The Netherlands
The Medicines Evaluation Board (MEB) has revised two policy documents for pharmaceutical companies on the requirements for product information:
- MEB 5: Package leaflet of pharmaceutical products
- Update sections 4, 5.1, 6, 6.2, 7, 7.1, 7.4.1
- Update Annex 1: Explanation of package leaflet sections in the QRD template
- MEB 6: Labeling of medicines for humans
- Update sections 6.1, 6.2, 6.4.2, 6.4.3, 6.4.5
- Update Annex 1: Clarification of sections in the QRD template
- Update Annex 3: URL via two-dimensional matrix of blocks (for example QR code)
- Update Annex 5 (new): Positive List of Icons (with standardized pictograms and accompanying sentences)
The new policy takes effect immediately.
Source: https://www.cbg-meb.nl/actueel/nieuws/2021/12/16/wijzigingen-in-beleid-productinformatie