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)

Article 21U.K.Application based on informed consent

By way of derogation from point (b) of Article 8(1), an applicant for a marketing authorisation for a veterinary medicinal product shall not be required to provide the technical documentation on quality, safety and efficacy if that applicant demonstrates permission, in the form of a letter of access, to use such documentation submitted in respect of the already authorised veterinary medicinal product.