Press Releases

Updated GVP Module V (Risk Management Systems) now published

On March 30 2017, EMA published the second revision of GVP Module V, which marketing authorisation holders and applicants can use for all RMP submissions as of 31 March 2017.

The second revision of GVP Module V includes the following important changes and clarifications: 

  • further clarification on the focus of RMPs in relation to an important identified or important potential risk and missing information
  • removal of duplication within GVP Module V
  • removal of duplication of information in other guidance documents
  • further guidance on the expected changes in the RMP during the life cycle of the product
  • updated requirements for different types of initial marketing authorisation applications, with the aim to create risk-proportionate RMPs 

The revised guidance has been updated in parallel to an amended RMP template for initial marketing authorisation applications. 

Use of GVP V (R2) and the new EU RMP template become mandatory from 31 March 2018. The first revision of the RMP template may be used:

  • until 30 September 2017 for RMPs submitted with the initial marketing authorisation application and responses to day 120 list of questions
  • until 30 March 2018 for all other RMP submissions, including D91 responses for an initial application under accelerated assessment

For further information see: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000360.jsp&mid=WC0b01ac0580b91135