Tesamorelin Netherlands: import rules

The short answer: tesamorelin cannot be freely imported into the Netherlands for personal use. There is no authorised tesamorelin product in the Netherlands or anywhere in the EU. The European marketing-authorisation application was withdrawn in June 2012^[1], and no replacement application has been submitted. Without a marketing authorisation, tesamorelin is an unlicensed medicine under Dutch law, and the only lawful route to access it runs through a prescriber who takes individual clinical responsibility for the decision.

This article explains how Dutch medicines law classifies tesamorelin, what the College ter Beoordeling van Geneesmiddelen (CBG-MEB) and the Inspectie Gezondheidszorg en Jeugd (IGJ) say about unlicensed medicines, what Dutch customs looks for, and what the grey-market picture looks like without endorsing it. This is not legal advice. If you are facing a decision with legal or clinical consequences, speak to a Dutch lawyer and a clinician who knows your situation.

Why tesamorelin has no authorised status in the Netherlands

Tesamorelin is a synthetic growth-hormone-releasing hormone (GHRH) analogue. The FDA approved it in the United States in 2010 under the brand Egrifta, for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. That remains the only marketing authorisation for tesamorelin anywhere in the world^[1].

Ferrer Internacional submitted a European marketing-authorisation application to the EMA in 2011. The application carried product number EMEA/H/C/002427. The Committee for Medicinal Products for Human Use (CHMP) raised concerns about the benefit-risk profile: the committee could not reliably distinguish HIV-related lipodystrophy from general obesity in clinical practice, doubted whether the reduction in visceral fat translated into meaningful health benefits for European patients, and flagged an elevated IGF-1 safety signal as a potential long-term cancer and diabetic-complication risk. The applicant withdrew on 21 June 2012^[1]. No sponsor has re-submitted.

Theratechnologies, which manufactures Egrifta and Egrifta SV in the US, has not sought a new EMA application. The Netherlands therefore has no registered product containing tesamorelin in the Geneesmiddeleninformatiebank, the Dutch medicines register maintained by the CBG-MEB^[4]. Any tesamorelin offered for sale in the Netherlands is, by definition, an unlicensed medicine.

How Dutch medicines law treats unlicensed medicines

The Netherlands regulates medicines through the Geneesmiddelenwet (Medicines Act). The CBG-MEB (College ter Beoordeling van Geneesmiddelen) is the national competent authority for marketing authorisations^[4]. For a medicine to be lawfully supplied in the Netherlands, it must hold either a CBG-MEB national authorisation or a centralised EMA authorisation that is valid across the EU and EEA. Tesamorelin holds neither.

Dutch law does provide a named-patient route for unlicensed medicines: a prescribing clinician may, on their own responsibility, request a special import of a medicine that is not authorised in the Netherlands. That route is intended for situations where an authorised alternative does not exist and the clinical need is documented. It is not a general consumer channel, and it is not accessible by ordering online. The prescriber bears clinical and legal responsibility for the decision, and the supply passes through a regulated pharmacy.

Selling or distributing an unlicensed medicine to the Dutch public without going through the named-patient route is not permitted under the Geneesmiddelenwet. Online vendors who ship tesamorelin directly to Dutch consumers are operating outside that framework, regardless of labels that describe the product as a 'research chemical' or 'for research use only'. If the substance meets the functional definition of a medicinal product, the medicines rules apply.

What the IGJ and CBG-MEB say about online and imported medicines

The Inspectie Gezondheidszorg en Jeugd (IGJ), the Dutch healthcare inspectorate, states clearly that prescription medicines may only be dispensed by a registered pharmacist or a pharmacy-owning GP^[5]. The IGJ specifically warns that medicines bought online may lack quality controls, carry incorrect dosing, or be contaminated. Suspected illegal online sales of medicines can be reported to the Landelijk Meldpunt Zorg (national healthcare reporting centre).

The CBG-MEB requires online pharmacies selling to Dutch consumers to display the EU common logo and be listed on aanbiedersmedicijnen.nl, the official Dutch verification registry. An overseas research-chemical vendor is not on that registry and does not carry the EU pharmacy logo. Purchasing from such a vendor falls outside the lawful supply chain the CBG-MEB and IGJ oversee.

Dutch customs and what it looks for

Dutch customs (Douane Nederland) screens international parcels, with a particular focus on pharmaceuticals and controlled substances arriving from outside the EU. Tesamorelin is typically presented as a lyophilised powder in a pharmaceutical-style vial, often with a lot number and an expiry date. That presentation is consistent with a pharmaceutical product and can attract customs attention.

When a parcel is intercepted, Douane Nederland can seize it and notify the recipient. The IGJ or the CBG-MEB may be involved if the substance is identified as an unlicensed medicine. Seized parcels are not returned. For a private individual receiving a single small shipment, the typical outcome is an administrative seizure and a written notification, but the matter can escalate depending on quantity, declared content, and whether any prior contact with enforcement exists. Distributing or reselling an unlicensed medicine is a separate and more serious offence than personal possession.

Labelling a vial of tesamorelin as a 'supplement' or 'peptide for research purposes' on a customs form does not override its regulatory classification if the substance is identified. Declared content and the actual substance are not always the same in grey-market shipments, and mislabelling carries its own risks.

The clinical evidence and why it matters here

The clinical trial programme for tesamorelin concentrated on a narrow and specific indication: reduction of visceral abdominal fat in adults with HIV-associated lipodystrophy. A 2012 review in the Annals of Pharmacotherapy concluded that tesamorelin significantly reduced waist circumference and visceral adipose tissue over 26 weeks of treatment in that population, with improvements maintained at 52 weeks in extension phases^[2]. A 2011 review in Drugs reached a similar conclusion but noted 'high cost and lack of long-term safety and adherence data' as meaningful limitations^[3].

The CHMP's 2012 concerns about the EMA application were partly about these same gaps: the long-term safety profile in European patients had not been demonstrated, and the IGF-1 elevation signal remained unresolved. Off-label interest in tesamorelin for general body-composition goals or longevity is discussed in some clinical and community contexts, but there is no controlled trial evidence for those applications. The on-label evidence base is specific to HIV-associated lipodystrophy and is the basis on which the FDA approval was and remains granted.

What we do not yet know

Published enforcement data specific to tesamorelin at Dutch customs is not available. The frequency with which Douane Nederland intercepts tesamorelin shipments, as distinct from broader pharmaceutical-parcel screening, is not publicly documented. The specific threshold at which Dutch enforcement escalates a personal-import seizure to a formal regulatory action has not been stated in any public document we can identify. The CBG-MEB has not published a formal ruling on tesamorelin's classification as a medicinal product under Dutch law, though the functional-product reasoning that applies to other unauthorised GHRH analogues applies here by extension.

Theratechnologies has not publicly announced any intention to re-submit a European marketing-authorisation application. Whether the company will seek EU authorisation in the future is not currently known.

For the broader picture on tesamorelin's pharmacology and evidence base, see the tesamorelin overview page. For the cross-country regulatory comparison, see tesamorelin regulation by country.

Medical disclaimer: This article is for educational and journalistic purposes only and does not constitute medical advice. Tesamorelin is an unlicensed medicine in the Netherlands. Always consult a qualified healthcare professional before using any peptide product. PeptideMethods.com does not sell, distribute, or facilitate the sale of any peptide product.

Regulatory disclaimer: This page reflects our understanding of Dutch regulatory status as of 2026-07-14. Regulations change. Verify with the CBG-MEB or a qualified Dutch lawyer before making any decision. PeptideMethods.com is not a law firm and does not provide legal advice.