Swissmedic Fees and Timelines
Short answer
Swissmedic is funded through procedural fees, an annual fee per authorisation, and supervisory levies. The amount is set by the Agency's Fee Ordinance and depends on the procedure type. Procedure timelines are regulatory times and do not include your own response times.
What does an authorisation cost?
The procedural fee rises with the assessment effort. A new active substance under the standard procedure runs into the mid five-figure range in francs, a generic well below that, and a notification procedure into four figures. On top, every authorisation carries an annual fee per pack presentation.
| Item | Range | Note |
|---|---|---|
| New authorisation with a new active substance | 40,000 to 70,000 | depending on the number of indications and pack presentations |
| New authorisation with a known active substance | 10,000 to 30,000 | depending on dossier scope |
| Generic authorisation | 5,000 to 15,000 | relies on a reference product |
| Procedure under Art. 13 TPA | reduced | discount against a full assessment |
| Notification procedure, co-marketing | 1,000 to 5,000 | identity check |
| Variation requiring assessment | 5,000 to 20,000 | new indication, new dosage |
| Variation requiring approval | 1,000 to 6,000 | quality changes |
| Notification under Art. 21 TPO | under 1,000 | lowest class |
| Annual fee per authorisation | a few hundred to a few thousand | per pack presentation, by turnover band |
What do establishment licences and inspections cost?
Licence fees are made up of a base fee for the decision plus the time spent on the inspection. The hourly rate for inspections and services is set out in the Fee Ordinance. Regional inspectorates apply the cantonal tariff.
- Granting or amending an establishment licence: base fee plus time spent.
- Inspection: preparation, on-site inspection days and report writing, charged at the hourly rate.
- GMP or GDP certificate: its own fee per certificate.
- Import and export licences for narcotics: a fee per licence.
- Scientific advice: charged by time spent, with a fixed minimum fee.
What timelines apply per procedure?
Swissmedic's timelines count only the days the dossier is with the authority. The applicant's response periods stop the clock. To plan the overall duration, add your own response times and around 30 days for formal review and notification of the decision to the regulatory time.
| Procedure | Regulatory time | Realistic overall duration |
|---|---|---|
| Standard procedure, new active substance | around 330 | 12 to 18 months |
| Procedure with pre-notification | around 200 | 9 to 13 months |
| Accelerated procedure | around 140 | 7 to 10 months |
| Art. 13 TPA with a foreign authorisation | around 200 | 9 to 14 months |
| Temporary authorisation | around 140 | 7 to 11 months |
| Variation requiring assessment | around 120 | 6 to 12 months |
| Notification procedure | around 60 | 2 to 4 months |
Where can fees and time realistically be reduced?
The biggest lever is dossier quality at submission: every round of questions avoided saves two to four months. Next come grouping variations, using Art. 13 TPA, and clarifying the dispensing category early so the medicinal product information does not need reworking twice.
Frequently asked questions
Must I pay the fee in advance?
Swissmedic invoices the procedural fee; it is owed regardless of the outcome. Even a refused or withdrawn application triggers the fee for the work already carried out.
Are there any concessions for small companies or orphan drugs?
Reductions exist for medicinal products for rare diseases and for certain procedures. They are set out in the Fee Ordinance and must be requested with reasoning.
What is the annual fee for?
It covers maintaining the authorisation, market surveillance and pharmacovigilance. It is charged per authorisation and pack presentation, regardless of turnover achieved.
Does a round of questions extend the regulatory time?
No, it stops it. The regulatory clock only resumes once your response has been received. The overall duration is still extended as a result.
Where do I find the current rates?
In the annex to the Fee Ordinance on Fedlex, and in the fee overview on swissmedic.ch. Both sources are linked; check the date of the version.
Sources
- Fedlex: Swissmedic Fee Ordinance (SR 812.214.5)
- Swissmedic: documents and forms
- Fedlex SR 812.212.21 TPO
Last updated: