GDP for Active Substances used as Starting Materials in Veterinary Medicinal Products: Obligation to Perform Audits

Recommendation

1/2 March 2023

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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.