Article 78

Location:

Title IV, chapter 3

Source:

1. The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and the representatives of the industry, consumers and patients and the health professions. These contacts may include the participation of observers in certain aspects of the Agency’s work, under conditions determined beforehand by the Management Board, in agreement with the Commission.

2. The committees referred to in Article 56(1) of this Regulation and any working parties and scientific advisory groups established in accordance with that Article or Article 139(3) of Regulation (EU) 2019/6 shall in general matters establish contacts, on an advisory basis, with parties concerned with the use of medicinal products for human use and of veterinary medicinal products, in particular patient organisations and healthcare professionals’ associations. Rapporteurs appointed by those committees may, on an advisory basis, establish contacts with representatives of patient organisations and healthcare professionals’ associations relevant to the indication of the medicinal product for human use or veterinary medicinal product concerned.