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

¹ In this Act:

a.

Medi­cin­al productsmeans products of chem­ic­al or bio­lo­gic­al ori­gin which are in­ten­ded or claimed to have a medi­cin­al ef­fect on the hu­man or an­im­al or­gan­ism, in par­tic­u­lar in the dia­gnos­is, pre­ven­tion or treat­ment of dis­eases, in­jur­ies and han­di­caps; blood and blood products are also con­sidered to be medi­cin­al products;

a^bis.⁹

Medi­cin­al products with in­dic­a­tionsmeans medi­cin­al products with an of­fi­cially au­thor­ised in­dic­a­tion in a spe­cif­ic field of ap­plic­a­tion which are in­ten­ded for use in ac­cord­ance with the rules of the med­ic­al and phar­ma­ceut­ic­al sci­ences;

a^ter.¹⁰

Complementary medicines with indicationsmeans medi­cin­al products with an of­fi­cially au­thor­ised in­dic­a­tion in a spe­cif­ic field of ap­plic­a­tion which are man­u­fac­tured ac­cord­ing to the man­u­fac­tur­ing reg­u­la­tions for complementary therapies such as homeopathy, anthroposophic medicine or traditional Asian medicine and whose field of application is determined according to theprin­ciples of the cor­res­pond­ing ther­apy ap­proach;

a^quater.¹¹ Complementary medicines without indications means com­ple­ment­ary medi­cines without an of­fi­cially au­thor­ised in­dic­a­tion in a spe­cif­ic field of ap­plic­a­tion which are in­ten­ded for use in in­di­vidu­al ther­apies;

a^quin­quies.¹² Herb­al medi­cines means medi­cin­al products with an au­thor­ised in­dic­a­tion which ex­clus­ively con­tain one or more herb­al sub­stances or herb­al pre­par­a­tions and which are not clas­si­fied as com­ple­ment­ary medi­cines;

a^sex­ies.¹³ Ori­gin­al pre­par­a­tion means a medi­cin­al product that is au­thor­ised by the Swiss Agency for Thera­peut­ic Products (Agency) as the first with a spe­cif­ic act­ive sub­stance, in­clud­ing all dosage forms au­thor­ised at the same time or later;

a^sep­ties.¹⁴ Gen­er­ic medi­cin­al productmeans a medi­cin­al product au­thor­ised by the Agency which is es­sen­tially the same as an ori­gin­al pre­par­a­tion and which is in­ter­change­able with the ori­gin­al pre­par­a­tion due to its identic­al act­ive sub­stances and its dosage form and dosage;

a^octies.¹⁵ Ref­er­ence pre­par­a­tionmeans a bio­lo­gic­al medi­cin­al product that is used in the au­thor­isa­tion doc­u­ment­a­tion for a bi­osim­il­ar product as a ref­er­ence for the com­par­ab­il­ity of its phar­ma­ceut­ic­al qual­ity, ef­fic­acy and safety;

a^novies.¹⁶ Bi­osim­il­ar productmeans a bio­lo­gic­al medi­cin­al product suf­fi­ciently sim­il­ar to a ref­er­ence pre­par­a­tion au­thor­ised by the Agency and that refers to its doc­u­ment­a­tion;

a^de­cies.¹⁷ Im­port­antmedi­cin­al products in­ten­ded to treat rare dis­eases (orphan drugs)means medi­cin­al products for hu­man use for which it has been proven that:

1.

they are in­dic­ated for the dia­gnos­is, pre­ven­tion or treat­ment of a life-threat­en­ing or chron­ic­ally de­bil­it­at­ing dis­ease af­fect­ing no more than five in ten thou­sand people in Switzer­land when the ap­plic­a­tion was sub­mit­ted, or

2.

they or their act­ive sub­stances are gran­ted the status of Im­port­ant medi­cin­al products in­ten­ded to treat rare dis­eases by an­oth­er coun­try with an equi­val­ent sys­tem of medi­cin­al product con­trol with­in the mean­ing of Art­icle 13;

b.¹⁸

Med­ic­al devices means products, in­clud­ing in­stru­ments, ap­par­at­us, equip­ment, in vitro dia­gnostics, soft­ware, im­plants, re­agents, ma­ter­i­als and oth­er goods or sub­stances which are in­ten­ded or claimed to have a med­ic­al use and whose prin­cip­al ef­fect is not ob­tained with a medi­cin­al product;

c.

