EU Regulation (EU) 2019/6 - Veterinary Medicinal Products

What it says

This Regulation sets rules for the authorization, manufacture, import, distribution, supply and use of veterinary medicinal products in the Union. It provides for marketing authorization procedures, requirements for manufacturers, pharmacovigilance for veterinary products, restrictions on the use of antimicrobials, and rules on the use of medicated feed.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Veterinary medicines are manufactured under GMP, with requirements that parallel those for human medicines.
• Antimicrobial stewardship is a central theme, with limits on preventive use and on certain classes.
• Authorization can follow a centralized or national route depending on the product.

What inspectors look for

• Whether manufacturing sites hold the needed authorization and follow GMP.
• Whether pharmacovigilance systems are in place.
• Whether distribution and supply follow the rules.

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