Does Switzerland grant market exclusivity for orphan drugs?

No. Switzerland grants no market exclusivity. The status brings a simplified authorisation procedure, priority processing and a waiver of the flat-rate fee for the new authorisation application, and on request 15 years of document protection under Art. 11b para. 4 TPA.

Can the status be granted before the medicine is authorised?

Yes. Under Art. 4 para. 3 TPLO the application may be filed before, at the same time as, or after the authorisation application. Swissmedic processes it independently and faster than the authorisation dossier, so the status is often in place while the authorisation review is still running.

Does an applicant need a Swiss company to apply for the status?

No. The orphan drug status application requires no manufacturing, import or wholesale licence and no registered office in Switzerland. An invoice address and a Swiss address for postal deliveries must be supplied. A Swiss-domiciled holder becomes necessary only for the marketing authorisation itself.

Is a foreign orphan designation enough?

It can be. Recognition as an important medicinal product for rare diseases in a country with equivalent medicinal product control under Art. 13 TPA is an alternative route. Swissmedic then expects the foreign dossier, the official designation decision, the assessment report where available and proof of product identity.

Orphan Drug Status Switzerland: Criteria & Application

Q: How rare must a disease be for orphan drug status in Switzerland?

No more than 5 in 10,000 people in Switzerland may be affected at the time the application is submitted, and the disease must be life-threatening or chronically debilitating. The threshold applies to the whole disease entity including all of its stages, not to a subgroup or an isolated line of therapy.

What orphan drug status means in Switzerland

Orphan drug status (ODS) is a formal Swissmedic decision classifying a human medicinal product as an important medicine for rare diseases. It is defined in Art. 4 para. 1 let. a decies of the Therapeutic Products Act and unlocks procedural relief. It says nothing about quality, safety or efficacy.

The implementation sits in the Ordinance on the Simplified Authorisation of Medicinal Products (TPLO, SR 812.212.23): Art. 4 to 7 TPLO govern recognition, amendment, withdrawal and publication of the status, while Art. 24 to 26 TPLO govern the authorisation of a medicine holding ODS. Swissmedic sets out its practice in guidance document ZL100_00_002, version 3.4, valid from 1 June 2026.

Which criteria Swissmedic applies to the rarity test

Two routes lead to the status and they are alternatives, not cumulative. Either the applicant proves Swiss prevalence of no more than 5 in 10,000 people for a life-threatening or chronically debilitating disease, or it relies on an existing orphan designation from an authority with equivalent medicinal product control. Unlike the European Union, Switzerland applies no significant-benefit criterion.

The rarity criterion applies to the disease in its entirety, including all of its stages. A subgroup carved out of a common disease does not become a rare disease on its own. Swissmedic assesses the indication wording against the underlying disease entity, not against the commercial target population.

Question	Swissmedic position
Is HER2-positive breast cancer a separate rare disease?	No. A subgroup defined by molecular genetic markers does not qualify separately; the disease entity counts.
Does restricting the indication to second-line treatment help?	No. An isolated stage of the disease is not a rare disease in its own right.
Is significant benefit over existing therapies required?	No. Switzerland has no significant-benefit criterion, in contrast to the EU.
Does a foreign designation suffice on its own?	Yes, if the authority has equivalent medicinal product control under Art. 13 TPA and product identity is documented.

How to file an orphan drug status application

The application can be filed before, at the same time as, or after the authorisation application under Art. 4 para. 3 TPLO. Swissmedic processes it independently of the authorisation dossier and faster, so the status is frequently granted before the medicine itself is authorised. No Swiss establishment licence is needed to apply.

