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

¹ The Re­spons­ible Per­son em­ployed by the hold­er of the mar­ket­ing au­thor­isa­tion de­cides on the mar­ket re­lease of a batch be­fore it is placed on the mar­ket.

² They check wheth­er:

a.

a val­id batch cer­ti­fic­ate is­sued by the man­u­fac­turer is avail­able and wheth­er the batch was man­u­fac­tured in con­form­ity with the GMP rules de­scribed in An­nex 1;

b.

the batch in ques­tion ful­fils the re­quire­ments of the au­thor­isa­tion;

c.

the con­di­tions de­scribed in Art­icles 11 and 12 have been ful­filled; and

d.

the en­tire sup­ply chain is in con­form­ity with the au­thor­isa­tion and the GDP⁵ rules de­scribed in An­nex 4.

³ Swiss­med­ic may spe­cify ad­di­tion­al checks.

⁴ The Re­spons­ible Per­son con­firms that the checks de­scribed in para­graphs 2 and 3 have been per­formed.