New Veterinary Medicines Regulation

A new Veterinary Medicines Regulation (Regulation (EU) 2019/6) has been introduced to modernise the existing rules on the authorisation and use of veterinary medicines in the European Union (EU). This becomes applicable on 28 January 2022.

The regulation contains new measures for increasing the availability and safety of veterinary medicines and enhances EU action against antimicrobial resistance. The European Medicines Agency (EMA) is working closely with the European Commission and other EU partners in preparation for the implementation of the new Regulation.

The main objectives of the new Regulation are to:

• Simplify the regulatory environment and reduce administrative burden for pharmaceutical companies developing veterinary medicines, for example through streamlined pharmacovigilance rules;
• Stimulate the development of innovative veterinary medicines, including products for small markets (minor use and minor species);
• Improve the functioning of the internal market for veterinary medicines;
• Strengthen EU action to fight antimicrobial resistance through specific measures ensuring prudent and responsible use of antimicrobials in animals, including reserving certain antimicrobials for the treatment of infections in people

See EMA at: https://www.ema.europa.eu/en/veterinary-regulatory/overview/implementation-new-veterinary-medicines-regulation

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)