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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 Farmatec, 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 database.
If you run a business in the Netherlands that packages, labels or prepares medicines or has these prepared, you require a manufacturer’s permit (in Dutch). This also applies if you import medicines from outside the European Economic Area (i.e. the EU plus Norway, Iceland and Liechtenstein).
You download the Dutch-language form 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.
If you have a wholesale business in medicines in the Netherlands, you require a wholesale permit (in Dutch). This permit is mandatory for purchasing and delivering medicines in countries within the European Economic Area.
You download the Dutch-language form 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 use (GDP). Forms (in Dutch) are also available if you want to change or withdraw your permit.
In the Netherlands, if you work with blood products or intermediate products, you may need a blood products permit (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 form. There are no costs involved in the application, changing or withdrawal of a permit.