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

¹ Any per­son ap­ply­ing for a li­cence to im­port medi­cin­al products must prove that:

a.

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

b.

each de­part­ment has a suf­fi­cient num­ber of qual­i­fied and com­pet­ent staff mem­bers to en­able it to achieve its qual­ity tar­gets;

c.

the tasks of all per­sons oc­cupy­ing key po­s­i­tions in the com­pany are set out in job de­scrip­tions and their hier­arch­ic­al po­s­i­tions are set out in or­gan­isa­tion­al charts;

d.

a Re­spons­ible Per­son in ac­cord­ance with Art­icles 17 and 18 is avail­able;

e.

the fa­cil­it­ies are or­gan­ised in an ap­pro­pri­ate way;

f.

the fa­cil­it­ies are de­signed, struc­tured, main­tained and mod­ern­ised reg­u­larly to guar­an­tee the safe im­port of medi­cin­al products;

g.

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

h.

the re­quire­ments and ob­lig­a­tions of Art­icles 15 and 16 are ful­filled;

i.

the man­u­fac­turer of the medi­cin­al products to be im­por­ted has a man­u­fac­tur­ing li­cence is­sued by a coun­try whose GMP con­trol sys­tem is con­sidered by Swiss­med­ic to be equi­val­ent, or which states that the medi­cin­al products are man­u­fac­tured in com­pli­ance with the GMP rules val­id in Switzer­land.

² Any per­son who ap­plies for a li­cence to trade whole­sale in medi­cin­al products or a li­cence to ex­port medi­cin­al products must ful­fil the re­quire­ments stated in para­graph 1 let­ters a–h; let­ters f and g ap­ply by ana­logy.

³ Swiss­med­ic may spe­cify fur­ther tech­nic­al re­quire­ments and de­tails.