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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 98 CELEX: 02019R0006-20220128 Certificates of veterinary medicinal products
1. On the request of a manufacturer or an exporter of veterinary medicinal products, or of the authorities of an importing third country, the competent authority or the Agency shall certify that: (a) the manufacturer holds a manufacturing authorisation; (b) the manufacturer possesses a certificate of good manufacturing practice as referred to in Article 94; or (c) the veterinary medicinal product concerned has been granted a marketing authorisation in that Member State or, in the case of a request to the Agency, that it has been granted a centralised marketing authorisation. 2. When issuing such certificates, the competent authority or the Agency, as applicable, shall take into account the relevant prevailing administrative arrangements with regard to the content and format of such certificates. |