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Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title
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)
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Article 23Applications for limited markets
1.By way of derogation from point (b) of Article 8(1), the applicant shall not be required to provide the comprehensive safety or efficacy documentation required in accordance with Annex II, if all of the following conditions are met:
(a)the benefit of the availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;
(b)the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.
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 safety or efficacy has been conducted due to the lack of comprehensive safety or efficacy data.
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