Importing and Exporting Medicinal Products in Switzerland
Short answer
Importing ready-to-use medicinal products requires a licence and, in addition, that the product is authorised in Switzerland or an exception applies. From the EEA, release there can be relied on; from third countries, full testing must be demonstrated.
What two questions determine the import route?
First: is the product authorised in Switzerland? Without authorisation, import is only possible through an exception. Second: does it come from the EEA or a third country? That determines the effort for batch release and the testing evidence required.
| Scenario | Licence | Batch release | Note |
|---|---|---|---|
| Authorised product from the EEA | Import licence | Reliance on EEA release possible | Document equivalence |
| Authorised product from a third country | Import licence | Demonstrate full testing in CH or the EEA | Check import testing |
| Unauthorised product, individual patient | Import by a healthcare professional | not applicable | Art. 49 MPLO, documented indication |
| Unauthorised product, trial | Import licence plus trial authorisation | GMP release of the investigational product | Observe the HRA and Clinical Trials Ordinance |
| Parallel import of an authorised product | Import plus simplified authorisation | Repackaging requires a licence | Art. 14 para. 2 TPA |
| Export from Switzerland | Export licence | depends on the destination country | Export certificates from Swissmedic |
How does batch release work on import?
Every batch placed on the Swiss market needs release by a Responsible Person. Where the batch originates in the EEA, release there can be relied on if a contract and the equivalence of controls are documented. From third countries, identity and content testing in Switzerland or the EEA is required.
- Check and document the supplier's origin and licensing status.
- Conclude a quality agreement with the manufacturer and the releasing site.
- Evidence the GMP status of the manufacturing site, with inspection evidence for third countries.
- Check batch documentation and certificates of analysis before every release.
- Assess transport conditions and temperature data for every shipment.
- Document the Responsible Person's release decision.
What applies to individual imports of unauthorised medicinal products?
Under Art. 49 MPLO, healthcare professionals may import unauthorised medicinal products in small quantities for individual patients where no equivalent authorised medicinal product is available. The import must be documented, and responsibility for use stays with the healthcare professional.
- Only by doctors or pharmacists holding a licence to practise.
- Small quantities for a specific patient.
- No equivalent medicinal product authorised in Switzerland available.
- Authorised in a country of origin with comparable medicinal product control.
- Documentation of the source, batch and recipient.
- No advertising and no sale to third parties.
What is needed for export?
Export requires an export licence within the licence scope. Many destination countries additionally require official documents: a Certificate of a Pharmaceutical Product under the WHO scheme, a free-sale certificate, or a GMP confirmation. Swissmedic issues these certificates on request.
Frequently asked questions
May I import a medicine authorised in the EU into Switzerland?
Only if it is also authorised in Switzerland or an exception applies, such as an individual import by a healthcare professional under Art. 49 MPLO or a parallel import with a simplified authorisation.
What is a parallel import?
The import by a third party of a medicinal product authorised in Switzerland from another market. It requires a simplified authorisation under Art. 14 para. 2 TPA and, because the product is repackaged, a manufacturing licence.
Do I need import testing for goods from third countries?
Generally yes, unless it can be shown that equivalent controls have already been carried out in the EEA or Switzerland. The scope is determined on a risk basis.
May a private individual import medicinal products?
For personal use in small quantities, roughly a month's supply, and not for narcotics or prohibited products. Resale is excluded.
How long does an export certificate take?
Plan for two to six weeks from a complete application. With several destination countries, a bundled application is worthwhile.
Sources
- Fedlex SR 812.212.1 MPLO, import and export
- Swissmedic: Import and Export
- Fedlex SR 812.21 TPA, Art. 14 and 20
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