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Government information 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). This also applies if you import medicines from outside the European Economic AreaExternal link (i.e. the EU plus Norway, Iceland and Liechtenstein).

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 intermediate products, you may need a blood products permitExternal link (in Dutch). You can apply to Farmatec for this licence.

Human tissue

Tissue and organ banksExternal link (in Dutch) or donor testing laboratoriesExternal link (in Dutch) in the Netherlands may require a licence or approval. This depends what they do with the human tissue. You can apply to Farmatec for this licence or approval.

This information is provided by

Netherlands Enterprise Agency