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Learn about the EU standards and guidelines for wholesale distribution of medicines and active substances. Find out how to obtain a wholesale distribution authorisation, register with EudraGMDP and comply with GDP inspections.
- Guidelines of 5 November 2013 on Good Distribution Practice of ...
The Commission has published EU Guidelines on Good...
- Guidance on good manufacturing practice and good distribution practice ...
The guidance provided by the working group in the form of...
- Guidelines of 5 November 2013 on Good Distribution Practice of ...
These Guidelines provide the principles and requirements for wholesale distributors of medicinal products for human use in the EU. They cover topics such as quality management, storage, transport, compliance and verification.
The guidance provided by the working group in the form of questions and answers (Q&As) provides additional interpretation of the European Union (EU) GMP guidelines and GDP guidelines published by the European Commission. The working group prepares these Q&As as the need arises.
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 Good Distribution Practices (GDP) for different types of pharmaceutical products, such as medicinal products, APIs and excipients. The web page provides links to EU, WHO, PIC/S and IPEC documents and resources on GDP.
Article 80(g) of Directive 2001/83/EC provides that distributors must comply with the principles and guidelines of good distribution practice (GDP). Manufacturers distributing their own products should also comply with GDP.
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.
