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EU cGMPs for ATMP - 2018 Advanced Therapy Medicinal Products

EU cGMPs for ATMP - 2018 Advanced Therapy Medicinal Products

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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

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.

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