Temporary authorisation under Art. 9a TPA and Art. 18 TPLO
A temporary authorisation lets Swissmedic authorise a medicine on an incomplete data set for a limited term, with conditions. The criteria of Art. 9a TPA and Art. 18 TPLO are cumulative and must be met at application, at completion and at every extension.
What a temporary authorisation is
A temporary authorisation is a full authorisation granted for a limited term and tied to conditions, on the basis of Art. 9a of the Therapeutic Products Act read with Art. 18 TPLO. It is designed for situations of serious unmet need where waiting for a complete data package would deny patients access, and it is common among orphan drugs.
It is a full authorisation, not a tolerated use. The product is authorised in Switzerland, carries an authorisation number and a product information, and appears in the Swissmedic list published under Art. 7 TPLO with the expiry of the temporary authorisation shown.
The criteria and why they are cumulative
The criteria are not alternatives. They must be satisfied together, and not only once: Swissmedic checks them at the time of application, again when the procedure is completed and again at every extension. A criterion that was met at filing but has since fallen away therefore threatens the authorisation rather than merely the extension.
Because the assessment is repeated, the holder is effectively under a continuing obligation to monitor the Swiss market. A temporary authorisation is not a stable position that can be assumed to persist until the data package is finished; it is a status that has to be re-earned at each decision point.
The criterion that decides most cases is availability: no authorised, alternative and equivalent medicinal product may be available in Switzerland, under Art. 9a para. 1 let. c TPA and Art. 18 let. b TPLO. This is a moving target, because a competitor authorisation granted in the meantime can change the answer.
How Swissmedic assesses equivalence
Equivalence is assessed on the substance of what the alternative product offers patients, not on its classification. Swissmedic compares indication, target population, mechanism of action, ease of use and the risk-benefit profile. A product that shares an indication but differs materially in mechanism or in practical usability is not automatically equivalent.
| Dimension compared | What it means in practice |
|---|---|
| Indication | Does the authorised product cover the same therapeutic indication? |
| Target population | Does it address the same patients, including age and disease stage? |
| Mechanism of action | Does it act through the same pharmacological route? |
| Ease of use | Is administration comparable in practical handling for patients and staff? |
| Risk-benefit profile | Is the overall benefit against risk comparable? |
None of the five dimensions is decisive on its own. The assessment asks whether patients would in substance have an authorised option, which is why an applicant should document the comparison across all five rather than relying on a single point of difference.
Conditions, term and extension
A temporary authorisation is granted with conditions and for a limited term, and it can be extended. The conditions typically require the holder to generate and submit the outstanding data. Because the criteria are re-examined at every extension, the holder must show both that the conditions have been served and that the underlying situation still qualifies.
- Swissmedic grants the authorisation for a limited term together with the conditions to be fulfilled.
- The holder works through the conditions, generating and submitting the outstanding documentation.
- Before expiry the holder applies for an extension, or for conversion once the data package is complete.
- Swissmedic re-examines the cumulative criteria, including whether an authorised, alternative and equivalent product has since become available in Switzerland.
An extension application is therefore best prepared as a dossier rather than a letter. It has to show what was done on the conditions and that the criteria of Art. 9a TPA and Art. 18 TPLO are still met at the moment of the extension decision.
What happens when the term expires
Expiry is not a formality. If no extension is granted and the authorisation is not converted, the temporary authorisation ends and the product is no longer authorised in Switzerland. Planning the data programme against the term is therefore part of the regulatory strategy from the day the authorisation is granted.
The term should therefore be read as a deadline for the data programme rather than as an administrative date. Companies that treat the conditions of Art. 18 TPLO as work to be started later usually discover that the outstanding studies cannot be completed inside the term granted.
- Conditions fulfilled and the data package complete: the path is conversion to an ordinary authorisation.
- Conditions outstanding but the criteria still met: an extension may be granted, again with conditions and for a limited term.
- Criteria no longer met, for instance because an equivalent product is now authorised in Switzerland: continuation is not available on this basis.
Access questions after expiry move to other instruments, in particular individual import under Art. 49 MPLO and individual-case reimbursement under Art. 71a to 71d KVV, each with its own requirements.
Finding the temporary authorisations on record
Temporary authorisations are visible in the public record. The Swissmedic list of medicinal products with orphan drug status published under Art. 7 TPLO carries the expiry of a temporary authorisation where applicable, alongside the authorisation status and number. This site keeps a list of temporary authorisations drawn from that data set.
The underlying data set has 728 rows as of 18/09/2026 and covers 321 medicines holding an authorisation number, which makes it possible to separate temporary authorisations from ordinary ones and to track the expiry dates on record.
Reading the expiry dates together with the authorisation status also shows where a temporary authorisation was converted or allowed to lapse, which is the most reliable public signal of how a data programme under Art. 18 TPLO conditions actually ended.
Frequently asked questions
When can Swissmedic grant a temporary authorisation?
Under Art. 9a TPA together with Art. 18 TPLO, when the statutory criteria are met cumulatively. A central condition is that no authorised, alternative and equivalent medicinal product is available in Switzerland, under Art. 9a para. 1 let. c TPA and Art. 18 let. b TPLO. The criteria are re-examined at every extension.
How is equivalence of an alternative product judged?
Swissmedic compares indication, target population, mechanism of action, ease of use and the risk-benefit profile. A product sharing only the indication is not necessarily equivalent. Because a competitor authorisation can be granted during the term, the answer can change between one extension and the next.
Can a temporary authorisation be extended?
Yes. It is granted with conditions for a limited term and can be extended. At each extension Swissmedic re-examines the cumulative criteria and reviews progress on the conditions, so an extension request is both a data submission and a fresh eligibility demonstration.
What happens if the term expires without an extension?
The authorisation ends and the product is no longer authorised in Switzerland. Access then depends on other instruments, in particular individual import by a healthcare professional under Art. 49 MPLO and individual-case reimbursement under Art. 71a to 71d KVV, each subject to its own conditions.
Where can I see which orphan drugs hold a temporary authorisation?
The Swissmedic list published under Art. 7 TPLO shows the authorisation status, the authorisation number and the expiry of a temporary authorisation where applicable, and is updated monthly. This site maintains a list of temporary authorisations based on that data set as of 18/09/2026.