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

¹ Hold­ers of a li­cence must ap­ply to Swiss­med­ic with the ne­ces­sary doc­u­ment­a­tion for any amend­ments to the con­tent of the li­cence.

² They must re­port the es­sen­tial de­tails of all ma­jor changes to fa­cil­it­ies, equip­ment or pro­ced­ures used in the man­u­fac­ture, test­ing or im­port and ex­port of medi­cin­al products, for whole­sale trad­ing or in trad­ing abroad with medi­cin­al products or for broker­age or agency activ­it­ies in con­nec­tion with medi­cin­al products and which could in­flu­ence qual­ity.

³ Swiss­med­ic shall re­spond to ap­plic­a­tions un­der para­graph 1 and make any ob­jec­tions to amend­ments as in para­graph 2 with­in a peri­od of 30 days.