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

¹ The Fed­er­al Coun­cil may, tak­ing in­to ac­count in­ter­na­tion­ally re­cog­nised reg­u­la­tions, provide that the res­ults of clin­ic­al tri­als car­ried out with a view to de­vel­op­ing a medi­cin­al product for hu­man use shall be pub­lished after the au­thor­isa­tion de­cision.

² For this pur­pose, the Con­fed­er­a­tion may op­er­ate a data­base or have it op­er­ated by third parties. This data­base may not con­tain any data that would al­low any ref­er­ence to per­sons par­ti­cip­at­ing in clin­ic­al tri­als.

³ The Fed­er­al Coun­cil:

a.

des­ig­nates the au­thor­ity re­spons­ible for main­tain­ing the data­base;

b.

spe­cifies the du­ties and pro­ced­ure with re­gard to pub­lic­a­tion;

c.

de­term­ines the con­tent and form of the res­ults to be pub­lished;

d.

de­term­ines the re­quire­ments for the con­tent and op­er­a­tion of the data­base;

e.

reg­u­lates the ac­cess to and use of the data.