EMA updates Questions and Answers Document

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The European Medicines Agency (EMA) provides answers to frequently asked questions on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) on its website. These have been compiled and agreed by the GMP/GDP Inspectors Working Group.

This Q&A guidance provides additional interpretation of the European Union (EU) GMP Guidelines and GDP Guidelines published by the European Commission. The list is regularly supplemented or updated. Currently, the legal requirements for veterinary medicinal products have been newly regulated in the EU. To this end, the previously applicable Directive 2001/82/EC - EU Codex for Veterinary Medicinal Products will be repealed on 28 January 2022 and replaced by Regulation (EU) 2019/6. This regulation includes provisions on authorisation, post-authorisation measures, manufacture, import, export, supply and use of veterinary medicinal products, as well as restrictions and sanctions. Accordingly, the questions and answers have now been updated.

The new chapter deals with requirements for active substances that are used as starting materials for the manufacture of veterinary medicinal products. The following questions, among others, are answered:

• Do active substances used as starting materials in veterinary medicinal products have to comply with the same GMP requirements for active substances (for human medicinal products)?
• Are there new obligations regarding active substances for the manufacture of veterinary medicinal products?
• Is a GMP certificate mandatory and how is it issued?
• What applies in the case of inspections?