Documents - Marketing authorisation medicines for human use

45 documents Marketing authorisation medicines for human use

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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

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

Previous versions of the Dutch QRD-template

Form | 01-01-2018

Parallel import dossier structure

Publication | 01-01-2018

Request to the MEB to act as Reference Member State in the Mutual recognition procedure (MRP / Repeat Use Procedure)

A request to the MEB to act as Reference Member State in the Mutual recognition procedure (MRP) should preferably be announced ...

Form | 01-01-2018

Declaration regarding the technical aspects of the readability of the patient information leaflet for pharmaceutical products for human use

Form | 01-01-2018

Application for the inclusion of QR code in national procedures

Form | 01-01-2018

MEB 47: Assessment criteria for combination packages

In policy document MEB 47 the MEB has described terms and conditions to assess applications for combination packages of medicinal ...

Directive | 19-12-2017

MEB 5: Package leaflet of pharmaceutical products

This policy document explains the policy regarding the package leaflet of pharmaceutical products in the Netherlands. Download ...

Policy document | 23-08-2017