New EU rules for safe and high-quality medicines for animals
The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) modernises the existing rules on the authorisation and use of veterinary medicines in the European Union (EU).
Regulation represents a major step forward in the field of veterinary medicinal products. It aims to harmonise regulations and practices across Member States. Its main objectives include improving the safety and availability of veterinary medicinal products, strengthening action to address antimicrobial resistance, enhancing the EU internal market for veterinary medicinal products, and reducing the administrative burden. Regulation (EU) 2019/6 repealed Directive 2001/82/EC and furthermore amended the provisions of Regulation (EU) 726/2004 relating to the authorisation and supervision of veterinary medicines, which currently governs the centralised marketing authorisation procedure for both human and veterinary medicines.
One development brought about by this reform is the establishment of new databases, reflecting a commitment to sharing information. In particular, the manufacturing and wholesale distribution database and a Union Product Database (UPD) that serves as a single source of information on all veterinary medicinal products authorised in the European Union and is accessible to the public. In addition, adverse reactions to veterinary medicinal products are collected on an ongoing basis through a new European Pharmacovigilance Database (EudraVigilance Veterinary). This will allow for early identification of potential risks to animal or human health through active monitoring of emerging adverse events.
To help address antimicrobial resistance, the risk of emergence of resistant bacteria is now included in the benefit-risk balance of veterinary medicinal products. This could lead to a marketing authorisation being refused. Similarly, the use of antimicrobials for preventive treatment of individual animals or groups of animals is now prohibited, except in exceptional cases. Lastly, to ensure that they remain effective, the criteria for determining which antimicrobial substances should be dedicated to human medicine are now established at Union level. Veterinary medicinal products containing such substances, already banned in France, will be banned throughout the European Union.
In accordance with Regulation (EU) 2019/6, the European Commission added two standalone GDP regulations to Eudralex Volume 4:
- Commission Implementing Regulation (EU) 2021/1248 on good distribution practice for veterinary medicinal products
- Commission Implementing Regulation (EU) 2021/1280 on good distribution practice for active substances used as starting materials in veterinary medicinal products
The documents are compiled analogously to the GDP guidelines for medicinal products for human use and their active substances. All documents can be found in Eudralex Volume 4.
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary (CMDv) has set up an area where numerous guidance documents and FAQ documents are made available – link. The EMA also publishes further general information and information on the UPD in particular.