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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 89 CELEX: 02019R0006-20220128 Application for manufacturing authorisation
1. An application for a manufacturing authorisation shall be submitted to a competent authority in the Member State in which the manufacturing site is located. 2. An application for a manufacturing authorisation shall contain at least the following information: (a) veterinary medicinal products which are to be manufactured or imported; (b) name or company name and permanent address or registered place of business of the applicant; (c) pharmaceutical forms which are to be manufactured or imported; (d) details about the manufacturing site where the veterinary medicinal products are to be manufactured or imported; (e) a statement to the effect that the applicant fulfils the requirements laid down in Articles 93 and 97. |