812.212.1MPLOFederal Council OrdinanceJan 1, 2019Original source
The sponsor notifies Swissmedic of all major changes affecting the medicinal product or its usage by analogy with Article 34 paragraph 3 letters a‑c of the Ordinance of 20 September 20131on Clinical Trials.2
The sponsor notifies Swissmedic of all adverse reactions and events in accordance with Article 59 TPA.
The sponsor sends Swissmedic a safety report once a year.