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  1. Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I) - Duplex with supplementary conditions

    Directive | 18-10-2024

  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 | 18-10-2024

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

    Directive | 18-10-2024

  4. 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

  5. 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

  6. Assessment report novel food status three ingredients derived from seeds of oilseed rape

    Report | 28-06-2024

  7. Presentations MEB Science Day 2024

    Publication | 16-04-2024

  8. Parallel import comparison form

    Form | 08-02-2024

  9. 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

  10. ATC codes and PT groups

    Publication | 24-05-2023