I.C.4. Preparedness planning in the EU for pharmacovigilance in public health emergencies

The pharmacovigilance systems of marketing authorisation holders, competent authorities in Member States and the Agency should be adaptable to public health emergencies. Preparedness plans should be developed as appropriate (see I.B.13.).

A public health emergency is a public health threat duly recognised either by the World Health Organization (WHO) or the Community in the framework of Decision No. 2119/98/EC of the European Parliament and of the Council.

Pharmacovigilance requirements for public health emergencies should be considered by the competent authorities in Member States, the European Commission and the Agency on a case-by-case basis and appropriately notified to marketing authorisation holders and the public. The Agency publishes its notifications on the Agency’s website.