The Rules Governing Medicinal Products
in the European Union
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.