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Teema: FW: Invitation to designate your member organisation(s) and its/their representative(s) in the new Coordination Group on Health Technology Assessment (HTA) under the Regulation (EU) 2021/2282
From:
[email protected] <
[email protected]>
Sent: Monday, February 7, 2022 11:50 AM
To:
[email protected]
Cc: AMPELAS Anna Eva <
[email protected]>; GIORGIO Flora <
[email protected]>; SISKA Ioana Raluca <
[email protected]>; MARIC Nina <
[email protected]>
Subject: Invitation to designate your member organisation(s) and its/their representative(s) in the new Coordination Group on Health Technology Assessment (HTA) under the Regulation (EU) 2021/2282
Dear Colleagues,
Please see in attachment the letter signed by Ms Sandra Gallina, Director General of DG Health and Food Safety, inviting you to designate your member organisation(s) and its/their representative(s) in the new Member State Coordination Group on HTA set up by Article 3 of the Regulation on HTA (EU) 2021/2282.
We would greatly appreciate receiving your response as soon as possible and in any event not later than 25 March 2022.
Please submit your responses to:
[email protected] <mailto:
[email protected]> and
[email protected] <mailto:
[email protected]> .
Looking forward for your reply,
With best regards,
On behalf of Anna-Eva Ampelas
Head of Unit B6 - Medical Devices, Health Technology Assessment
HTA Team of DG SANTE, Unit B6
European Commission
DG Health and Food Safety
Unit B6 - Medical Devices, Health Technology Assessment
1049 Brussels/Belgium
Ref. Ares(2022)832316 - 04/02/2022
EUROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Director-General
Brussels,
Your Excellency,
Subject: Invitation to designate member(s) to the Coordination Group on
Health Technology Assessment (HTA) under Regulation (EU)
2021/2282
Regulation (EU) 2021/2282 of 15 December 2021 on health technology assessment
(HTA) establishes the Member State Coordination Group on HTA.
With this note, the Commission invites you to designate your member(s) to the
Coordination Group, as well their appointed representative(s) pursuant to Article 3(2) of
the Regulation.
In line with Article 3(8) of the Regulation, in order to provide expertise on HTA for
medicinal products and medical devices, you are now invited to designate your
member(s) and appointed representative(s) for the two configurations of the Coordination
Group on HTA: on medicinal products and medical devices (the latter covering also in
vitro diagnostic medical devices).
Please note that according to Article 3(4) of the Regulation, the Coordination Group
shall, in principle, act by consensus. Where consensus cannot be reached and voting will
be required, each Member State shall have one vote irrespective of the number of
authorities and bodies designated as members to the Coordination Group.
Members of the Coordination Group will be invited to designate their national or regional
authorities and bodies as members of its subgroups at a later stage.
In accordance with Recital 20 of the Regulation, with the goal of ensuring a high level of
competence and the highest scientific quality of joint work, the members of the
Coordination Group should be designated in particular amongst authorities and bodies
responsible for HTA.
I would be grateful if you would fill out the templates in Annexes I and II to this letter, as
soon as possible and in any event not later than 25 March 2022. In case of identical
members designated for the two configurations of the Coordination Group, please fill out
only one template, specifying its validity for both configurations.
By email to:
Permanent Representatives of the EU Member States
For your information, the first meeting of the Coordination Group is planned for 21 June
2022 in Brussels. According to the epidemiological situation closer to the date, we will
inform you if the meeting will need to be held remotely or in hybrid format. More details
will be sent closer to the meeting once the members of the Coordination Group are
designated.
Should you need additional information, you may contact, Anna-Eva Ampelas, Head of
Unit B6 (
[email protected], +32 2 2960541), Flora GIORGIO, Deputy
Head of Unit B6 (
[email protected], + 32 2 2952781) or SANTE HTA
(
[email protected]).
Yours sincerely,
(e-signed)
Sandra GALLINA
c.c.: Health attachés of the EU Member States
2
Annex I
Members designated for the medicinal products’ configuration of the Coordination
Group on HTA and their appointed representatives
Member States wishing to designate more than one member are kindly invited to
duplicate the below template
*Contact details should include email address and phone number
MEMBER STATE
Member 1 (name, address of the
designated organisation)
Representative of member 1 (name and
contact details*)
Alternate representative of member 1
(name and contact details*)
3
Annex II
Members designated for the medical devices’ configuration of the Coordination
Group on HTA and their appointed representatives
Member States wishing to designate more than one member are kindly invited to
duplicate the below template
*Contact details should include email address and phone number
MEMBER STATE
Member 1 (name, address of the
designated organisation)
Representative of member 1 (name and
contact details*)
Alternate representative of member 1
(name and contact details*)
Electronically signed on 04/02/2022 11:17 (UTC+01) in accordance with article 11 of Commission Decision C(2020) 4482
4
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Teema: Webdesktop: Kiri nr 14-4/128 / Esindajate nimetamine -
Coordination Group on Health Technology Assessment (HTA)
Tere!Edastan Euroopa Komisjoni kirja. Vastamise tähtaeg on
25.03.2022.Reg. number: 14-4/128Reg. kuupäev: 07.02.2022Sisu: Invitation
to designate your member organisation(s) and its/their representative(s)
in the new Coordination Group on Health Technology Assessment (HTA) under
the Regulation (EU) 2021/2282. Tähtaeg 25.03.2022.Heade soovidegaTiiu
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