Go to content

Documents

208 documents

Enter search criteria
Fill in keyword(s) to narrow your search.
Period
You can select a specific type of a document or publication you are looking for, such as press releases or speeches.
Sort by:
Subscribe to the latest documents

  1. 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 | 01-11-2024

  2. GS-list

    The list of active substances in products that may qualify for sale general sale (GS list) was updated by the MEB on 24 October ...

    Policy document | 24-10-2024

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

    Directive | 18-10-2024

  4. 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

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

    Directive | 18-10-2024

  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 | 01-10-2024

  7. 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

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

    Report | 28-06-2024

  9. Presentations MEB Science Day 2024

    Publication | 16-04-2024

  10. Parallel import comparison form

    Form | 08-02-2024

Go to