The holder of a licence for activities with blood or labile blood products must appoint a person who is responsible for haemovigilance in accordance with Art. 28 para. 1 of the Medicinal Products Licensing Ordinance (MPLO, SR 812.212.1). This obligation applies particularly to manufacturers of labile blood products (i.e. specifically the blood transfusion services) and to establishments that are authorised to store blood.
Art. 65 para. 4 of the Therapeutic Products Ordinance (TPO, SR 812.212.21) requires institutions which use labile blood products to set up a quality assurance (QA) system for the use of labile blood products in keeping with the current state of medical science and technology. According to this definition, this applies to all institutions which perform transfusions of labile blood products, and hospitals and doctors’ practices in particular. These institutions designate a person who is responsible for fulfilling the reporting duty (referred to below as the RPHv).
According to Art. 28 para. 2 MPLO, this person must be a doctor and must have the necessary professional knowledge. This person has an obligation to report adverse drug reactions in accordance with Art. 61 and 65 TPO (Art. 28 para. 3 MPLO). The responsibility of RPHv begins with the establishment of haemovigilance processes in their institutions and, in particular, the observance of the following legal provisions: obligation to notify in accordance with Art. 59 TPA, obligation to record in accordance with Art. 39 TPA, and obligation to archive in accordance with Art. 40 TPA.
Responsible Persons for Haemovigilance should ideally manage or be actively involved in the QA operations of the respective institutions. They have access to information relevant to incidents, can mandate investigations and can take actions to optimise the transfusion process.
While RPHv do not need to be employees of the company, their responsibilities must in all cases be defined in writing (Art. 28 para. 4 and 5 MPLO). The adequate and timely access to relevant data must also be guaranteed in this case in order to comply with the statutory reporting obligations. The powers (authority to issue instructions) must correspond to the role.
Swissmedic may also recognise persons with other professional qualifications as RPHv. Such persons must possess sufficient knowledge and experience in the field of transfusion medicine and/or immunohaematology, and their suitability is checked on a case-by-case basis.
The RPHv must be registered by submitting the original registration form "Meldung der Haemovigilanceverantwortliche Person in Spitälern und anderen Institutionen", signed by the RPHv personally, to Swissmedic.