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If you run a pharmaceutical business in the Netherlands and you want to market a certain medicine, you will need to have this medicine registered with the Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen, CBG). You must submit a file to the CBG that contains all the chemo-pharmaceutical, pharmacological, toxicological and clinical (research) data. Once the medicine has been approved, it will be included in the Register of Medicinal Products and given a registration number. You will then obtain a trading permit for medicines.
Medicinal products research
If the research comes 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).
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).