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Are your products correctly classified under Article 34, Reg. (EU) 2019/6?

Written by Leonardo Giraudo | Apr 6, 2023 1:30:49 PM

Prescription status of Veterinary Medicinal Products 

Article 34 of Regulation (EU) 2019/6 has defined the rules applicable for the classification of the prescription of Veterinary Medicinal Products. On 27 January 2023, the Committee for Veterinary Medicinal Products (CVMP) published its guideline on the application of Article 34 of Regulation (EU) 2019/6. Medicines that are on the market and do not require a prescription must be variated for the prescription status through a Variation Requiring Assessment G.I.6 Change in the legal status of a medicinal product for centrally authorized products.