Recommendation of changes to product information translated into all official languages of the EU

By William Chin, PhD, Scientific Coordinator, EUCRAF

In order to facilitate consistent implementation of product-information changes across the EU and reduce administrative burden for stakeholders, the  European Medicines Agency (EMA) has started to translate its recommendation based on the assessment of safety signals - 3 weeks after publication in English - into all official languages of the European Union (EU) as well as Norwegian and Icelandic.

What initiate recommendation to product information?

  • Detection safety signals on a new or incompletely documented adverse event caused by a medicine.
  • The Pharmacovigilance Risk Assessment Committee (PRAC) will assess these reported safety signals.
  • PRAC will recommend changes to product information in the interest to protect public health when a causal relationship between the medicine and the reported adverse event is confirmed.
  • For centrally authorised medicine, PRAC submits recommendation to the Committee for Medicinal Products for Human Use (CHMP).
  • For signal concerns a nationally authorised medicine, recommendation is submitted to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).


1. EMA News and Events, 18 February 2105, Safety signals: recommendations now available in all EU languages