Veterinary medicinal products
Medicines intended for animal use must be safe, effective, and of high quality, while also promoting environmental protection and public health. This includes safeguarding against risks like antimicrobial resistance.
Authorisation of medicines for veterinary use
Medicines for veterinary use can be authorised in two ways in the EU:
- Centralised authorisation: This is granted by the European Commission, based on the scientific evaluation of the European Medicines Agency (EMA). This route is required for certain biotech-based veterinary medicines.
- National authorisation: This is managed by national authorities and can involve either a decentralised procedure, a mutual recognition procedure or a subsequent recognition procedure (in all three procedures several countries agree on an approval), or a national (single-country) procedure.
The requirements and procedures for marketing authorisation, as well as the rules for monitoring authorised products are laid down in the EU veterinary medicines regulation.
The EMA provides guidance and scientific evaluation at all stages of the centralised authorisation process and processes common to all veterinary medicines, including:
- Research and development stage: how to design and run clinical trials for veterinary medicines, compliance standards, how to establish maximum residue limits for veterinary medicines, and developing medicines for veterinary limited markets.
- Marketing authorisation stage: how to obtain a centralised authorisation for a veterinary medicine.
- Post-authorisation stage: safety monitoring of veterinary medicines on the market, through pharmacovigilance, applications for variations to the marketing authorisation, submitting product data to the EMA, and reporting product defects or recalls.
Additionally, if your company qualifies as a micro, small or medium enterprise (SME), you will have access to dedicated support and incentives, including reduced fees for scientific advice, regulatory and procedural assistance, and early dialogue through the EMA SME Office.
Clinical trials for veterinary medicines
Clinical trials for veterinary medicines are regulated at the national level in each EU country. However, there is guidance available for multicentre/multinational trials, which can help streamline the process.
The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDv) for veterinary medicinal products offers resources and guidance for conducting these trials.
GMO assessments
If your veterinary medicine involves genetic modification (e.g. the use of recombinant DNA technology), it will be subject to the EU GMO Framework (see links below), already at the stage of veterinary medicine under investigation. This framework ensures the safety of genetically modified organisms including their use in veterinary medicinal products.
Residues in foodstuffs of animal origin
If your veterinary medicine is used in food-producing animals, such as those used for production of meat, milk, or eggs, you must ensure that any residues left in foodstuffs of animal origin are within the established safe limits for human consumption (maximum residue limits).
EU legislation
EMA veterinary medicine regulatory overview
EU regulation on veterinary medicines
EU regulation on maximum residue levels for veterinary medicines
EU GMO Framework relevant for veterinary medicines: