Authorisation transfer: changing the holder of a Swiss authorisation
The fastest way to a Swiss holder is not a new application but a change of holder on an existing authorisation. External providers run these transfers as projects with one goal: the certificate changes name and the product stays on the shelf.
What is an authorisation transfer in Switzerland?
An authorisation transfer is the administrative change that replaces the Marketing Authorisation Holder named on a Swissmedic certificate with another company, while the authorisation itself, its number and its conditions stay in force. Swissmedic treats it as a change that needs prior approval, not as a new authorisation.
That distinction matters commercially. A new application restarts the assessment; a transfer keeps the authorisation number, the approved product information and, if it is handled correctly with the Federal Office of Public Health, the entry and the price on the Spezialitätenliste. For an in-market product the transfer is almost always the right instrument.
Which documents does a transfer need?
A transfer file is small compared with a dossier, but every piece has to be right, and a missing signature costs a review cycle. This is the set external providers prepare.
- Swissmedic's application form for the change of holder, signed by the old and the new holder.
- A declaration of the transferring holder that the new holder receives the dossier and takes over the duties.
- Proof of the Swiss domicile of the new holder, that is the commercial register entry.
- The current approved product information and the planned Swiss texts with the new holder's name.
- Artwork plans: which packs change at which print run, and what happens to stock already labelled.
- For reimbursed products, the parallel notification to the FOPH so the SL entry follows the holder.
- Where relevant, updated technical and pharmacovigilance agreements and the new RPPV details.
Transfer or new application?
Use a transfer when a valid Swiss authorisation exists and you want continuity of number, product information, SL entry and supply. Use a new application when no Swiss authorisation exists, or when the product itself changes so much that the existing one no longer describes it.
How long does a change of holder take?
Plan on one to two months of preparation and roughly one Swissmedic review cycle for the decision, so about three months in total from a clean start to the amended certificate. Portfolio transfers are not proportionally slower: twelve authorisations filed as one project with one contact person run in parallel.
| Phase | Typical duration | Who acts |
|---|---|---|
| Contract and document collection | 2 to 4 weeks | Both parties |
| File preparation and signatures | 1 to 2 weeks | external MAH providers |
| Swissmedic review of the change | About one review cycle | Swissmedic |
| Amended certificate and product information | Immediately after approval | external MAH providers |
| Artwork and stock transition | Next planned print run | You and external MAH providers |
| SL entry follow-up at the FOPH | Parallel to the transfer | external MAH providers |
How do external providers avoid a supply interruption?
A supply gap in a transfer almost always comes from artwork, not from the authority. Packs carry the holder's name, and if you reprint everything on the day of approval you stop production. External providers sequence it instead: approval first, then a transition period in which existing stock keeps circulating and new print runs carry the new name.
- Agree the artwork transition with Swissmedic as part of the change, not afterwards.
- Keep the old holder responsible for released stock until it is sold through, in writing.
- Move pharmacovigilance intake on the day of approval so no report lands at a dead address.
- Notify the wholesaler and the hospital pharmacies before, not after, the invoice sender changes.
- Keep the SL entry and price continuous with a parallel notification to the FOPH.
What a transfer costs
Two cost blocks: the Swissmedic fee for a change requiring approval, charged per authorisation according to the current fee ordinance, and their project fee for preparing and running the transfer. Portfolio transfers get a volume rate because the second and the twelfth file are far cheaper to produce than the first.
Frequently asked questions
Can we transfer an authorisation while a variation is pending?
It is possible but it complicates both files, because the pending change belongs to the old holder and the decision may arrive after the transfer. External providers normally either let the variation finish first or file it again under the new holder. Which is faster depends on the type of change.
Does the authorisation number change?
No. The authorisation keeps its number, its approved indication and its dispensing category. Only the holder details change, which is exactly why a transfer is preferable to a new application for a marketed product.
What happens to the Spezialitätenliste entry?
The SL entry is administered by the Federal Office of Public Health, separately from Swissmedic. External providers notify the FOPH in parallel so the listing and the price follow the new holder. Handled this way the product stays reimbursed without a gap.
Who is liable for batches released before the transfer?
The releasing party stays responsible for what it released, and the contract says so explicitly. The new holder takes over the duties going forward, including the handling of complaints on older batches, with an information duty back to the previous holder.
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.