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

Any per­son ap­ply­ing for a li­cence in ac­cord­ance with Art­icle 44 para­graph 1 must prove that:

a.

they have a li­cence to im­port medi­cin­al products;

b.

if these are ready-to-use medi­cin­al products destined for the Swiss mar­ket, they have the cor­res­pond­ing au­thor­isa­tion;

c.

they en­sure the safe and law­ful im­port of the medi­cin­al products and ac­cept re­spons­ib­il­ity for this;

d.

the man­u­fac­tur­ing and im­port of the medi­cin­al products and whole­sale trad­ing in medi­cin­al products are in con­form­ity with the GMP rules de­scribed in An­nex 1 and the GDP rules de­scribed in An­nex 4;

e.

in the case of blood and blood products for use in hu­mans, in ad­di­tion to let­ters a–d:

1.

no patho­gens or in­dic­a­tion of the pres­ence of patho­gens can be de­tec­ted,

2.

each in­di­vidu­al blood dona­tion is ana­lysed us­ing tests that cor­res­pond to state-of-the-art sci­entif­ic and tech­nic­al know­ledge,

3.

blood and plasma are only im­por­ted un­mixed, un­less Swiss­med­ic has ex­cep­tion­ally gran­ted a li­cence to im­port mixed products,

4.

the re­quire­ments in ac­cord­ance with Art­icle 27 para­graph 1 let­ter c and Art­icles 34, 35 and 37 are ad­hered to.