43/Euratom (OJ L 180, 9.7.1997, p. 22).
(16) OJ L 246, 17.9.1980, p. 1. Directive as amended by Directive 84/467/Euratom (OJ L 265, 5.10.1984, p. 4), repealed with effect from 13 May 2000 by Directive 96/29/Euratom (OJ L 314, 4.12.1996, p. 20).
(17) OJ L 250, 19.9.1984, p. 17. Directive as amended by Directive 97/55/EC (OJ L 290, 23.10.1997, p. 18).
(18) OJ L 298, 17.10.1989, p. 23. Directive as amended by Directive 97/36/EC (OJ L 202, 30.7.1997, p. 60).
(19) OJ L 184, 17.7.1999, p. 23.
(20) OJ L 207, 30.7.1986, p. 1.
(21) OJ L 15, 17.1.1987, p. 38. Directive repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40).
(22) OJ L 187, 9.6.1975, p. 23.
(23) OJ L 55, 11.3.1995, p. 7. Regulation amended by Regulation (EC) No 1146/98 (OJ L 159, 3.6.1998, p. 31).
ANNEX I
ANALYTICAL, PHARMACOTOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTS
INTRODUCTION
The particulars and documents accompanying an application for marketing authorization pursuant to Articles 8 and 10(1) shall be presented in four parts, in accordance with the requirements set out in this Annex and taking account of the guidance published by the Commission in The rules governing medicinal products in the European Community,Volume II: Notice to applicants for marketing authorizations for medicinal products for human use in the Member States of the European Community.
In assembling the dossier for application for marketing authorization, applicants shall take into account the Community guidelines relating to the quality, safety and efficacy of medicinal products published by the Commission in The rules governing medicinal products in the European Community, Volume III and its supplements: Guidelines on the quality, safety and efficacy of medicinal products for human use.
All information which is relevant to the evaluation of the medicinal product concerned shall be included in the application, whether favourable or unfavourable to the product. In particular, all relevant details shall be given of any incomplete or abandoned pharmacotoxicological or clinical test or trial relating to the medicinal product. Moreover, in order to monitor the benefit/risk assessment after marketing authorization has been granted, any change to the data in the dossier, any new information not in the original application and all pharmacovigilance reports, shall be submitted to the competent authorities.
The general sections of this Annex give the requirements for all categories of medicinal products; they are supplemented by sections containing additional special requirements for radiopharmaceuticals and for biological medicinal products, such as immunological medicinal products derived from human blood or plasma. The additional special requirements for biological medicinal products are also applicable to medicinal products obtained through processes mentioned in Part A and the first indent of Part B of the Annex to Regulation (EEC) No 2309/93.
Member States shall also ensure that all tests on animals are conducted in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulation and administrative provisions of the Member States regarding the protection of animals for experimental and other scientific purposes(1).