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
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/)
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