GDP for Active Substances used as Starting Materials in Veterinary Medicinal Products: Obligation to Perform Audits
![GDP in Switzerland (GDP 3)](files/eca/userImages/training.img/Z-GDP3-GDP-in-Switzerland-neues-Layout.jpg)
Recommendation
12 September 2024
Basel, Switzerland
Specifics in the Distribution of Medicinal Products (Course in english language!)
The European Medicines Agency (EMA) has updated its list of questions and answers on Good Manufacturing Practice (GMP) and Good Distribution Practice (GMP). The newly added chapter from February 2022 deals with the requirements for active substances used as starting materials in veterinary medicinal products.
A total of six questions are answered. Question 2 deals with the new obligations for active substances used as starting materials in veterinary medicinal products under the Veterinary Medicines Regulation. The following is clarified:
"The Veterinary Medicines Regulation requires manufacturers and importers of veterinary medicinal products to:
- verify that manufacturers, importers and distributors within the Union from whom they source the active substances have registered their activities in the territory of the Member State where they are established; and
- perform audits based on a risk-assessment on the manufacturers, distributors and importers from whom they source the active substances."
A short summary of the question and answer document can be found here.
The complete list of questions and answers is available on the EMA website.
Related GMP News
16.07.2024Templates for Shortage Prevention and Mitigation Plans issued by EMA
16.07.2024New Measures to Report Medicine Disappearances
16.07.2024GDP Non-Compliance Report for Czech Wholesale Distributor
16.07.2024Checklist for Implementation of GDP Principles - Part 9: Transportation
12.06.2024EU adopts Supply Chain Law - Implications for pharmaceutical Companies