Amended policy on national implementation of additional risk minimisation measures

The Medicines Evaluation Board (MEB) has amended its policy for the national implementation of additional risk minimisation measures (MEB 45). The policy concerns medicinal products for human use.

The main changes are:

  1. Clarification of the assessment documents to be submitted:
    • In case of changes to already approved additional risk minimisation material: offer a clean version and a track changes version of the material.
    • Alongside the assessment documents, provide a web address (direct link) where the risk minimisation material will become available digitally and online.
    • If applicable, describe the controlled access/controlled distribution program.
    • Do not include personal data in the risk minimisation material (General Data Protection Regulation / AVG).
  2. It is emphasized that publication of the material on the MEB's Medicines Information Bank is not sufficient. The marketing authorisation holder must have his own web page available with online additional risk minimisation material.
  3. Description of controlled access and controlled distribution system (new chapter).
  4. Risk minimisation material for generics/biosimilars/hybrids/parallels shall, where possible, be identical to the material of the reference product.
  5. The brand name of a product can be mentioned once in combination with active substance name in risk minimisation material for the patient / parents / caregiver of the patient. This applies, among other things, to innovator products of which no generics are authorised. If market exclusivity expires, the marketing authorisation holder will remove the brand name.
  6. Recommendation for use of comprehensible language, preferably language level B1, in risk minimisation material for patients. A reference to the MEB toolkit for patient-friendly writing has been added.
  7. The term 'Patient Alert Card' has been replaced by 'Patient Card'.
  8. Does the risk minimisation material consist of a patient card? Then preferably include the patient card in the packaging of the medicine, if possible.
  9. Use of QR code in risk minimisation material that refers to the online risk minimisation material.
  10. Customisation of the templates:
    • The template additional risk minimisation material for prescribers / healthcare professionals has been adapted with standard title and optional QR code.
    • The template additional risk minimisation material for the patient, the parents and / or caregivers of the patient has been adapted with the possibility of including product brand name and optional QR code.
    • New: template for a patient card.
  11. Instructions for active distribution and dissemination on request have been clarified. New: A decision tree for distribution possibilities.

The changes were made on the basis of experiences with the implementation of additional risk minimisation materials in practice.

The new policy will take effect on 30 March 2022, and will not apply to ongoing proceedings. Previously approved additional risk minimisation material must comply with the new rules from the moment a planned update of the material is submitted for review.

Policy formulation

For amendment of the policy, the MEB evaluated issues of related procedures and carried out a public consultation in which the policy was submitted to healthcare professional associations and the pharmaceutical industry.