Medicinal products and medical devices; Medical equipment (ICS 11.040), Pharmaceutics (ICS 11.120)
Proposal for a Regulation of the European Parliament and of the Council on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (COM(2020) 725) (53 page(s), in English)
This draft Regulation provides for, within the European Medicines Agency, a framework for and the means to:
(a) prepare for and manage the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;
(b) monitor and report on shortages of medicinal products for human use and medical devices;
(c) provide advice on medicinal products for human use with the potential to address public health emergencies ('candidate medicines');
(d) provide support for the medical device expert panels designated in accordance with Commission Implementing Decision (EU) 2019/1396.