In the European Union, an effective and rigorous examination and registration system exists for placing veterinary medicinal products on the market. The EU registration process (a.k.a. marketing authorisation process) ensures that only those products meeting defined standards of quality, safety and efficacy, which have been thoroughly tested and carefully reviewed by independent experts, reach the marketplace.
This is a lengthy and complex procedure and is ultimately designed to protect the public, animals and the environment from poor quality or unsafe medicines. The links below outline the steps involved in this process.
Each EU Member State has its own independent regulatory authority, authorised to perform independent scientific evaluations of veterinary medicinal products. In addition, the European Medicines Agency serves as a pan-EU regulatory agency for human and veterinary medicines.
To ensure that the EU operates as a single market, the registration requirements for all EU Member States have been harmonised. However, some medicines are only needed in certain Member States (some diseases are localised, or only occur in very hot or very cold conditions). The system is therefore flexible, and includes three different routes through which a marketing authorisation may be obtained.
If an applicant wishes to market the product in just one Member State (for example, a national company that intends to market a product only in its own territory), it applies for authorisation to the official regulatory authority in that country alone.
If an applicant wishes to market the product in more than one Member State, and does not wish to use, or is not eligible for, the Centralised Procedure, then it may use the Decentralised Procedure. Under this procedure the data dossier is submitted to one national authority, which carries out a scientific evaluation. This is later sent to other Member States, requesting ‘mutual recognition’ of the draft opinion (new products) or decision (existing products) of the national authority of the first Member State.
If an applicant wishes to market its product throughout the EU, it may use the Centralised Procedure. Under this procedure, dossiers are submitted directly to the EMEA, and resulting EU-wide marketing authorisations are valid in all Member States. Use of the Centralised Procedure is compulsory for certain biotechnology products, while applicants may request its use for other innovative products.