The Rules Governing Medicinal Products in the European Union Volume 4
Good Manufacturing Practice Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
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.