Saatja: Zuk Magdalena <
[email protected]>
Saaja: Esindus EL juures üldaadress,
[email protected],
[email protected], Zuk Magdalena
Teema: Executive Steering Group on Shortages and Safety of Medicinal Products-Estonia
Your Excellency,
Please find attached a letter signed by the European Medicines Agency's Executive Director requesting the nomination of a representative to the Agency's EU Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).
The letter is accompanied by an Annex compiling the responsibilities of the EU Executive Steering Group on Shortages and Safety of Medicinal Products. Kindly note that members of the EU Executive Steering Group on Shortages and Safety of Medicinal Products will have to make decisions in an urgent manner, to allow for timely and coordinated actions in the EU.
You are kindly invited to address nominations to the European Medicines Agency’s Executive Director Emer Cooke at your earliest convenience, by 15 March 2022.
Please do not hesitate to contact me should you have any questions regarding this request for nomination.
Yours sincerely,
MSSG Secretariat
Magdalena Żuk
Supply and Availability of Medicines and Devices (SAM)
Regulatory Science and Innovation Task Force (TRS)
European Medicines Agency
Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands
Telephone +31 (0)88 781 7204
[email protected]<mailto:
[email protected]> | www.ema.europa.eu<https://www.ema.europa.eu/en> | For directions, see How to find us<https://www.ema.europa.eu/en/about-us/contact/how-find-us>
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HE Mr Aivo Orav
Permanent Representation of Estonia
to the European Union
Rue Guimard 11-13
B-1040 Brussels
BELGIUM
11 February 2022
EMA/86620/2022
Executive Director
Your Excellency,
Subject: Nomination of a representative in the Executive Steering Group on Shortages and
Safety of Medicinal Products of the European Medicines Agency (EMA)
Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a
reinforced role for the European Medicines Agency in crisis preparedness and management for
medicinal products and medical devices, lays down the procedures for preparing, preventing,
coordinating and managing the impact of public health emergencies and major events on medicinal
products at Union level. It foresees the establishment of the Executive Steering Group on
Shortages and Safety of Medicinal Products, the so-called ‘Medicines Shortages Steering Group
(MSSG)’ within the Agency.
The Executive Steering Group on Shortages and Safety of Medicinal Products, among others, will:
• ensure a robust response to public health emergencies and major events;
• evaluate the information related to the major event or the public health emergency and consider
the need for urgent and coordinated action with regard to the safety, quality, and efficacy of the
medicinal products concerned and provide recommendations to the Commission and Member
States on any appropriate action required at Union level on the medicinal products concerned to
safeguard their quality, safety and efficacy;
• develop recommendations and coordinate measures, which may be taken by the Commission,
Member States, marketing authorisation holders and other entities, including representatives of
healthcare professionals and patient organisations, to prevent or mitigate potential or actual
shortages in the context of a major event or public health emergency;to safeguard the supply of
medicinal products and to ensure a high level of human health protection;
• establish lists of critical medicinal products to ensure monitoring of those products.
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union
© European Medicines Agency, 2022. Reproduction is authorised provided the source is acknowledged.
Article 3(2) of Regulation (EC) No 2022/123 stip ulates that the Executive Steering Group on Shortages
and Safety of Medicinal Products shall consist of a representative of the Agency, a representative of the
Commission and one representative appointed by each Member State. Therefore, to allow the Agency
to begin preparations for the new Executive Steering Group established by the Regulation, I am writing
to ask you to nominate a member from your country. Please note that the formal appointment of
MSSG members will take place after the Regulation becomes applicable on 1 March 2022.
In making the nominations, I would like to draw your attention to the need for the Executive Steering
Group members to be able to make decisions on behalf of their Member State in a urgent manner,
even during meetings, to allow for timely and coordinated actions in the EU. For the full list of
responsibilities of the MSSG please refer to Annex I.
I would also like to remind you of the policy in place at the Agency regarding the handling of
competing interests of scientific committees’ members and experts, which will also be applied to
members of the new Executive Steering Group. For further details please use the following link (EMA
Policy 0044 - Handling of competing interests). In making the nomination for your Member State,
please ensure that the nominee is or will be included in the Agency’s European experts list with a
declaration of interest and CV as this is a requirement before a member can be involved in the
activities of the Executive Steering Group. The contact point for the Agency’s Experts database in your
Member State can be of assistance for this inclusion in the European experts list.
It is anticipated that the Medicines Shortages Steering Group will convene its first virtual meeting on
24 March 2022, thereafter meetings will be held at the European Medicines Agency in Amsterdam or
will be held remotely. A response within a month would therefore be appreciated. Please address your
nominations to my attention, indicating full contact details for your nominee along with the nominee’s
CV and declaration of interest if not included in the European experts list.
A copy of this letter will be shared with the head of the relevant competent authorities in your country.
