GDP: Questions & Answers about the Scope of the EU-GDP Guidelines

Recommendation

14/15 December 2021

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The European GDP Association has recently updated its "Good Distribution Practices (GDP) - FAQs". In this second set of questions and answers, details about the scope are addressed. The following ambiguities are clarified:

Do the EU-GDP Guidelines apply for:

• Veterinary products?
• Investigational Medicinal Products (IMPs)?
• Active Pharmaceutical Products (APIs) and Excipients?
• Hubs?

But the issuance of official GDP certificates is also explained. It is pointed out that "transport companies do not need to hold a wholesale distribution authorisation to transport medicinal products". But, of course, they need to "follow the parts of the GDP guideline relevant to their activities, amongst others Chapter 9". EU competent supervisory authorities carry out GDP inspections (and issue GDP certificates) only of companies holding wholesale distribution authorisations or companies which are aiming for one. Some are also part of GMP inspections at pharmaceutical manufacturers.

Find out more in the FAQs on the European GDP Association website.