Swissmedic has updated the Guidance document on parallel imports. In particular, the changes concern clarifications on country of export, additions to the requirements for packaging, storage instructions and information on handling in the medicinal product information for parallel imported medicinal products
Following finalisation of the EMA Reflection paper on a tailored clinical approach in biosimilar development, the Guidance document Authorisation Biosimilar has been adapted accordingly
As of 15 November 2026, the prior registration of active substances in the EMA SMS database (Substances Management Services) will become a mandatory requirement for their inclusion in establishment licences and GMP certificates
Die neue intravenöse Formulierung (100 mg und 350 mg, Konzentrat zur Herstellung einer Infusionslösung) enthält Sorbitol und ist daher bei Patientinnen und Patienten mit hereditärer Fruktoseintoleranz (HFI) kontraindiziert
Swissmedic monitors all therapeutic products on the market in Switzerland. Our independent experts ensure the therapeutic products you and your loved ones need are effective, safe and of the highest quality.
What is a medicinal product?
Did you know that tea can also be a medicinal product? But what exactly constitutes a medicinal product and how does it differ from other products? You will find answers to these and other questions in this video.
Delimitation questions in human health
In order for a product to be sold, it must comply with the relevant legal regulations. However, it’s not often immediately apparent which product group it belongs to. In this video, we explain what different categories there are, and when a product is really a therapeutic product – and when it is not!
The obligation to register products for medical devices, in vitro diagnostic medical devices, as well as systems and procedure packs in swissdamed has applied since 1 July 2026 (communication.
The factsheet “Economic operators” (PDF, 1 MB, 01.05.2026) and the “swissdamed” section of the website have been updated.
Further information on the EU Regulations and their implementation in Switzerland is available under: Legal framework.
What is a medical device? How do medical devices come onto the market? How do you recognise a medical device? Based on examples, our videos answer these and a number of other questions.
Swissmedic is the Swiss authority responsible for the authorisation and supervision of therapeutic products. Swissmedic's activities are based on the Law on Therapeutic Products.
