GDP: Questions & Answers about the Scope of the EU-GDP Guidelines
Recommendation
9 September 2025
Basel, Switzerland
Specifics in the Distribution of Medicinal Products
Register now for ECA's GMP Newsletter
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.
Related GMP News
15.07.2025New Swissmedic Technical Interpretation on Returns of Medicinal Products
15.07.2025Two new GDP Non-Compliance Reports from Austria and Ireland published in the EudraGMDP database
15.07.2025Reminder: Participate in the GDP Implementation Survey until 31 July 2025
15.07.2025PDA Publishes Results of Transportation Validation Benchmarking Survey
10.06.2025Stimuli Article Proposes Revision of USP Definition of Controlled Room Temperature (CRT)
10.06.2025New MHRA Blog Post: Supplying Medicines to Ships, Aircraft and Oil Platforms