Medicinal Product Authorisation in Switzerland: Procedures, Timelines, Fees
No ready-to-use medicinal product may be placed on the market in Switzerland without a Swissmedic marketing authorisation. This hub guides you through every procedure, from a new authorisation for a new active substance to a variation of an existing authorisation.
Which marketing authorisation procedure applies to my medicinal product?
The choice of procedure follows two questions: is the active substance new to Switzerland, and is there already an authorisation from a recognised foreign authority? A new active substance without a foreign authorisation follows the standard procedure, a product already authorised abroad goes through Art. 13 of the Therapeutic Products Act (TPA, HMG), and a generic goes through Art. 12 TPA.
| Procedure | Legal basis | Typical case | Swissmedic time |
|---|---|---|---|
| Standard procedure, new authorisation | Art. 9 et seq. TPA, Art. 3 et seq. TPO | New active substance, complete dossier | around 330 days |
| Procedure with pre-notification | Art. 6 TPO | New active substance under tight planning constraints | around 200 days |
| Accelerated authorisation procedure | Art. 7 TPO | Serious, disabling disease with no therapeutic alternative | around 140 days |
| Authorisation based on a foreign authorisation | Art. 13 TPA, Art. 16 TPO | EMA, FDA or Access authorisation already granted | around 200 days |
| Temporary authorisation | Art. 9a TPA, Art. 18 et seq. TPO | Incomplete data, high medical need | around 140 days |
| Authorisation of a generic | Art. 12 TPA | Relies on an originator product | around 330 days |
| Notification procedure | Art. 15 TPA | Co-marketing, certain complementary medicinal products | around 60 days |
The Swissmedic time column counts only the days the dossier is with the authority. The time the applicant needs to answer the List of Questions comes on top of that. In practice, plan for twelve to eighteen months from submission to decision.
Who may submit a marketing authorisation application?
The applicant is the future marketing authorisation holder. Under Art. 10 para. 1 let. c TPA, it must have its domicile, registered office or a branch in Switzerland; let. b of the same provision additionally requires a manufacturing, import or wholesale dealing licence. A foreign company with no Swiss presence therefore cannot submit directly and instead uses a subsidiary or a mandated Swiss marketing authorisation holder.
- Swiss presence under Art. 10 para. 1 let. c TPA: domicile, registered office or a branch.
- Distribution additionally requires a wholesale dealing or import licence under the MPLO.
- The marketing authorisation holder bears the pharmacovigilance obligations and must appoint a person responsible for pharmacovigilance.
- It must be able to initiate batch recalls and is the addressee of all Swissmedic decisions.
How is a Swiss marketing authorisation dossier structured?
Switzerland works with the Common Technical Document in five modules. Modules 2 to 5 correspond in content to the EU dossier and can be adopted unchanged. Module 1 is Switzerland-specific: forms, medicinal product information in German, French and Italian, packaging drafts and proof of Swiss domicile.
What applies after authorisation?
The authorisation is valid for five years and is renewed on request, which must be submitted at least six months before expiry. Under Art. 16a TPA it lapses if the medicinal product is not placed on the market within three years of authorisation or is off the market for three years. Variations must be notified or approved.
All guides in this hub
11 guides
- Featured5 min
New Marketing Authorisation for a Medicinal Product at Swissmedic
A new authorisation is the standard procedure under Art. 9 TPA for a medicinal product not yet authorised in Switzerland. Swissmedic assesses quality, safety and efficacy on the basis of a complete CTD dossier. The pure regulatory time is around 330 days, with an overall duration of twelve to eighteen months.
Read the guide - Featured3 min
Procedure with Pre-Notification under Art. 6 TPO
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.
Read the guide - Featured3 min
Temporary Authorisation under Art. 9a TPA
A temporary authorisation allows a medicinal product with an as yet incomplete dossier to be placed on the market where there is a life-threatening disease with no therapeutic alternative and a benefit is foreseeable. It is granted for a limited period subject to conditions and must be converted into an ordinary authorisation once the missing data has been supplied.
