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

¹A fine not ex­ceed­ing 50,000 Swiss francs shall be im­posed on any per­son who wil­fully:²⁴⁷

a.

man­u­fac­tures, places on the mar­ket, im­ports or ex­ports, or trades in a for­eign coun­try thera­peut­ic products or ex­cipi­ents which do not con­form to the re­quire­ments stated in the Phar­ma­co­poeia;

b.

con­tra­venes the reg­u­la­tions on the ad­vert­ising of medi­cin­al products;

c.²⁴⁸

vi­ol­ates an ob­lig­a­tion un­der this Act to no­ti­fy, re­gister or dis­close;

d.

vi­ol­ates the ob­lig­a­tions to la­bel, keep re­cords, to archive or to co­oper­ate;

e.

vi­ol­ates the ob­lig­a­tion of secrecy, un­less there is a vi­ol­a­tion of Art­icle 162, 320 or 321 of the Crim­in­al Code²⁴⁹;

f.²⁵⁰

com­mits an of­fence re­ferred to in Art­icle 86 para­graph 1 let­ters a–g where the thera­peut­ic product is in­ten­ded ex­clus­ively for per­son­al use or in­volves an over-the-counter medi­cin­al productor a Class I medical devicein ac­cord­ance with An­nex IX to Dir­ect­ive 93/42/EEC²⁵¹ con­cern­ing med­ic­al devices;

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g.²⁵²fails to com­ply with a rul­ing against him or her which refers to the pen­al­ties provided for in this art­icle;

h.²⁵³

in­fringes the ob­lig­a­tion of trans­par­ency laid down in Art­icle 56.

² If the per­son con­cerned acts in a pro­fes­sion­al ca­pa­city in the cases re­ferred to in para­graph 1 let­ter a, b, e or f, he or she shall be li­able to a mon­et­ary pen­alty.²⁵⁴

³ If the per­son con­cerned acts through neg­li­gence, the pen­alty shall be a fine not ex­ceed­ing 20,000 Swiss francs.²⁵⁵

⁴ At­tempts and aid­ing and abet­ting are also of­fences.

⁵ The right to pro­sec­ute con­tra­ven­tions and ex­ecute the pen­al­ties for con­tra­ven­tions are sub­ject to a time lim­it of five years.

⁶In par­tic­u­larly minor cases, pro­sec­u­tion and sen­ten­cing may be waived.