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:

RMP format

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

Risk management plans for COVID-19 vaccines (new)

NewMarketing 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 will publish 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:

Public summaries of RMPs

EMA publishes summaries of RMPs for centrally authorised medicines. These are intended to allow stakeholders wider access to the information behind the decision-making process of European regulatory authorities when they review the safety of a medicine or active substance.

For further information on RMP summaries and their role, see:

Topics

How useful was this page?

Add your rating
Average
17 ratings
5 ratings
5 ratings
9 ratings