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

¹ The pur­pose of this Act is to pro­tect hu­man and an­im­al health and to guar­an­tee that only high qual­ity, safe and ef­fect­ive thera­peut­ic products are placed on the mar­ket.

² It shall fur­ther­more:

a.

pro­tect the con­sumers of thera­peut­ic products against fraud;

b.

help to en­sure that the thera­peut­ic products placed on the mar­ket are used in ac­cord­ance with their pur­pose and in mod­er­a­tion;

c.

help to en­sure that a re­li­able and well-or­gan­ised sup­ply of thera­peut­ic products, to­geth­er with the ne­ces­sary tech­nic­al in­form­a­tion and ad­vice, is avail­able throughout the coun­try.

³ In the im­ple­ment­a­tion of this Act, in par­tic­u­lar in the en­act­ment of the reg­u­la­tions and in the ap­plic­a­tion to an in­di­vidu­al case, it must be en­sured that:

a.

the ef­fi­ciency and in­de­pend­ence of the con­trol of thera­peut­ic products is guar­an­teed in Switzer­land;

b.

fa­vour­able con­di­tions ex­ist for re­search and de­vel­op­ment in the thera­peut­ic product sec­tor;

c.

all play­ers com­pet­ing in the mar­ket ful­fil the same leg­al re­quire­ments of safety and qual­ity.

¹ This Act ap­plies to:

a.³

the hand­ling of medi­cin­al products and med­ic­al devices (thera­peut­ic products);

b.

nar­cot­ics as defined in the Nar­cot­ics Act of 3 Oc­to­ber 1951⁴, in­so­far as they are used as thera­peut­ic products;

c.

thera­peut­ic treat­ments, such as gene ther­apy, in­so­far as they dir­ectly re­late to thera­peut­ic products; the Fed­er­al Coun­cil may en­act pro­vi­sions spe­cif­ic to this sub­ject.

² The Fed­er­al Coun­cil may com­pletely or par­tially ex­empt med­ic­al devices in­ten­ded for use on an­im­als or in veter­in­ary dia­gnostics from the scope of this Act.

³ It may make sub­ject to this Act cer­tain products without an in­ten­ded med­ic­al pur­pose which are com­par­able to med­ic­al devices in terms of func­tion­ing and risks pro­file.⁵

¹ For thera­peut­ic products which con­tain or con­sist of de­vi­tal­ised hu­man tis­sues or cells, or de­riv­at­ives there­of, the Fed­er­al Coun­cil shall spe­cify re­quire­ments for the dona­tion, re­mov­al, test­ing and de­vi­tal­isa­tion of these tis­sues or cells.

² It may make sub­ject to spe­cif­ic re­quire­ments of this Act and of the Trans­plant­a­tion Act of 8 Oc­to­ber 2004⁷ products which con­tain or con­sist of de­vi­tal­ised hu­man tis­sues or cells, or de­riv­at­ives there­of, and are not thera­peut­ic products, but func­tion as thera­peut­ic products. In ad­di­tion, it may also spe­cify re­quire­ments for the dona­tion, re­mov­al, test­ing and de­vi­tal­isa­tion of such tis­sues or cells, or de­riv­at­ives there­of.

³ Hu­man tis­sue or hu­man cells may only be re­moved or used for the man­u­fac­ture of products as spe­cified in para­graphs 1 and 2 if con­sent has been ob­tained for re­mov­al. For this tis­sue and these cells, neither fin­an­cial gain nor any oth­er ad­vant­age may be offered, gran­ted, de­man­ded or ac­cep­ted.

¹Any per­son hand­ling thera­peut­ic products must take all meas­ures ne­ces­sary ac­cord­ing to the state of the art to en­sure that hu­man or an­im­al health is not en­dangered.

² The state of the art in sci­ence and tech­no­logy must be con­sidered for com­ple­ment­ary medi­cines without in­dic­a­tions, in­clud­ing the prin­ciples of the cor­res­pond­ing ther­apy ap­proach.⁸

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

¹ A li­cence from the Agency shall be re­quired by those who:²⁶

a.

man­u­fac­ture medi­cin­al products;

b.

add medi­cin­al products to an­im­al feed.

