The Medicines Evaluation Board (MEB) has amended its policy regarding the national implementation of ‘additional Risk Minimization Measures‘ (aRMM) (MEB 45). This is still a draft version.
The main changes are:
1. Clarification of the assessment documents to be provided.
2. Inclusion of the brand name of the product once, in aRMM for patients, under specific conditions.
3. Recommendation for a legible, short aRMM in clear language.
4. Possibility to include a QR on the packaging or in the package leaflet for the aRMM for patients and their carers. The QR code can also be included in the aRMM itself.
5. Preference to enclose the patient card in the medicine packaging, if possible.
6. The term ‘Patient Alert Card’ has been replaced by ‘Patient Card’.
7. Customization of the templates in line with all the changes.
8. Addition of a decision tree for distribution options.
The MEB invites interested parties and stakeholders to comment on this revised policy document via the public consultation response form no later than 2 August 2021.