Article 13 · Commission Implementing Regulation (EU) 2025/117

Contents

Article 13Meeting with the health technology developer#

1.The following participants shall be invited to the meeting referred to in Article 18(7) of Regulation (EU) 2021/2282:

(a)the representatives of the health technology developer;

(b)the assessor and co-assessor;

(c)individual experts selected in accordance with Article 6;

(d)other representatives of the JSC Subgroup than the ones listed in point (b);

(e)the staff members of the HTA secretariat responsible for providing secretariat support to the JSC Subgroup.

2.In addition to the participants listed in paragraph 1, where the joint scientific consultation is carried out in parallel with the expert panel consultation, the following participants shall be invited to the meeting as referred to in Article 18(8) of Regulation (EU) 2021/2282:

(a)the advisors of the expert panel involved in the expert panel consultation;

(b)the staff members of the European Medicines Agency providing secretariat support to the expert panel.

On request from the European Medicines Agency, patients selected in accordance with the relevant rules of the European Medicines Agency to participate during the consultation with the expert panels may be invited to the meeting for an exchange of views.On request from the health technology developer, representatives from the notified body chosen by the health technology developer may be invited to the meeting for an exchange of views as observers.

3.The meeting referred to in paragraph 2 shall be held virtually. It shall be co-chaired by the assessor or co-assessor and one of the rapporteurs for the expert panel consultation.

4.Before the meeting referred to in paragraph 2, the European Medicines Agency shall send to the HTA secretariat the list of meeting participants who are to be invited to the meeting in accordance with paragraph 2.