Article 26 Terms of the marketing authorisation in exceptional circumstances
United Kingdom
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 requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;
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;
a requirement to conduct post-authorisation studies.
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.