Permission to supply drugs without marketing authorisation
Dutch law prohibits the supply of any pharmaceutical product which does not have a marketing authorisation for the Netherlands. However, an exception can be made in the interests of individual patient care, provided no registered alternative product is available within the European Union.
Permission to supply a pharmaceutical product without marketing authorisation must be obtained from the Health Care Inspectorate (under Article 3.17 of the Medicines Act Regulatory Instrument [Regeling Geneesmiddelenwet]). Such permission can be sought by a manufacturer, distributor, established pharmacist or a general practitioner who administers his or her own pharmacy.
A separate application form must be completed for each product. The application must state the condition which the product is intended to treat. The first application must be accompanied by a declaration signed by the doctor wishing to prescribe the product. The manufacturer remains liable for the safety of the product at all times.
The application form and doctor's declaration can be downloaded below (Dutch only). For further information, please contact Meldpunt IGZ.
Meer informatie