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

¹ The Agency may, in ac­cord­ance with a sim­pli­fied pro­ced­ure un­der Art­icle 14 para­graph 1, tem­por­ar­ily au­thor­ise medi­cin­al products for life-threat­en­ing or de­bil­it­at­ing dis­eases if:

a.

they are com­pat­ible with the pro­tec­tion of health;

b.

their use is ex­pec­ted to have a ma­jor thera­peut­ic be­ne­fit; and

c.

no au­thor­ised, al­tern­at­ive or equi­val­ent medi­cin­al product is avail­able in Switzer­land.

² The Agency shall de­term­ine the evid­ence to be sub­mit­ted for the eval­u­ation of an ap­plic­a­tion pur­su­ant to para­graph 1.