The European Medicines Agency (EMA) has initiated a series of actions to respond to the ongoing monkeypox outbreak, which has been escalated by the World Health Organization (WHO) to a Public Health Emergency of International Concern (PHEIC) on Saturday 23 July.

This is the first new PHEIC to be declared since the regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices has become applicable.

Since the start of the recent monkeypox outbreak, EMA has been monitoring the situation closely and already taken multiple actions to prepare for and support the EU response.

This includes the Agency’s recommendation on 22 July to approve an extension of indication for the vaccine Imvanex to protect adults from monkeypox disease.

The new powers given to the Agency under its extended mandate trigger additional activities now that monkeypox has been declared a public health emergency.

Press Release EMA in "Related documents"