Veterinary Medicinal Products
The EU regulation governing the authorisation, manufacture, import, distribution, and pharmacovigilance of veterinary medicinal products. Applying since January 2022, it replaced Directive 2001/82/EC, expanded scope (including euthanasia substances), and substantially strengthened provisions to combat antimicrobial resistance.
Veterinary medicinal products across the EU market — from manufacturing authorisation and GMP through distribution and safety surveillance.
- 01Hold appropriate manufacturing/import authorisation and comply with veterinary GMP
- 02Operate a pharmacovigilance system for veterinary medicines
- 03Apply antimicrobial-resistance controls and use restrictions
- 04Meet EU product-database and traceability obligations
Adopted December 2018 and applicable since 28 January 2022, replacing Directive 2001/82/EC with expanded scope and stronger antimicrobial-resistance measures.
Regulation (EU) 2019/6: frequently asked questions
Quick answers to common questions about Regulation (EU) 2019/6.
What is Regulation (EU) 2019/6?
Regulation (EU) 2019/6 — Veterinary Medicinal Products — is a regulation issued by the European Commission — EudraLex (European Union). The EU regulation governing the authorisation, manufacture, import, distribution, and pharmacovigilance of veterinary medicinal products. Applying since January 2022, it replaced Directive 2001/82/EC, expanded scope (including euthanasia substances), and substantially strengthened provisions to combat antimicrobial resistance.
Who does Regulation (EU) 2019/6 apply to?
Veterinary medicinal products across the EU market — from manufacturing authorisation and GMP through distribution and safety surveillance.
What are the key requirements of Regulation (EU) 2019/6?
EC Regulation (EU) 2019/6 requires, among other things: Hold appropriate manufacturing/import authorisation and comply with veterinary GMP; Operate a pharmacovigilance system for veterinary medicines; Apply antimicrobial-resistance controls and use restrictions; Meet EU product-database and traceability obligations.
When was Regulation (EU) 2019/6 last updated?
The current version of Regulation (EU) 2019/6 dates from January 2022. Adopted December 2018 and applicable since 28 January 2022, replacing Directive 2001/82/EC with expanded scope and stronger antimicrobial-resistance measures.
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When Regulation (EU) 2019/6 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.