Documents - Marketing authorisation medicines for human use

48 documents Marketing authorisation medicines for human use

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  1. 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 | 18-10-2024

  2. Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I)

    Directive | 18-10-2024

  3. 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 | 01-10-2024

  4. MEB 37: Legal status of supply

    This document describes the policy of the Medicines Evaluation Board for awarding a legal status of supply.

    Policy document | 21-08-2024

  5. MEB 14: Parallel importation: marketing authorisation and maintenance

    Parallel import is the importation – and subsequent marketing in the Netherlands – of a medicinal product authorised elsewhere in ...

    Policy document | 18-07-2024

  6. Parallel import comparison form

    Form | 08-02-2024

  7. MEB 39: Policy for assigning RVG numbers

    This document describes the Medicines Evaluation Board policy for assigning RVG numbers. This policy is based on the definitions ...

    Policy document | 02-10-2023

  8. GS-list 21

    The list of active substances in products that may qualify for sale general sale (GS list) was updated by the MEB on 20 October ...

    Policy document | 20-10-2022

  9. MEB 42: Renewal of medicinal products for human use authorised through the national procedure

    The MEB decides whether to renew the marketing authorisation for each product authorised through the national procedure.

    Policy document | 03-08-2022

  10. MEB 45: National implementation of additional risk minimisation measures

    An important element of a risk management plan (RMP) is a clear description of the necessary measures in order to minimise the ...

    Policy document | 30-03-2022