² The Fed­er­al Coun­cil reg­u­lates ex­emp­tions from the li­cence re­quire­ment. In par­tic­u­lar, it may:

a.²⁷

make the man­u­fac­ture of medi­cin­al products un­der Art­icle 9 para­graph 2 let­ters a–c^bis sub­ject to a man­dat­ory can­ton­al li­cence or re­port­ing re­quire­ment;

b.

ex­empt from the li­cence re­quire­ment live­stock hold­ers who add medi­cin­al products to an­im­al feed in­ten­ded for their own live­stock.

³ It may provide for a licence requirement in accordance with the corresponding internationally recognised requirements for the manufacture of certain categories of pharmaceutical excipients which present an increased risk to patients.²⁸

¹ The li­cence shall be is­sued if:

a.

the ne­ces­sary tech­nic­al and op­er­a­tion­al con­di­tions are ful­filled;

b.

an ap­pro­pri­ate sys­tem of qual­ity as­sur­ance ex­ists.

² The com­pet­ent au­thor­ity shall veri­fy by in­spec­tion that the con­di­tions are ful­filled.

¹ The man­u­fac­ture of medi­cin­al products and phar­ma­ceut­ic­al ex­cipi­ents whose man­u­fac­ture re­quires a li­cence must con­form to the re­cog­nised rules of good man­u­fac­tur­ing prac­tice.²⁹

² The Fed­er­al Coun­cil shall spe­cify the re­cog­nised rules of good man­u­fac­tur­ing prac­tice. In do­ing so, it shall take ac­count of in­ter­na­tion­ally re­cog­nised guidelines and stand­ards.

Pub­lic phar­ma­cies and pub­lic hos­pit­als must hold a man­u­fac­tur­ing li­cence that cov­ers the fol­low­ing:

a.

pub­lic phar­ma­cies: a li­cence au­thor­ising at least the man­u­fac­ture of medi­cin­al products in ac­cord­ance with Art­icle 9 para­graph 2 let­ter a;

b.

hos­pit­al phar­ma­cies: a li­cence au­thor­ising at least the man­u­fac­ture of medi­cin­al products in ac­cord­ance with Art­icle 9 para­graph 2.

Medi­cin­al products and ex­cipi­ents placed on the mar­ket must meet the re­quire­ments of the Phar­ma­co­poeia or oth­er phar­ma­co­poei­as re­cog­nised by the Agency provided that such re­quire­ments ex­ist.

¹ Ready-to-use medi­cin­al products and veter­in­ary medi­cin­al products in­ten­ded for the man­u­fac­ture of medi­cin­al food­stuffs (pre­mixed medi­cin­al products) may be placed on the mar­ket only if au­thor­ised by the Agency; the fore­go­ing is without pre­ju­dice to in­ter­na­tion­al agree­ments on the re­cog­ni­tion of mar­ket­ing au­thor­isa­tions.

² The fol­low­ing shall be ex­empt from au­thor­isa­tion:

a.³²

medi­cin­al products pre­pared ac­cord­ing to a doc­tor’s pre­scrip­tion by a pub­lic phar­macy or a hos­pit­al phar­macy, or un­der man­date to the lat­ter by an­oth­er es­tab­lish­ment hold­ing a man­u­fac­tur­ing li­cence, and for a giv­en per­son or group of per­sons or for a giv­en an­im­al or live­stock (ma­gis­tral for­mula); on the basis of a pre­scrip­tion, the medi­cin­al product may be man­u­fac­tured by the pub­lic phar­macy or the hos­pit­al phar­macy as re­quired or on a small in­dus­tri­al scale but may only be dis­pensed on a doc­tor’s pre­scrip­tion;

