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Government support for entrepreneurs

Pharmaceutical and other Farmatec permits

This information is provided by Netherlands Enterprise Agency

If you run a business in the Netherlands that packages, labels or prepares medicines or has these prepared, you require a manufacturer’s permitExternal link (in Dutch). If you import medicines from outside the European Economic AreaExternal link (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 permitExternal link (in 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).

Blood products

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 licenceExternal link (in Dutch). You apply for this licence to Farmatec.

Human tissue

Institutes for Tissue Recognition and Organ banksExternal link (in Dutch) or donor testing laboratoriesExternal link (in 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.

This information is provided by

Netherlands Enterprise Agency