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EudraLex Vol 4, Annex 13: Investigational Medicinal Products. 3 Feb 2010 EU Guidelines to. Good Manufacturing Practice. Medicinal Products for Human and Veterinary Use. Annex 13. Investigational Medicinal EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which ANNEX 13 REVISION 1 the detailed guidelines of Good Manufacturing Practice for Medicinal Products The application of GMP to the manufacture of investigational .. of Directive 2001/83/EC and subject to an EU marketing authorisation, 20 Dec 2017 Annex 13: Detailed Commission Guideline on GMP for IMPs published. It supplements the EU Clinical Trials Regulation (CTR) 536/2014 by specifying principles and guidelines for good manufacturing practice (GMP) for investigational medicinal products (IMPs) for human use and arrangements for inspections. 29 Jan 2010 Guidance Document - Annex 13 to the Current Edition of the Good . and Table 2 were removed since they apply to European ( EU ) Member States and The " GMP Guidelines (GUI-0001)" and a link to the Food and Drug 29 Jan 2018 As previously reported the final "Detailed Commission guidelines on GMP for in December 2017 in Annex 13 of the EU GMP-Guidelines. appropriate GMP conditions, most aspects of this annex derive from human GCP The principles and many of the detailed guidelines of Good Manufacturing Annex 13 doesn't contain any reference for the necessity to minimise the risk of the Amend Definitions as of the glossary in Eudralex Volume 4 (GMP).What's the importance of Annex 13 Labeling Requirements? . the labeling requirements laid out in Annex 13 of the EU GMP guidelines This annex details