Pharmaceutical and other Farmatec permits

This information is provided by

Netherlands Enterprise Agency, RVO

If your company is involved in the (whole)sale or packaging of medicines you need a permit. In the Netherlands you apply for these permits to FarmatecExternal link, an executive body of the Ministry of Health, Welfare and Sport (VWS). You need a permit if your company:

  • packages, labels or prepares medicines or has medicines prepared
  • imports medicines from outside the EEA
  • is a wholesaler in medicines

You can find licenced companies in the European Medicines Agency’s EudraGMDP databaseExternal link.

Manufacturer’s permit

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).

You download the Dutch-language formExternal link and send the completed form with requested evidential documents attached in duplicate to Farmatec, Postbus 16114, 2500 BC Den Haag. You can also use this form if there are relevant changes, such as a change in Qualified Person/QP. The costs for application amount to €2600, subsequently you pay a yearly fee of € 3200.

Wholesale 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 download the Dutch-language formExternal link and send the completed form and requested evidential documents to Farmatec. The costs for application amount to €1700, subsequently you pay a yearly fee of € 1600. You must comply with the European guidelines on Good Distribution Practice of medicinal products for human useExternal link (GDP). Forms (in Dutch) are also available if you want to changeExternal link or withdrawExternal link your permit.

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 need this permit if

  • you source blood products or intermediate products from countries outside of the EEA
  • you export blood products or intermediate products to a country outside the EEA
  • you deliver blood products that are not blood products that must be registered as per the Medicines Act, and intermediate products within the EEA except the Netherlands.

You can apply to Farmatec for this licence using the Dutch-language formExternal link. There are no costs involved in the application, changing or withdrawal of a permit.

Human tissue

Tissue and organ banksExternal link (in Dutch) in most cases require approval. This depends on what they do with the human tissue. There are no costs involved in applying for this approvalExternal link (in Dutch).

Donor testing laboratoriesExternal link (in Dutch) in the Netherlands require a licence. There are no costs involved in applying, changing or withdrawingExternal link of this licence (in Dutch).

This information is provided by

Netherlands Enterprise Agency, RVO