Documents - Marketing authorisation medicines for human use

46 documents Marketing authorisation medicines for human use

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  1. 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

  2. MEB 16: Duplex marketing authorisation

    A duplex marketing authorisation is a marketing authorisation for a product of which the dossier is identical to that of a ...

    Policy document | 10-03-2021

  3. GS-list 18

    The list of active substances in products that may qualify for sale general sale (GS list) was updated by the MEB on 22 October ...

    Policy document | 22-10-2020

  4. Terms and conditions for package fee and reduced fee for copy DCP application - human products

    The term package fee entails that a group of products (each with an individual RVG number) is only billed once at the tariff ...

    Publication | 01-09-2020

  5. 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

  6. 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

  7. Declaration for the package leaflet of parallel imported products

    Form | 01-01-2020

  8. 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

  9. List of patient-friendly terms for the package leaflet

    In order to optimise the readability of the package leaflet, the MEB has revised the list of patient-friendly terms. The list has ...

    Policy document | 28-06-2019

  10. MEB 21: Statement of ‘abbreviated indications’ on OTC medicinal product packaging

    Directive 2001/83/EC discusses European regulations on labelling. In accordance with Article 54(n), the outer packaging of ...

    Policy document | 10-05-2019