Selling medicines in Europe: the company that holds the licences
A medicine enters the European market through a company that is based in the EU. That company holds the marketing authorisation, employs or contracts the responsible persons and holds the import and wholesale licences. For a company from the United States, India, Switzerland, the United Kingdom or Asia, a Dutch company is the usual way to get there.
Ask about your situationTo sell a medicine in the European Union you need a permit to sell it, called a marketing authorisation. The company that holds that permit, the marketing authorisation holder (MAH), must be established in the EU or the European Economic Area. Only a company established in the EU or the EEA can hold it. Holdwise sets up the Dutch company that can, and arranges the licence work with specialist partners.
On this page: the four roles the EU requires, which licences a Dutch company applies for, what Holdwise does and what a regulatory partner does, and the questions pharma companies ask us first.
Four roles the EU requires, and where they must be
European medicines law works with named roles. Each role belongs to a company or a person in the EU. A company from outside the EU fills them in one of two ways: it hires a service provider for each role, or it sets up its own European company and puts the roles there.
The marketing authorisation holder (MAH). This is the company that owns the permit to sell the medicine. It must be established in the EU or the European Economic Area (EEA). The MAH is responsible for the product on the market: labelling, safety reporting, variations and renewals. The name of the MAH is printed on every pack.
The qualified person for pharmacovigilance (QPPV). Every MAH must have one person who is responsible for safety monitoring. That person must live and work in the EU or the EEA, and must be reachable at all times. Behind the QPPV is a safety file called the pharmacovigilance system master file (PSMF).
The importer and the qualified person (QP). A medicine that is made outside the EU must be imported by a company that holds a manufacturing and importation authorisation (MIA). Each batch is tested or checked and released for the EU market by a qualified person (QP) who works for that importer. Only after that release may the batch be sold.
The wholesaler. A company that stores and ships medicines to pharmacies, hospitals and other wholesalers needs a wholesale distribution authorisation (WDA). It works under the rules for good distribution practice (GDP) and has a named responsible person for GDP.
Many pharma companies from outside the EU start with a service provider for each role. As soon as sales are real, they set up their own EU company. The reasons are always the same: the marketing authorisation stays in the group, contracts with distributors and hospitals are signed by a company you own, and the value you build in Europe is yours.
Which permit: central, decentralised or national
There are three ways to get a marketing authorisation. The centralised procedure goes through the European Medicines Agency (EMA) in Amsterdam and gives one permit for the whole EU. It is compulsory for medicines made with biotechnology, for cancer, diabetes, HIV and several other areas, and for orphan medicines. Other medicines may use it too.
The decentralised procedure and the mutual recognition procedure go through the national authorities. One country leads, the others follow. In the Netherlands the authority is the Medicines Evaluation Board (CBG-MEB) in Utrecht. A national procedure gives a permit for one country only.
Whichever procedure you use, the applicant and later the holder of the permit is an EU company. Regulatory affairs specialists prepare the dossier. The Dutch company signs it and holds the result.
Why the Netherlands for a pharma entry
The Netherlands is where the EMA is. Since 2019 the agency is in Amsterdam, and the regulatory consultancies, law firms and clinical research organisations that work with it are around it. The Leiden Bio Science Park, the Amsterdam and Utrecht university medical centres and the Rotterdam port cluster for temperature-controlled logistics are within an hour of each other.
The Dutch licensing office for pharma companies is Farmatec, part of the CIBG agency of the Ministry of Health. It issues the manufacturing and importation authorisation, the wholesale distribution authorisation and the registration for active pharmaceutical ingredients. Supervision is done by the Health and Youth Care Inspectorate (IGJ). Both work in English with foreign applicants.
On the tax side, a Dutch company pays 19% corporate tax on the first €200,000 of profit and 25.8% above that. Profit that comes from your own patents can qualify for the innovation box, where the rate is 9%. Dividends to a parent company in a treaty country usually go out without Dutch dividend tax. And with the Article 23 licence, import VAT is reported in the VAT return and nothing is paid at the border: on a €2 million shipment that keeps €420,000 in your business.
Read more about the tax side on setting up a subsidiary in Europe and the innovation box.
Active ingredients and clinical trials
Active pharmaceutical ingredients (API) that come from outside the EU need an importer that is registered with the Dutch authority. Each shipment comes with a written confirmation from the authority of the country where the ingredient was made, unless that country is on the EU list of countries with equivalent rules, such as the United States, Switzerland and Japan.
If your product is still in development, the Dutch company can also be the legal representative for your clinical trials in Europe. That is a separate page: clinical trials in Europe with a legal representative in the Netherlands.
Based on Directive 2001/83/EC and Regulation (EC) 726/2004 as applied in September 2026, the Dutch Medicines Act (Geneesmiddelenwet) and the licensing pages of Farmatec and the CBG-MEB. Regulatory files are prepared by specialised partners; Holdwise coordinates.
Who does what
Holdwise sets up and runs the Dutch company and stays your single point of contact. Specialist partners do the licence and product work. You keep one contact, one file and one invoice.
Your company
- Own the product, the dossier and the intellectual property
- Decide the countries, the price and the distribution model
- Provide the technical and quality documents from your factory
- Sign the power of attorney; nobody travels to the Netherlands
The Dutch base
- Sets up the Dutch company (a BV), by power of attorney, with the notary
- Registered office in the Netherlands, with the KVK number, tax number and VAT number
- Bank account, the customs number (EORI) and the Article 23 licence
- Bookkeeping, VAT returns, annual accounts and corporate tax
- Substance: decisions, contracts and books in the Netherlands
- Single point of contact for every partner below
Licences and product rules
- Regulatory affairs: the marketing authorisation dossier and the variations
- The QPPV and the pharmacovigilance system, as a service or in-house
- The importer licence (MIA), the wholesale licence (WDA) and the qualified person
- Licensed pharma warehousing and cold chain logistics near Rotterdam and Schiphol
- Trial insurance, patent attorneys, pharma-specialised employment contracts
The route, step by step
What happens from your first question to the day your first product is on the European market.
- One question. You tell us what you make, where it is made, which countries you want to sell in and whether you have a distributor in Europe already. We answer in writing with the structure that fits and one written proposal.
- The Dutch company. The notary sets up the BV by power of attorney. The parent company is the shareholder. You get the KVK number, the tax number, the VAT number and the customs number. The bank file starts on day one, because banks take the longest.
- The roles. With the regulatory partner we decide which roles go into your own company and which ones stay with a service provider for now. The MAH is almost always your own company. The QPPV and the QP are often contracted in the first year.
- The licences. The partner prepares the licence applications for Farmatec: importer, wholesaler or both. The Dutch company signs. The authority inspects before it grants the licence.
- The permit to sell. The marketing authorisation goes through the EMA or through the CBG-MEB. The Dutch company is the applicant and the holder.
- Operations. Stock in a licensed warehouse, batches released by the QP, invoices from the Dutch company, VAT and bookkeeping done. You receive one monthly overview and one point of contact.
Related guides
The other parts of the route to Europe, on the same site.
Common questions
Ask about your own situation
Tell us what you make or sell, where your company is and which countries you want to sell in. You get a written answer. Where a Dutch company fits, we write down what it would look like and what it costs.
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