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

¹ The Agency and the oth­er au­thor­it­ies en­trus­ted with the en­force­ment of this Act shall mon­it­or, with­in the lim­its of their powers, wheth­er the man­u­fac­ture, dis­tri­bu­tion, dis­pens­ing and main­ten­ance of, and claims re­lat­ing to thera­peut­ic products are law­ful. For this pur­pose, they may carry out an­nounced and un­an­nounced in­spec­tions.¹³⁵

² The Agency shall veri­fy the thera­peut­ic products placed on the mar­ket. It shall veri­fy that the medi­cin­al products con­form to the mar­ket­ing au­thor­isa­tion and that the med­ic­al devices sat­is­fy the leg­al re­quire­ments.

³ The Agency shall be re­spons­ible for mon­it­or­ing the safety of thera­peut­ic products. To this ef­fect, it shall in par­tic­u­lar col­lect the no­ti­fic­a­tions re­ferred to in Art­icle 59, eval­u­ate them, and take the ne­ces­sary ad­min­is­trat­ive meas­ures.

⁴ The Agency and the oth­er au­thor­it­ies en­trus­ted with the im­ple­ment­a­tion of this Act may take samples, re­quest es­sen­tial in­form­a­tion and doc­u­ments, and ask for any help ne­ces­sary for this pur­pose. Neither the samples nor any oth­er kind of help will be com­pensated for.¹³⁶

⁵ In the course of their mon­it­or­ing ser­vices, the can­tons shall no­ti­fy the Agency or the Fed­er­al Of­fice of Pub­lic Health (FOPH) in ac­cord­ance with their re­spect­ive re­spons­ib­il­it­ies of any events, find­ings or com­plaints. The Agency or the FOPH shall take the ne­ces­sary ad­min­is­trat­ive meas­ures. The can­tons may also take the ne­ces­sary ad­min­is­trat­ive meas­ures in the case of a ser­i­ous dir­ect threat to health.¹³⁷