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 IV POST-MARKETING AUTHORISATION MEASURES

Section 4 Harmonisation of the summaries of product characteristics for nationally authorised products

Article 69 Scope of the harmonisation of summaries of product characteristics of a veterinary medicinal product

A harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in Articles 70 and 71 for:

(a)

reference veterinary medicinal products which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which marketing authorisations have been granted in accordance with Article 47 in different Member States for the same marketing authorisation holder;

(b)

generic and hybrid veterinary medicinal products.