Authorisation process for veterinary medicinal products in Europe
Authorisation process for veterinary medicinal products in Europe
Since January 2022, a new European Regulation (2019/6) has governed the marketing of veterinary medicinal products. This Regulation seeks to guarantee the safety and effectiveness of treatments for animals, while limiting the risks to public health and the environment. The main stages of this rigorous process are as follows:
- Filing of the marketing authorisation application (MAA)
Any company that wishes to market a veterinary medicinal product in Europe must obtain a marketing authorisation (MA). The application procedure can differ depending on the number of countries involved:
-The centralised procedure valid throughout the EU; managed by the European Medicines Agency (EMA).
-The decentralised or mutual recognition procedures for several countries.
-The national procedure for a single country. - Scientific evaluation
The marketing authorisation application is evaluated by independent experts. The application must provide proof of the quality, harmlessness and efficacy of the medicinal product, based on analytical, toxicological and clinical tests. - The authorisation decision
For the centralised and national procedures, the final decision as to whether to grant the marketing authorisation lies with the European Commission and the national authority, respectively, after having considered the experts' opinions. - Post-authorisation monitoring
Once veterinary medicinal products are placed on the market, their use – especially in the case of antibiotics – is closely monitored. Adverse effects are collected and analysed to ensure the medicinal products' safety.
This highly regulated authorisation process ensures that only medicinal products with a risk-benefit ratio that is favourable for animals, consumers and the environment are available. In this way, it contributes to the careful and responsible use of antibiotics in veterinary medicine.
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