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MEB policy documents

  • MEB 5: Package leaflet of pharmaceutical products
  • MEB 6: Labelling of pharmaceutical products
  • MEB 8: Guideline on the excipients in the label and the package leaflet of medicinal products for human use (Dutch translation)
  • MEB 9: Objection procedure
  • MEB 13: Nomenclature of pharmaceutical products
  • MEB 14: Parallel import: marketing authorisation and maintenance
  • MEB 15: Replica marketing authorisation (only applies to existing marketing authorisations)
  • MEB 16: Duplex marketing authorisation
  • MEB 18: Written and verbal opinion procedure for a proposed primary judgement by the MEB
  • MEB 21: Statement of ‘abbreviated indications’ on OTC medicinal product packaging
  • MEB 27: MEB commentary on the ‘Guideline on Summary of Product Characteristics’
  • MEB 37: Legal status of supply
  • MEB 39: Policy for assigning RVG numbers
  • MEB 41: MEB policy concerning marketing authorisations without Dutch translations of the product information and/or mock-ups
  • MEB 42: Renewal of medicinal products for human use authorised through the national procedure
  • MEB 43: Two-round assessment policy for national procedures
  • MEB 44: Direct Healthcare Professional Communications (DHPCs)
  • MEB 45: National implementation of additional risk minimisation measures
  • MEB 47: Assessment criteria for combination packages
  • MEB 48: National informed consent application
  • MEB 49: Compassionate Use Programme
  • Terms and conditions for package fee and reduced fee for copy DCP application - human products
  • Question and answer document pertaining to variations for medicines for human use
  • Question and answer document concerning changes not covered by the Variation Regulation 1234.2008 (as amended by Regulation 712/2012)
  • Disinfectant products: Distinguishing between biocidal products and medicinal products (human and veterinary)
  • List of patient-friendly terms

News

  1. Changes to product information policy

    The Medicines Evaluation Board (MEB) recently revised a number of policy documents for pharmaceutical companies relating to the ...

    23-03-202012:00
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