On this page
If you run a business in the Netherlands that packages, labels or prepares medicines or has these prepared, you require a manufacturer’s permit (Dutch). If you import medicines from outside the European Economic Area (i.e. the EU plus Norway, Iceland and Liechtenstein), you also need a manufacturer’s permit. If you have a wholesale business in medicines in the Netherlands, you require a wholesale permit (Dutch). This permit is mandatory for purchasing and delivering medicines in countries within the European Economic Area. You can obtain the permits from Farmatec, which falls under the Ministry of Health, Welfare and Sport (VWS).
In the Netherlands, if you work with blood products or products made from human blood (not approved for human use), you may need a designation or licence (Dutch). You apply for this licence to Farmatec.
Tissue establishments, organ banks (Dutch) or donor testing laboratories (Dutch) in the Netherlands may require a licence or recognition. This depends on their specific activities with regard to the human tissue. Farmatec issues this licence or recognition.