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

¹ Clin­ic­al tri­als of thera­peut­ic products re­quire au­thor­isa­tion from the Agency in ad­vance.

² Ex­emp­ted from man­dat­ory au­thor­isa­tion are clin­ic­al tri­als in­volving au­thor­ised medi­cin­al products used in ac­cord­ance with the product in­form­a­tion.¹²⁵

³ The Fed­er­al Coun­cil may:

a.

for oth­er tri­als, grant an ex­emp­tion from man­dat­ory au­thor­isa­tion or spe­cify man­dat­ory no­ti­fic­a­tion;

b.

for clin­ic­al tri­als of veter­in­ary thera­peut­ic products, spe­cify man­dat­ory au­thor­isa­tion or no­ti­fic­a­tion;

c.¹²⁶

make modi­fic­a­tions to clin­ic­al tri­als sub­ject to man­dat­ory au­thor­isa­tion.

⁴ As part of the au­thor­isa­tion pro­ced­ure, the Agency shall veri­fy:

a.

in the case of medi­cin­al products, wheth­er they com­ply with the rules of Good Man­u­fac­tur­ing Prac­tice and of medi­cin­al product safety;

b.

in the case of med­ic­al devices, wheth­er:

1.

the med­ic­al devices meet the re­quire­ments spe­cified in Art­icle 45, in­so­far as com­pli­ance with these re­quire­ments is not the sub­ject of the clin­ic­al tri­al,

2.

the risks as­so­ci­ated with a med­ic­al device are duly con­sidered in the clin­ic­al tri­al,

3.

the in­form­a­tion on the med­ic­al device is in line with cur­rent sci­entif­ic know­ledge and is cor­rectly in­dic­ated in the pro­tocol.¹²⁷

⁵ …¹²⁸

⁶ The Fed­er­al Coun­cil shall reg­u­late the au­thor­isa­tion pro­ced­ure. It may define the re­quired form of the ap­plic­a­tion and stip­u­late that the sub­mis­sion of ap­plic­a­tions, cor­res­pond­ence and the pub­lic­a­tion of de­cisions must be ef­fected elec­tron­ic­ally.¹²⁹

⁷ …¹³⁰

⁸ In is­su­ing reg­u­la­tions in ac­cord­ance with para­graphs 3 and 6, the Fed­er­al Coun­cil shall have re­gard to the re­cog­nised in­ter­na­tion­al reg­u­la­tions.¹³¹