[eu]cite

Home Health & Pharmaceuticals Health Technology Assessment Regulation

Chapter IV · SUPPORT FRAMEWORK › Article 28

Commission support for the Coordination Group

The Commission shall support the work of the Coordination Group and act as its secretariat. In particular, the Commission shall:

(a)

host in its premises the meetings of the Coordination Group and of its subgroups;

(b)

decide on conflict of interest in accordance with the requirements set out in Article 5 and in the general procedural rules to be adopted in accordance with Article 25(1), point (a);

(c)

request the dossier from the health technology developer in accordance with Article 10;

(d)

supervise the procedures for joint clinical assessments and inform the Coordination Group about possible breaches thereof;

(e)

provide administrative, technical and IT support;

(f)

set up and maintain the IT platform pursuant to Article 30;

(g)

publish the information and documents, including the Coordination Group’s annual work programmes, annual reports, summary minutes of its meetings, and reports and summary reports of joint clinical assessments, on the IT platform, in accordance with Article 30;

(h)

facilitate the cooperation, in particular through the exchange of information, with the European Medicines Agency on the joint work referred to in this Regulation related to medicinal products, including the sharing of confidential information;

(i)

facilitate the cooperation, in particular through the exchange of information, with expert panels and the Medical Device Coordination Group on the joint work referred to in this Regulation related to medical devices and in vitro diagnostic medical devices, including the sharing of confidential information.

also move between articles