b.³³

medi­cin­al products pre­pared as re­quired or on a small in­dus­tri­al scale by a pub­lic phar­macy, a hos­pit­al phar­macy, a drug­store or by an­oth­er es­tab­lish­ment hold­ing a man­u­fac­tur­ing li­cence, con­form­ing to a spe­cial mono­graph of the Phar­ma­co­poeia or an­oth­er phar­ma­co­poeia or a for­mu­lary re­cog­nised by the Agency, and which are sup­plied to their own cus­tom­ers (of­fi­cin­al for­mula);

c.³⁴

non-pre­scrip­tion medi­cin­al products pre­pared as re­quired or on a small in­dus­tri­al scale by a pub­lic phar­macy, a hos­pit­al phar­macy, a drug­store or by an­oth­er es­tab­lish­ment hold­ing a man­u­fac­tur­ing li­cence, with­in the lim­its of the es­tab­lish­ment’s right to dis­pense in com­pli­ance with Art­icle 25, ac­cord­ing to its own for­mula or a for­mula pub­lished in the spe­cial­ised lit­er­at­ure, which are in­ten­ded for dis­pens­ing to the es­tab­lish­ment's own cus­tom­ers;

c^bis.³⁵ medi­cin­al products for which it is proven that there is no au­thor­ised or avail­able al­tern­at­ive medi­cin­al product that is ap­plic­able and equi­val­ent and which are man­u­fac­tured in a hos­pit­al phar­macy in ac­cord­ance with the hos­pit­al’s own phar­ma­ceut­ic­als list, on a small in­dus­tri­al scale, and are in­ten­ded for dis­pens­ing to its own cus­tom­ers;

d.

medi­cin­al products in­ten­ded for clin­ic­al tri­als;

e.

medi­cin­al products which can­not be stand­ard­ised;

f.³⁶

medicinal products that were authorised in a canton on 1 January 2002 and which were still on the market when the Amendment of 18 March 2016 came into force; they must be labelled accordingly and may only be placed on the market in the canton concerned and only supplied by persons entitled to supply medicinal products under this Act.

^2bis An es­tab­lish­ment with a man­u­fac­tur­ing li­cence may be com­mis­sioned to man­u­fac­ture medi­cin­al products (con­tract man­u­fac­ture) in ac­cord­ance with para­graph 2 a–c^bis.³⁷

^2terCom­pan­ies hold­ing a man­u­fac­tur­ing li­cence is­sued by the Agency may man­u­fac­ture a com­ple­ment­ary medi­cine for which no al­tern­at­ive and equi­val­ent medi­cin­al product is demon­strably avail­able or au­thor­ised, even without a con­tract man­u­fac­tur­ing or­der in ac­cord­ance with para­graph 2^bis, and mar­ket them to com­pan­ies which are au­thor­ised to man­u­fac­ture these products in ac­cord­ance with para­graph 2 let­ters a, b and c. A com­pany may not man­u­fac­ture more than 100 pack­ages of such a medi­cin­al product with a max­im­um total of 3,000 daily doses; in the case of homeo­path­ic and an­thro­po­soph­ic medi­cin­al products, this re­stric­tion ap­plies to each di­lu­tion in­di­vidu­ally.³⁸

^2quater The Fed­er­al Coun­cil shall lay down the qual­it­at­ive and quant­it­at­ive cri­ter­ia for the medi­cin­al products man­u­fac­tured in ac­cord­ance with para­graphs 2 let­ters a–c^bis and 2^bis, and the qual­it­at­ive cri­ter­ia for the medi­cin­al products man­u­fac­tured in ac­cord­ance with para­graph 2^ter.³⁹

³ The Fed­er­al Coun­cil may make pro­vi­sion for a re­quire­ment of au­thor­isa­tion for the pro­duc­tion or man­u­fac­tur­ing pro­cess used in mak­ing medi­cin­al products which can­not be stand­ard­ised.

⁴ …⁴⁰

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.

¹ The Agency may tem­por­ar­ily au­thor­ise the use of medi­cin­al products re­ferred to in Art­icle 9 para­graph 2 let­ter d on cer­tain per­sons or on cer­tain cat­egor­ies of per­sons out­side clin­ic­al tri­als.

