What is the legal status of the European Pharmacopoeia?

05.08.2019

Question of the Week

The European Pharmacopoeia is binding in the European Union. The legal basis for this is provided by EU Directives 2001/82/EC, 2001/83/EC, and 2003/63/EC (as amended) for medicinal products for human use and veterinary medicinal products.

[GMP Compliance Adviser, Chapter 14.K.4]

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