The European Medicines Agency (EMA) has
announced the launch of a new platform designed to routinely monitor shortages
of centrally authorized medicines. This platform is a direct result of Regulation
(EU) 2022/123, which aims to improve preparedness for and mitigation of
medicine shortages across EU member states.
Key Points:
Platform
Availability:
The European Shortages Monitoring Platform (ESMP) is now accessible
online.
Mandatory
Usage:
Starting from February 2, 2025, all Marketing Authorization Holders (MAHs)
with centrally authorized products will be required to use the ESMP.
Early
Familiarity:
EMA encourages MAHs to familiarize themselves with the platform before the
mandatory deadline.
Data
Submission:
Until February 2, 2025, MAHs and National Competent Authorities (NCAs) can
submit data on supply, demand, and availability of both centrally and
nationally authorized medicines to the EMA's Executive Steering Group on
Shortages and Safety of Medicinal Products (MSSG).
Medicine
Monitoring:
The platform will be used for routine monitoring of all centrally
authorized medicines and may also be used for monitoring nationally
authorized medicines under special circumstances.
The European Medicines Agency (EMA) has announced the launch of a new platform designed to routinely monitor shortages of centrally authorized medicines.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant sanofi-aventis, s.r.o., against the decision of the State Institute for Drug Control from 23. 3. 2021, under the no. SUKLS172396/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant sanofi-aventis, s.r.o. - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 9. 4. 2021, under the no. SUKLS182256/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Egis Pharmaceuticals PLC - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 12. 4. 2021, under the no. SUKLS182359/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Egis Pharmaceuticals PLC - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Union of Health Insurance Companies, against the decision of the State Institute for Drug Control from 10. 8. 2022, under the no. SUKLS85858/2022:
the decision under
appeal is reversed and the issue is referred back to the State Institute for
Drug Control for reappraisal.
A decision of the Ministry of Health regarding the appeal of the appelant Union of Health Insurance Companies - the decision is reversed and the issue is referred back for reappraisal.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 15. 3. 2021, under the no. SUKLS246602/2020:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V. - the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Ipsen Pharma S.A.S., against the decision of the State Institute for Drug Control from 12. 3. 2021, under the no. SUKLS306733/2020:
the decision under
appeal is reversed and the issue is referred back to the State Institute for
Drug Control for reappraisal.
A decision of the Ministry of Health regarding the appeal of the appelant Ipsen Pharma S.A.S. - the decision is reversed and the issue is referred back for reappraisal.
A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Union of Health Insurance Companies, against the decision of the State Institute for Drug Control from 29. 3. 2021, under the no. SUKLS265370/2018:
the remainder of the appeal is dismissed and the decision under appeal is upheld.
A decision of the Ministry of Health regarding the appeal of the appelant Union of Health Insurance Companies - the appeal is dismissed and the decision under appeal is upheld.
