This guideline complements the Delegated Regulation (EU) No 2017/1569 of 23 May 2017, on good manufacturing practice (GMP) for investigational medicinal products (IMP) and arrangements for inspections, that has as legal basis the first subparagraph of Article 63(1) of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and the detailed Commission guidelines No C(2017) 8179 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.
The guideline lays down the principles for management of the investigational medicinal products by the sponsor for use in a clinical trial and in accordance with Good Clinical Practice (GCP) which are at the interface with, and complementary to, Good Manufacturing Practice