Risk management plans

Companies are required submit a risk-management plan (RMP) to the European Medicines Agency (EMA) when applying for a marketing authorisation. To help applicants, guidance is available on how to submit RMPs.

RMPs include information on:

• a medicine's safety profile;
• how its risks will be prevented or minimised in patients;
• plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine;
• measuring the effectiveness of risk-minimisation measures.

In the European Union (EU), companies must submit an RMP to the Agency at the time of application for a marketing authorisation. For medicines that do not have an RMP, one may be required with any application involving a significant change to the marketing authorisation.

In addition, for nationally authorised medicinal products, any national competent authority (NCA) in the EU can request an RMP whenever there is a concern about a risk affecting the benefit-risk balance of a medicine.

RMPs are continually modified and updated throughout the lifetime of the medicine as new information becomes available. Companies need to submit an updated RMP:

• at the request of EMA or an NCA;
• whenever the risk-management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit-risk profile or as a result of an important pharmacovigilance or risk-minimisation milestone being reached.

When justified by risk, the competent authority can also specify a date for submission of the next RMP as a condition of the marketing authorisation in exceptional cases.

RMPs can only be submitted at the same time as the periodic safety update report (PSUR) if the change in the RMP comes as a consequence of the PSUR.

For more information, see:

• Module V – Risk-management systems on Good pharmacovigilance practices
• Practical questions and answers to support the implementation of the variations guidelines

Guidance on the format for RMPs is available in a single document. This is available in PDF and in Word formats below.

Marketing authorisation applicants for COVID-19 vaccines should follow EMA's guidance on preparing RMPs for COVID-19 vaccines, together with the guidance in this section 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 publishes the full body of the RMP (plus Annex 4) for all authorised COVID-19 vaccines, in line with its exceptional transparency measures for COVID-19 medicines.

For more information, see:

• Guidance for medicine developers and other stakeholders on COVID-19
• COVID-19 vaccines: development, evaluation, approval and monitoring

Since July 2022, EMA publishes RMPs (main body and annexes 4 and 6) for centrally authorised products that:

• contain a new active substance
• are of particular public interest

For all other centrally authorised products, EMA publishes summaries of RMPs.

The aim is to increase transparency of the safety review process for a medicine or active substance.

The RMP or RMP summary is available on each medicine page. Alternatively, a list of all RMP summaries is available.

For further information on RMP summaries and on the anonymisation of protected personal data (PPD) and assessment of commercially confidential information (CCI) during the preparation of RMPs, see:

Guidance is available for marketing authorisation holders of centrally authorised medicines on the procedural and regulatory aspects to the RMP lifecycle during the post authorisation phase:

• Risk management plans (RMP) in post-authorisation phase: questions and answers