Putting new medicines on the market

This information is provided by

Netherlands Enterprise Agency, RVO

Do you run a pharmaceutical business in the Netherlands and do you want to put a new medicine on the market? You will need to have this medicine registered with the Medicines Evaluation Board (MEB, College ter Beoordeling van Geneesmiddelen, CBG).

You must submit a dossier to the CBG that contains all the chemo-pharmaceutical, pharmacological, toxicological, clinical and other research data. Product information should be submitted in Dutch. In some cases, medicines without a Dutch translation of the product information may be authorised.

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.

Drug research

If the research falls under the Medical Research (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).

Marketing authorisation

Different types of medicinal products require different types of marketing authorisation. For generic medicinal products, a complete dossier is not required. There is also a simplified procedure for products that have identical dossiers to products already authorised. Medicines for children have a stricter procedure.

Labels

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. This information should be present in braille as well on the package. The labelling text is assessed by the MEB.

Package leaflet

If you market a medicine, you must supply it together with a package leaflet. This leaflet contains product information for the patient in plain language. Package leaflets relating to new medicines or to medicines that have changed significantly must be submitted to consumer panels. The package leaflet must be approved by the Medicines Evaluation Board (CBG).

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.

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).

This information is provided by

Netherlands Enterprise Agency, RVO