The Netherlands
On March 30, 2022, the Dutch Health Authorities (MEB) updated the local policy regarding aRMM which is applicable for new and updated materials. No changes are required for aRMM that are already approved by MEB nor for ongoing procedures. The most important changes are:
- Clarification of the documents that should be provided for the assessment by MEB
- Emphasis that the company must have its own (non-promotional) webpage with aRMM materials
- Addition of a description of controlled access and controlled distribution system
- The brand name can be mentioned once in combination with the active substance in materials for patients/parents.
- Use of QR code in aRMM which links to the online aRMM materials
More information regarding the update of the Dutch aRMM policy can be found here: https://www.cbg-meb.nl/actueel/nieuws/2022/03/30/aangepast-beleid-nationale-implementatie-additionele-risicominimalisatie-maatregelen