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

¹ The Agency may at any time carry out an in­spec­tion to de­term­ine wheth­er the con­duct of the clin­ic­al tri­al meets the re­quire­ments spe­cified in this Act and in the Hu­man Re­search Act of 30 Septem­ber 2011¹³⁴.

² The Fed­er­al Coun­cil may, hav­ing re­gard to re­cog­nised in­ter­na­tion­al reg­u­la­tions, spe­cify no­ti­fic­a­tion and in­form­a­tion re­quire­ments, con­cern­ing in par­tic­u­lar:

a.

the com­ple­tion or dis­con­tinu­ation of a clin­ic­al tri­al;

b.

ad­verse events ob­served in con­nec­tion with a clin­ic­al tri­al;

c.

in­cid­ents oc­cur­ring dur­ing the con­duct of a clin­ic­al tri­al which may af­fect the safety or health of the par­ti­cipants or call in­to ques­tion the ac­quis­i­tion of re­li­able and ro­bust data.

³ It shall reg­u­late the no­ti­fic­a­tion pro­ced­ure and the ex­change of in­form­a­tion. It may stip­u­late that no­ti­fic­a­tion and the ex­change of in­form­a­tion must be ef­fected elec­tron­ic­ally.