Documents - Marketing authorisation medicines for human use

46 documents Marketing authorisation medicines for human use

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  1. Question and answer document pertaining to variations for medicines for human use

    Policy document | 31-01-2022

  2. Withdrawal of marketing authorisation at the request of the marketing authorisation holder

    A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons. After completing ...

    Form | 01-01-2022

  3. Pictograms from the Positive list for medicine packages

    The MEB makes the following set of pictograms, including the established accompanying text, available for use on the medicine ...

    Policy document | 16-12-2021

  4. 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 ...

    Policy document | 16-12-2021

  5. MEB 5: Package leaflet of pharmaceutical products

    This policy document explains the policy regarding the package leaflet of pharmaceutical products in the Netherlands. Download ...

    Policy document | 16-12-2021

  6. MEB 44: Direct Healthcare Professional Communications (DHPCs)

    This document is based on the Guideline on Good Pharmacovigilance Practices (GVP) Module XV – Safety communication, and is aimed ...

    Policy document | 06-04-2021

  7. MEB 43: Two-round assessment policy for national procedures

    Limiting the number of assessment rounds ensures that the (legally) stipulated time within which the MEB must make a decision ...

    Policy document | 01-08-2020

  8. MEB 13: Nomenclature of pharmaceutical products

    This document describes the requirements which the marketing authorisation holder has to fulfil when submitting a proposal for a ...

    Policy document | 23-03-2020

  9. Declaration for the package leaflet of parallel imported products

    Form | 01-01-2020

  10. Explanation of the Interest Form - MEB-ZIN Parallel Procedures pilot

    Accelerating patient access to reimbursable innovative medicines has been on the wish list of the government, patient ...

    Publication | 10-07-2019