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

¹ Hold­ers of a li­cence for hand­ling blood and labile blood products must main­tain re­cords of all safety-rel­ev­ant activ­it­ies, in par­tic­u­lar in re­la­tion to the col­lec­tion of blood, and the man­u­fac­ture, re­lease, dis­tri­bu­tion, de­struc­tion and re­call of blood or labile blood products.

² They must en­sure that blood or labile blood products can be traced back to the donor. For this pur­pose, each blood dona­tion must be giv­en a donor num­ber that makes it pos­sible at any time to clearly identi­fy the dona­tion, the donor's med­ic­al his­tory, every blood product made from his dona­tion and all doc­u­ments re­lated to these products.

³ Whenev­er blood is donated, the fol­low­ing in­form­a­tion must be re­cor­ded in de­tail:

a.

the date and iden­ti­fic­a­tion of the dona­tion and the donor;

b.

in­form­a­tion on the de­cision on donor suit­ab­il­ity and, if rel­ev­ant, the reas­on for ex­clud­ing a donor;

c.

the test res­ults and their in­ter­pret­a­tion.

⁴ Each pro­tocol must be signed by a per­son who is au­thor­ised to do so by the qual­ity man­age­ment sys­tem.