Illustrative scenarios, not client results

Case 1: orphan drug launch for a US biotech

A US biotech with an approved EU dossier and an estimated forty Swiss patients wanted the product available in Switzerland. Founding a Swiss entity, hiring a responsible person for pharmacovigilance and building a quality system for one product was not defensible against that patient number.

• Situation. EU authorisation in place, no Swiss entity, no Swiss safety function, treating centres already asking for the product.
• What external providers did. Filed the Swiss application using the foreign assessment results under Art. 13 HMG, produced product information in German, French and Italian, took the holder position, set up pharmacovigilance with their RPPV and Swiss batch release.
• Then. Filed the Spezialitätenliste application with the FOPH, built the international price comparison and the therapeutic cross-comparison, negotiated a workable limitation.
• Result. Authorisation and reimbursement in the same calendar year as the submission, one Swiss contact for the centres, zero Swiss headcount for the client.

Case 2: twelve authorisations transferred for a generics company

A European generics manufacturer divested a Swiss portfolio of twelve authorisations. The buyer needed the holder changed quickly while the products stayed on pharmacy shelves and on the Spezialitätenliste, because a delisting would have destroyed the value of the deal.

• Situation. Twelve authorisations, multiple pack sizes, all reimbursed, all in active supply.
• What external providers did. Ran the twelve holder changes as one project with a single communication line to Swissmedic, sequenced product information and artwork so no pack had to be withdrawn, and notified the FOPH in parallel for each SL entry.
• The risk external providers managed. Artwork. A simultaneous reprint of twelve products would have interrupted supply, so new print runs carried the new holder and released stock sold through under an agreed rule.
• Result. All twelve transferred within one review cycle, no supply interruption, no delisting, no emergency reprint.

Case 3: first Swiss entry for an Asian manufacturer

An Asian manufacturer had a Swiss sales partner but no licensed importer, no Swiss holder and no clarity on the dispensing category their product would receive. The classification question alone decided whether the commercial plan made sense.

• Situation. Product manufactured in Asia, a Swiss sales partner without a licence, an unclear dispensing category.
• What external providers did. Clarified the classification with Swissmedic before submission, held the authorisation, imported under their own establishment licence with their named responsible person, and released each batch for the Swiss market after checking the manufacturer's documentation against the Swiss authorisation.
• What that avoided. An establishment licence application by the client, a Swiss quality system build-up and a Swiss responsible person hire.
• Result. First commercial delivery to the Swiss wholesaler eleven weeks after approval, a clean GDP trail from the plant to the wholesaler.

What the three cases have in common

In all three the client had the science and the supply and was missing the Swiss legal layer: a domicile, a safety person, a licence, a quality system and someone to write in German to the authority. That layer is a product, not a project, and it can be rented.

The decision is rarely about whether Switzerland is attractive. It is about whether you can enter it without building a company you do not need.

Illustrative scenarios, not client results