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.

EC 22.11.2017

EudraLex 22.11.2017

Guidelines GMP specific to Advanced Therapy Medicinal Products

EU 2017

IT

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