Transcription of Guidelines Detailed Commission guidelines on good
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Guidelines Detailed Commission guidelines on good
EUROPEAN. Commission . Brussels, C(2017) 8179 final Guidelines Detailed Commission Guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014. EN EN. 1 INTRODUCTION. 2 These Guidelines are based on the second subparagraph of Article 63(1) of Regulation 3 (EU) No 536/20141. 4 These Guidelines complement Commission Delegated Regulation (EU) 2017/1569 of 23. 5 May 2017 supplementing Regulation (EU) No 536/2014 on the good manufacturing 6 practice for investigational medicinal products for human use and arrangements for 7 inspections2 that has as its legal basis the first subparagraph of Article 63(1) of 8 Regulation (EU) No 536/2014. 9 These Guidelines lay down appropriate tools to address specific issues concerning 10 investigational medicinal products with regard to good manufacturing practice.
30 to investigational medicinal products, not specifically mentioned in these guidelines, are 31 Part I, Chapters 2, and 6, and Part III. 1 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
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