Do you run a pharmaceutical business in the Netherlands and do you want to put a new medicine on the market? You need a marketing authorisation from the Medicines Evaluation Board (MEB, College ter Beoordeling van Geneesmiddelen, CBG).
There are different procedures for receiving marketing authorisation. The procedure you choose depends on the type of medicinal product and its intended market:
- the national procedure allows you to market the medicine solely on the Dutch market
- the decentralised procedure allows you to put the medicine on the markets of EU-member states
- the centralised procedure makes your medicine available to all inhabitants of Europe.
- the mutual recognition procedure makes your medicine available to the Dutch market by recognition of the assessment by a Reference Member State (RMS)
Products that have identical dossiers to previously authorised products can follow a simplified procedure. Medicines for children have a stricter procedure
A marketing authorisation is valid for 5 years. After 5 years, the MEB will evaluate it.
Submit a dossier
To apply for a marketing authorisation, you must submit a dossier to the MEB that contains among others:
- the composition of the medicine
- its functioning, safety and risks involved with use
- text for the package leaflet and packaging
The product information should be submitted in Dutch. In some cases, medicines without a Dutch translation of the product information may be authorised.
For generic medicinal products, submitting a complete dossier is not required.
If the research falls under the Medical Research Involving Human Subjects Act (Wet medisch-wetenschappelijk onderzoek met mensen, WMO) or the Embryos Act (Embryowet), you must first have the research protocol reviewed by a Medical Research Ethics Committee (Medisch-Ethische Toetsingscommissie, METC) or the Central Committee on Research Involving Human Subjects (CCMO).
Approved medicines carry labels. The label has to include information about the name of the product, the active ingredient, its strength and the expiry date, among others. This information should be present in braille as well on the package. The labelling text is assessed by the MEB.
If you market a medicine, you must supply it together with a package leaflet. This leaflet is intended for the end-user and must contain product information in plain language. Package leaflets relating to new medicines or to medicines that have changed significantly must be submitted to and be approved by the MEB.
MEB Medicines Information Bank
Once the medicine has been approved, it will be included in the MEB Medicines Information Bank and given a registration number. Once you have obtained a trading permit, you remain responsible for the quality, effect and safety of the medicines you produce.
Notification of quality defects in medicines
If you market medicines in the Netherlands and you notice a quality defect, you must notify the Health Care Inspectorate (IGZ, in Dutch). Quality defects for medicines which received marketing authorisation through the centralised procedure need to be reported to the European Medicines Agency (EMA) instead.
Maximum prices for medicines
If you manufacture medicines in the Netherlands, you must comply with the Maximum Prices for Medicines Regulation (Regeling maximumprijzen geneesmiddelen). This regulation contains the maximum prices (in Dutch) which you are allowed to charge for medicines, being the maximum purchase prices for pharmacists. Farmatec, part of the Ministry of Health, is responsible for setting these prices.