Independent. Not Swissmedic.
Swiss pharmaceutical authorisation, explained
For international pharmaceutical businesses planning a Swiss launch: compare authorisation routes, dossier requirements and establishment responsibilities before discussing your project with a Swiss partner.
Discuss your Swiss projectArrow keys select, Enter opens the guide.
- 45guides
- 8languages
- 69glossary entries
Topics
Eight topics that touch every authorisation
Each card leads into a hub with child pages, tables and sources.
Marketing Authorisation Procedures
New marketing authorisations, pre-notification, the accelerated procedure, Art. 13 TPA and temporary authorisation compared.
Read the guideFees and Timelines
What a procedure costs and how long it takes, with ranges for each procedure type.
Read the guideEstablishment Licences
Manufacturing, wholesale dealing, import and export, with requirements and application documents.
Read the guideResponsible Person Duties
Training, duties, authority to instruct and deputising for the Responsible Person under the MPLO.
Read the guideDispensing Categories
Categories A, B, D and E: who may dispense, what Art. 45 TPO allows and what happened to category C.
Read the guideLaws and Ordinances
TPA, TPO, MPLO, MedDO, HRA and narcotics law, with the articles that matter day to day.
Read the guideSwissmedic Explained
Mandate, contact details in Bern, databases, ELViS, the Journal, plus forms and portals.
Read the guideGlossary A to Z
Therapeutic products law terms explained in two to four sentences, with links to the guides.
Read the guide
Who publishes this guide
- Independent publishing
- Public sources
- Swiss market focus
- Eight website languages
Starting path
Start here: three steps to authorisation
The sequence is the same for every human medicinal product, whichever procedure applies.
- 1
Choose the procedure
New authorisation, procedure with prior notification, fast-track, Art. 13 TPA or temporary authorisation. The choice sets both the timeline and the fee.
- 2
Prepare the dossier
CTD modules 1 to 5, the Swiss Module 1 with product information in three languages, and a marketing authorisation holder domiciled in Switzerland.
- 3
Submit via the portal
Submission through the Swissmedic Portal, validation, formal review, then scientific assessment with rounds of questions (List of Questions).
Featured
The most read guides
- Authorisation
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.
- Authorisation
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.
- Authorisation
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.
Change log
Latest updates
What we reviewed most recently in this knowledge base.
Questions and answers
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.
Is Swissmedic a federal office?
No. Swissmedic is a public-law institution of the Confederation with its own legal personality and its own accounts. It is legally separate from the FOPH but works together with it.
How do I reach Swissmedic?
Head office: Hallerstrasse 7, 3012 Bern, telephone +41 58 462 02 11. Technical enquiries generally go through the relevant division or the Portal; procedural actions require the written form.
Planning an authorisation or a licence?
Describe your question or support needs. Your enquiry reaches the website operator. Specialist services are delivered by separately appointed providers; forwarding requires your consent.
- Independent publishing
- Public sources
- Swiss market focus
- Eight website languages