Bring your orphan drug to Switzerland
You can enquire about orphan drug status, authorisation and reimbursement in Switzerland. Any specialist service and its scope are agreed separately with the external partner.
- Public Swissmedic data
- Four language versions
Switzerland is not an annex to the EU but a market of its own: its own authorisation by Swissmedic, its own pricing by the FOPH, its own language requirements for the product information and an authorisation holder domiciled in Switzerland. For an orphan drug with a few hundred patients, all of that has to stay lean.
You can enquire about orphan drug status, authorisation and reimbursement in Switzerland. Any specialist service and its scope are agreed separately with the external partner.
The route to a Swiss authorisation
- 01
Assessment and strategy
Checking prevalence against the 5 in 10,000 criterion, aligning with the foreign designation, choosing the procedure (Art. 13 TPA, Art. 14 para. 1 let. f TPA, temporary authorisation under Art. 9a TPA).
2 to 4 weeks - 02
Orphan drug status application
Preparing the scientific documentation under Art. 4 TPLO, or the foreign decision together with the reference authority's documentation, filing it and handling Swissmedic's questions.
in parallel - 03
Authorisation dossier
Building the CTD, the Swiss product information in German, French and Italian, packaging material, and fee planning with the waived flat-rate fee.
6 to 12 weeks - 04
Assessment
Answering the list of questions, priority handling of the application, negotiating conditions where a temporary authorisation applies.
per Swissmedic time limits - 05
Reimbursement
The SL application to the FOPH with the foreign price comparison and the therapeutic cross comparison, preparing price models and the case for the limitation.
from authorisation - 06
Operations
Pharmacovigilance and reporting, batch release, GDP-compliant logistics, supply to hospital pharmacies and wholesalers, and enquiries from healthcare professionals.
ongoing
Possible topics for an enquiry
- Authorisation holder role with a Swiss domicile, including the responsible person
- Orphan drug status application and status administration, including the duty to notify changes abroad
- Authorisation, variations, renewals and indication extensions
- Product information in three national languages and packaging review
- SL application, price negotiation and the cost-effectiveness dossier
- Pharmacovigilance system, signal management and reports to Swissmedic
- GDP storage, batch release and distribution across Switzerland
- Support for individual imports and compassionate use programmes before authorisation
About this service
The publisher is Swiss Orphan Access. This directory presents publicly available Swissmedic data. Swiss Orphan Access handles enquiries about this independent directory. Details are shared with external specialists only by separate agreement.
- 321medicines with status
- 220rare diseases
Frequently asked questions
Do we need our own Swiss company?
For the authorisation yes, because the authorisation holder must be domiciled in Switzerland.
How long does market entry take?
From a complete dossier, plan for the Swissmedic assessment time limit and then for the SL procedure at the FOPH. Orphan drug status is normally decided considerably faster than the authorisation and can be applied for in advance.
Can patients be treated before authorisation?
Yes, through compassionate use under Art. 9b para. 1 TPA or through individual import by the treating healthcare professional under Art. 49 MPLO.
What does authorising an orphan drug cost?
The flat-rate fee for the new authorisation application is waived for medicines with orphan drug status (Art. 9 let. a FeeO-Swissmedic). Fees remain for variations and for the fast-track procedure.
Do we keep control of the price?
Pricing is settled with the FOPH and the strategy stays yours.