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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 26 CELEX: 02019R0006-20220128 Terms of the marketing authorisation in exceptional circumstances
1. In the exceptional circumstances referred to in Article 25, a marketing authorisation may be granted subject to one or more of the following requirements for the marketing authorisation holder: (a) a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product; (b) a requirement to notify to the competent authorities or the Agency, as applicable, of any adverse event relating to the use of the veterinary medicinal product; (c) a requirement to conduct post-authorisation studies. 2. Where a veterinary medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety or efficacy has been conducted due to the lack of comprehensive quality, safety or efficacy data. |