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) (c. 6)

CHAPTER II MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS

Section 7 Examination of applications and basis for granting marketing authorisations

Article 30 Information on manufacturers in third countries

The competent authority or the Agency, as applicable, to which the application has been submitted in accordance with Article 6 shall ascertain, through the procedure laid down in Articles 88, 89 and 90, that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 8(1). A competent authority or the Agency, as applicable, may request the relevant competent authority to present information ascertaining that the manufacturers of veterinary medicinal products are able to carry out the activities referred to in this Article.