What a parallel import is
In a parallel import a third party sources a medicine where it is cheaper and brings it into Switzerland without belonging to the distribution network of the Swiss authorisation holder. The product is the same or very close, the trade route is different, and the price is usually lower.
The appeal lies in the price gap between markets. The effort lies in the fact that the importer takes on the full regulatory responsibility normally carried by the authorisation holder of the original.
Its own authorisation and an operating licence
An authorisation in the EU is not enough. Anyone placing a medicine on the Swiss market needs an authorisation from Swissmedic and, on top of that, an operating licence for import. The authorisation covers the product, the licence covers the activity. Without both, distribution is unlawful.
- Authorisation application to Swissmedic, subject to a fee, referencing the product authorised abroad.
- An authorisation holder with a registered office, branch office or domicile in Switzerland under Art. 10 TPA.
- Swiss-compliant labelling of the pack, including the authorisation number and the dispensing category.
- Professional product information and package leaflet in the required official languages.
- A dispensing category set by Swissmedic, which may differ from the foreign classification.
- Operating licence for import, granted by Swissmedic after an inspection.
- A responsible person with the required training and experience, genuinely available at the site.
- Batch-wise release of every imported batch before it is placed on the market.
- GDP compliant storage and transport, including temperature monitoring and a documented cold chain.
Simplified procedures for medicines already authorised in a country with comparable medicines control affect the scope of assessment, not the duty to obtain an authorisation. A parallel import therefore receives its own five-digit authorisation number and its own authorisation holder.
The ongoing duties of any other Swiss authorisation apply as well: pharmacovigilance with reporting of serious adverse reactions, upkeep of the product information, traceability, and notification of market events such as supply interruptions.
Patents, trade marks and the price
The regulatory route can be open while the import is still blocked: Swiss patent law keeps patent-protected medicinal products outside the exhaustion rule. Trade mark law, by contrast, applies international exhaustion, which is why repackaging and relabelling are a recurring dispute.
Practical consequence: every project starts with a patent check. For as long as a relevant patent or supplementary protection exists for the product in Switzerland, the right holder can prevent a parallel import, regardless of whether Swissmedic would grant the authorisation. Once protection lapses, that hurdle falls away.
Repackaging turns on how far the pack may be altered for the Swiss market without infringing the original manufacturer's trade mark rights. The assessment depends on the individual case, so anyone planning a project takes legal advice up front.
On price: a parallel import can be listed on the Spezialitätenliste of the Federal Office of Public Health (FOPH) and is then priced in the same regime as other entries, with a foreign price comparison and a therapeutic cross-comparison. Readers interested in the pricing side will find the structure of the specialities list on our sibling site swissreimbursement.com.
Personal use is a different thing
Commercial parallel imports are often confused with individual private imports. Individuals may import medicines in small quantities for their own use, and a healthcare professional may obtain a non-authorised medicine in a small quantity for one specific patient under the conditions of the licensing ordinance.
| Constellation | Needs a Swiss authorisation | Needs an operating licence | Who may do it | Typical volume |
|---|---|---|---|---|
| Commercial parallel import | yes, its own authorisation | yes, for import | Legal person with a registered office, branch office or domicile in Switzerland | Ongoing distribution, trade volumes |
| Co-marketing | yes, its own authorisation as a co-marketing medicine | depends on the activity | A company with the consent of the holder of the base product | Ongoing distribution, trade volumes |
| Private import for own use | no, within the exception | no | An individual, for themselves | Small quantity, roughly a month's supply |
| Import by a healthcare professional for a specific patient | no, within the exception | no for that individual supply | A healthcare professional acting in their profession | Small quantity for the individual case |
Both exceptions are narrow: small quantity, no trade, no advertising, no passing on to third parties. They permit neither distribution nor stockholding and create no entitlement to reimbursement by health insurance.
Anyone importing regularly and selling in Switzerland is running a commercial parallel import and needs an authorisation and an operating licence. The personal-use exception does not cover that.
How a parallel import is set up
A project runs in a fixed order: check the market and the intellectual property first, then build the Swiss structure, then obtain the licence and the authorisation, and only at the end decide on a specialities list application. Reversing the order means paying twice.
- Market and IP check: price gap, sourcing route, patent position and trade mark situation in Switzerland.
- Establish or appoint an eligible Swiss authorisation holder that meets Art. 10 TPA with a registered office, branch office or domicile in Switzerland.
- Apply to Swissmedic for the operating licence for import, and provide the responsible person and the quality system.
- Build the dossier and the texts: reference to the foreign product, product information, package leaflet and pack labelling in the required official languages.
- File the authorisation application with Swissmedic and await the authorisation number and dispensing category.
- Set up batch release, a GDP compliant supply chain and pharmacovigilance.
- Optional: apply to the FOPH for listing on the Spezialitätenliste if reimbursement by basic insurance is the goal.
In this directory parallel imports appear as entries of their own, with their own five-digit authorisation number and their own authorisation holder. A search on a brand name can therefore return two or more hits held by different companies. Compare the authorisation holder field on the detail pages to tell the original and the parallel import apart.
Frequently asked questions
Does a parallel import need its own Swissmedic authorisation?
Yes. An EU or other foreign authorisation is not enough. Swiss market placement requires Swissmedic authorisation, a holder with a registered office, branch office or domicile in Switzerland under Art. 10 TPA, an import licence, and Swiss-compliant labelling and product information.
Can a patent stop a parallel import?
Yes. Swiss patent law keeps patent-protected medicinal products outside the exhaustion rule. While a relevant patent or supplementary protection is in force, the right holder can prevent a parallel import even where Swissmedic would grant an authorisation. That is why the patent check comes first in any project.
May I import medicines for my own use?
Individuals may import medicines in small quantities for their own use. This is a narrow exception: no trade, no passing on, no advertising and no entitlement to reimbursement. It has nothing to do with a commercial parallel import, which needs an authorisation and an operating licence.
Is a parallel import reimbursed by health insurance?
Only if it is listed on the Spezialitätenliste of the Federal Office of Public Health. Listing has to be applied for, and the price is set in the same regime as for other entries. A Swissmedic authorisation on its own creates no entitlement to reimbursement by basic insurance.
Why does one brand name return several authorisations?
Because a parallel import receives its own authorisation with its own five-digit number and its own authorisation holder. The same pattern shows up with co-marketing medicines. Compare the authorisation holder field on the detail pages of this directory to work out which entry is which.