• Marketing authorisations of veterinary medicinal products which have been revoked on the basis of a withdrawal pursuant to the former legislation (Medicinal Products Act (AMG))

Upon receipt of a withdrawal notification of the marketing authorisation for a veterinary medicinal product, the marketing authorisation is revoked pursuant to Section 9 (5) of the Veterinary Medicinal Products Act (TAMG), in conjunction with Art. 58 (6) and (13) of Regulation (EU) 2019/6. This automatically also terminates the marketability of a veterinary medicinal product. Contrary to the previous regulation in Section 31 (4) Medicinal Products Act (AMG), sell-off is no longer provided for under the new Veterinary Medicinal Products Act (TAMG).

The respective database entries in the Union product database (UPD) and the corresponding interfaces of the national Pharmnet.Bund database are made by the BVL.

The withdrawal of marketing authorisation for a veterinary medicinal product notified by the marketing authorisation holder is announced by the BVL in the Federal Gazette (Bundesanzeiger).

Marketing authorisations of veterinary medicinal products which have been revoked on the basis of a withdrawal pursuant to the former legislation (Medicinal Products Act (AMG))

Marketing authorisations for veterinary medicinal products that have already been revoked due to a withdrawal in accordance with Medicinal Products Act (AMG) Section 31 (1), but which are still marketable on the basis of a formerly granted two-year sell-off period, are still listed in the UPD for the duration of their remaining marketability. The corresponding data entries as well as monitoring of the respective deadlines are carried out by the BVL.

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