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
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
The Guidance document Drug Safety Signals HMP has been comprehensively revised, its structure has been modified and its content has been clarified; in parallel, the Signal Notification Form has been revised and adapted to the new requirements
