Risk-management plans

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Companies are required submit a risk-management plan (RMP) to the European Medicines Agency (EMA) when applying for a marketing authorisation. To help applicants, EMA developed guidance 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;
  • risk factors for developing adverse reactions;
  • 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, it is likely that one will 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 formats

The guidance on the format for RMPs is available in three ways:

  • an integrated RMP with all of the modules in one document;
  • an abridged format suitable for use for generic medicines;
  • the complete set of individual modules.

These are available as PDF and as Word versions in the tables below.

Submitting RMPs

Currently, companies need to submit a complete RMP each time an update is required using the integrated format below. RMPs for generic medicines can follow the abridged version below.

In the future, companies will only need to submit the modules that have changed so that the Agency can build a complete RMP based on the latest version of each module. This will be possible once the electronic system for building complete RMPs has been developed.

The separate modules are provided below for use within companies. Separate modules should not be submitted to the Agency at this stage.

Public summaries of RMPs

In March 2014, the Agency began publishing 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:

Table of contents


Integrated PDF version

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Document(s) Language Status First published Last updated Effective Date
Guidance on format of the risk-management plan in the European Union – in integrated format (English only)   2012-11-08 2013-08-21  

Integrated Word version

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Document(s) Language Status First published Last updated Effective Date
Guideline on good pharmacovigilance practices (GVP) 3 - Module V – Risk management systems (Rev 2) (English only) draft: consultation closed 2016-02-29    
Draft guidance on format of the risk management plan (RMP) in the EU – in integrated format (English only) draft: consultation closed 2016-02-29    
Guidance on format of the risk-management plan in the European Union – in integrated format (English only)   2012-11-14 2013-08-21  

Abridged PDF version for generics

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Document(s) Language Status First published Last updated Effective Date
Guidance on format of the risk-management plan in the European Union for generics (English only)   2012-11-08 2013-08-21  

Abridged Word version for generics

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Document(s) Language Status First published Last updated Effective Date
Guidance on format of the risk-management plan in the European Union for generics (English only)   2012-11-14 2013-08-21  

Separate modules: PDF versions

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Document(s) Language Status First published Last updated Effective Date
Guidance on format of the risk-management plan in the European Union part I: Product overview (English only)   2012-11-08    
Guidance on format of the risk-management plan in the European Union part II: Module SI - Epidemiology of the indication(s) and target population (English only)   2012-11-08    
Guidance on format of the risk-management plan in the European Union part II: Module SII - Non-clinical part of the safety specification (English only)   2012-11-08 2013-08-21  
Guidance on format of the risk-management plan in the European Union part II: Module SIII - Clinical-trial exposure (English only)   2012-11-08    
Guidance on format of the risk-management plan in the European Union part II: Module SIV - Populations not studied in clinical trials (English only)   2012-11-08 2013-08-21  
Guidance on format of the risk-management plan in the European Union part II: Module SV - Post-authorisation experience (English only)   2012-11-08    
Guidance on format of the risk-management plan in the European Union (EU) part II: Module SVI - Additional EU requirements for the safety specification (English only)   2012-11-08    
Guidance on format of the risk-management plan in the European Union part II: Module SVII - Identified and potential risks (English only)   2012-11-08    
Guidance on format of the risk-management plan in the European Union part II: Module SVIII - Summary of the safety concerns (English only)   2012-11-08 2013-08-21  
Guidance on format of the risk-management plan in the European Union part III: Pharmacovigilance plan (English only)   2012-11-08    
Guidance on format of the risk-management plan in the European Union part IV: Plans for post-authorisation efficacy studies (English only)   2012-11-08    
Guidance on format of the risk-management plan in the European Union part V: Risk-minimisation measures (English only)   2012-11-08    
Guidance on format of the risk-management plan in the European Union part VI: Summary of activities in the risk-management plan by product (English only)   2012-11-08 2013-08-21  
Guidance on format of the risk-management plan in the European Union part VII: Annexes (English only)   2012-11-08    

Separate modules: Word versions

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Document(s) Language Status First published Last updated Effective Date
Guidance on format of the risk-management plan in the European Union part I: Product overview (English only)   2012-11-14    
Guidance on format of the risk-management plan in the European Union part II: Module SI - Epidemiology of the indication(s) and target population (English only)   2012-11-14    
Guidance on format of the risk-management plan in the European Union part II: Module SII - Non-clinical part of the safety specification (English only)   2012-11-14 2013-08-21  
Guidance on format of the risk-management plan in the European Union part II: Module SIII - Clinical-trial exposure (English only)   2012-11-14    
Guidance on format of the risk-management plan in the European Union part II: Module SIV - Populations not studied in clinical trials (English only)   2012-11-14 2013-08-21  
Guidance on format of the risk-management plan in the European Union part II: Module SV - Postauthorisation experience (English only)   2012-11-14    
Guidance on format of the risk-management plan in the European Union (EU) part II: Module SVI - Additional EU requirements for the safety specification (English only)   2012-11-14    
Guidance on format of the risk-management plan in the European Union part II: Module SVII - Identified and potential risks (English only)   2012-11-14    
Guidance on format of the risk-management plan in the European Union part II: Module SVIII - Summary of the safety concerns (English only)   2012-11-14 2013-08-21  
Guidance on format of the risk-management plan in the European Union part III: Pharmacovigilance plan (English only)   2012-11-14    
Guidance on format of the risk-management plan in the European Union part IV: Plans for postauthorisation efficacy studies (English only)   2012-11-14    
Guidance on format of the risk-management plan in the European Union part V: Risk-minimisation measures (English only)   2012-11-14    
Guidance on format of the risk-management plan in the European Union part VI: Summary of activities in the risk-management plan by product (English only)   2012-11-14 2013-08-21  
Guidance on format of the risk-management plan in the European Union part VII: Annexes (English only)   2012-11-14    

Old template

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Document(s) Language Status First published Last updated Effective Date
Template for European Union risk-management plan (English only) adopted 2006-09-27    

Related links

This old risk-management-plan template has been superseded. It was in use until 10 April 2013.