Guides
Orphan drug status, authorisation, reimbursement and care in Switzerland, explained with the relevant articles of the TPA, TPLO and KVV.
- Orphan drug status in Switzerland: criteria, application and advantages8 min
- Orphan drug authorisation in Switzerland: the simplified procedure and Art. 13 TPA7 min
- Reimbursement of orphan drugs: the specialities list and Art. 71a to 71d KVV6 min
- Temporary authorisation under Art. 9a TPA and Art. 18 TPLO6 min
- Compassionate use in Switzerland and individual import under Art. 49 MPLO6 min
- Orphan drug pricing in Switzerland: foreign price comparison and therapeutic cross comparison6 min
- The national concept for rare diseases in Switzerland and the role of kosek6 min
- Patient organisations for rare diseases in Switzerland: ProRaris and Orphanet5 min
- Orphan drugs compared: Switzerland, the European Union and the United States7 min
- Market entry for orphan drugs in Switzerland: holder, product information, distribution and listing6 min
Frequently asked questions
How does a medicine obtain orphan drug status in Switzerland?
On application to Swissmedic. It requires a life-threatening or chronically debilitating disease affecting no more than 5 in 10,000 people in Switzerland, or an existing recognition in a country with comparable medicinal product control (Art. 4 para. 1 let. a decies TPA, Art. 4 TPLO).
What does the status actually give you?
The simplified authorisation procedure (Art. 14 para. 1 let. f TPA), priority assessment, a waiver of the flat-rate fee for the new authorisation application and, on request, 15 years of document protection (Art. 11b para. 4 TPA). There is no market exclusivity as in the EU.
How current is the data on Guides?
Swissmedic publishes the list of medicinal products with orphan drug status under Art. 7 TPLO and updates it monthly. The date of the data set processed here is shown at the foot of every page.
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