The new Risk Management Plan format – a major improvement for generic and well-established products

By Ea Dige

On 30 March 2017 EMA published Revision 2 of the guidance on the format for RMPs with major revisions both to guidance (GVP module V) and template. Several sections of the RMP, which previously required considerable resources to prepare, have been defined in a new way, with less repetition and duplication.

The new format supports a better overview in case an RMP needs to be updated due to new safety findings during the lifecycle of the product.

A highlight of the changes

RMP modules that are no longer applicable:

  • Epidemiology of the target indications and target population (Part II-Module SI)
  • Post-authorization experience (Part II-Module SV)
  • Additional EU requirements for the safety specification (Part II-Module SVI)

RMP modules that are still applicable:

  • Identified and potential risks (Part II-Module SVII): The proposed safety concerns must be justified based on evidence from published scientific literature. Listing none of the safety concerns from literature is also possible when this is justified.
  • Summary of safety concerns (Part II-Module SVIII): It is now expected that the safety specification is the same as that of the RMP for the reference medicinal product, if available. This means that Safety concerns do not ‘have to’ be evaluated and presented based on considerations from the applicant.
  • If a ‘reference risk information’ is not available, then all relevant information (e.g. public assessment documents and literature) should be included when preparing the Summary, in the same way as previously required.

A number of documents no longer need to be provided as an annex to the RMP, as they are already included in module 1.3 of the CTD.

These documents are no longer required:

  • Current (or proposed) SmPC and PIL (previously Annex 2)
  • Worldwide marketing authorisation status by country (previously Annex 3)
  • Mock up examples (previously Annex 11)

The Summary of the Risk Management Plan – Part VI:

  • In the previous version (Revision 1) the format and content of the Summary was described as ‘A scientific summary, written for the lay reader’. Presenting this in lay language was challenging.
  • In Revision 2 the summary will be easier to write as the RMP summary should be written and presented clearly using a plain-language approach, using technical terms where relevant.

Transition dates

Use of the new Risk Management Plan (RMP) template becomes mandatory as of 31 March 2018.
For open applications including D91 responses – Revision 1 of RMP is accepted until 31 March 2018.

For detailed information, we refer to the pdf ‘Good Pharmacovigilance Practices’ on the EMA website.

EMA  guide (link to pdf)

Get guidance for preparation and evaluation of your Risk Management Plans

PharmAdvice specializes in supporting customers with Risk Management Plans for new applications as well as revisions, making sure that current good pharmacovigilance practices are followed.

For questions and support in regards to Safety Variations, please contact Ea Dige.

Contact information

For an initial talk, please feel free to contact Ea directly at: +45 4450 3203, or via

Ea DigePharmacovigilance Manager and QPPV, MD
Ea has more than 20 years of experience from the international pharmaceutical industry with special focus on post-marketing safety surveillance, surveillance of safety during clinical trials and previous experience as Medical Assessor at the Danish Health and Medicines Authority.