(Art. 13 para. 2 let. d, 15 para. 2, 17 para. 2, 20 para. 3, 45 let. d, 49 para. 5)
The following guidelines apply as rules of Good Distribution Practice (GDP):
1. European Commission Guidelines of 19 March 20153on principles of Good Distribution Practice of active substances for medicinal products for human use,
2. Implementing Regulation (EU) 2021/12804;
c. Special provisions for medicated feedingstuffs: by analogy with** Regulation (EU) 2019/45.
Communication of the European Commission, OJ C 343 of 23.11.2013, p. 1. ↩
Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council; Amended by OJ L 272 of 30.7.2021, p. 46. ↩
Communication of the European Commission, OJ C 95 of 21.3.2015, p. 1. ↩
Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council; last amended by OJ L 279 of 3.8.2021, p. 1. ↩
Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC; last amended by OJ L 4 of 7.1.2019, p. 1. ↩
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