Selling medicines in Europe: the company with the licences

The roles EU law requires, and where they must be based

European medicines law requires certain roles, each held by a company or a person established in the EU or the EEA. A manufacturer from outside the EU or the EEA can hire a service provider for each role or set up its own European company to take them on.

The marketing authorisation holder owns the permit to sell the medicine and must be established in the EU or the EEA. It is responsible for the product on the market, including labelling, safety reporting, changes to the authorisation (variations) and renewals, and its name is printed on every pack.

Every marketing authorisation holder needs one person who is responsible for monitoring the safety of the medicine, the QPPV. That person must live and work in the EU or the EEA and be reachable at all times, and the safety work is documented in a file called the pharmacovigilance system master file (PSMF).

A medicine made outside the EU or the EEA must be imported by a company with a licence to manufacture and import medicines, the manufacturing and importation authorisation (MIA). A qualified person working for that importer tests or checks each batch and releases it for the market in the EU or the EEA, and only then may the batch be sold.

A company that stores and ships medicines to pharmacies, hospitals and other wholesalers needs a wholesale distribution authorisation (WDA), and so does a company that only buys and resells medicines. The wholesaler works under the rules for good distribution practice (GDP) and appoints a responsible person for them.

Choosing between a central, decentralised or national permit

In the centralised procedure you apply to the EMA in Amsterdam, which assesses the application and gives its advice, after which the European Commission grants one permit for the whole EU and the EEA countries Iceland, Liechtenstein and Norway. The procedure is compulsory for medicines made with biotechnology, for medicines for rare diseases (orphan medicines) and for medicines with a new active substance for cancer, diabetes, HIV and several other diseases, and other medicines may use it as well.

In the decentralised procedure and the mutual recognition procedure you apply to the national authorities, with one country leading the assessment and the others following it. In the Netherlands that authority is the Medicines Evaluation Board in Utrecht (CBG-MEB). A national procedure gives a permit for one country only.

Whichever procedure you use, the applicant, and later the holder of the permit, is a company established in the EU or the EEA. Regulatory affairs specialists prepare the dossier, and the Dutch company signs it and becomes the holder of the permit.

Why pharma companies choose the Netherlands

The EMA has been in Amsterdam since 2019, and the regulatory consultancies, law firms and clinical research organisations that work with the agency are based nearby. The Leiden Bio Science Park, the university medical centres in Amsterdam and Utrecht and the Rotterdam port cluster for temperature-controlled logistics all lie within an hour of each other.

Dutch licences for pharma companies come from Farmatec, part of the licensing agency of the Ministry of Health (CIBG). Farmatec issues the manufacturing and importation authorisation, the wholesale distribution authorisation and the registration for active pharmaceutical ingredients, and the Health and Youth Care Inspectorate (IGJ) supervises the companies.

A Dutch company pays 19% corporate tax on the first €200,000 of profit and 25.8% above that. Profit from research and development that the company does itself can qualify for a reduced rate of 9% (innovation box), provided the company holds a declaration for that work (S&O-verklaring) from the government agency for entrepreneurs, the Netherlands Enterprise Agency (RVO). A patent of the parent company is excluded. Dividends paid to a parent company in a country with a tax treaty with the Netherlands are usually exempt from Dutch dividend tax.

With the Article 23 licence the company reports import VAT in its VAT return, and the payment at the border falls away, although any customs duty remains due at import. On a €2 million shipment of medicines at 9% VAT, the company keeps €180,000 that it would otherwise pay upfront. Our guides on setting up a subsidiary in Europe and the innovation box explain the tax side in more detail.

Active ingredients and clinical trials

An importer of active pharmaceutical ingredients (API) from outside the EU or the EEA must be registered with the Dutch authority. Each shipment needs a written confirmation from the authority of the country where the ingredient was made, except where that country is on the EU list of countries with equivalent rules, such as the United States, Switzerland and Japan.

For a product still in development, the Dutch company can also act as the legal representative for your clinical trials in Europe, as our guide to clinical trials in Europe with a legal representative in the Netherlands explains.

How long it takes

The notary signs the deed once all documents are complete, and opening a bank account usually takes four to eight weeks, with the application prepared by our team. Farmatec has 90 days by law to decide on a complete application for the import and wholesale licences, and the inspectorate visits the company before Farmatec grants the licence.

The marketing authorisation takes longest. In the central procedure the European Medicines Agency has 210 days for its assessment, plus the time you need to answer its questions, before the European Commission takes its decision, so the process lasts about a year in total. The national authorities also have 210 days in the decentralised procedure. A good regulatory partner plans the licences and the dossier in parallel, so your company is ready on the day you receive the permit.

The unique code on every pack

Under the EU rule against falsified medicines, every pack of prescription medicine sold in the EU or the EEA has a unique code in a square barcode and a seal that shows whether the pack has been opened. The holder of the marketing authorisation uploads the codes to the European hub, which the European Medicines Verification Organisation (EMVO) manages, and pays a yearly fee to the national verification system of each country where it sells. The pharmacy scans the code before it hands the pack to the patient.

The task falls to the marketing authorisation holder, which is your Dutch company. The regulatory partner sets up the connection to the hub once, before the first pack is sold.

Price and reimbursement for sales in the Netherlands

Sales in the Netherlands itself fall under the Medicines Prices Act (Wet geneesmiddelenprijzen), which sets a maximum price for each medicine based on the prices in Belgium, France, Norway and the United Kingdom and updates it twice a year. The National Health Care Institute (Zorginstituut Nederland) assesses whether health insurers pay for the medicine under the Dutch reimbursement system for medicines (GVS). Very expensive hospital medicines first go through a waiting period known as the lock (de sluis), while the Ministry of Health negotiates the price.

These steps follow the marketing authorisation and concern only your price per pack in the Netherlands, because the right to sell in Europe comes from the authorisation itself. Most companies use the Netherlands as their base and make their first sales elsewhere in the EU.

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. Innovation box from the Dutch tax office (Belastingdienst), conditions for the innovation box (checked on 7 October 2026). Specialised partners prepare the regulatory files, and we coordinate the work.