COVID-19 guidance: post-authorisation

Duing the COVID-19 public health emergency, the European medicines Agency (EMA) mobilised extra resources to monitor safety and manage risk, particularly with COVID-19 vaccines. EMA provided guidance on pharmacovigilance, risk management and other topics.

The guidance in this section was intended for use during the COVID-19 public health emergency. Some of it remains relevant, either for COVID-19 medicines or if another public health emergency were to happen. Please see individual topics for more information.   

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.

The principles in this guidance remain relevant for COVID-19 vaccines after the public health emergency:

Pharmacovigilance plan of the EU Regulatory Network for COVID-19 vaccines

Reference Number: EMA/333964/2020

For more information, see:

• Pharmacovigilance: Overview

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 principles in this guidance remain relevant for COVID-19 vaccines after the public health emergency:

Consideration on core requirements for RMPs of COVID-19 vaccines

Reference Number: EMA/PRAC/73244/2022

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

EMA publishes the full body 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:

• Risk management plans

Periodic safety update reports for COVID-19 vaccines

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

Consideration on core requirements for PSURs of COVID-19 vaccines

Adopted Reference Number: EMA/362988/2021

More information:

• Periodic safety update reports (PSURs)
• Good pharmacovigilance practices
• Monitoring of COVID-19 medicines

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.

The principles in this guidance remain relevant for COVID-19 vaccines after the public health emergency:

Procedural guidance for variant strain(s) update to vaccines intended for protection against human coronavirus

Adopted Reference Number: EMA/175959/2021 Rev.2

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: 

• Evaluation and marketing authorisation: adapting COVID-19 vaccines to SARS-CoV-2 variants