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

¹ Any per­son draw­ing blood from per­sons for the pur­pose of trans­fu­sion or the man­u­fac­ture of thera­peut­ic products or for sup­ply to a third party must pos­sess an op­er­at­ing li­cence is­sued by the Agency.

² The li­cence shall be is­sued if:

a.

the ne­ces­sary tech­nic­al and op­er­a­tion­al con­di­tions are ful­filled;

b.

an ap­pro­pri­ate sys­tem of qual­ity as­sur­ance ex­ists.

³ The Agency shall veri­fy by in­spec­tion that the li­cens­ing con­di­tions are ful­filled.

⁴ Es­tab­lish­ments such as hos­pit­als which only stock blood or blood products must pos­sess a can­ton­al op­er­at­ing li­cence. The can­tons shall lay down the con­di­tions and the pro­ced­ure for grant­ing this li­cence. They shall carry out peri­od­ic­al in­spec­tions.