National policy for labelling of medicinal products amended
The Medicines Evaluation Board (MEB) has amended the national policy for labelling medicinal products for human use (MEB 6). As a result of the changes in labelling policy, the policy documents for the Summary of Product Characteristics (SmPC) (MEB 27) and package leaflet (MEB 5) have also been updated.
The MEB held a public consultation on the proposed amendments. The responses were incorporated in the policy document, where possible.
The most important changes are:
- The commentary to Marketing authorisations without Dutch translations of the product information or mock-ups has been expanded in line with the policy document ‘MEB policy concerning marketing authorisation without Dutch translations of the product information and/or mock-ups’ (MEB 41).
- The commentary to Images/Representations of the indication now states that the listing of the abbreviated indication is subordinate to the listing of the product name on the packaging.
- New section on safety features:
- Information is added on the listing of safety features on the packaging within the framework of the European Falsified Medicines Directive 2011/62/EU.
- Information has been added on sections 17 and 18 (unique identifiers).
- Information has been added on combining multiple codes (QR code and 2D barcode) on the packaging. This has also been adapted in Annex 3.
- In the section on Childproof Packaging/Senior-citizen friendly Packaging, information is added on translations of claims on child safety on the packaging in Dutch product information in accordance with changed national policy.
Annex 1: Commentary to sections in the QRD template of the packaging
In Annex section 1, information has been added on the listing of the abbreviated pharmaceutical form on small primary packaging. Policy document MEB 46 on in-use shelf-life of primary packaging has now been integrated in its entirety in section 8. As a result, the policy document ‘Listing shelf-life on the packaging of OTC medicinal products’ has been terminated (MEB 46).
Section 11 adds that the sentence ‘Trademark of <xxx>’ is accepted in the package leaflet and on the packaging, but not in the SmPC, which is in line with the inclusion of the symbols ® and ™ in the product name. Finally, a commentary to the new sections 17 and 18 is included in line with QRD template version 4.
MEB 5: Package leaflet of pharmaceutical products
This policy document explains the policy regarding the package leaflet of pharmaceutical products in the Netherlands.
MEB 6: Labelling of pharmaceutical products
The presentation of the primary and secondary packaging of a medicinal product are determining factors in the recognition of a...
MEB 27: MEB commentary on the ‘Guideline on Summary of Product Characteristics’
This document serves as a commentary on the ‘Guideline on Summary of Product Characteristics’.
MEB 41: MEB policy concerning marketing authorisations without Dutch translations of the product information and/or mock-ups
The MEB is aware of the fact that medicinal products are not always marketed immediately after authorisation. Following the...