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

¹ The li­cence is gran­ted if:

a.

the ap­plic­a­tion is com­plete;

b.

the ap­plic­ant ful­fils all rel­ev­ant con­di­tions at all fa­cil­it­ies for the activ­it­ies ap­plied for.

² Swiss­med­ic shall sus­pend the sub­stant­ive as­sess­ment of the ap­plic­a­tion if crim­in­al pro­ceed­ings are pending against a Re­spons­ible Per­son in ac­cord­ance with Art­icles 5, 6, 17, 18, 23 or 26, as a res­ult of which Swiss­med­ic con­cludes that the con­di­tions for ad­equate tech­nic­al su­per­vi­sion are no longer ful­filled.

³ If a Re­spons­ible Per­son is un­der in­vest­ig­a­tion for in­fringing the TPA or the Nar­cot­ics Act of 3 Oc­to­ber 1951¹¹ in crim­in­al pro­ceed­ings, Swiss­med­ic may sus­pend the cor­res­pond­ing li­cence.

⁴ It may de­mand a stand­ard private ex­tract from the VOSTRA in­form­a­tion sys­tem of the Re­gister of Crim­in­al Re­cords or an ex­tract from a for­eign crim­in­al re­cords re­gister.¹²

⁵ The ap­plic­ant is gran­ted a single li­cence for all activ­it­ies in the ap­plic­a­tion in ac­cord­ance with the TPA and this Or­din­ance.