Documents - Marketing authorisation medicines for human use

Declaration for the package leaflet of parallel imported products

Form | 01-01-2020

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

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

Form | 01-05-2019

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

MEB 8: Guideline on the excipients in the label and the package leaflet of medicinal products for human use

Policy document | 11-09-2018

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