Tuesday, 12 March 2024 14.00 - 16.00 h
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:
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.