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New Regulation (EU) 2022/123 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
 

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PXL/HO/Cir-152/2021-22                                                                            Date: 18.03.2022

Hyderabad

 

 

SubjectNew Regulation (EU) 2022/123 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL.

 

This is with reference to the New Regulation (EU) 2022/123 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices.

 

-The EC states that the regulation is an important pillar of the European Health Union. This Regulation provides for a framework for and the means of:

 

*preparing for, preventing, coordinating and managing the impact of public health emergencies on medicinal products and on medical devices and the impact of major events on medicinal products and on medical devices at Union level;

*monitoring, preventing, and reporting on shortages of medicinal products and on shortages of medical devices.

*setting up an interoperable information technology (IT) platform at Union level to monitor and report on shortages of medicinal products;

*providing advice on medicinal products that have the potential to address public health emergencies;

 

-EU has revised the mandate of the European Medicines Agency (EMA),  taking an important step towards EMA's reinforcement in crisis preparedness and management for medicinal products and medical devices. As per the reinforced mandate given, the Agency can facilitate a coordinated EU-level response to health crises by monitoring and mitigating the risk of shortages of critical medicines and medical devices.

 

*providing scientific advice on medicines that may have the potential to treat, prevent or diagnose the diseases causing those crises;

*coordinating studies to monitor the effectiveness and safety of medicinal products intended to treat, prevent or diagnose diseases related  to the public health crisis;

*coordinating clinical trials for medicinal products intended to treat, prevent or diagnose diseases related to the public health crisis.

*transferring the expert panels of the Medical Device Regulation to the Agency.

 

 -The new legislation also formally establishes the Medicines and Medical Devices Shortages Steering Group and the Emergency Task Force. Further, EMA will be tasked with the monitoring of events, including medicine shortages, which might lead to a crisis situation including the reporting of shortages of critical medicines during a crisis. The Agency will also coordinate responses of EU countries on shortages of critical Medical devices and in vitro diagnostics occurring in crisis situations, after an initial transition period.

 

-Other action envisaged is that EMA will set up, maintain and manage, by early 2025, a European Shortages Monitoring Platform to facilitate data collection and reporting by companies and Member States on shortages, supply and demand of critical medicines. EMA has also been given the responsibility to coordinate twelve EU expert panels to provide advice to Member States and the EC on high-risk medical devices and in-vitro diagnostic medical devices.

 

-Under its extended mandate, EMA will also facilitate a coordinated EU-level response to public health emergencies

 

*reinforcing the activities of the COVID-19 EMA pandemic Task Force (COVID-ETF) in providing scientific advice and reviewing available scientific evidence on medicines with the potential to address a public health emergency, and supporting existing EMA committees with their authorization and safety monitoring of medicines.

 

*coordinating independent vaccine effectiveness and safety monitoring studies using relevant data held by public authorities;

 

* investing in and leveraging real-world evidence to support crisis preparedness and response. This includes the establishment of a pan-European network of real-world data, DARWIN EU, which will provide EMA’s scientific committees with real-world evidence from health care databases across the EU.

 

 The Regulation will enter into force on 01 Feb 2022 and will apply from 1 March 2022. The Regulation's provisions on shortages monitoring of medical devices, except for the transfer of the expert panels, will apply 12 months after the entry into force of the Regulation. 

 

The published regulation and a fact sheet on EU health agencies are attached.

 

 

 

With regards,

 

 

Udaya Bhaskar

Director General

 

Encl: Regulation and Fact Sheet on EU Health