Compliance with good manufacturing practice (“GMP”) is mandatory for all medicinal products that have been granted a marketing authorisation. Likewise, the manufacture of investigational medicinal products must be in accordance with GMP. Advanced therapy medicinal products that are administered to patients under Article 3 of Directive 2001/83/EC (so called “hospital exemption”) must be manufactured under equivalent quality standards to the manufacturing of advanced therapy medicinal products with a marketing authorisation.
Article 5 of Regulation (EC) No 1394/2007 mandates the Commission to draw up guidelines on good manufacturing practice specific to advanced therapy medicinal products ("ATMPs"). Article 63(1) of Regulation (EU) No 536/2014 also empowers the Commission to adopt and publish detailed guidelines on good manufacturing practice applicable to investigational medicinal products.
EC 22.11.2017
EudraLex 22.11.2017
Requisiti di protezione fisica passiva e modalità di redazione dei piani di protezione fisica
Art. 1. Finalità e campo di applicazione
Il presente decreto stabilisce i requisiti ...
REACH Authorisation Decisions List of authorisation decisions adopted on the basis of Article 64 of Regulation (EC) No 1907/2006 (REACH). The list also includes refer...
ID 21684 | 12.04.2024
Decreto 4 aprile 2024 Entrata in vigore dei testi, nelle lingue inglese e francese, pubblicati nel supplemento 11.4...
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024
