Saatja: <
[email protected]>
Saadetud: 05.05.2023 09:40
Adressaat: <
[email protected]>
Koopia: <
[email protected]>
Teema: Follow-up meeting of the National Competent Authorities for Blood and Blood
Components on 25 and 26 April 2023
Manused: image002.jpg
Dear colleagues, dear national authorities for blood and blood components,
It was our pleasure to have you all in our meeting last week. As promised, we herewith provide you with
a short list of follow-up actions:
- You can provide us until 12th May with your further comments on the mock-ups and
presentations regarding the future EU SoHO digital platform you (these files are available on
CircaBC). We will compile and forward them to the consultants working to draft the technical
specifications of the platform.
- We will keep you informed on the interactions between the Critical Entity Resilience directive
(CER) and the proposal for the SoHO regulation. If you would in the meantime be approached
and asked for actions in the context of the CER, please let us know.
- The report titled "Blood Donation in the EU: Exploring Behavioural Insights for Innovative
Interventions" is now available for download on CircaBC, together with the presentation given.
We kindly request that you take a moment to review the report and provide. In particular, we
would appreciate it if you could revise your Country Profile and integrate any information
related to the year 2021 that you deem necessary. To assist you in this process, we encourage
you to compare your profile with those of other Member States. Furthermore, we have included
tables from page 63 to page 70 (Section 7.28) that summarize the EU 27 Blood Donation
Panorama Findings, which you may find helpful in identifying areas where additional
information can be provided. Any feedback you may have should be sent by 12th of May to
[email protected].
- An ad-hoc working group will be established to develop recommendations on the approval of
non-DEHP blood bag sets, with the aim of streamlining and accelerating that process, as the
devices become available. FR, IT, SE and CY indicated already interest to participate. Please
send any further nominations for this working group to
[email protected] by May
19th. We would also be very grateful if any representative would be willing to volunteer (by the
same deadline) to co-ordinate that initiative, with secretarial support from the SoHO team.
Furthermore, note for your information:
- The next Council Working Party meeting to discuss the SoHO proposal will take place on 15th
May and will focus on protection of recipients and offspring (chapter VII)
- The next virtual meeting is planned on 24th May and will be a joint meeting of the competent
authorities for blood, tissues & cells and organs.
- Transfusion of CCP was authorized and extensively studied by blood services and establishments
during the first COVID waves (2020). At the occasion of development of a nasal spray
application, a survey of pharma authorities indicated that some considered this to be a
medicinal product, while showing openness for classification under the new SoHO regulation.
We expect EMA and pharma colleagues to come back soon to you with an extended survey on
CCP to collect your views as SoHO authorities.
Further minutes will be provided later.
With kind regards,
The SoHO team.
European Commission
DG SANTE (Health and Food Safety)
Unit D2 – Medical Products: quality, safety, innovation
Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium
http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm