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. 

Guidance is available for marketing authorisation holders and applicants for COVID-19 vaccines on pharmacovigilance, risk management and other post-authorisation topics.

Pharmacovigilance plan for COVID-19 vaccines

The pharmacovigilance plan for COVID-19 vaccines sets out how EMA and the national competent authorities in the EU Member States identify and evaluate any new information that arises promptly, including any safety signals that are relevant for the benefit-risk balance of these vaccine:

Risk management for COVID-19 vaccines

Marketing authorisation applicants for COVID-19 vaccines should follow EMA's guidance on preparing risk management plans (RMPs) for COVID-19 vaccines, together with guidance on Risk management plans and Good pharmacovigilance practices, which apply to all medicines:

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:

Periodic safety update reports for COVID-19 vaccines

Guidance is available for marketing authorisation holders on preparing periodic safety update reports (PSURs) for COVID-19 vaccines. The guidance should be used together with EMA’s global guidance on PSURs and on good pharmacovigilance practices:

Updating authorised COVID-19 vaccines to address SARS-CoV-2 variants

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: 

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