Federal Act
on Medicinal Products and Medical Devices
(Therapeutic Products Act, TPA)


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Art. 18 Mandatory licence

1 A li­cence gran­ted by the Agency is re­quired by any per­son who pro­fes­sion­ally:

a.
im­ports ready-to-use medi­cin­al products in­ten­ded for dis­tri­bu­tion or dis­pens­ing;
b.
ex­ports ready-to-use medi­cin­al products in­ten­ded for dis­tri­bu­tion or dis­pens­ing;
c.
trades medi­cin­al products in for­eign coun­tries from Switzer­land, without their en­ter­ing Switzer­land;
d.
acts from Switzer­land as a broker or agent for medi­cin­al products.72

2 The Fed­er­al Coun­cil shall spe­cify the re­quire­ments for activ­it­ies un­der para­graph 1.73

3 It may is­sue ex­emp­tions from the re­quire­ment of li­cence for:

a.
med­ic­al pro­fes­sion­als who work across bor­ders;
b.
in­ter­na­tion­al or­gan­isa­tions.

4 Goods stored in a cus­toms ware­house or a bon­ded ware­house shall be con­sidered to be im­por­ted.74

5 The Fed­er­al Coun­cil may is­sue spe­cial reg­u­la­tions for goods in trans­it.

6 If an­oth­er State re­quests ex­port cer­ti­fic­ates and at­test­a­tions for the im­port­ing of medi­cin­al products, the Agency may is­sue such doc­u­ments to per­sons hold­ing an au­thor­isa­tion to ex­port.

72 Amended by An­nex No 2 of the FD of 29 Sept. 2017 (Medicrime Con­ven­tion), in force since 1 Jan. 2019 (AS 2018 4771; BBl 2017 3135).

73 Amended by An­nex No 2 of the FD of 29 Sept. 2017 (Medicrime Con­ven­tion), in force since 1 Jan. 2019 (AS 2018 4771; BBl 2017 3135).

74 In­ser­ted by An­nex No 17 of the Cus­toms Act of 18 March 2005, in force since 1 May 2007 (AS 2007 1411; BBl 2004 567).

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