Clinical trials in Europe: the legal representative your sponsor needs
A company from outside the European Union (EU) and the European Economic Area (EEA) that sponsors a clinical trial in Europe must appoint a legal representative established there, although the countries of the trial may accept a contact person in its place. The rule applies, for example, to sponsors from the United States, the United Kingdom, Switzerland and Asia. A contract research organisation (CRO) can act as representative, and so can your own Dutch company, which can later become the company that sells the product.
Ask about your situationClinical trials with medicines in the EU and the EEA fall under the Clinical Trials Regulation (CTR), and every application is submitted through one portal, the Clinical Trials Information System (CTIS). A sponsor established outside the EU or the EEA appoints a legal representative there, although the countries of the trial may accept a contact person in its place. The representative makes sure the sponsor meets its obligations under the regulation and acts as the contact point for the authorities. We set up the Dutch company that can be your legal representative and work with clinical research and regulatory partners on the trial itself.
In the Netherlands the Central Committee on Research Involving Human Subjects (CCMO) and an accredited ethics committee review the trial. If your own Dutch company is to be the legal representative, set it up before you file the application.
Tell us what you make or sell, where your company is and what you plan in Europe. Our team looks at it and replies with the steps and the dates that apply to you.
Who does what
We set up and manage the Dutch company. Specialist partners do the licence and product work. We are your only contact, with one file for all the work.
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 at a notary in your own country
The Dutch company
- Set up the Dutch company (a BV), by power of attorney, with the notary
- Registration with the Dutch Chamber of Commerce (KVK), tax number and VAT number
- Bank account and bookkeeping for trial payments to sites and vendors
- Annual accounts and the corporate tax return
- 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, drug safety monitoring (pharmacovigilance) and data management
- Trial insurance under the Dutch decree
- Import of the investigational product and its release by a qualified person
- Clinical trial agreements with hospitals, in Dutch and English
The steps to the European market
What happens from your first question to the day your first product is on the European market.
- You tell us what the product is, the phase of the trial, the countries and whether you have a CRO, and we reply with a suitable structure and a proposal.
- 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, and we prepare the bank application.
- Your Dutch company becomes the legal representative, and the partner drafts the sponsor delegation, the insurance and the agreements with the sites.
- The CRO or regulatory partner files the trial in CTIS with the Dutch company as legal representative, and the CCMO and the ethics committee review it.
- The investigational medicine is either made in the EU or imported and released there by a licensed importer and a qualified person.
- After the trial the same company applies for the marketing authorisation, becomes its holder and sells the product, so everything stays in one company.
What the legal representative does
Under the regulation, a sponsor established outside the EU or the EEA must have a legal representative established in the EU or the EEA, who makes sure the sponsor meets its obligations under the regulation (Article 74(1)). The representative is named in the application in CTIS and receives the letters from the authorities.
A country that hosts a trial on its own may accept a contact person on its territory in place of a representative, and when a trial takes place in several countries, all of them may accept a contact person in the EU or the EEA (Clinical Trials Regulation, Article 74(3)). The authorities in the countries of your trial can tell you which option applies.
The role of legal representative is free of licence requirements. A contract research organisation (CRO) that offers the service can take it, and so can a law firm or a company in your own group. The choice determines who signs the contracts, who keeps the data and who is liable.
A CRO or your own European company
A CRO is a quick choice of legal representative for a first trial, because it already knows CTIS, the ethics committees and the inspectorate. Its role ends when the trial ends.
Your own Dutch company suits a sponsor that plans several trials in Europe or will sell the product there afterwards. The same company then holds the trial contracts, the trial insurance and later the marketing authorisation, so your group keeps the knowledge, the relationships and the value. A CRO still manages the trial day to day, while your company signs and bears the responsibility.
Tell us what you make or sell, where your company is and what you plan in Europe. Our team looks at it and replies with the steps and the dates that apply to you.
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 CCMO coordinates the review and acts as the Dutch authority in CTIS, and 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. An investigational medicine made outside the EU or the EEA is imported by a company with a manufacturing and importation authorisation for investigational medicinal products, and a qualified person in the EU or the EEA, the expert who certifies each batch, then releases it.
Trials with medical devices, called clinical investigations, fall under the Medical Device Regulation (MDR), and the CCMO and an ethics committee review them as well. Here too a sponsor from outside the EU appoints a legal representative, although a country may accept a contact person for a study that takes place only on its territory.
Why the Netherlands for European trials
The European Medicines Agency is based in Amsterdam, and the university medical centres in Amsterdam, Leiden, Rotterdam and Utrecht, the Netherlands Cancer Institute and the Leiden Bio Science Park are all within about an hour of each other. Dutch investigators are used to international protocols and English is common in research, although hospitals, the CCMO and the tax office work mainly in Dutch.
A Dutch company that acts as legal representative is set up by power of attorney, with the parent as shareholder, and pays 19% corporate tax on the first €200,000 of profit and 25.8% on profit over that amount. Dividends it pays to a parent company in a country with a tax treaty are usually free of Dutch dividend tax. The same company can later hold the marketing authorisation, as our guide to selling medicines in Europe explains.
How long the review takes
The countries of the trial assess the science, the medicine and the risks for participants together, after the reporting country has checked within 10 days that the application is complete (the validation). That joint review takes 45 days, plus up to 31 days when the reviewers ask questions. Each country also assesses the national aspects, such as the consent forms, the insurance, the sites and the investigators, and decides within 5 days after the review. From a complete application to a decision takes about two to three months, and the reviewers can add 50 days to consult experts when the trial uses an advanced therapy medicine, such as a gene or cell therapy, or a medicine made with biotechnology.
Arrange the Dutch company, the trial insurance and the contracts with the sites before you file the application.
Safety reports, patient data and the file after the trial
During the trial the sponsor reports suspected unexpected serious side effects (SUSARs) to the European safety database within 7 or 15 days, depending on how serious they are, and files a safety report once a year. The legal representative must be able to show that the sponsor does this. In practice the clinical research organisation prepares the reports, and your Dutch company signs and files them.
The European data protection rules, the General Data Protection Regulation (GDPR), apply to trial data of European patients. A Dutch company that acts only as legal representative stays outside the role of responsible party under the GDPR, which it takes on only when it is the sponsor itself. A sponsor based outside the EU must also appoint a data protection representative in the EU, a separate appointment under Article 27 of the GDPR. After the trial the complete file, the trial master file, is kept for 25 years. Your own Dutch company can keep it for that entire period, whereas a service provider hands it back to you when its contract ends.
Based on Regulation (EU) 536/2014 (Clinical Trials Regulation), Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2016/679 (GDPR). Also based on the Dutch Medical Research Involving Human Subjects Act (WMO) and the CCMO guidance, as applied in September 2026. Specialised partners prepare the trial files, and our team coordinates their work.
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. Our team replies with advice.
Related guides
More guides about selling in Europe.