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

¹ Hold­ers of a li­cence to handle blood or labile blood products must im­me­di­ately take the ne­ces­sary pro­tect­ive meas­ures if they no­tice that:

a.

at the time of dona­tion the donor did not ful­fil the cri­ter­ia re­quired to be con­sidered a suit­able donor;

b.

the tests for trans­mit­table dis­eases have not been car­ried out in ac­cord­ance with the reg­u­la­tions;

c.

the donor has un­der­gone sero­con­ver­sion or has con­trac­ted a blood-borne in­fec­tion;

d.

the re­cip­i­ent of a dona­tion de­vel­ops a post-trans­fu­sion in­fec­tion which could be traced back to the donor;

e.

ser­i­ous de­fects in re­la­tion to the GMP rules de­scribed in An­nex 1 have oc­curred dur­ing the blood col­lec­tion pro­cess or the man­u­fac­tur­ing of labile blood products.

² The meas­ures that will be taken if the situ­ations de­scribed in para­graph 1 let­ters b–e oc­cur must be re­por­ted to Swiss­med­ic.

³ Meas­ures taken in the event of oc­cur­rences de­scribed in para­graph 1 let­ters c and d may in­volve in­vest­ig­a­tions in­to pre­vi­ous dona­tions or oth­er donors.

⁴ In­sti­tu­tions which use blood and labile blood products in pa­tients must in­form the man­u­fac­tur­ers on re­quest of the rel­ev­ant in­form­a­tion about use of the labile blood product and about the con­clu­sion of the tra­cing pro­ced­ure if in­vest­ig­a­tions as de­scribed in para­graph 3 are car­ried out.