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On 16 February 2022, Committee for Veterinary Medicinal Products (CVMP), the committee that is responsible for preparing the European Medicines Agency's (EMA) opinions on all questions concerning veterinary medicines, adopted the scientific advice on the designation of antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. This advice relates to the implementing act referred to in Article 37(5) of Regulation (EU) 2019/6.
The EMA’s scientific recommendations, together with the methodology used and the outcome of evaluations of different antimicrobial groups, are provided in this advice. Supplementary information, including supporting monographs prepared for antiviral and antifungal classes/substances and the ATC(vet) codes for substances included in each antimicrobial grouping are presented in the Annex.
Article 37(5) of the Regulation mandates the designation of antimicrobials that shall be reserved for human use only, in order to preserve their efficacy for the treatment of certain critical infections in humans. These designated antimicrobials cannot be included in EU-authorised veterinary medicines or used to treat any animal.
February 21, 2022/ EMA/ European Union.
https://www.ema.europa.eu/
