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to support the implementation of the variations guidelines in the centralised procedure: document with track changes - superseded
Guidance on RMP format
Guidance on the format for RMPs is available in a single document. This is available in PDF and in Word formatsbelow.
Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2.0.1)
AdoptedLegal effective date: Reference Number: EMA/164014/2018 Rev. 2.0.1
English (EN) (492.64 KB - PDF)
First published: Last updated:
Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2.0.1)
AdoptedLegal effective date: Reference Number: EMA/164014/2018 Rev. 2.0.1
English (EN) (564.5 KB - DOC)
First published: Last updated:
Risk management plans for COVID-19 vaccines
Marketing authorisation applicants for COVID-19 vaccinesshouldfollow EMA's guidance on preparing RMPsfor COVID-19 vaccines, together with the guidance in this section andGood pharmacovigilance practices, which apply to all medicines.
The guidance reflects special safety monitoring measures forCOVID-19 vaccinesby providingconsiderations and requirements for several sections of the RMP.
EMA publishesthe full bodyof the RMP (plus Annex 4)for all authorised COVID-19 vaccines, in line with its exceptional transparency measures for COVID-19 medicines.
Consideration on core requirements for RMPs of COVID-19 vaccines
Reference Number: EMA/PRAC/73244/2022
English (EN) (339.77 KB - PDF)
First published: Last updated:
For more information, see:
- Guidance for medicine developers and other stakeholders on COVID-19
- COVID-19 vaccines: development, evaluation, approval and monitoring
Publication of RMPs and their summaries
From 20 October2023,EMA is publishingRMPs(main body andannexes 4 and 6)forall centrally authorised products:
- initial evaluations;
- RMP updates.
EMA nolonger publishesRMP summariesfrom thesame date.
The aim is to increase transparencyof thesafety reviewprocess for all centrally authorised products.
The RMP or RMP summary is available on each medicinepage. Alternatively, a historicallist of allRMP summaries is available.
For furtherinformation on RMPs and on the anonymisation of personal data (PD)and assessment of commercially confidential information (CCI)during the preparation of RMPs, see:
Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)
Reference Number: EMA/781194/2021 Rev. 1
English (EN) (151.67 KB - PDF)
First published: Last updated:
Template: Declaration for the risk management plan (RMP) publication
English (EN) (17.73 KB - DOCX)
First published: Last updated:
Post-authorisation guidance
Guidance is available for marketing authorisation holders of centrally authorised medicines on the procedural and regulatory aspects to the RMPlifecycle during the post authorisation phase:
- Risk management plan (RMP): questions and answers
Superseded templates
Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2)
Reference Number: EMA/PRAC/613102/2015 Rev.2 accompanying GVP Module V Rev.2
English (EN) (539.09 KB - PDF)
First published: Last updated:
Guidance on format of the risk-management plan in the European Union – in integrated format (Rev. 1)
AdoptedLegal effective date: Reference Number: EMA/465932/2013
English (EN) (314.42 KB - PDF)
First published: Last updated:
Guidance on format of the risk-management plan in the European Union for generics (Rev. 1)
AdoptedLegal effective date: Reference Number: EMA/465933/2013
English (EN) (230.41 KB - PDF)
First published: Last updated:
Template for European Union risk-management plan (superseded)
Reference Number: EMEA/192632/2006
English (EN) (190.06 KB - PDF)
First published: Last updated:
Related content
- Good pharmacovigilance practices
- Guidance for medicine developers and other stakeholders on COVID-19
Topics
Regulatory and procedural guidance
Pharmacovigilance
