Procedure with Pre-Notification under Art. 6 TPO
Short answer
In the procedure with pre-notification, you notify Swissmedic of the application in advance and receive a shortened, bindingly scheduled regulatory time of around 200 days in return. This requires a complete, submission-ready dossier on the announced date. Anyone who misses the date falls back into the standard procedure.
Who benefits from pre-notification?
It benefits companies that need to time market entry against something else, such as an EU authorisation, a price application to the FOPH, or production planning. The gain lies less in the absolute duration than in predictability: you know the assessment windows in advance and can reserve response capacity for them.
- New active substances with a parallel EU or Access procedure.
- Products where a price application to the FOPH is to follow immediately after authorisation.
- Portfolios with several applications per year where internal capacity needs to be planned.
How does pre-notification work?
Pre-notification is submitted in writing via the Portal, generally around 60 days before the planned submission date. It states the active substance, indication, procedure type, the binding submission date, and confirmation that the dossier will be complete by that date. Swissmedic confirms the date or proposes an alternative.
- Submit the pre-notification with product details and a binding submission date.
- Wait for confirmation from Swissmedic with a reserved assessment window.
- Submit the dossier exactly on the confirmed date, complete and formally checked.
- Go through the shortened assessment, generally with one round of questions.
- Receive the preliminary decision and final decision within the announced timeline.
What timelines and fees apply?
The regulatory time is around 200 days, compared with around 330 days in the standard procedure. The fee matches the fee for the underlying procedure; an additional fee is charged for the pre-notification itself. The current Fee Ordinance is authoritative.
| Feature | Standard procedure | Pre-notification |
|---|---|---|
| Regulatory time (benchmark) | around 330 days | around 200 days |
| Rounds of questions | two, sometimes three | generally one |
| Submission date | flexible | bindingly announced |
| Dossier maturity at submission | high | complete, no follow-up submissions |
| Additional fee | none | fee for the pre-notification |
| Fallback if the date is missed | not applicable | standard procedure |
How does this differ from the accelerated procedure?
The procedure with pre-notification is an organisational tool open to any application. The accelerated authorisation procedure under Art. 7 TPO is a substantive privilege that requires a serious disease with no equivalent alternative. The two procedures cannot be combined.
Frequently asked questions
How early must I pre-notify?
Generally around 60 days before the planned submission date. With several applications in the same quarter, notifying earlier is advisable because assessment windows are limited.
What happens if my dossier is not ready by the date?
The reserved slot lapses and the application is processed under the standard procedure. A fresh pre-notification for a later date is possible but incurs the pre-notification fee again.
Does the procedure also apply to generics?
Yes. Pre-notification is not tied to a new active substance; for generics it is particularly useful when the expiry of a patent or of first applicant protection sets the timing of market entry.
Does pre-notification reduce the number of questions?
No, but it typically reduces the number of rounds of questions to one, because the dossier is complete at submission and fewer formal queries arise.
Sources
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