Permits for working with medicinal products and body material
Do you work with medicinal products, active pharmaceutical ingredients (APIs), blood products, intermediates, body material or tissue? For example, your company is involved in the (whole)sale or packaging of medicines. In the Netherlands you must register, or apply for a permit or approval to Farmatec, an executive body of the Ministry of Health, Welfare and Sport (VWS).
Preparing and importing medicines
You need a manufacturer’s permit (in Dutch) if you:
- prepare medicines or have them prepared. This includes activities such as packaging and labelling
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 can find licenced companies in the European Medicines Agency’s EudraGMDP database.
Applying for a manufacturer’s permit
To apply for a manufacturer’s permit you download the Dutch-language application 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. Your application will only be assessed after this payment. Once the permit is granted you pay a yearly fee of € 3200.
Applying for a wholesale permit
To apply for a wholesale permit you download the application form (in Dutch) and send the completed form plus the requested documents in duplicate to Farmatec. The costs for application amount to €1700, and 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 are also available if you want to change or withdraw your permit (in Dutch).
Brokering medicines
Do you negotiate the sale or purchase of medicines for another party? Then you are a broker of medicinal products. As a broker of medicines you must register with Farmatec (in Dutch). Brokering is only allowed:
- between suppliers and customers in the EEA
- in medicines that have market authorisation in the EEA
Selling medicines online
Do you sell medicines online? You have to register with Online Suppliers of Medicines (Online Aanbieders Medicijnen, in Dutch) and be included in the list of authorised suppliers (in Dutch). You should also put the official logo of Online Aanbieders Medicijnen on your website. CIBG monitors online suppliers of medicines.
Manufacturing or selling APIs for human use
Do you manufacture or distribute medicines with active pharmaceutical ingredients (APIs)? Then you must register with Farmatec (in Dutch). This applies if you import, export, deliver, store, sell, or prepare medicines with active ingredients for human use.
Manufacturing or selling APIs for veterinary use
Are you a manufacturer, importer, or distributor of APIs used as starting material for veterinary medicine? You must register with the CBG’s Veterinary Medicinal Products Unit (Bureau Diergeneesmiddelen). If you meet all requirements, you will be included in the European EudraGMDP database with approved companies.
Narcotics
If you work with narcotics that are covered by the Opium Act, you must request exemption from the Opium Act for this. For example, if you make, possess, store, sell, or transport these substances.
General practitioner with pharmacy
Are you a general practitioner (GP) and do you have a pharmacy at your practice? If so, you must have a dispensing GP licence (vergunning apotheekhoudende huisartsen, in Dutch).
Blood products
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.
Human tissue
Do you run a tissue or organ bank, or a donor testing laboratory? In most cases you need a donor testing laboratory licence (in Dutch) or approval for tissue and organ banks (in Dutch). For example, for testing body material, or storing and processing tissue. There are no costs involved in applying for approval nor in applying, changing, or withdrawing of a licence (in Dutch).