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

¹ The fol­low­ing may be placed on the mar­ket fol­low­ing no­ti­fic­a­tion to the Agency:

a.

com­ple­ment­ary medi­cines without in­dic­a­tions, the act­ive sub­stances of which are in­cluded in lists for spe­cif­ic ther­apy ap­proaches;

b.

oth­er medi­cin­al products or groups of medi­cin­al products for which, due to their low risk po­ten­tial, a sim­pli­fied mar­ket­ing au­thor­isa­tion proves to be dis­pro­por­tion­ate.

² The Agency shall draw up the lists re­ferred to in para­graph 1 let­ter a. It shall de­term­ine the medi­cin­al products or groups of medi­cin­al products re­ferred to in para­graph 1 let­ter b and reg­u­late the no­ti­fic­a­tion pro­ced­ure.