---
url: "https://dfylegitscript.com/blog/non-us-telehealth-operations-and-legitscript-certification"
title: "Non-US operations, cross-border shipping and certification"
description: "A telehealth business incorporated outside the United States can hold LegitScript certification, but the review follows the patient rather than the company, so what decides the application is where patients are, where prescribers are licensed and where the medicine ships from."
published: "2026-02-14T16:26:43+00:00"
modified: "2026-03-02T12:03:59+00:00"
---

# Non-US operations, cross-border shipping and certification

A telehealth business incorporated outside the United States can hold LegitScript certification, but the review follows the patient rather than the company, so what decides the application is where patients are, where prescribers are licensed and where the medicine ships from.

## Key takeaways

- The review follows the patient rather than the company, so where patients are, where prescribers are licensed and where the medicine ships from decide the application.
- Cross-border shipping is a structural constraint rather than a logistics preference, and it is the fact most often left out of a first submission.
- Opacity rather than complexity is what fails: a group with several entities is ordinary, and a group whose structure cannot be explained on one page is not.
- Translated pages are part of the reviewed surface, so a claim removed in English that survives in another language is still a live claim.

Two different situations get filed under the same heading, and they have very
different answers. One is a business incorporated outside the United States
serving American patients. The other is a business serving patients outside the
United States that needs certification for commercial reasons. Sorting out which
one you are is the first step.

## The review follows the patient, not the company

Where you are incorporated is a fact the reviewer records. It is not the fact
that decides the application.

What decides it is where your patients are, because that determines which
prescribing rules apply, which licensure is required, and which shipping
restrictions bite. A company registered anywhere can serve American patients
provided the clinicians treating them are licensed in the states those patients
are in and the medicine is dispensed by a pharmacy licensed to ship there.

So the questions are the same questions, applied to a more complicated set of
facts:

- Which states or countries do your patients live in?
- Where are your prescribers licensed, and does that cover those patients?
- Which pharmacy dispenses, where is it licensed, and where may it ship?
- Does your product cross a border on the way to a patient?

That last one is where non-US operators most often discover a genuine problem.

## Cross-border shipping is the hard constraint

Importing prescription medicines into the United States for consumer sale is
restricted, and the restrictions are not resolved by a well-drafted terms of
service page. A model where medicine is dispatched from outside the United States
to American patients is a structural issue rather than a presentational one, and
it is the version of this question that most often ends with a change to the
model rather than to the website.

The workable pattern for a non-US company serving American patients is
domestic: prescribers licensed in the states served, a pharmacy licensed and
shipping domestically, and a corporate structure that does not obscure who is
responsible for what.

## Structure that obscures is worse than structure that is complex

Non-US operations frequently involve several entities: a holding company in one
jurisdiction, an operating company in another, a professional corporation
employing clinicians, a technology entity licensing the platform.

That is unremarkable and reviewers see it constantly. What causes problems is a
structure that cannot be explained, or that appears designed to make
responsibility hard to locate. Ownership through jurisdictions with limited
public registries invites the reviewer to ask who is behind the business, and
the answer needs to be available.

State it plainly, with a diagram if it helps, in the submission. The alternative
is a request for information that starts from suspicion.

## What non-US operators consistently underestimate

**State-level licensure.** Operators from single-regulator jurisdictions
routinely expect one national approval. Clinical practice in the United States is
licensed state by state, and coverage gaps against the states you market to are
visible in a lookup.

**The privacy layer.** Compliance with a data protection regime elsewhere is not
compliance with the American health privacy framework. A Notice of Privacy
Practices is a distinct document from a website privacy policy and from a
European-style privacy notice.

**Payments.** Cross-border acquiring for high integrity risk healthcare
categories is harder than domestic acquiring, and the certification requirement
arrives through the acquiring bank either way, which
[the payments article](/blog/telehealth-payment-processing-and-high-risk-mcc-codes)
explains.

**Language and localisation.** Sites serving several markets from one domain
carry claims in several languages, and every one of them is part of the
application. A translated page that overstates the product is exactly the same
problem as an English one, and it is the page nobody in the head office reads.

## Serving patients outside the United States

The mirror situation. A business treating patients elsewhere may still need
certification, because the counterparties requiring it, card networks,
acquirers, advertising platforms, operate internationally.
[Who actually requires it](/blog/who-requires-legitscript-certification) is the
same list wherever you are.

Here the review assesses your model against the rules that apply where your
patients are: local prescribing requirements, local pharmacy regulation, local
advertising restrictions on medicines, which are frequently stricter than
American ones.

## The domain question is bigger for you

Multi-market operators tend to have more domains: country domains, language
subdomains, legacy brands from earlier markets. Certification attaches to a
website, so the estate decides the arithmetic, and
[what drives the cost](/legitscript-certification-cost) is worth reading with the
registrar list open.

Consolidating markets onto fewer certified domains, where the business allows
it, is usually the cheaper answer, and
[how brands should think about domain architecture](/blog/legitscript-certification-for-dtc-telehealth-brands)
applies with more force here than anywhere else.

## Where to start

Map patients to prescribers to pharmacies to shipping routes, and find the gaps.
If a medicine crosses a border to reach a patient, resolve that before anything
else, because it is the one item on the list that a better application cannot
fix. Everything else on this page is preparation, and preparation is what
separates a short review from
[the constraints that accumulate without certification](/blog/what-happens-to-a-telehealth-clinic-without-certification).

## The documents that take longest to obtain from abroad

Start these first, because they are the ones with a lead time you do not
control.

- Certified corporate documents from a non-English registry, with translations.
- Ownership evidence where the chain passes through a jurisdiction with a
  limited public registry.
- Identity verification for principals who are not resident in the market you
  are certifying for.
- Licensure evidence for clinicians credentialed through a third party.
- The pharmacy agreement, where the pharmacy is domestic and the contracting
  entity is not.

None of these is difficult. All of them take longer than the applicant expects,
and all of them are the kind of thing that turns into a request for information
if the submission goes in without them.

## A structure diagram is worth writing

One page: the entities, where each is registered, what each does, who owns what,
and which one contracts with the pharmacy and employs or contracts the
clinicians.

Reviewers are not hostile to complexity, they are hostile to opacity, and a
diagram supplied unprompted converts a suspicious-looking structure into a
documented one. It also has a second life: acquirers, partners and buyers ask
the same question, and the same page answers it.

If you would rather have all of this prepared and filed on your behalf, that is
what
[the expedited application service](/expedited-legitscript-application) is, and
the honest scope of it is set out in
[what we actually do](/blog/what-we-actually-do-when-we-file-an-application).

## Frequently asked questions

### Can a company incorporated outside the United States be certified?

Yes. Incorporation is recorded rather than decisive. What decides the application is where your patients are, where your prescribers are licensed, and where the medicine is dispensed and shipped from.

### Can I ship prescription medicines into the United States to my patients?

Importing prescription medicines for consumer sale is restricted, and a model that depends on it is a structural problem rather than a presentational one. The workable pattern is domestic dispensing by a pharmacy licensed to ship to the states you serve.

### Do my non-English pages form part of the application?

Yes. Every page a patient can reach is part of the marketing surface, and a translated page that overstates the product is the same problem as an English one. Localised sites need the same claims review as the primary market.

## Disclaimer

LegitScript is a trademark of LegitScript LLC. VeriScripts is an independent application-preparation service. It is not affiliated with, endorsed by, or certified by LegitScript LLC, and claims no sponsorship or partnership with it. We prepare, submit, and manage the application; LegitScript alone decides whether certification is granted. "LegitScript" is used here only to name the certification these applications are for.