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 X REGULATORY NETWORK

Article 144 Tasks of the coordination group

The coordination group shall have the following tasks:

(a)

examine questions concerning mutual recognition and decentralised procedures;

(b)

examine advice from the pharmacovigilance working party of the Committee concerning risk management measures in pharmacovigilance related to veterinary medicinal products authorised in Member States and issue recommendations to the Member States and to the marketing authorisation holders, as necessary;

(c)

examine questions concerning variations to the terms of marketing authorisations granted by Member States;

(d)

provide recommendations to Member States whether a specific veterinary medicinal product or a group of veterinary medicinal products is to be considered a veterinary medicinal product within the scope of this Regulation;

(e)

coordinate the selection of the lead authority responsible for the assessment of the results of the signal management process referred to in Article 81(4);

(f)

draw up and publish an annual list of reference veterinary medicinal products which shall be subject to harmonisation of the summaries of product characteristics in accordance with Article 70(3).