Documents - Marketing authorisation medicines for human use

52 documents Marketing authorisation medicines for human use

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

Policy document | 05-10-2018

Letter to stakeholders regarding the implementation of safety features under the Falsified Medicines Directive 2011/62/EU

The delegated Regulation on the characteristics of the safety features and the new medicine verification system will apply as of ...

Publication | 01-10-2018

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

Directive | 18-06-2018

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

Directive | 18-06-2018

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 | 18-06-2018

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 | 11-06-2018

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 | 11-06-2018

GS-list 15

The list of active substances in products that may qualify for sale general sale (GS list) was updated by the MEB on 30 May 2018. ...

Policy document | 30-05-2018

Parallel import comparison form

Form | 03-04-2018

MEB 48: National informed consent application

An Article 10c 'Informed Consent' application ( article 10c of Directive 2001/83/EC)  is an application for marketing ...

Policy document | 02-03-2018