Our Life Science Consultant expert, Vânia, tells us about the new veterinary medicines regulation and its implementation.
The Veterinary Medicines Regulation (Regulation (EU) 2019/6 will bring up-to-date the existing rules on the regulatory procedures and use of veterinary medicines in the European Union (EU) on 28th January 2022. The new legislation contains measures to increase the availability and safety of veterinary drugs and boost EU actions against antimicrobial resistance.
The objectives of the new Regulation:
- Simplify the regulatory environment and reduce administrative burden for pharmaceutical companies.
- Stimulate the development of innovative veterinary medicines.
- Improve the internal market operations for veterinary medicines.
- Support the fight on antimicrobial resistance through specific measures. As a result, this will ensure the prudent and responsible use of antimicrobials in animals.
The benefits of the Regulation
- Increasing availability and access to safe and high-quality medicines for veterinarians, farmers and pet owners.
- Reduced administrative burden and give better incentives for pharmaceutical companies by developing new and innovative veterinary medicines.
- New and enhanced rules regarding the safe and rational use of antimicrobials.
Some of the issues covered are new requirements for the collection of data on the sales and use of antimicrobials in animals. Also, the development of a Union Product Database on veterinary medicines will provide information on all veterinary drugs that have been approved and their availability throughout the EU Member States.
The European Parliament and the European Council adopted Regulation (EU) 2019/6 in December 2018 that repeals Directive 2001/82/EC and amends the provisions of Regulation (EU) 726/2004 relating to the approval and supervision of veterinary medicines, which currently governs the centralized marketing authorization procedure for both human and veterinary medicines. It will become valid from 28th January 2022.
The European Medicines Agency (EMA) has launched a new webpage. Consequently, stakeholders can find all the relevant information and updates about the implementation of the Regulation (EU) 2019/6.