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
Swissmedic will complete technical implementation of eCTD v4.0 by the end of 2026 and is now publishing version 1.1 of the package for the Swiss Implementation Guide
Swissmedic is supplementing its existing guidance documents with a structured collection of FAQs on key requirements and procedures relating to the risk management of human medicinal products
Swissmedic specifies the requirements for the presentation of undesirable effects and interactions and adds information on environmental and disposal aspects
