Import and wholesale under a Swiss establishment licence
You do not need your own Swissmedic establishment licence to sell in Switzerland. External providers import, store and wholesale your product under their establishment licence, with a named responsible person and a GDP audit trail from the plant to the pharmacy.
Who needs an establishment licence in Switzerland?
Anyone who manufactures, imports, exports or wholesales medicinal products in Switzerland needs a Swissmedic establishment licence, the Betriebsbewilligung. The licence is granted for defined activities and requires a suitable quality system and a named technically responsible person. Selling from abroad directly into the Swiss trade is not a substitute.
For a foreign company with one or a few products, applying for an own licence means building a warehouse process, a quality system and hiring a qualified responsible person before the first sale. Using an existing licence holder removes that fixed cost and the application time.
What external providers do under their licence
External providers take the product from your manufacturing site or EU warehouse into the Swiss market: customs, import, release, storage, order handling and delivery to wholesalers, hospitals and pharmacies, with the documentation that a GDP inspection expects.
- Import into Switzerland with customs and, where required, narcotics documentation.
- Batch release for the Swiss market by their Qualified Person.
- GDP-compliant storage, including temperature-controlled and cold chain.
- Wholesale to the Swiss trade: full-line wholesalers, hospital pharmacies, direct pharmacy accounts.
- Order to cash: order intake, delivery, invoicing, returns and credit notes.
- Traceability per batch and per delivery, ready for a recall.
- Optional serialisation and pack handling where your market requires it.
| Own licence | Under their licence | |
|---|---|---|
| Lead time before first sale | Application plus build-up | Contract plus qualification only |
| Responsible person | You hire one | Named in their licence |
| Quality system | You build and maintain it | Ours, inspected |
| Warehouse | You rent and qualify one | GDP-qualified, in place |
| Fixed cost | Permanent | Per unit and per service |
| Control | Full | Contractual, with quarterly reporting |
How Swiss distribution is structured
Swiss pharmaceutical distribution is concentrated: a small number of full-line wholesalers serve the retail pharmacies and drugstores, while hospitals buy through their own pharmacies and through purchasing groups, often on tender. A launch plan that only addresses wholesalers misses the hospital channel, which is where specialty and orphan products actually move.
- Decide the channel mix: wholesale, direct to hospital pharmacy, or both.
- Get the product into the article master data of the wholesalers, with the correct pack codes and prices.
- Set list price and margins consistently with the reimbursement status of the product.
- Agree delivery service levels, because Swiss pharmacies expect next-day supply.
- Prepare the hospital channel: tender calendars, purchasing groups, clinical contacts.
Cold chain, narcotics and special cases
Temperature-controlled products need qualified storage, validated transport and documented excursion handling. Narcotics need additional permissions and record keeping. Both are routine for the providers, but they change the cost per delivery, so external providers quote them explicitly rather than hiding them in a handling fee.
Frequently asked questions
Can we keep our own distributor and use you only for import?
Yes. A frequent split is that external providers import and release, and your appointed Swiss distributor handles sales. The important part is that the licensed steps stay with a licence holder and the responsibilities are written down.
Do you handle parallel import or exports from Switzerland?
Their licence covers import, export and wholesale as licensed activities. What external providers will not do is help construct a distribution route that undermines your own pricing or the reimbursement conditions of the product.
What documentation does an inspector want to see?
The establishment licence and its scope, the responsible person's appointment, the quality system documentation, technical agreements with you and your manufacturer, batch release records, temperature records and a traceable delivery history per batch. All of it is kept in Switzerland.
How fast can you deliver the first commercial order?
The first delivery depends on approval, final artwork, production and release. Agree a product-specific schedule with the appointed provider.
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.