Annex 1

(Art. 4 para. 2, 7 para. 2, 13 para. 2 let. a, 27 para. 1 let. c, 37 para. 1 let. e,
45 let. d)

International rules of Good Manufacturing Practice

1. The following guidelines apply as rules of Good Manufacturing Practice (GMP):
   1. Commission Directive 2003/94/EC of 8 October 2003¹laying down the principles and guidelines of Good Manufacturing Practice in respect of medicinal products for human use and investigational medicinal products for human use;
   2. Commission Directive 91/412/EEC of 23 July 1991²laying down the principles and guidelines of Good Manufacturing Practice for veterinary medicinal products;
   3. Guide to Good Manufacturing Practice for medicinal products for human use and medicinal products for veterinary use of the European Commission (EudraLex, Volume 4)³;
   4. Principles and Guidelines for Good Manufacturing Practice in accordance with the Convention for the mutual recognition of inspections in respect of the manufacture of pharmaceutical products of 8 October 1970⁴.
2. Special provisions for medicated feedingstuffs: Council Directive 90/167/EEC of 26 March 1990⁵laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community.
3. Special provisions for blood and blood products: The Guidelines for Good Practice described in the annex to Recommendation R (95) 15 of the Council of Europe of 12 October 1995⁶on the preparation, use and quality assurance of blood components.