Welcome to SEQ Veterinary Regulatory Services, your partner for a seamless registration process in compliance with EU Medicines Directives.
Evolution of Veterinary Medicines Registration Process: The regulatory registration process, rooted in the 1965 EC Medicines Directive, has undergone significant evolution. In the 1980s, EC Directives aimed at enhancing and harmonizing the registration process for medicinal products within the European Union were introduced. Tightening controls continued in the 1990s with legislation covering residues in food, a centralized registration procedure, and adherence to Good Manufacturing Practice.
EU Veterinary Medicines Directives Overview: Key EU Veterinary Medicines Directives, including Directive 2001/82/EC, Directive 2004/28/EC, Consolidated Directive, Directive 2009/53/EC, and Directive 2009/9/EC, provide the framework for veterinary medicinal product registration. These directives emphasize variations, amendments, and the marketing authorization process.
Objectives of Veterinary Medicines Registration: The primary objectives of registration are to ensure the safety of the animal, consumers of food derived from treated animals, handlers of the product, and the environment. Additionally, it aims to guarantee consistent high quality, stability, and efficacy of veterinary medicinal products in line with information leaflet claims.
For more information on SEQ Veterinary Regulatory Services, please contact us at enquiries@nerin.co.im.
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