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

¹ Any per­son ap­ply­ing for a li­cence to trade in for­eign coun­tries must prove that:

a.

the fa­cil­it­ies op­er­ate a sys­tem to en­sure the phar­ma­ceut­ic­al qual­ity of medi­cin­al products and that the com­pany man­age­ment and staff in the in­di­vidu­al de­part­ments con­cerned take an act­ive part in this sys­tem;

b.

a Re­spons­ible Per­son in ac­cord­ance with Art­icle 23 is avail­able;

c.

the fa­cil­it­ies are or­gan­ised in an ap­pro­pri­ate way;

d.

a doc­u­ment­a­tion sys­tem is avail­able that com­prises the work­ing in­struc­tions, pro­cess de­scrip­tions and pro­to­cols of the rel­ev­ant pro­ced­ures in­volved in the activ­it­ies;

e.

due di­li­gence is ex­er­cised as de­scribed in Art­icle 22.

² Swiss­med­ic may spe­cify fur­ther tech­nic­al re­quire­ments and de­tails.

³ The li­cence does not en­title the hold­er to is­sue man­u­fac­tur­ing or­ders.