RMP formats

The guidance on the format for RMPs is available with all modules in one document. This is available in PDF and in Word format in the tables below.

Revised RMP template and transitional arrangements

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

Its use for all RMP submissions becomes mandatory as of 31 March 2018.

Marketing authorisation holders and applicants may still use the first revision of the template:

  • until 30 September 2017 for RMPs submitted with the initial marketing authorisation applicationand 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.

Guidance on the format of the risk management plan(RMP) in the EU – in integrated format (Rev. 2)

Posted on the EMA website