The Medicines Evaluation Board (CBG) has revised its policies on patient leaflets and labelling of medicinal products (documents MEB-5 and MEB-6), with significant updates, especially regarding the use of pictograms. The largest change is in MEB-6, where the layout of standardized pictograms has been updated, and the Positive List of Pictograms has expanded to include additional warnings and usage instructions. This expanded pictogram set, developed in collaboration with industry stakeholders, can now also be used in patient leaflets (MEB-5), allowing users to easily access critical information on proper use and safety. These pictograms, accompanied by approved text, aim to make essential warnings and instructions more accessible and easier for patients to understand.
CBG provides a set of approved pictograms and related standardized texts in the Positive List of Pictograms, listed as an annex in both MEB5 and MEB6. These pictograms are allowed in the packaging and leaflets of Dutch medicines only in their designated format and colours, along with the prescribed text, and must be implemented at the initiative of the license holder. Due to the extensive nature of the list, CBG has decided to publish it on its website following the final approval of MEB5 and MEB6. Links to the Positive List will be included in the final versions of these policy documents, and for the purpose of this public consultation, the list has been attached as a separate annex.
The CBG is now inviting public feedback on the proposed changes through a consultation process.
Key Changes in MEB-5: Patient Leaflet for Medicinal Products
- QR Code: Information on submission timelines for QR code declarations has been moved to Annex 2.
- Logos and Pictograms: The section on logos and pictograms has been moved to “Special Content Criteria.” The updated pictogram policy now aligns with labelling policy, allowing standardized pictograms from the Positive List to be included in the leaflet, always accompanied by approved text.
- CE Marking: Corrected to align with EMA guidelines.
Key Changes in MEB-6: Labelling for Medicinal Products
- Braille Policy: Content on braille and braille exemptions has been moved to separate sections with no policy changes.
- Sticky Notes: Text has been clarified regarding the use of sticky notes on mock-ups during the submission process; policy remains unchanged.
- Pictogram Policy: The explanation for the approved pictogram set available for license holders has been updated to reflect the new set.
- Bulk Packaging: The section on stock and bulk packaging has been clarified without changes to policy.
In MEB6’s annexes, changes include updated layout and colour requirements for pictograms and the term “product name” has been clarified in line with MEB-13, the CBG’s naming policy document. Braille exemptions and the labelling of active ingredients on packaging have also been clarified. Annex 5 has been updated to include the new pictogram designs in their approved format and colour scheme.
This public consultation provides stakeholders the chance to comment on these proposed policy revisions before finalization.
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