MAH transfer in Switzerland: steps, documents and timeline
A complete guide to changing the Marketing Authorisation Holder on a Swissmedic authorisation: what Swissmedic needs, what the Federal Office of Public Health needs, what happens to your artwork and stock, and how long to plan for.
What is an MAH transfer?
An MAH transfer changes the company named as Marketing Authorisation Holder on an existing Swissmedic authorisation. The authorisation stays in force with its number, its approved indication, its dispensing category and its product information. Swissmedic handles it as a change that requires prior approval, so the new holder may only act once the decision is issued.
Companies transfer authorisations for four reasons: a portfolio sale, a corporate reorganisation, the end of a distribution partnership, or the decision to replace an own Swiss entity with a service holder. The mechanics are the same in all four cases; only the commercial documents differ.
Transfer, not re-application
A transfer keeps the authorisation alive. A re-application starts a new assessment, a new number and a new SL procedure, and it puts your product out of the market in the meantime. If a valid Swiss authorisation exists, a transfer is nearly always the correct instrument.
The eight steps of a Swiss holder change
Every transfer external providers run follows the same sequence. The order matters: signatures before filing, filing before artwork, and the reimbursement notification in parallel rather than afterwards.
- Agree the commercial terms. Asset purchase or service mandate, who pays which fee, who keeps liability for released stock.
- Collect the documents. Swissmedic transfer form, declarations from both holders, commercial register extract of the new holder, current product information.
- Sign the technical and pharmacovigilance agreements. Who reports adverse reactions from which date, who handles complaints on old batches.
- File the change with Swissmedic. One file per authorisation, filed together for a portfolio.
- Notify the Federal Office of Public Health for reimbursed products so the SL entry and the price follow the holder without a gap.
- Receive the amended authorisation and update the Swiss product information with the new holder's name.
- Run the artwork transition. New packs carry the new name from the next print run; released stock is sold through under an agreed rule.
- Switch the operational addresses. Pharmacovigilance intake, medical information, complaint handling and the wholesaler master data, all on the same day.
Document checklist
The file itself is thin. What delays transfers is missing signatures, an outdated commercial register extract or product information that does not match the current approved version. This checklist is what external providers send on day one.
| Document | Provided by | Note |
|---|---|---|
| Swissmedic application for change of holder | Both parties | Signed by authorised signatories |
| Declaration of the transferring holder | Old holder | Confirms handover of dossier and duties |
| Declaration of the receiving holder | New holder | Accepts the holder duties |
| Commercial register extract | New holder | Proves the Swiss domicile per Art. 10 HMG |
| Current approved product information | Old holder | Basis for the updated Swiss texts |
| Draft product information with new holder | New holder | German, French and Italian |
| Pharmacovigilance agreement | Both parties | Names the RPPV from the transfer date |
| Artwork and stock plan | Both parties | Avoids an emergency reprint |
| FOPH notification for SL products | New holder | Keeps reimbursement continuous |
How long does it take: a 90-day plan
For a single authorisation with cooperative parties, 90 days from kick-off to an amended certificate is a realistic plan. Two thirds of that is document work and one third is authority time. Portfolio transfers use the same calendar because the files run in parallel.
| Days | Activity | Owner |
|---|---|---|
| 1 to 14 | Terms agreed, checklist issued, documents requested | Both parties |
| 15 to 30 | Agreements signed, product information drafted in three languages | New holder |
| 30 to 35 | Transfer file assembled and submitted to Swissmedic | New holder |
| 35 to 40 | Parallel notification to the FOPH for SL products | New holder |
| 40 to 80 | Swissmedic review, questions answered | Swissmedic and new holder |
| 80 to 90 | Amended certificate, product information published, addresses switched | New holder |
| After 90 | Artwork at the next print run, stock sold through | Both parties |
What a transfer costs
Three cost blocks. Swissmedic charges a fee per authorisation for a change requiring approval, set in the federal fee ordinance and payable by the applicant. Then there is the project work: file preparation, three-language product information, FOPH notification, artwork coordination. Third, the ongoing annual fee, which simply moves to the new holder.
Because the fee schedule is revised periodically, external providers quote the authority fee from the current ordinance rather than from memory and pass it through at cost.
The five mistakes external providers see most often
- Reprinting all artwork on approval day. Plan the transition instead and keep selling released stock under an agreed rule.
- Forgetting the FOPH. Swissmedic does not update the Spezialitätenliste. A missed notification can cost the price or the listing.
- Leaving pharmacovigilance intake at the old address. A report that lands nowhere is a reportable failure, not an administrative detail.
- Filing while a variation is pending. The decision may arrive addressed to the previous holder. Sequence the two.
- No rule for old batches. Write down who handles a complaint on a batch released before the transfer, before anyone needs it.
Frequently asked questions
Can the new holder start selling before Swissmedic approves the transfer?
No. Until the change is approved the previous holder is the legal holder, and invoices, product information and safety reporting must reflect that. This is why the commercial handover date in the contract should be tied to the Swissmedic decision, not to a fixed calendar date.
Do we need new artwork immediately?
No, if the transition is agreed with the authority as part of the change. Packs already released stay sellable and new print runs carry the new holder. A hard cut-over is expensive and almost never necessary.
Can we transfer only some pack sizes?
The holder is attached to the authorisation, and an authorisation covers its approved pack configurations. Splitting a single authorisation between two holders is not possible; separate authorisations can of course be transferred separately.
What happens to the pharmacovigilance case history?
It transfers with the duties. The new holder needs access to the Swiss case history to assess new reports in context, so the pharmacovigilance agreement specifies the handover format and the retention obligations of both sides.
Does a transfer trigger a new five-year renewal date?
No. The authorisation keeps its existing validity and renewal date. The new holder inherits the renewal obligation, which is one more reason to check the expiry date before signing a portfolio deal.
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.