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

¹ A med­ic­al pro­fes­sion­al who has a can­ton­al dis­pens­ing li­cence may im­port small quant­it­ies of a ready-to-use hu­man medi­cin­al product that is not au­thor­ised in Switzer­land provided:

a.

the medi­cin­al product is in­ten­ded for a spe­cif­ic pa­tient or for emer­gen­cies;

b.

the medi­cin­al product has been au­thor­ised by a coun­try with a com­par­able reg­u­lat­ory sys­tem; and

c.

for the medi­cin­al product con­cerned:

1.

no al­tern­at­ively us­able medi­cin­al product is au­thor­ised in Switzer­land,

2.

an al­tern­at­ively us­able medi­cin­al product is au­thor­ised in Switzer­land, but is not avail­able on the Swiss mar­ket, or

3.

it is not ap­pro­pri­ate to switch the med­ic­a­tion to a medi­cin­al product au­thor­ised and avail­able in Switzer­land.

² Treat­ing phys­i­cians with a can­ton­al pro­fes­sion­al li­cence may im­port small quant­it­ies of ready-to-use hu­man medi­cin­al products that are not au­thor­ised in Switzer­land if:

a.

they have per­formed a risk ana­lys­is to con­firm the ap­pro­pri­ate­ness of the us­age and no­ti­fied the com­pet­ent can­ton­al au­thor­it­ies of their con­clu­sions be­fore the medi­cin­al products are im­por­ted; and

b.

the medi­cin­al product:

1.

ful­fils the con­di­tions de­scribed in para­graph 1 let­ters a and c, and

2.

has been au­thor­ised by a coun­try with a com­par­able reg­u­lat­ory sys­tem for use in a clin­ic­al tri­al.

³ Phar­macists with phar­ma­ceut­ic­al re­spons­ib­il­ity in a hos­pit­al phar­macy may im­port small quant­it­ies of ready-to-use hu­man medi­cin­al products to sup­ply their own cus­tom­ers if the con­di­tions in para­graph 1 let­ters b and c or the con­di­tions in para­graph 1 let­ter c and 2 let­ters a and b are ful­filled.

⁴ Med­ic­al pro­fes­sion­als as de­scribed in Art­icle 25 para­graph 1 let­ters b and c TPA who have a can­ton­al pro­fes­sion­al li­cence may im­port small quant­it­ies of non-pre­scrip­tion ready-to-use hu­man medi­cin­al products that are not au­thor­ised in Switzer­land un­der the terms of their dis­pens­ing li­cence provided the con­di­tions in para­graph 1 are ful­filled.

⁵ Pri­or to im­port, im­port­ing per­sons must check in each case wheth­er the rel­ev­ant re­quire­ments in para­graphs 1–4 are met and en­sure that the medi­cin­al products are trans­por­ted in con­form­ity with the GDP rules de­scribed in An­nex 4.

⁶ They must keep a re­cord of the check de­scribed in para­graph 5 and of the time when the check was car­ried out and the im­port took place, and the nature, num­ber and in­ten­ded use of the im­por­ted hu­man medi­cin­al products.

⁷ The im­port of medi­cin­al products for an­im­als by veter­in­ari­ans is sub­ject to Art­icles 7‒7d of the Veter­in­ary Medi­cin­al Products Or­din­ance of 18 Au­gust 2004¹⁵.¹⁶