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

¹ Any per­son ap­ply­ing for a li­cence to col­lect blood for trans­fu­sion or the man­u­fac­ture of medi­cin­al products in ac­cord­ance with Art­icle 34 TPA must prove that:

a.

the con­di­tions de­scribed in Art­icle 3 have been ful­filled;

b.

the Re­spons­ible Per­son ful­fils the con­di­tions of Art­icles 5 and 6 and has a uni­versity de­gree in medi­cine or a life sci­ence and the sci­entif­ic and med­ic­al ex­per­i­ence needed to col­lect blood;

c.

blood is col­lec­ted in com­pli­ance with the GMP rules de­scribed in An­nex 1;

d.

due di­li­gence is ex­er­cised as de­scribed in Art­icles 28–38.

² Swiss­med­ic may spe­cify fur­ther tech­nic­al re­quire­ments and de­tails.