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Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance) article 96 CELEX: 02019R0006-20220128 Record keeping
1. The holder of a manufacturing authorisation shall record the following information in respect of all veterinary medicinal products that it supplies: (a) date of the transaction; (b) name of the veterinary medicinal product, and marketing authorisation number if applicable, as well as pharmaceutical form and strength, as appropriate; (c) quantity supplied; (d) name or company name and permanent address or registered place of business of the recipient; (e) batch number; (f) date of expiry. 2. The records referred to in paragraph 1 shall be available for inspection by competent authorities for one year after the date of expiry of the batch or at least five years from recording, whichever is longer. |