Putting new medicines on the market

Do you run a pharmaceutical business in the Netherlands and do you want to put a new or modified medicine on the market? You need a marketing authorisation from the Medicines Evaluation Board, MEB (College ter Beoordeling van Geneesmiddelen, CBG).

Applying for marketing authorisation

How you can apply for market authorisation depends on the intended market and whether this is for the 1st time. There are different procedures:

• You follow the national procedure to market a medicine on the Dutch market for the first time.
• If a medicine is already authorised in an EU country and you want bring it to market in another member state, for example the Netherlands, you follow the mutual recognition procedure. This makes your medicine available to the Dutch market by recognition of the assessment by a Reference Member State (RMS).
• If you want to put a medicine to market in more EU countries, you follow the decentralised procedure.
• If you want to put a medicine to market in all EU countries, you follow the centralised procedure.

Medicines for children have a stricter procedure.

For the marketing authorisation, you must provide a dossier of the medicine. The medicine is then assessed for safety and efficacy. Which organisation assesses this depends on the procedure. For the Dutch market (national procedure), the Dutch Medicines Evaluation Board (CBG) issues the marketing authorisation. A marketing authorisation for the Dutch market is valid for 5 years. After 5 years, the CBG considers whether to renew your marketing authorisation. If you receive a marketing authorisation, you must ensure that the medicine remains safe and continues to work.

Products that have identical dossiers to previously authorised products can follow a simplified procedure.

Submit a dossier

To apply for a marketing authorisation, you must submit a dossier to the MEB. This dossier must meet European requirements. The dossier must contain information on, among others:

• the product characteristics, patient package leaflet, and packaging text
• the composition, preparation, and quality control of the medicine
• the efficacy and safety of the medicinal product in humans

The product information should be submitted in the language of the country you bring the medicine to market, so in Dutch for the Netherlands. 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.

Medicines Information Bank

Once the MEB has approved your medicine and you get a marketing authorisation, it will be included in the MEB Medicines Information Bank and given a registration number. The Medicines Information Bank contains official information on all al medicines authorised in the Netherlands.

Labels and package leaflet

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 must be approved by the MEB.

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 (in Dutch).

Notification of quality defects in medicines

Do you market medicines in the Netherlands and you notice a quality defect? Or do you expect or experience shortages? You must make a notification to the Medicine shortages and defects notification centre.