Guides
Guides to medicine authorisation in Switzerland
Eight sourced explanations of the terms used across the directory: dispensing categories, the authorisation number, product information, generics, parallel imports and the duties of an authorisation holder.
- What dispensing category B meansDispensing category B means the medicine may only be supplied against a medical or veterinary prescription, and the prescription may be dispensed repeatedly if the prescriber says so. Roughly half of all medicines authorised in Switzerland sit in this category.4 min read
- The authorisation number explainedThe authorisation number is the five-digit number under which Swissmedic authorised a medicine. It identifies the product, not the pack. Extended by the strength number and the pack code it describes one concrete trade item, for example 57786 01 001.4 min read
- Swissmedic, the Compendium and the specialities listAnyone searching for a Swiss medicine ends up in one of three directories that are routinely treated as the same thing. Only one proves authorisation, only one proves reimbursement, and the best known of them is a commercial product of a private company.5 min read
- How a medicine reaches the Swiss marketBefore a medicine is sold in Switzerland it passes through the Swissmedic procedure: a CTD dossier, scientific assessment, questions, a preliminary decision and a final decision. An SL application may be prepared, submitted and assessed while authorisation is still pending; final SL listing requires authorisation.6 min read
- Generics and biosimilars in SwitzerlandA generic contains the same active substance in the same pharmaceutical form as the originator and relies on its documentation once bioequivalence is shown. A biosimilar is a biological medicine highly similar to an authorised reference product. It is not a generic.4 min read
- Authorisation holder: the dutiesThe authorisation holder is the legal person in whose name Swissmedic granted the authorisation. It remains responsible for quality, safety and information throughout the authorisation and, under Art. 10 TPA, must have a registered office, branch office or domicile in Switzerland.4 min read
- How to read a Swiss product informationThe Fachinformation is the professional product information approved by Swissmedic. It is a legally binding part of the authorisation, published on swissmedicinfo.ch, and always follows the same sequence of sections. Knowing that sequence turns a search into a jump.5 min read
- Parallel imports of medicinesA parallel import is a medicine already authorised abroad that is brought into Switzerland outside the distribution channel of the Swiss authorisation holder and sold here in competition with the domestic product. In regulatory terms it is no special case: it needs its own Swiss authorisation.7 min read