Clinical trials in Europe: the legal representative your sponsor needs
A company from the United States, the United Kingdom, Switzerland or Asia that sponsors a clinical trial in the EU must appoint a legal representative that is established in the EU. That can be a contract research organisation. It can also be your own Dutch company, which later becomes the company that sells the product. This page explains the role and the Dutch route.
Ask about your situationClinical trials with medicines in the EU run under the Clinical Trials Regulation (CTR). Applications go through one portal, the Clinical Trials Information System (CTIS). A sponsor that is established outside the EU appoints a legal representative in the EU. That representative is responsible for the sponsor’s duties under the regulation and is the address for the authorities. Holdwise sets up the Dutch company that can be your legal representative, and works with clinical research and regulatory partners for the trial itself.
On this page: what the legal representative does, how the Dutch review works, why sponsors choose the Netherlands, and the steps from your first question to the first patient.
What the legal representative does
The regulation says that a sponsor that is established outside the EU must ensure that a legal representative is established in the EU. The representative is responsible for making sure the sponsor meets its obligations under the regulation. Letters from the authorities go to the representative. The representative is named in the application in CTIS.
For a trial in more than one EU country the legal representative is always required. For a trial in one country only, that country may accept a contact person instead. Which option applies to your trial is checked with the authority of the country where the trial runs.
The legal representative is a role, not a licence. It can be a contract research organisation (CRO) that offers the service, a law firm, or a company in your own group. The choice matters for who signs contracts, who holds the data and who is liable.
A CRO or your own European company
A CRO as legal representative is the quick route for a first trial. The CRO already knows CTIS, the ethics committees and the inspectorate. The role ends when the trial ends.
Your own Dutch company as legal representative is the route for a sponsor that plans more than one trial in Europe, or that will sell the product in Europe afterwards. The same company then holds the trial contracts, the trial insurance and later the marketing authorisation. The knowledge, the relationships and the value stay in your group. A CRO still runs the trial day to day; your company signs and is responsible.
How a trial is reviewed in the Netherlands
In the Netherlands, trials with medicines are reviewed under the Medical Research Involving Human Subjects Act (WMO). The Central Committee on Research Involving Human Subjects (CCMO) coordinates the review and is the Dutch authority in CTIS. The ethical review is done by an accredited medical research ethics committee (METC) or by the CCMO itself.
The sponsor must have trial insurance for the participants under the Dutch insurance decree. The investigational medicine, if it is made outside the EU, is imported by a company with a manufacturing and importation authorisation for investigational medicinal products and released by a qualified person in the EU.
Trials with medical devices, called clinical investigations, follow the Medical Device Regulation and are also reviewed by the CCMO and an ethics committee. The sponsor outside the EU appoints a legal representative here too, unless the country accepts a contact person for a single-country study.
Why the Netherlands for European trials
The European Medicines Agency is in Amsterdam. Eight university medical centres, the Netherlands Cancer Institute and the Leiden Bio Science Park are within an hour of each other. Dutch investigators are used to international protocols, and English is the working language in hospitals, at the CCMO and at the tax office.
A Dutch company as legal representative is set up by power of attorney, with the parent as shareholder. It pays 19% corporate tax on the first €200,000 of profit and 25.8% above that. Dividends to a parent company in a treaty country usually go out without Dutch dividend tax. Later, the same company holds the marketing authorisation: read selling medicines in Europe.
Based on Regulation (EU) 536/2014 (Clinical Trials Regulation), Regulation (EU) 2017/745 (MDR), the Dutch Medical Research Involving Human Subjects Act (WMO) and the CCMO guidance, as applied in September 2026. Trial 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 protocol, the product and the data
- Choose the countries, the sites and the CRO
- Provide the investigational product and the manufacturer documents
- Sign the power of attorney; nobody travels
The Dutch base
- Sets up the Dutch company (a BV), by power of attorney, with the notary
- Registered office, KVK number, tax number and VAT number
- Bank account and bookkeeping for trial payments to sites and vendors
- Annual accounts, corporate tax return, substance in the Netherlands
- Single point of contact for the CRO, the insurer and the importer
Licences and product rules
- The CTIS application and the ethics committee file
- Trial monitoring, pharmacovigilance during the trial, data management
- Trial insurance under the Dutch decree
- Import and qualified person release of the investigational product
- Clinical trial agreements with hospitals, in Dutch and English
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 the product is, the phase of the trial, the countries and whether you have a CRO. 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 with the parent as shareholder. You receive the KVK number, the tax number and the VAT number. The bank file starts on day one.
- The role. Your Dutch company becomes the legal representative. The partner drafts the sponsor delegation, the insurance and the agreements with the sites.
- The application. The CRO or regulatory partner files the trial in CTIS with the Dutch company as legal representative. The CCMO and the ethics committee review.
- The product. The investigational medicine is imported and released in the EU by a licensed importer and a qualified person, or made in the EU.
- After the trial. The same company applies for the marketing authorisation, holds it and sells the product. Nothing has to be moved to another entity.
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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