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These Guidelines are based on EU law and provide tools for wholesale distributors of medicinal products for human use. They cover quality management, storage, transport, compliance and verification of GDP.
- Good distribution practice | European Medicines Agency (EMA)
In addition to the Directives mentioned above, two European...
- Good Manufacturing and Distribution Practices - European Commission
Specific GMP Guidelines have been developed for ATMPs....
- Good distribution practice | European Medicines Agency (EMA)
Learn about the EU legal framework and guidance on GDP for medicines and active substances. Find out how to obtain a wholesale distribution authorisation and access the EudraGMDP database.
These guidelines provide stand-alone guidance on Good Distribution Practice (GDP) for importers and distributors of active substances for medicinal products for human use. They complement the rules on distribution set out in the guidelines of EudraLex Volume 4, Part II, and apply also to distributors of active substances manufactured by themselves.
Find the most important guidelines on GDP for medicinal products, APIs, excipients and blood products from various sources, including EU, WHO and PIC/S. Learn more about GDP training, audits, membership and activities from the European GDP Association.
Learn about the legal requirements and guidance for good manufacturing practices (GMP) of medicinal products for human and veterinary use in the EU. Find out the mutual recognition agreements (MRAs) and related agreements on GMP with third countries, such as the US and Japan.
The Commission guidelines on GDP of medicinal products for human use, were first published in 1994 and revised in 2013 to take into account recent advances in appropriate storage and distribution practices.
5 lis 2013 · EU law Download Order Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use Text with EEA relevance
