Documents

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

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

Assessment report 2’-fucosyllactose, applicant FrieslandCampina Nederland B.V.

A report on the assessment of 2’-fucosyllactose by the company FrieslandCampina Nederland B.V. for substantial equivalence to ...

Report | 19-12-2017

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 to ...

Report | 19-12-2017

Assessment report Allanblackia seed oil, applicant Unilever

A report on the initial assessment of Allanblackia seed.

Report | 17-12-2017

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