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Overview of approved compassionate use programmes

The MEB can give permission for bringing a medicinal product on the market that has not (yet) been granted a marketing...

Publication | 21-12-2017

Assessment report 2’-fucosyllactose, applicant DuPont Nutrition & Biosciences ApS.

A report on the assessment of 2’-fucosyllactose by the company DuPont Nutrition & Biosciences ApS for substantial equivalence...

Report | 19-12-2017

Scientific advice during the development of a medicinal product

Before a medicinal product can be authorised and brought onto the market, several steps must be followed. The Medicines...

Leaflet | 27-10-2017

Overview of withdrawals following consideration of patients’ interest 2017

The overview of withdrawals following consideration of patients’ interest 2017 states for which medicinal products the...

Publication | 22-09-2017

Assessment report UV-treated mushrooms

A report on the initial assessment of UV-treated mushrooms  by the applicant companies, Banken Champignons Groep BV and JK...

Report | 20-09-2017

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 | 05-09-2017

Package leaflets vaccines (in Dutch)

Overview of the vaccines that are authorised in the Netherlands, with a reference to the package leaflet (in Dutch).

Publication | 28-08-2017

MEB 5: Package leaflet of pharmaceutical products

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

Directive | 23-08-2017

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...

Directive | 23-08-2017

MEB 27: MEB commentary on the ‘Guideline on Summary of Product Characteristics’

This document serves as a commentary on the ‘Guideline on Summary of Product Characteristics’.

Directive | 23-08-2017