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

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 14 November 2018 (Status as of 1 January 2020)


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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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