![]() ![]() Medicinal products affected by any of these actions are considered 'withdrawn products'.įor more information, see Notifying a change of marketing status. non-application for the renewal of a marketing authorisation. Bravecto is a veterinary medicine used to treat parasitic infestations in dogs and cats.request for the withdrawal of a marketing authorisation In addition, EMA is funding the Big Data in Veterinary Medicines Regulation: a data landscape analysis research project.The rules relating to the Agency's fees are governed by the fee regulation (Council Regulation (EC) No 297/95) and its implementing rules, as well as the pharmacovigilance fee regulation (Regulation (EU) No 658/2014). The European Medicines Agency (EMA) charges fees for the services it provides. withdrawal of a medicinal product from the market This content applies to human and veterinary medicines.suspension of marketing of a medicinal product Accord Animal Health took the opportunity to join with key industry stakeholders at the recent, and first, European Medicines Agency (EMA) Veterinary Awareness.temporary or permanent cessation of marketing of a medicinal product.EMMAvet is here to provide your dogs and cats with the urgent medical attention they need, at hours convenient to your lifestyle. Marketing authorisation holders have to notify the competent authorities of any of the following actions they intend to take: 1628A Belle View Boulevard Alexandria VA 22307. EMA by emailing notifying EMA, please use the Cover letter template for notification of "withdrawn products" by marketing authorisation holders and the Template to be used to notify the European Medicines Agency and concerned Member States of 'withdrawn products' report table.įor detailed guidance, see Notifying a change of marketing status. The European Medicines Agency (EMA) provides guidance and support to companies researching and developing veterinary medicines.en/documents/report/ categorisation-antibiotics-european-union-answer. ![]() Marketing authorisation holders should notify a withdrawn product to: Vet Rec 182:637 Chantziaras I, Boyen F, Callens B, Dewulf J (2014). ![]()
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