On the basis of Art. 3 of the Veterinary Medicinal Products Act (TAMG) of, the so-called sunset clause pursuant to Section 31 (1) sentence 1 number 1 of the Medicinal Products Act (AMG) shall no longer apply to veterinary medicinal products with effect from 28 January 2022.

Within the Medicinal Product Act (AMG), it was legally stipulated that marketing authorisations could expire due to the Sunset Clause if a pharmaceutical entrepreneur had not made use of the marketing authorisation for a period of three years, i.e. had not placed the medicinal product on the market. This resulted in the obligation for pharmaceutical entrepreneurs to notify the higher federal authority, for veterinary medicinal products the BVL, of the manufacturing and marketing of an authorised veterinary medicinal product. According to Regulation (EU) 2019/6, in conjunction with the new Veterinary Medicinal Products Act (TAMG), the sunset clause is no longer covered by legislation.

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