Confirm the applicant set-up: no manufacturing, import or wholesale licence and no registered office in Switzerland are required, but an invoice address and a Swiss address for postal deliveries must be provided.
Define the wording of the rare disease precisely, covering the full disease entity rather than a stage or a marker-defined subgroup.
Compile the scientific documentation demonstrating the criteria of Art. 4 paras. 1 and 2 TPLO, in particular the Swiss prevalence estimate and its sources.
Where the application relies on a foreign recognition, add all administrative and scientific documentation submitted to the foreign authority, a copy of the official orphan designation decision and the assessment report if available.
Where several countries have granted a designation, submit the decisions of all of those authorities, with the full documentation for the reference authority only.
Add documentary evidence that the medicinal product or the active substance is identical to the one covered by the foreign designation.
Submit the application to Swissmedic and await the decision, which may come with restrictions and conditions.

Swissmedic decides on the application and may attach restrictions and conditions, most often to the wording of the orphan disease. A status granted with a narrowed wording still counts as orphan drug status, but the narrowed wording is what governs the later authorisation and any indication extension.

What advantages the status brings

The status is a procedural instrument. It opens the simplified authorisation procedure under Art. 14 para. 1 let. f TPA together with Art. 24 para. 1 TPLO, secures priority processing of the authorisation application, waives one flat-rate fee and allows longer document protection on request. Switzerland grants no market exclusivity of any kind.

Simplified authorisation procedure under Art. 14 para. 1 let. f TPA and Art. 24 para. 1 TPLO.
Priority processing of the authorisation application by Swissmedic.
Waiver of the flat-rate fee for the new authorisation application under Art. 9 let. a FeeO-Swissmedic (SR 812.214.5).
Fifteen years of document protection on request under Art. 11b para. 4 TPA.

Two limits matter for budgeting. Variations have been subject to fees since 1 January 2019, so post-authorisation lifecycle work is charged as for any other product. The surcharge for fast-track procedures also remains payable despite the status.

Restrictions, notification duties and withdrawal

Swissmedic may grant the status subject to restrictions and conditions, typically on the wording of the orphan disease. Changes to the status abroad must be reported to Swissmedic immediately under Art. 5 para. 2 TPLO. The status is not permanent and can be withdrawn on request or ex officio.

Withdrawal on request of the status holder under Art. 6 let. a TPLO.
Withdrawal ex officio when the criteria are no longer met under Art. 6 let. b TPLO.
Withdrawal when it cannot be demonstrated, on request, that the sum of all authorised and requested ODS indications for the same active substance within the same disease affects at most 5 in 10,000 people, under Art. 6 let. c and d TPLO.

The cumulative test in Art. 6 let. c and d TPLO is the one that surprises applicants with broad development programmes. Each additional indication for the same active substance within the same disease counts towards the same prevalence ceiling, so a successful pipeline can erode the basis of the status.

Transferring the status to a new holder

A transfer of orphan drug status is a documentary exercise driven by the incoming holder. Swissmedic requires a written application from the future status holder together with declarations from both sides. The wording of the orphan disease must be reproduced exactly so that the transferred status remains identifiable in the published list.

The future status holder files a written application naming the current holder and the new holder.
The previous holder provides a legally signed declaration of assignment naming the medicinal product and the wording of the orphan disease.
The new holder provides an acceptance declaration.

Swissmedic then records the new holder in the list published under Art. 7 TPLO. Because the list shows the applicant or authorisation holder, a transfer that is not properly documented leaves the public record pointing at a company that no longer holds the status.

Where the granted statuses are published

Swissmedic publishes the list of medicinal products with orphan drug status online under Art. 7 TPLO and updates it monthly. The list is the authoritative public record for anyone screening the Swiss landscape, and it shows both the regulatory status and the commercial identity of each entry.

Active substance, applicant or authorisation holder and the rare disease.
Date the status was granted and, where applicable, the date of withdrawal.
Authorisation status, authorisation number, product name and date of first authorisation.
Expiry of a temporary authorisation where applicable, and the authorised indication.

The data set behind this site reproduces that list with 728 rows as of 18/09/2026, covering 321 medicines with an authorisation number, 220 rare diseases, 460 active substances, 150 companies and 53 withdrawn statuses.

Orphan drug status in Switzerland: criteria, application and advantages