Swissmedic has updated the templates for Patient Information (PI) and Information for Healthcare Professionals (FI), introducing an optional section for instructions for use.
MAHs must ensure new medicinal product information texts use updated templates by 1 July 2026 and revise existing texts at the earliest opportunity if they include instructions for use.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
New optional section for instructions for use; updated templates must be used for new medicinal product information texts from 1 July 2026.
MAHs must use updated PI/FI templates for new submissions and variations to ensure appropriate presentation of safety information and instructions.
MAHs must use updated PI/FI templates for new submissions and variations, and incorporate the optional 'Gebrauchsanweisungen' section from 1 July 2026.
This change ensures that safety information and instructions for use are clearly presented, improving readability and user-friendliness for patients and healthcare professionals.
MAHs must ensure new medicinal product information texts use updated templates by 1 July 2026 and revise existing texts at the earliest opportunity if they include instructions for use.
Suppliers must implement new protocols for safety reporting and record-keeping as per the proposed framework.
Manufacturers must implement processes for device registration in swissdamed before placing devices on the market, with immediate attention needed for vigilance-reportable incidents.
Manufacturers must adjust labeling workflows to incorporate e-labelling mechanisms, such as QR codes, for P and GSL medicines by the stipulated date.
Ensure compliance with updated SUSAR reporting timelines (15 days), notify SFDA of Phase IV trials within 20 working days post-IRB approval, and prepare for the financial fee of 15,000 Saudi Riyals for clinical trial evaluations.
