Contents
Article 12Meeting 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 5;
(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 on medicinal products is carried out in parallel with the scientific advice, the following participants shall be invited to the meeting referred to in Article 18(8) of Regulation (EU) 2021/2282:
(a)the coordinators for scientific advice;
(b)other members of the scientific advice working party of the Committee for Medicinal Products for Human Use than the ones listed in point (a);
(c)the staff members of the European Medicines Agency responsible for providing secretariat support to the scientific advice working party.
On request from the European Medicines Agency, other experts selected in accordance with the relevant rules of the European Medicines Agency to participate during the scientific advice may be invited to the meeting for an exchange of views.
3.The meeting referred to in paragraph 2 shall be held virtually. It shall be co-chaired by the assessor or co-assessor for the joint scientific consultation and one of the coordinators for scientific advice.
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.
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