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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 47 CELEX: 02019R0006-20220128 Procedure for national marketing authorisation
1. The procedure for granting or refusing a national marketing authorisation for a veterinary medicinal product shall be completed within a maximum of 210 days of the submission of the valid application. 2. The competent authority shall prepare an assessment report containing the information referred to in Article 33. 3. The competent authority shall make the assessment report publicly available, after deleting any commercially confidential information. |