Consideration on Core Requirements for Risk Management Plans of COVID-19 Vaccines —CoreRMP19 Guidance

The guidance reflects special safety monitoring measures for COVID-19 vaccines by providing considerations and requirements for several sections of the RMP.

EMA will publish the full body of the RMP (plus Annex 4) for all authorized COVID-19 vaccines, in line with its exceptional transparency measures for COVID-19 medicines.

This coreRMP19 document addresses the planning for post-marketing surveillance for COVID-19 vaccines in the context of marketing authorization in the EU.