Documents - Marketing authorisation medicines for human use

MEB 49: Compassionate Use Programme

Medicinal products can only be marketed if a marketing authorisation has been granted. In cases of compassionate use, medicinal ...

Policy document | 19-12-2024

Question and answer document concerning changes not covered by the Variation Regulation 1234/2008 (as amended by Regulation 712/2012)

Policy document | 12-11-2024

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

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

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

Directive | 18-10-2024

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

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

Directive | 18-10-2024

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

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

Parallel import comparison form

Form | 08-02-2024