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
In the release on September 23rd, we enable the viewing of specialist data for complementary medicines in the notification procedure (Chapter 7 KPTPO; basic company dossier, master dossier and medicines (single notifications)) for marketing authorisation holders. Furthermore, the submission of major changes in accordance with Article 41(2) of the AMBV has been introduced for establishment licence holders.
Specialist data for complementary medicines in the notification procedure (Chapter 7 KPTPO) in the Swissmedic Portal for marketing authorisation holders
Specialist data for complementary medicines in the notification procedure (Chapter 7 KPTPO) in the Swissmedic Portal for marketing authorisation holders
Swissmedic publishes the new «Schweizerische Gute Praxis der Materiovigilance in der In-vitro-Diagnostik» (GPMV-IVD). This guideline is intended to support professionals using in vitro diagnostic medical devices (IVDs) for medical purposes, as well as persons responsible for the implementation of medical device vigilance in the field of in vitro diagnostics
Changes to text elements are no longer required for applications for a change of status between main authorisation and export licence for veterinary medicinal products submitted on or after 1 September 2026