Man­u­fac­ture means all stages in the man­u­fac­ture of a thera­peut­ic product, from the ac­quis­i­tion of the pre­curs­ors and the pro­cessing to the pack­aging, stor­age and de­liv­ery of the end products, and in­clud­ing the qual­ity con­trols and batch re­lease;

d.

Pla­cing on the mar­ket means the dis­tri­bu­tion and dis­pens­ing of thera­peut­ic products;

e.¹⁹

Dis­tri­bu­tion means the trans­fer or re­lease, either free of charge or in re­turn for pay­ment, but not the dis­pens­ing, of a thera­peut­ic product and in­cludes the activ­it­ies of brokers and agents;

f.

Dis­pens­ing means the trans­fer or re­lease, either free of charge or in re­turn for pay­ment, of a ready-to-use thera­peut­ic product destined for use by the pur­chaser or for use on a third party or on an­im­als;

f^bis.²⁰

Pre­scrip­tionmeans the re­cor­ded de­cision of a qual­i­fied med­ic­al pro­fes­sion­al is­sued in ac­cord­ance with Art­icle 26 para­graph 2 to a spe­cif­ic per­son, grant­ing that per­son a right of ac­cess to med­ic­al ser­vices such as care ser­vices, med­ic­a­tion, ana­lyses or med­ic­al devices;

g.

Phar­ma­co­poeia (Phar­ma­co­poeia Euro­paea and Phar­ma­co­poeia Hel­vetica) means a col­lec­tion of reg­u­la­tions on the qual­ity of medi­cin­al products, ex­cipi­ents and cer­tain med­ic­al devices;

h.²¹

New act­ive sub­stance means an act­ive sub­stance which is au­thor­ised for the first time in Switzer­land pur­su­ant to an or­din­ary pro­ced­ure un­der Art­icle 11. Act­ive sub­stances pre­vi­ously only au­thor­ised in medi­cin­al products for hu­man use shall be con­sidered new act­ive sub­stances if they are used in products for veter­in­ary use, and vice versa;

i.²²

Pub­lic phar­macymeans a phar­macy li­censed by the can­ton, run by a phar­macist, which guar­an­tees reg­u­lar open­ing hours and of­fers dir­ect ac­cess to the pub­lic;

j.²³

Hos­pit­al phar­macymeans a phar­macy in a hos­pit­al es­tab­lish­ment which is run by a phar­macist and of­fers, in par­tic­u­lar, phar­ma­ceut­ic­al ser­vices to the cus­tom­ers of the hos­pit­al; for the pre­par­a­tion of ra­dio­phar­ma­ceut­ic­als in ac­cord­ance with Art­icle 9 para­graph 2 let­ter a and para­graph 2^bis, an in­tern­al ra­dio­phar­ma­ceut­ic­al es­tab­lish­ment is also deemed to be a hos­pit­al phar­macy;

k.²⁴

Pro-phar­macymeans the can­ton­ally ap­proved dis­pens­ing of medi­cin­al products in a doc­tor’s prac­tice or an out­pa­tient health­care ser­vice whose phar­macy is un­der the pro­fes­sion­al re­spons­ib­il­ity of a doc­tor with a pro­fes­sion­al li­cence.

²The Fed­er­al Coun­cil may, by or­din­ance, dis­tin­guish between the terms used in this Act as well as those used in para­graph 1, define them in great­er de­tail, and may provide for ex­cep­tions based upon new find­ings in sci­ence and tech­no­logy as well as on in­ter­na­tion­al de­vel­op­ments.

³ It may, for the area of med­ic­al devices, by or­din­ance, spe­cify dif­fer­ent defin­i­tions for the terms lis­ted in para­graph 1, provided that this serves the pur­pose of in­ter­na­tion­al har­mon­isa­tion.²⁵