Brochure: The Marketing Authorisation process for animal medicines in Europe

01/02/2019

This brochure outlines the Marketing Authorisation procedures to which animal medicinescompanies must adhere to obtain a licence for placing products on the European market.

The rules governing medicinal products for veterinary use in the European Union (EU) sets standards and procedures so that these important products are correctly regulated, both before and after entering the marketplace.

Before any new veterinary medicinal product can be placed on the market, an in-depth review must be carried out by the regulatory authorities, which then decide whether or not the product meets the required standards.

For this “Marketing Authorisation process”, any new medicine needs to be supported by a detailed data dossier that establishes the safety, quality and efficacy of a product.

The data dossier is reviewed by independent experts working on behalf of European andnational regulators. They conduct a comprehensive scientific assessment of the data, including a benefit-risk analysis, to decide whether or not to recommend that the medicine be granted a Marketing Authorisation, with defined conditions of use.