Swissmedic and the EMA compared
What actually differs between an EU marketing authorisation and a Swiss one, function by function, and what that means for a company that already has an approved EU dossier.
Is a Swiss authorisation the same as an EU one?
No. The two systems ask similar scientific questions and use similar dossier formats, but they are separate legal regimes. The EU grants either a centralised authorisation valid across the Union or national authorisations coordinated between member states. Switzerland grants a national authorisation under its own Therapeutic Products Act, with its own holder requirement, its own product information rules and its own reimbursement procedure.
| Topic | European Union | Switzerland |
|---|---|---|
| Authority | EMA and national agencies | Swissmedic, Bern |
| Legal basis | EU pharmaceutical legislation | HMG (SR 812.21) and its ordinances |
| Scope of one authorisation | Centralised: whole Union | Switzerland only |
| Holder requirement | Established in the EU or EEA | Domicile, seat or branch in Switzerland (Art. 10 HMG) |
| Use of foreign assessments | Mutual recognition within the EU | Art. 13 HMG: foreign results must be taken into account |
| Product information languages | Per member state | German, French and Italian |
| Validity | Renewal rules per EU regime | Five years, then renewal |
| Safety reporting portal | EudraVigilance | Swissmedic ElViS |
| Serious case deadline | 15 days | 15 days |
| Reimbursement | National, member state by member state | Spezialitätenliste at the FOPH |
| Dispensing categories | Per member state | A, B, D, E |
| GMP inspections | EU framework | Mutual recognition arrangement with the EU |
What Art. 13 HMG does and does not give you
Art. 13 HMG obliges Swissmedic to take account of the assessment results of an authority with comparable medicinal product control when the same product is already authorised there. In practice a complete, current foreign assessment report reduces the depth of the Swiss review and the number of questions. It is not automatic recognition: you file a Swiss application, you get a Swiss decision, and Swissmedic may reach a different conclusion.
What travels from an EU dossier
Travels well: quality and non-clinical modules, clinical study reports, the risk management plan as a basis, GMP certificates under the mutual recognition arrangement. Does not travel: the authorisation itself, the holder, the product information texts, the labelling, the dispensing category, the price and the reimbursement decision.
Pharmacovigilance: two systems, one case
Both systems require the holder to collect and report suspected adverse reactions and to keep the label current. The difference is the address and the responsible person: Swiss cases go to Swissmedic through ElViS, and the responsible person for pharmacovigilance has to be reachable in Switzerland. A QPPV in the EU does not satisfy the Swiss requirement.
- Serious Swiss cases: report within 15 days of awareness.
- Non-serious Swiss cases: within 60 days of awareness.
- Periodic safety reports: on the cycle agreed with Swissmedic, usually derived from the international cycle.
- The Swiss product information is the reference for expectedness, not the EU SmPC.
Reimbursement is where the systems diverge most
In the EU, reimbursement is national and varies from HTA-heavy systems to simple listings. In Switzerland there is one list, the Spezialitätenliste, one authority, the Federal Office of Public Health, and a largely mechanical price logic: an international price comparison against reference countries plus a therapeutic cross-comparison against listed alternatives, with periodic reviews.
The consequence for a European launch sequence is concrete: the prices you agree in reference countries will be read back into your Swiss price. Model the Swiss comparison before you sign European price agreements, not after.
What this means for your Swiss project
- Reuse the science, rebuild the administration. The modules travel; the forms, texts and labels do not.
- Solve the holder question first, because nothing can be filed without a Swiss domicile.
- Budget three language versions of the product information from the start, including their maintenance.
- Set up Swiss pharmacovigilance intake with a Swiss responsible person before approval, not after.
- Treat reimbursement as a parallel project with its own timeline and its own dossier.
Frequently asked questions
Can we use our EU SmPC as Swiss product information?
As a source text, yes. As the Swiss document, no. Swiss product information follows Swiss structure and terminology, is approved by Swissmedic and must exist in German, French and Italian. Differences in the approved indication or dispensing category also make a literal translation wrong.
Does our EU QPPV cover Switzerland?
No. Switzerland requires a responsible person for pharmacovigilance who can be reached in Switzerland. The Swiss role can be closely coordinated with your QPPV, and the pharmacovigilance agreement defines the interface, but the Swiss function has to exist.
Is a Swiss authorisation cheaper than an EU one?
The authority fees are of a different order than a centralised EU procedure, but the fixed local cost of a holder, three languages, a safety function and licensed import is what dominates a small-market business case. This is why the service holder model exists.
Does Swissmedic accept EU GMP certificates?
In the framework of the mutual recognition arrangement between Switzerland and the EU, GMP inspection results and batch certification in the manufacturing area are recognised, which is why EU manufacturing sites are normally accepted without a Swiss inspection. The Swiss market release step still applies.
Which is faster, Swissmedic or the EMA?
They are not comparable in a single number, because the procedures, the clock rules and the question phases differ. In practice a Swiss submission that uses a complete foreign assessment report under Art. 13 HMG is fast, and the slowest part of a Swiss project is usually the applicant's own dossier adaptation, not the authority.
Enquire about Swiss MAH support
Describe your product, dossier status and support needs. Enquiries reach the website operator at info@mahswitzerland.com. Provider qualifications, availability and contracts must be checked separately.
- Independent information portal
- Public Swiss sources, independent explanations, and enquiries about external specialist services.