Ordinance
on Licensing in the Medicinal Products Sector
(Medicinal Products Licensing Ordinance, MPLO)


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Art. 38 Additional safety measures

1 Blood and labile blood products may only be used for ho­mo­log­ous trans­fu­sions if the leu­co­cytes have been de­pleted in a val­id­ated state-of-the-art sci­entif­ic or tech­nic­al pro­ced­ure.

2 Plasma may only be used for ho­mo­log­ous trans­fu­sions if, in ad­di­tion to the safety meas­ure de­scribed in para­graph 1 and the tests de­scribed in Art­icle 30:

a.
it has been stored for four months and on ex­piry of the dead­line a new test on the donor pro­duced a neg­at­ive res­ult; or
b.
it has un­der­gone a pro­ced­ure to in­ac­tiv­ate or elim­in­ate vir­uses.

3 Plate­let con­cen­trates may only be used in Switzer­land if ap­pro­pri­ate meas­ures are taken to mit­ig­ate the risk of bac­teri­al con­tam­in­a­tion.

4 Un­used auto­log­ous dona­tions must not be used for ho­mo­log­ous trans­fu­sions or to man­u­fac­ture blood products.

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