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

¹ Any per­son who im­ports the fol­low­ing medi­cin­al products that are au­thor­ised or not sub­ject to au­thor­isa­tion or blood and blood products in­to Switzer­land re­quires a li­cence for each ship­ment:

a.

im­mun­o­lo­gic­al medi­cin­al products;

b.

blood and blood products.

² A li­cence is not re­quired for the im­port of in­di­vidu­al batches of:

a.

al­ler­gens;

b.

blood that is au­thor­ised or not sub­ject to au­thor­isa­tion and blood products of this kind if these medi­cin­al products:

1.

are im­por­ted in med­ic­al emer­gen­cies or for auto­log­ous trans­fu­sion,

2.

are not in­ten­ded for use in hu­mans, or

3.

have an of­fi­cial batch re­lease from one of the con­trol au­thor­it­ies be­long­ing to the Of­fi­cial Con­trol Au­thor­ity Batch Re­lease Net­work (OCABR Net­work);

c.

im­mun­o­lo­gic­al medi­cin­al products that are au­thor­ised or not sub­ject to au­thor­isa­tion provided an of­fi­cial batch re­lease from one of the con­trol au­thor­it­ies be­long­ing to the OCABR Net­work is avail­able for the batch to be im­por­ted.

³ In the in­terest of pro­tect­ing health, Swiss­med­ic may im­pose tem­por­ary or per­man­ent man­dat­ory li­cens­ing on the im­port of in­di­vidu­al batches of im­mun­o­lo­gic­al medi­cin­al products or of blood and blood products that are au­thor­ised or not sub­ject to au­thor­isa­tion even if an of­fi­cial batch re­lease as de­scribed in para­graph 2 let­ter b num­ber 3 is avail­able.