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

¹ The Agency shall make pro­vi­sion for sim­pli­fied pro­ced­ures for the au­thor­isa­tion of cer­tain cat­egor­ies of medi­cin­al products where this is com­pat­ible with the qual­ity, safety and ef­fic­acy re­quire­ments, and where there is no con­flict with Swiss in­terests or in­ter­na­tion­al agree­ments. In par­tic­u­lar, this ap­plies in the case of:

a.

medi­cin­al products made with known act­ive sub­stances;

a^bis.⁵⁰

medi­cin­al products whose act­ive sub­stances are used in a medi­cin­al product which, when the ap­plic­a­tion was sub­mit­ted, has been au­thor­ised as a medi­cin­al product for at least 10 years in at least one EU or EFTA coun­try and which is com­par­able in terms of in­dic­a­tions, dosage and meth­od of ad­min­is­tra­tion;

a^ter.⁵¹

non-pre­scrip­tion medi­cin­al products with in­dic­a­tions which, when the ap­plic­a­tion was sub­mit­ted, have been proven to have been used med­ic­ally for at least 30 years, and for at least 15 years in EU and EFTA coun­tries;

a^quater.⁵²

medi­cin­al products which, when the ap­plic­a­tion was sub­mit­ted, have been au­thor­ised as medi­cin­al products for at least 15 years in a can­ton;

b.⁵³

com­ple­ment­ary medi­cines;

c.⁵⁴

…

c^bis.⁵⁵

herb­al medi­cines;

d.⁵⁶

medi­cin­al products pre­pared by a hos­pit­al phar­macy or in the hos­pit­al’s own ra­dio­phar­ma­ceut­ic­al unit for the needs of the hos­pit­al;

e.

medi­cin­al products pre­pared by the army and used in the con­text of the co­ordin­ated army med­ic­al corps;

f.

im­port­ant medi­cin­al products for rare dis­eases;

g.

veter­in­ary medi­cin­al products, which are in­ten­ded ex­clus­ively for an­im­als not kept for the pro­duc­tion of food­stuffs.

² The Agency shall make pro­vi­sion for a sim­pli­fied au­thor­isa­tion pro­ced­ure in the case of an ap­plic­a­tion from an­oth­er per­son re­spons­ible for the pla­cing on the mar­ket of a medi­cin­al product which is already au­thor­ised in Switzer­land and which is im­por­ted from a coun­try with an equi­val­ent au­thor­isa­tion sys­tem:

a.

if the medi­cin­al product sat­is­fies the same re­quire­ments as the medi­cin­al product already au­thor­ised in Switzer­land, in par­tic­u­lar in re­gard to the la­belling and the med­ic­al in­form­a­tion men­tioned in Art­icle 11;

b.

if the oth­er per­son re­spons­ible for pla­cing the medi­cin­al product on the mar­ket can con­tin­ue to guar­an­tee that all the au­thor­ised medi­cin­al products that he dis­trib­utes ful­fil the same re­quire­ments of safety and qual­ity as those of the first ap­plic­ant.

³ …⁵⁷