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

¹ Any per­son who wil­fully:

a.

man­u­fac­tures, places on the mar­ket, uses, pre­scribes, im­ports or ex­ports, or trades in a for­eign coun­try medi­cin­al products without the re­quired mar­ket­ing au­thor­isa­tion or li­cence, or con­trary to the due di­li­gence re­quire­ments stip­u­lated in Art­icles 3, 7, 21, 22, 26, 29 and 42;

b.

uses an­ti­bi­ot­ic sub­stances con­trary to the re­stric­tions or pro­hib­i­tions laid down in Art­icle 42apara­graph 2;

c.²³⁸

vi­ol­ates, when hand­ling blood or blood products, the ban on pay­ment for blood dona­tions, on the fit­ness of the donor to give blood, on the ob­lig­a­tion to test, on the ob­lig­a­tion to re­cord or archive or due di­li­gence re­quire­ments in ac­cord­ance with Art­icle 37, or fails to take the ne­ces­sary pro­tec­tions and safe­guards;

d.²³⁹

places on the mar­ket, ex­ports or uses med­ic­al devices which do not sat­is­fy the re­quire­ments of this Act, or uses med­ic­al devices without the ne­ces­sary tech­nic­al or op­er­a­tion­al re­quire­ments be­ing ful­filled;

e.

vi­ol­ates the due di­li­gence re­quire­ment pur­su­ant to Art­icle 48 or the ob­lig­a­tion to main­tain med­ic­al devices;

f.

per­forms a clin­ic­al tri­al on a hu­man be­ing which does not sat­is­fy the re­quire­ments of this Act, or al­lows the same to be per­formed;

g.

un­law­fully cop­ies, fals­i­fies or in­cor­rectly names medi­cin­al products or med­ic­al devices, or places on the mar­ket, uses, im­ports or ex­ports, or trades in a for­eign coun­try, un­law­fully copied, fals­i­fied or in­cor­rectly named medi­cin­al products or med­ic­al devices;

h.

vi­ol­ates a pro­hib­i­tion un­der Art­icle 55.

i.²⁴⁰

places on the mar­ket products which do not meet the re­quire­ments spe­cified by the Fed­er­al Coun­cil in ac­cord­ance with Art­icle 2a;

j.²⁴¹

of­fers, grants, de­mands or ac­cepts a fin­an­cial gain or oth­er ad­vant­age for hu­man tis­sue or hu­man cells or uses such tis­sues or cells for the man­u­fac­ture of products as spe­cified in Art­icle 2a;

k.²⁴²

re­moves or uses hu­man tis­sue or hu­man cells for the man­u­fac­ture of products as spe­cified in Art­icle 2a in the ab­sence of con­sent for re­mov­al.

[tab]

shall be li­able to a cus­todi­al sen­tence not ex­ceed­ing three years or to a mon­et­ary pen­alty.

² Any person who, in the cases referred to in paragraph 1 letters a–g and i–k:

a.

knows or must as­sume that the vi­ol­a­tion spe­cific­ally en­dangers hu­man health;

b.

achieves a high turnover or makes sub­stan­tial profits through com­mer­cial activ­ity.

shall be li­able to a cus­todi­al sen­tence not ex­ceed­ing ten years or a mon­et­ary pen­alty.²⁴³

³ Any per­son act­ing as a mem­ber of a gang in­volved in the il­li­cit trade in thera­peut­ic products in the cases re­ferred to in para­graph 1 let­ters a, c, d, f, g and i–k shall be li­able to a cus­todi­al sen­tence not ex­ceed­ing ten years or to a mon­et­ary pen­alty.²⁴⁴

⁴ If the per­son con­cerned acts through neg­li­gence, he or she shall be li­able to a mon­et­ary pen­alty. In minor cases, a fine may be im­posed.²⁴⁵