EU cGMPs for ATMP - 2018: Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products

EudraLex
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

Adoption 22 November 2017
In Operation: 22 May 2018

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 equivalent quality standards to the manufacturing of advanced therapy medicinal products with a marketing authorisation.