EMA’s new mandate enters into force as of March 1

01/03/2022 News Europe 328 Views
EMA’s new mandate enters into force as of March 1

As of March 1, the regulation reinforcing the European Medicines Agency (EMA)’s role in crisis preparedness and management of medicinal products and medical devices becomes applicable. It puts some of the structures and processes established by EMA during the COVID-19 pandemic on a more permanent footing, while entrusting several new tasks to the EMA.

EMA is now responsible for monitoring medicine shortages that might lead to a crisis situation, as well as reporting shortages of critical medicines during a crisis. The Agency will also coordinate responses of EU / EEA countries to shortages of critical medical devices and in-vitro diagnostics in crisis situations, after an initial transition period up to 2 February 2023.

Over the next few weeks and months, EMA will set up a number of new bodies and formalise existing ones to manage the new tasks.

Read more here.

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