Vorherige Seite
    Commission Implementing Regulation (EU) 2024/3169 of 18 December 2024 laying down... (32024R3169)
    1 - 220 - 21
    Nächste Seite
    EU - Rechtsakte: 16 Science, information, education and culture
    (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.

    Article 13

    Joint scientific consultation outcome document

    1.   Where, after the submission of the amended briefing package, the health technology developer submits updates related to the amended development plan for the relevant medicinal product, the JSC Subgroup shall ensure that those updates are considered in the outcome document, provided that it receives them no later than 10 days before the meeting referred to in Article 18(7) of Regulation (EU) 2021/2282.
    2.   In addition to the rules set out in paragraph 1, where the joint scientific consultation on medicinal products is carried out in parallel with the scientific advice, the following shall apply:
    (a) the health technology developer shall submit the amended development plan referred to in paragraph 1 at the same time to the HTA secretariat and the European Medicines Agency;
    (b) the Coordination Group shall approve the joint scientific consultation outcome document and the Committee for Medicinal Products for Human Use of the European Medicines Agency shall adopt the advice letter to the health technology developer within the deadline set in the timetable referred to in Article 4(1);
    (c) the HTA secretariat and the European Medicines Agency shall exchange with each other the outcome document approved by the Coordination Group and the advice letter adopted by the Committee for Medicinal Products for Human Use on the same day as sending them to the health technology developer.

    Article 14

    Correspondence during joint scientific consultations

    Any documentation referred to in Regulation (EU) 2021/2282 and in this Regulation shall be sent in a digital format and shall be exchanged with and between the Coordination Group, the JSC Subgroup, the HTA Secretariat, the health technology developer and individual experts during joint scientific consultations on medicinal products through the HTA IT platform.

    Article 15

    Personal data processing

    1.   The Commission shall be the controller of the processing of personal data collected for the purpose of conducting joint scientific consultations on medicinal products under this Regulation.
    2.   The categories of personal data necessary for the purpose referred to in paragraph 1 are:
    (a) the identity, email address and affiliation of the representatives appointed to the Coordination Group and the JSC Subgroup;
    (b) the identity and email address of individual experts in any of the following cases:
    (i) they are identified as relevant for joint scientific consultation;
    Markierungen
    Leseansicht
    Verwendung von Cookies.

    Durch die Nutzung dieser Website akzeptieren Sie automatisch, dass wir Cookies verwenden. Cookie-Richtlinie

    Akzeptieren