Legal routes to a peptide treatment in the Netherlands

The IGJ updated its position on off-label prescribing in February 2026, and adjusted it in May 2026. Outside a standard, the doctor must weigh benefit against side effects on current science. The doctor must check your up-to-date medicine history. You must be told more than usual, and your explicit consent goes in your file. You are watched more closely for side effects.³

The legal basis is article 40(3)(c) of the Medicines Act and article 3.17 of the Medicines Regulation. The IGJ can grant the exemption only if all of these are true:^2,17

• the doctor finds the treatment necessary;
• no adequate medicine is available in the Netherlands;
• the supplier keeps records of amounts, patients and side effects.

In practice the IGJ asks for:⁵

• a declaration signed by a doctor in the Dutch BIG register, with a patient code instead of your name, valid for one year;
• on page 2, the treatments you already had or that were considered, and why approved medicines cannot be used;
• the official product information from the country of origin, or, for a product approved nowhere, the Investigator’s Brochure or IMPD;
• a valid GMP certificate when the product comes from outside the EEA, MRA countries and the UK, or comes from there without a licence.

Money, convenience or a different form of the same medicine are not accepted as reasons. The supplier must record side effects and report them to Lareb.⁵

Two documents are the problem. For a product approved nowhere, the IGJ asks for the trial files a company writes about it: the Investigator’s Brochure or the IMPD. It also asks for proof that the product was made under GMP.⁵ A vial sold for “research” comes with neither. A supplier would need a manufacturer that makes the peptide to medicine standards and can show it.

There must also be no adequate medicine for your condition on the Dutch market.¹⁷ The route is real for medicines approved in another country but not sold here.⁵

Where to look. Ask your GP or specialist, or a patient organisation. You can also search the Dutch register Onderzoekmetmensen.nl, the EU’s public trial website, or ClinicalTrials.gov. The CCMO does not match people with studies.^7,22

What it involves. You get written information and time to decide. You sign a consent form. There is often a check first to see if you can take part.²¹ In early trials (phase 1 and 2), patients usually do not get better from taking part. Patients usually get travel costs only, and do not pay for the study medicine.⁷

Your rights under EU law. The expected benefits must justify the risks. You can leave at any time without giving a reason and without any harm to you.²³

The insurance has limits. Harm must be reported within four years. Harm you were told about in advance is usually not covered.²¹