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

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 14 November 2018 (Status as of 28 January 2022)


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Art. 1 Object and definition of terms

1 This Or­din­ance reg­u­lates:

a.
the man­u­fac­ture of medi­cin­al products;
b.
whole­sale trad­ing in medi­cin­al products;
c.
the im­port, ex­port and trans­it trade in medi­cin­al products;
d.
trad­ing in medi­cin­al products in for­eign coun­tries from Switzer­land;
e.
the ex­tract­ing of blood for trans­fu­sions or for the man­u­fac­ture of medi­cin­al products to­geth­er with oth­er es­sen­tial ele­ments of trans­fu­sion safety in hand­ling blood and labile blood products;
f.
broker­age or agency activ­it­ies in con­nec­tion with medi­cin­al products;
g.
tem­por­ary li­cences to use medi­cin­al products in ac­cord­ance with Art­icle 9b para­graph 1 TPA.

2 With the ex­cep­tion of Art­icles 27, 28 and 47, this Or­din­ance ap­plies by ana­logy to the hand­ling of trans­plant products as de­scribed in Art­icle 2 para­graph 1 let­ter c of the Trans­plant­a­tion Or­din­ance of 16 March 20072.

3 Art­icles 29–38 do not ap­ply to trans­plant products de­scribed in Art­icle 2 para­graph 1 let­ter c num­ber 2 of the Trans­plant­a­tion Or­din­ance of 16 March 2007.

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