Additional labels on primary packaging are not permitted for parallel imported human medicinal products. Medicinal products that have already been authorised have a transitional period of one year to apply for the required changes
Due to changes to the medicinal products categories and the central publication of officially mandated information material by conformation, an update to the forms New authorisation of human medicinal products and Variations and extensions HAM is necessary
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
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
Swissmedic has revised the guidance document “Mobile technologies” and the “Questions and answers on mobile technologies” and clarified the requirements on the use of QR codes on medicinal product packaging
The changes take account of the completed changeover of the reporting process via the gateway from E2B(R2) to E2B(R3) and the requirements of GVP Module VI Addendum II
This checklist serves as a tool for Swissmedic in the context of its inspection activities in hospitals and may be used by healthcare facilities to carry out gap analyses with regard to the requirements of the GPMV-Spital
