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
- is a broker 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.
Are you a broker of medicinal products? Brokering means all activities related to buying and selling (brokering) of medicines, except wholesale activities, which do not include the physical handling of the medicinal products. The activity consists of negotiating independently on behalf of another legal or natural person. As a broker of medicines you must register with Farmatec (in Dutch). You may only broker medicines that have market authorisation.
Manufacturing or selling APIs
Do you manufacture or distribute APIs (Active Pharmaceutical Ingredients)? You should register with Farmatec.
APIs for human use
If you are a manufacturer or wholesaler of medicines with active ingredients for human use and you import, export, deliver, store, sell or prepare these, you must register with Farmatec (in Dutch).
APIs for veterinary use
Are you a manufacturer of dealer/distributor of APIs used as veterinary medicine? If you are in possession of for instance veterinary medicinal products that have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties you must register with Farmatec (in Dutch).
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.