Saatja:
[email protected]
Saaja:
[email protected]
Teema: Newsletter December 2022
Kuupäev: 2022-12-01 15:00
Dear national competent authorities for blood, tissues & cells and
organs,
We are writing to update you on our recent activities and some more
general news.
1. EU funding and EU4Health calls for 2023 have now been announced
* The EU4Health Work programme for 2023 has been adopted and published:
https://health.ec.europa.eu/publications/2023-eu4health-work-programme_en
and includes, for SoHO, activities strengthening the implementation of the
legislation on blood, tissues and cells and organs and in particular:
* action grants on the safety and quality of new substances of human
origin (breast milk, faecal microbiota transplants) (HS-g-23-50.01-02)
with estimated call publication in Q1/2023 for an amount of 400.000 € for
each of the two subtopics: breast milk and faecal microbiota transplants.
* action grants on facilitating organ paired exchange (HS-g-23-51) with
estimated call publication in Q1-Q2/2023 for an amount of 600.000€.
* If you wish to stay informed on this and other calls, we invite you
to follow the EU4Health webpage where additional information is available.
2. Rapid Alerts platforms will migrate early December
As previously announced, the Rapid Alert platforms for Blood and Tissues
& Cells will migrate to a new environment on 6 December 2022. No
action is expected from you, you will be immediately able to use the new
platforms. Data will be fully moved to the new environment. Users can
experience a new look and feel while the functionalities remain the same
as in the previous version, but a two-factor authentication will be in
place. The Vigilance Expert Subgroup (VES) is working to further improve
the system. We will keep you informed when new features will be
implemented.
3. SARE reporting will soon be piloted for organs
The Vigilance Expert Subgroup (VES) is organizing a pilot of European
level submission of nationally collected Serious Adverse Events and
Serious Adverse Reactions in organ transplantations, as required under the
Directive 2010-53. Competent Authorities for organs were already informed
and invited to forward the draft pilot summary to their delegated bodies
if they will be participating on their country’s behalf. Competent
authorities will be asked to send data collected during the current year
(2022) early in 2023.
4. Report on the implementation of the Organs Directive is publicly
available
After consulting you on the draft, the final Report from the Commission
to the European Parliament, the Council, the European Economic and Social
Committee and the Committee of Regions on the implementation of Directive
2010/53/EU of the European Parliament and of the Council of 7 July 2010 on
standards of quality and safety of human organs intended for
transplantation, and its annex, was adopted on 30 November 2022 and is
available here.
Once more, we would like to thank the Competent Authorities involved for
their participation in the survey: your replies have helped us to draft
this comprehensive report.
5. 5. A new infographic is available on the use of the Emergency
Support Instrument
Back in summer 2020, Emergency Support Instrument (ESI) funds have been
allocated to support blood establishments with CCP collection by
increasing their plasmapheresis capacity. The results of those investments
are now summarised in an infographic that can be downloaded here
If you wish to reach the SoHO team, please contact us at
[email protected].
Best wishes,
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
Saatja: <
[email protected]>
Saadetud: 01.12.2022 17:00
Adressaat: <
[email protected]>
Koopia: <
[email protected]>
Teema: Newsletter December 2022
Dear national competent authorities for blood, tissues & cells and
organs,
We are writing to update you on our recent activities and some more
general news.
1. EU funding and EU4Health calls for 2023 have now been announced
* The EU4Health Work programme for 2023 has been adopted and published:
and includes, for SoHO, activities strengthening the implementation of
the legislation on blood, tissues and cells and organs and in particular:
* action grants on the safety and quality of new substances of human
origin (breast milk, faecal microbiota transplants) (HS-g-23-50.01-02)
with estimated call publication in Q1/2023 for an amount of 400.000 Ђ for
each of the two subtopics: breast milk and faecal microbiota transplants.
* action grants on facilitating organ paired exchange (HS-g-23-51) with
estimated call publication in Q1-Q2/2023 for an amount of 600.000Ђ.
* If you wish to stay informed on this and other calls, we invite you
to follow the webpage where additional information is available.
2. Rapid Alerts platforms will migrate early December
As previously announced, the Rapid Alert platforms for Blood and Tissues
& Cells will migrate to a new environment on 6 December 2022. No
action is expected from you, you will be immediately able to use the new
platforms. Data will be fully moved to the new environment. Users can
experience a new look and feel while the functionalities remain the same
as in the previous version, but a two-factor authentication will be in
place. The Vigilance Expert Subgroup (VES) is working to further improve
the system. We will keep you informed when new features will be
implemented.
3. SARE reporting will soon be piloted for organs
The Vigilance Expert Subgroup (VES) is organizing a pilot of European
level submission of nationally collected Serious Adverse Events and
Serious Adverse Reactions in organ transplantations, as required under
the Directive 2010-53. Competent Authorities for organs were already
informed and invited to forward the draft pilot summary to their
delegated bodies if they will be participating on their countrys behalf.
Competent authorities will be asked to send data collected during the
current year (2022) early in 2023.
4. Report on the implementation of the Organs Directive is publicly
available
After consulting you on the draft, the final Report from the Commission
to the European Parliament, the Council, the European Economic and Social
Committee and the Committee of Regions on the implementation of Directive
2010/53/EU of the European Parliament and of the Council of 7 July 2010
on standards of quality and safety of human organs intended for
transplantation, and its annex, was adopted on 30 November 2022 and is
available .
Once more, we would like to thank the Competent Authorities involved for
their participation in the survey: your replies have helped us to draft
this comprehensive report.
5. 5. A new infographic is available on the use of the Emergency
Support Instrument
Back in summer 2020, Emergency Support Instrument (ESI) funds have been
allocated to support blood establishments with CCP collection by
increasing their plasmapheresis capacity. The results of those
investments are now summarised in an infographic that can be downloaded
If you wish to reach the SoHO team, please contact us at .
Best wishes,
The SoHO team.
European Commission DG SANTE (Health and Food Safety)
Unit D2 Medical Products: quality, safety, innovationOffice address: Rue
Breydel 2, 06/004, B-1049 Brussels/Belgium