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What the new European Regulation 2022/123 brings in the field of medicines and medical devices

New Regulation of the European Parliament and of the Council (EU) 2022/123 of 25 January 2022 on reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices has been so far almost unnoticed by the public professional, despite the fact that for medicinal products, it has been in force since March this year and for for medical devices from 2 February 2023.

The regulation is part of the EU legislative package aimed at ensuring a so-called European health union, a system under which all EU countries will work together to and respond to health crises together. It was prompted by the experience of the Covid-19 pandemic and the discovery of significant barriers to addressing threats to public health throughout the Union. We realised how dependent the Union is on external resources for the production of pharmaceuticals and medical devices, and how the lack of coordination and the necessary structures undermine the ability of the Union and the member states to respond quickly and effectively to challenges arising during public health emergencies.

The aim of the Regulation is to harmonise and strengthen the rules for monitoring shortages of medicines and medical devices and to facilitate research and development of medicines that have the potential to treat, prevent or diagnosis of diseases causing public health crises.

The Regulation is currently being adapted to the Czech legal system. An internal comment procedure is underway for the amendment to the Medicinal Products Act and the Medical Devices Act, which on the one hand establishes new competences for the Ministry of Health, resp. State institute for drug control (SÚKL), and on the other, it the field of medicines, imposes an obligation on the holders of authorisations, distributors and pharmacies, and in the field of medical devices on manufacturers, authorised representatives, health service providers, importers and distributors to provide the necessary cooperation and information on products included in the list of critically important medicines or medical devices to the SÚKL.

The Regulation thus represents the first step in building a comprehensive EU system to

to ensure that the problem of shortages of medicines and medical devices in the EU is solved.

Author: Aneta Dostálová


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