CHAPTER IVPOST-MARKETING AUTHORISATION MEASURES
Article 69Scope 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.