Read the guide - 3 min
Accelerated Authorisation Procedure under Art. 7 TPO
The accelerated authorisation procedure shortens the regulatory time to around 140 days. Swissmedic admits it where there is a serious, disabling or life-threatening disease, no equivalent therapy is authorised, and a high therapeutic benefit is expected. Admission to the procedure must be requested separately.
Read the guide - Featured3 min
Art. 13 TPA: Authorisation Using Foreign Assessment Results
Under Art. 13 TPA, Swissmedic takes into account the assessment results of a recognised foreign authority when a medicinal product is already authorised there. The dossier remains complete, but the assessment focuses on deviations and Swiss specifics. Regulatory time drops to around 200 days.
Read the guide - 3 min
Authorising Generics and Biosimilars in Switzerland
A generic is authorised under Art. 12 TPA by reference to an originator product authorised in Switzerland; the decisive factor is proof of bioequivalence. Biosimilars follow their own, considerably larger programme involving analytical, preclinical and clinical comparability. Both are only possible once first applicant protection has expired.
Read the guide - 3 min
Co-Marketing Medicinal Products in Switzerland
A co-marketing medicinal product is identical to an already authorised base product and is marketed only under a different name and by a different marketing authorisation holder. It is authorised through the notification procedure, receives its own authorisation number, and shares the fate of the base authorisation.
Read the guide - Featured4 min
Variations to an Authorisation at Swissmedic
Every variation to a Swiss authorisation falls into one of four classes under the TPO: notifiable within twelve months, subject to prior notification, requiring approval, or requiring approval with assessment. Classifying it correctly determines the timeline, the fee, and from when you may implement the change.
Read the guide - Featured4 min
Swissmedic Fees and Timelines
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.
Read the guide - 3 min
Swissmedic, EMA and FDA Compared
Swissmedic is a national authority outside the EU system: no automatic recognition, but a duty to take foreign assessment results into account under Art. 13 TPA. Dossier format and scientific requirements match the international standard, while the procedure itself is smaller, more direct and quicker to engage with.
Read the guide - 3 min
CTD Dossier for Swissmedic and the Swiss Module 1
Swissmedic uses the Common Technical Document with five modules. Modules 2 to 5 can be adopted from the EU or US dossier. Module 1 is Switzerland-specific and contains the forms, the trilingual medicinal product information, packaging drafts and proof of Swiss domicile.
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Frequently asked questions
Does every medicinal product need a Swissmedic marketing authorisation?
Every ready-to-use medicinal product placed on the market in Switzerland needs an authorisation (Art. 9 para. 1 TPA). Exceptions include formula magistralis preparations compounded by a pharmacy for a specific person, medicinal products for clinical trials, and individual imports by healthcare professionals under Art. 49 MPLO.
Does Swissmedic automatically recognise an EU authorisation?
No. There is no automatic recognition and no mutual recognition agreement for medicinal product authorisations. However, under Art. 13 TPA, Swissmedic can take into account the assessment results of a recognised foreign authority, which reduces dossier scope, timeline and fee.
How long does a new authorisation take overall?
The pure Swissmedic time under the standard procedure is around 330 days. With the applicant's response times, formal review and notification of the decision, a procedure takes twelve to eighteen months in practice.
What does an authorisation cost?
Fees are governed by the Ordinance on the Fees Charged by the Swiss Agency for Therapeutic Products. New authorisations for a new active substance run into five figures in francs, with generics and notification procedures well below that. Details and ranges are in the guide to fees and timelines.
Must the medicinal product information be in three languages?
Yes. The prescribing information and patient information must be submitted in German, French and Italian; pack texts must be available in at least the three official languages in which the product is distributed. The German and French versions are generally assessed in full.
Sources
- Swissmedic: Authorisation of Human Medicinal Products
- Fedlex SR 812.21 Therapeutic Products Act (TPA)
- Fedlex SR 812.212.21 Therapeutic Products Ordinance (TPO)
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