812.212.1MPLOFederal Council OrdinanceJan 1, 2019Original source
The holder of a licence for activities with blood or labile blood products must appoint a person responsible for haemovigilance.
The Responsible Person must be a doctor and have the appropriate technical knowledge.
This person has an obligation to report adverse drug reactions in accordance with Articles 61 and 65 TPO1.
Swissmedic may also recognise persons with other professional qualifications as Responsible Persons, provided they possess sufficient knowledge and experience.
While Responsible Persons do not need to be employees of the company, their responsibilities must in all cases be defined in writing.