Additional Risk Minimisation Measures (aRMM)

To marketing authorisation holders: Change in receipt of aRMM at the Icelandic Medicines Agency (IMA)

2.6.2017

From 1 June 2017 IMA will take seven days to ensure that all relevant documents are enclosed in an application for aRMM evaluation. This is done to facilitate IMAs review of the material.

The following documents should be provided: 

  • A list of proposed recipients (by speciality)
  • Cover letter to doctors/healthcare professionals

All documents should be provided in .doc/.docx format. Missing documents will be requested. When all documents have been submitted the application is considered valid (day 0) and an email confirming receipt will be sent to the applicant.