Yours faithfully
Emer Cooke Digitally signed by Emer Cooke
Date: 2022.02.14 17:10:45 +01'00'
Emer Cooke
Executive Director
Enc.:
Annex I
List of responsibilities of the MSSG
Nomination of a representative in the Executive Steering Group on Shortages and
Safety of Medicinal Products of the European Medicines Agency
Page 2/4
ANNEX I
LIST OF RESPONSIBILITIES OF THE MSSG
Where the major event or public health emergency may affect the safety, quality, and efficacy of
medicinal products the MSSG will:
1. Evaluate the information related to the major event or the public health emergency and consider
the need for urgent and coordinated action with regard to the safety, quality, and efficacy of the
medicinal products concerned;
2. Provide recommendations to the Commission and Member States on any appropriate action
required at Union level on the medicinal products concerned in accordance with the provisions of
Directive 2001/83/EC or Regulation (EC) No 726/2004;
3. Consult with the CVMP whenever the public health emergencies and major events relate to
zoonoses or diseases affecting only animals that have or may have a major impact on human
health, or where the use of active ingredients of veterinary medicinal products may be useful to
address the public health emergency or the major event
Where the major event or public health emergency may lead to shortages of medicinal products in
more than one Member State the MSSG will:
a) Establish a list with the main therapeutic groups of medicinal products for ensuring emergency
care, surgeries and intensive care, with a view to inform the preparation of the critical medicines
lists;
b) Adopt a list of medicinal products considered as critical either during a major event and/or during
the public health emergency. The list shall be updated whenever necessary until the termination of
the recognition of the public health emergency. The list may be updated in accordance with the
outcomes of the review process undertaken by the Agency’s Committees, and where appropriate,
the MSSG will liaise with the ETF;
c) Adopt and make publicly available a set of information necessary to monitor the supply and
demand of medicinal products included on the lists;
d) Monitor supply and demand of medicinal produc ts included on those lists with a view to identifying
any potential or actual shortages of those medicinal products;
e) Report regularly the results of its monitoring to the Commission and the medicines shortage SPOC
working party, and, in particular, signal any potential or actual shortages of medicinal products
included on the critical medicines lists or any event that is likely to lead to a major event. Those
reports may also be made available to other actors in the pharmaceutical supply chain, where
relevant, and in accordance with relevant competition rules;
f) Provide aggregated data and forecasts of demand to the Commission or the sub-networks. The
MSSG will use data from ESMP when fully func tional and will liaise with the European Centre for
Disease Prevention and Control (ECDC) to obtain epidemiological data, models and development
scenarios to help forecast medicinal product needs, and with the Executive Steering Group on
Shortages of Medical Devices where medicinal products included on the critical medicines lists are
administered with a medical device. The aggregated data and forecasts of demand may also be
made available to other actors in the pharmaceutical supply chain, where relevant, and in
accordance with competition rules with a view to better prevent or mitigate potential or actual
shortages;
Nomination of a representative in the Executive Steering Group on Shortages and
Safety of Medicinal Products of the European Medicines Agency
Page 3/4
g) Liaise with the Health Security Committee established in Decision No 1082/2013/EU and, in the
case of a public health emergency, any other advisory committee on public health emergencies
established pursuant to Union law as well as with the ECDC;
h) Develop recommendations and coordinate measures (including crisis communication), which may
be taken by the Commission, Member States, marketing authorisation holders and other entities,
including representatives of healthcare professionals and patient organisations, to prevent or
mitigate potential or actual shortages in the context of a major event or public health emergency;
i) In collaboration with the EMA, support the development of the technical and functional
specifications of the ESMP as well as of standardised reporting terminology and relevant guidance
to Marketing Authorisation Holders and Member States;
The MSSG shall inform the Commission and the Executive Director of the Agency, once it considers
that the major event has been sufficiently addressed. On the basis of that information or on its own
initiative, the Commission or the Executive Director may confirm that the assistance of the MSSG is no
longer needed.
Nomination of a representative in the Executive Steering Group on Shortages and
Safety of Medicinal Products of the European Medicines Agency
Page 4/4
From: Zuk Magdalena <
[email protected]>
Sent: Wednesday, February 16, 2022 9:49 AM
To: Esindus EL juures üldaadress <
[email protected]>
Cc:
[email protected];
[email protected]; Zuk Magdalena
<
[email protected]>
Subject: Executive Steering Group on Shortages and Safety of Medicinal Products-Estonia
Your Excellency,
Please find attached a letter signed by the European Medicines Agency's Executive Director
requesting the nomination of a representative to the Agency's EU Executive Steering Group on
Shortages and Safety of Medicinal Products (MSSG).
The letter is accompanied by an Annex compiling the responsibilities of the EU Executive Steering
Group on Shortages and Safety of Medicinal Products. Kindly note that members of the EU
Executive Steering Group on Shortages and Safety of Medicinal Products will have to make
decisions in an urgent manner, to allow for timely and coordinated actions in the EU.
You are kindly invited to address nominations to the European Medicines Agency’s Executive
Director Emer Cooke at your earliest convenience, by 15 March 2022.
Please do not hesitate to contact me should you have any questions regarding this request for
nomination.
Yours sincerely,
MSSG Secretariat
Magdalena Żuk
Supply and Availability of Medicines and Devices (SAM)
Regulatory Science and Innovation Task Force (TRS)
European Medicines Agency
Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands
Telephone +31 (0)88 781 7204
[email protected] | www.ema.europa.eu | For directions, see How to find us
This message and any attachment contain information which may be confidential or otherwise protected from
disclosure. It is intended for the addressee(s) only and should not be relied upon as legal advice unless it is
otherwise stated. If you are not the intended recipient(s) (or authorised by an addressee who received this
message), access to this e-mail, or any disclosure or copying of its contents, or any action taken (or not taken)
in reliance on it is unauthorised and may be unlawful. If you have received this e-mail in error, please inform
the sender immediately.
________________________________________________________________________
This e-mail has been scanned for all known viruses by European Medicines Agency.
________________________________________________________________________
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