Documents - Marketing authorisation medicines for human use

50 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 | 23-03-2020

MEB 6: Labelling of pharmaceutical products

The presentation of the primary and secondary packaging of a medicinal product are determining factors in the recognition of a ...

Policy document | 23-03-2020

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 | 20-01-2020

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 | 01-01-2020

Declaration for the package leaflet of parallel imported products

Form | 01-01-2020

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 | 30-12-2019

GS-list 16

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 | 17-12-2019

Explanation of the Interest Form - MEB-ZIN Parallel Procedures pilot

Accelerating patient access to reimbursable innovative medicines has been on the wish list of the government, patient ...

Publication | 10-07-2019

List of patient-friendly terms for the package leaflet

In order to optimise the readability of the package leaflet, the MEB has revised the list of patient-friendly terms. The list has ...

Policy document | 28-06-2019

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