Temporary Authorisation Swissmedic (Art. 9a TPA)

What requirements must be met?

Art. 9a TPA requires three elements at the same time: a serious, disabling or life-threatening disease, the absence of an authorised equivalent medicinal product, and a high expected therapeutic benefit. In addition, the applicant must present a realistic plan for generating the missing data within the limited period.

A serious, disabling or life-threatening disease as the target indication.
No authorised, equivalent therapeutic alternative in Switzerland.
High expected therapeutic benefit based on the data available.
A binding data plan: ongoing or planned studies with milestones.
A risk management plan with enhanced monitoring and reporting obligations.

What conditions are typical?

Typical conditions include submitting final study reports by set dates, shortened periodic safety update reports, a controlled distribution channel, a patient registry, and training material for prescribing healthcare professionals. The conditions are part of the decision, and failure to meet them can lead to revocation.

Temporary authorisation at a glance
Feature	Rule
Legal basis	Art. 9a TPA, Art. 18 to 20 TPO
Regulatory time (benchmark)	around 140 days
Validity	time-limited, generally two years, renewable
Conditions	follow-up data, enhanced pharmacovigilance, sometimes a registry
Goal	conversion into an ordinary authorisation
If not met	non-renewal or revocation

How is it renewed or converted?

Before the time limit expires, you submit an application documenting the state of compliance with the conditions. If the data is complete, the authorisation is converted into an ordinary authorisation with a five-year validity. If it is only partly complete, the time limit can be extended, usually with adjusted conditions.

Document the status of the conditions continuously, not only at the end of the time limit.
Submit a renewal or conversion application at least six months before expiry.
Enclose the final study reports, an updated benefit-risk assessment and pharmacovigilance data.
Update the medicinal product information to reflect the new data.
Receive the decision: conversion, renewal or refusal.

How does this differ from compassionate use?

The temporary authorisation is a genuine authorisation: the product may be advertised, distributed and reimbursed via the Specialities List. Compassionate use under Art. 9b TPA, by contrast, is a temporary permit for the use of an unauthorised medicinal product in individual patient groups, without market access.

Frequently asked questions

How long is a temporary authorisation valid?

Generally two years. It can be renewed as long as the conditions are being credibly pursued. Indefinite renewal without progress on the data is not envisaged.

Can a temporarily authorised medicinal product go on the Specialities List?

Yes. The FOPH can include a temporarily authorised medicinal product in the Specialities List, often with a limitation and a pricing model. Inclusion is a separate procedure and not part of the authorisation.

Is the temporary authorisation the same as the EU conditional marketing authorisation?

It is functionally comparable but legally distinct. An EU CMA is not automatically recognised; however, Swissmedic can take the assessment results into account under Art. 13 TPA.

What happens if the conditions are not met?

Swissmedic can decline to renew the authorisation or revoke it. In practice, a request with a deadline usually comes first, then restriction of the indication, and only after that revocation.

Temporary Authorisation under Art. 9a TPA