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The Ministry of Health has issued new guidelines regarding the management of veterinary antibiotics that are already on the market. In accordance with the European Regulation, batches of antimicrobial veterinary medicinal products subject to a change in dispensing regime can still be sold while stocks last, but only with a non-repeatable prescription via REV and only in pharmacies, parapharmacies, and wholesalers.
The Ministry’s note addressed to pharmaceutical companies and distributors states that Article 34 of the new European regulation allows for the classification of veterinary medicinal products with certain characteristics as subject to veterinary prescription. This includes antimicrobial veterinary medicinal products, which were previously not subject to veterinary prescription.
The Ministry has instructed holders of marketing authorizations for veterinary medicines to re-evaluate compliance with the regulation and notify any changes in classification for the modification of the dispensing method. The new regulation also specifies that the relevant veterinary prescription for antimicrobial veterinary drugs is valid for five days from the date of issue.
The change in dispensing regime means that these medicines can only be sold by authorized establishments and must be collected from commercial establishments included in the regulation. The Ministry has also provided clarification on the possibility of running out of stocks of medicines intended for pets, stating that batches of veterinary medicines containing antimicrobials can be sold while stocks last, but only with a non-repeatable prescription via REV.
These new guidelines have implications for pharmacists and drug supply channels, as they must adhere to the updated dispensing regulations for veterinary antibiotics. Stay connected with us for more updates on the pharmaceutical sector and subscribe to our newsletter for the latest news in veterinary medicine and antibiotic management.