Good Manufacturing Practice :The Rules Governing Medicinal Products in the European Union. Volume 4

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(7) of Directive 2001/83/EC1 (so called “hospital exemption”) must be manufactured under equivalente quality standards to the manufacturing of advanced therapy medicinal products with a marketing authorisation.

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