# 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: Terms of the marketing authorisation in exceptional circumstances

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eur/2019/6/article/26 (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/article-26
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.