[eu]cite

Home› Food & Health Safety› Veterinary Medicinal Products Regulation

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.

←→ also move between articles