Documents - Marketing authorisation medicines for human use

53 documents Marketing authorisation medicines for human use

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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 | 10-05-2019

MEB 21: Statement of ‘abbreviated indications’ on OTC medicinal product packaging

Directive 2001/83/EC discusses European regulations on labelling. In accordance with Article 54(n), the outer packaging of ...

Policy document | 10-05-2019

Declaration on modification of information in the printed SmPC and package leaflet pertaining to patented indications

Form | 01-05-2019

Product types and fees

The list of product types indicates the various product types handled by the MEB. The choice of the product type determines the ...

Publication | 01-01-2019

Scientific advice during the development of a medicinal product

The MEB can provide scientific advice and contributes with this advice to the development of medicines. See the leaflet for ...

Leaflet | 01-01-2019

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 | 08-11-2018

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