Swissmedic, the Compendium and the specialities list: which is which?

The Swissmedic list is an official source for authorisation status

Whether a medicine may be placed on the Swiss market is decided by Swissmedic alone. The legal basis is the Therapeutic Products Act (TPA, SR 812.21): no authorisation, no marketing. Swissmedic publishes the list of authorised human and veterinary medicines monthly as a spreadsheet export, with authorisation number, holder and dispensing category.

That list is the only source proving the legal fact of authorisation. Everything else online that looks official is either a publication of the approved product information or a price and reimbursement list. This directory is built directly on the Swissmedic export and states the data cut-off used for every entry.

swissmedicinfo.ch versus compendium.ch

swissmedicinfo.ch is the legally mandated publication platform for the product information and patient information approved by Swissmedic. compendium.ch, by contrast, is the Arzneimittel-Kompendium der Schweiz, a commercial product of HCI Solutions, a company of the Galenica group.

The difference is not academic. swissmedicinfo.ch carries exactly the text Swissmedic approved, with nothing added. The Compendium adds editorial material, images, interaction data and products that are not medicines at all. It is an excellent day-to-day reference, but it is neither an authorisation register nor legal evidence.

When a holder changes the product information, the new version is published on swissmedicinfo.ch once approved. In case of doubt that version governs. For documentation that has to survive an inspection, cite swissmedicinfo.ch and not the Compendium.

The FOPH specialities list only governs reimbursement

The specialities list (SL) is maintained by the Federal Office of Public Health (FOPH) under the health insurance act and its ordinance. It lists the medicines reimbursed by compulsory health insurance, with a maximum price and any limitation. It covers only a subset of the medicines Swissmedic has authorised.

• Absent from the SL does not mean not authorised. Many authorised medicines were never submitted for listing, or were removed later.
• Listed on the SL does not always mean paid for. A limitation can restrict reimbursement to certain indications, prior treatments or quantities.
• Removal from the SL ends reimbursement, not authorisation. The medicine stays marketable and can be paid for privately.

The list is also a price list: ex-factory price, public price and distribution margin are fixed in it. Anyone looking for prices or limitations has to go to the SL, because Swissmedic publishes no prices. For SL research alone our network runs the sibling site swissreimbursement.com.

The sequence: authorisation first, reimbursement second

The procedures can overlap: an SL application may be submitted and assessed before the final Swissmedic decision, particularly once a positive preliminary decision is available. Under Early Access, steps may run concurrently or in close succession. Final SL listing still requires Swissmedic authorisation.

1. Swissmedic grants the authorisation and approves product information, leaflet and dispensing category.
2. The holder files the SL application with the FOPH, usually with a foreign price comparison and a therapeutic cross comparison.
3. The Federal Medicines Commission advises the FOPH on listing, limitation and classification.
4. The FOPH decides on listing, maximum price and any limitation, published in the continuously updated specialities list.
5. Every three years the conditions of listing are reviewed, which can lead to price cuts or removal.

In practice months pass between authorisation and listing. During that gap a medicine is legally available but not covered by insurance. That gap explains the most common confusion of all: the pharmacy may supply it, yet the insurer does not automatically pay.

Which register answers which question

For authorisation use the Swissmedic list, for the approved text swissmedicinfo.ch, for price and reimbursement the specialities list, for everyday clinical reference the Compendium. The table shows who runs each register and what it actually proves.