how do i obtain marketing authorisation for a medicinal product?

The work of assessing medicinal products is carried out at the MEB by staff employed in Pharmacotherapeutic groups 1 to 4 and the Botanicals & Novel Foods units.

Pharmaceutical companies can approach the MEB for scientific advice prior to submitting a dossier.

Chemical-pharmaceutical data and pharmacological and toxicological data are assessed on behalf of the MEB agency by experts at the National Institute for Public Health and the Environment (RIVM).

Marketing authorisations
Once the MEB has assessed and approved a medicinal product, it issues marketing authorisation. Applicants can request two forms of marketing authorisation for a medicinal product: a National marketing authorisation or a European marketing authorisation. There are three different procedures by which marketing authorisation can be obtained: the national procedure, the centralised procedure and the mutual recognition procedures.

National marketing authorisation
Two procedures are available to applicants wishing to obtain a national marketing authorisation from the MEB. These are the national procedure and the mutual recognition procedures. If the national procedure is followed, the medicinal product will only be placed on the market in the Netherlands. If the applicant opts for a mutual recognition procedure, then the medicinal product can be placed on the market in various European countries.

The mutual recognition procedures (the Decentralised procedure and the Mutual recognition procedure) are based on the principle that member states recognise marketing authorisations issued in another European Union (EU) member state. The assessment report of the country which granted the first marketing authorisation for the medicinal product in question is made available to the other member states. Mutual recognition procedures are coordinated by the Coordination group for Mutual recognition and Decentralised procedures (CMD(h)).

More information about the National procedure >>
More information about the Mutual recognition procedures >>

European marketing authorisation
Applicants wishing to obtain a European marketing authorisation from the European Commission must follow the centralised procedure. Manufacturers receive a marketing authorisation that is valid in all EU member states. The centralised procedure is coordinated by the European Medicines Agency (EMeA). Scientific consultations between the member states take place in the European assessment committee, the Committee for Medicinal Products for Human Use (CHMP). All members of this European committee are given the opportunity in turn to conduct assessments on new medicinal products. The CHMP submits an opinion to the European Commission which then grants marketing authorisation.
If you would like to find out more about the EMEA and/or the CHMP and their activities, go to: www.emea.europa.eu.

More information about the Centralised procedure >>

Dossier and evaluation
A company has to submit a dossier for the evaluation of a medicinal product. This dossier, which has to meet current European requirements concerning content and layout, consists of five modules:

• Module 1 contains administrative data, including the  Summary of Product Characteristics, the package leaflet and the labelling text. In European jargon ‘SPC’ or ‘SmPC’ is mostly used as abbreviation for ‘Summary of Product Characteristics’. This documents holds the most important scientific data about the medicinal product for doctors and pharmacists.
• Module 2 includes the summaries of the chemical-pharmaceutical, pharmacological-toxicological and the clinical-pharmacological dossier.
  • Module 3 consists of the chemical-pharmaceutical data, i.e. all data about the composition and preparation as well as quality control of a medicinal product.
  • Module 4 consists of pharmacological toxicological data. This includes all data about a medicinal product collected from animals ( animal experiments) relating to toxicity and the mechanism of action of a medicinal product.
  • In Module 5 the clinical-pharmacological data are gathered. The data on the efficacy and safety of the product in humans appear in this part of the dossier.

More information on Dossiers >>