COVID-19 guidance: post-authorisation
The European medicines Agency (EMA) is mobilising extra resources to monitor safety and manage risk in the pandemic, particularly with COVID-19 vaccines. This is because exceptionally large numbers of people are expected to receive them.
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 bofy of RMPs (plus Annex 4) for all authorised COVID-19 vaccines, in line with its exceptional transparency measures for COVID-19 medicines.
For more information, see:
Procedural guidance is available on submitting a variation application to address SARS-CoV-2 variants by updating the composition of an authorised COVID-19 vaccine, including recommendations on how to name the variant vaccine:
A reflection paper is also available on the data needed to support the approval of COVID-19 vaccine adaptations in the EU. For more information: