New EU rules for safe and high-quality medicines for animals finally become effective.
Last week saw the European Medicines Agency Veterinary Medicinal Products Regulation come into force with a steadfast goal of stimulating innovation and increasing drug availability.
Determined to ensure the delivery of quality medicines for veterinarians, farmers, and pet owners to treat and prevent animal diseases, and also supporting the European Union action against antimicrobial resistance (AMR), the EMA’s Executive Director Emer Cooke stated that ’’Today marks the start of a new era in the regulation of medicines for animals”.
“The tools and systems introduced by the new Regulation will ensure wider access to information on medicines for animals to all stakeholders, and will also provide for enhanced monitoring of suspected side effects. Importantly, prudent and responsible use of antimicrobials in animals is now embedded in the Regulation and will help us fight against antimicrobial resistance.’’
The new Regulation contains measures that will simplify regulatory processes, striving to reduce the administrative burden for current marketing authorization holders and developers of new and innovative veterinary medicines, therefore aiming to further encourage medicine innovation and development.
Finally, for the first time, information about all veterinary medicines authorized in the EU and European Economic Area (EEA) countries will be available on a central website (https://lnkd.in/dR32W523) something which is also widely praised by the industry.
As holders of GMP certification for veterinary medicinal products, and specializing in toxicological and pharmacokinetic studies, QUINTA-ANALYTICA are amongst the first to applaud the new regulations and, with 25 years of pharma experience across human and animal medicines, we congratulate any changes which increase availability, and ultimately aid patients, whether human or otherwise!
February 10, 2022