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Amendment of the policy on labeling of human medicines

The Netherlands

The policy on labeling of medicinal products for human use (MEB 6) has been amended by the Medicines Evaluation Board (MEB). As a consequence, the policy on the summary of product characteristics (MEB 27) and the package leaflet (MEB 5) have been updated as well.

The most important changes are the following:

  • The ‘Marketing Authorizations without Dutch translations of the product information or mock-ups’ has been aligned with the policy document MEB 41 on ‘College policy on marketing authorizations without Dutch translations of the product information and/or mock-ups’.
  • In the section on ‘Images/Representations of the indication’, it has been added that the abbreviated indication is subordinate to the listing of the product name on the packaging.
  • New section on safety features:
    • Information has been added concerning the listing of safety features on the packaging in accordance with the European Falsified Medicines Directive.
    • Information has been added regarding unique identifiers
  • A topic concerning the combination of multiple codes (QR-code and 2D-barcode) on the packaging has been implemented. This has been adapted in Annex 3 as well.
  • With regard to childproof packaging/senior-citizen friendly packaging, a section on the translation into Dutch of claims concerning child safety present on the packaging and the product information has been added.

More information and policy documents can be consulted at the CBG website.

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