² It may also au­thor­ise the tem­por­ary or quant­it­at­ive mar­ket­ing of a medi­cin­al product to bridge the tem­por­ary un­avail­ab­il­ity of an identic­al medi­cin­al product au­thor­ised in Switzer­land, provided that:

a.

the medi­cin­al product is au­thor­ised in an­oth­er coun­try that has equi­val­ent medi­cin­al product con­trol; and

b.

no es­sen­tially identic­al medi­cin­al product is au­thor­ised and avail­able in Switzer­land.

¹ Any per­son ap­ply­ing for a mar­ket­ing au­thor­isa­tion must:⁴³

a.⁴⁴

prove that the medi­cin­al products with in­dic­a­tions or pro­ced­ures are of high qual­ity and are safe and ef­fect­ive;

a^bis.⁴⁵

in the case of com­ple­ment­ary medi­cines without in­dic­a­tion, at any time on the basis of doc­u­ment­a­tion:

1.

prove that they are of high qual­ity, and

2.

cred­ibly demon­strate that the medi­cin­al product in ques­tion does not pose a risk to the safety of con­sumers;

b.

be a hold­er of an au­thor­isa­tion to man­u­fac­ture, im­port or con­duct whole­sale trade is­sued by the com­pet­ent au­thor­ity;

c.

have a re­gistered ad­dress, re­gistered of­fice or a branch of­fice in Switzer­land.

² The Agency shall veri­fy that the con­di­tions for grant­ing the mar­ket­ing au­thor­isa­tion are ful­filled. To this ef­fect, it may carry out product-spe­cif­ic in­spec­tions.

¹ The ap­plic­a­tion for a mar­ket­ing au­thor­isa­tion must con­tain all of the es­sen­tial data and doc­u­ments for its as­sess­ment, in par­tic­u­lar:

a.

the name of the medi­cin­al product;

b.

the name of the man­u­fac­turer and the dis­trib­ut­or;

c. the man­u­fac­tur­ing pro­cess, the com­pos­i­tion, the qual­ity and the sta­bil­ity of the medi­cin­al product.

² The ap­plic­a­tion for a mar­ket­ing au­thor­isa­tion for the fol­low­ing medi­cin­al products must in­clude the in­form­a­tion and doc­u­ments lis­ted be­low:

a.

Medi­cin­al products with in­dic­a­tion:

1.

the res­ults of phys­ic­al, chem­ic­al, phar­ma­ceut­ic­al and bio­lo­gic­al or mi­cro­bi­o­lo­gic­al tests,

2.

the res­ults of phar­ma­co­lo­gic­al and tox­ic­o­lo­gic­al tests and clin­ic­al tri­als, in­clud­ing all res­ults from tri­als in spe­cif­ic pop­u­la­tion groups,

3.

the thera­peut­ic ef­fects and the un­desir­able ef­fects,

4.

the la­belling, the in­form­a­tion sup­plied about the medi­cin­al product, and the dis­pens­ing meth­od and meth­od of ad­min­is­tra­tion,

5.

an as­sess­ment of the risks and, if ne­ces­sary, a plan for their sys­tem­at­ic re­cord­ing, in­vest­ig­a­tion and pre­ven­tion (phar­ma­covi­gil­ance plan),

6.

the pae­di­at­ric in­vest­ig­a­tion plan re­ferred to in Art­icle 54a;

b.

Medi­cin­al products for an­im­als raised for food pro­duc­tion:

1.

the in­form­a­tion and doc­u­ments re­ferred to in let­ter a,

2.

the de­tec­tion of residues,

3.

the with­draw­al peri­ods.

³ In ad­di­tion to the in­form­a­tion and doc­u­ments re­ferred to in para­graph 1, the ap­plic­a­tion for the au­thor­isa­tion of the pro­cesses in­dic­ated in Art­icle 9 para­graph 3 must in­clude those re­ferred to in para­graph 2 let­ter a.

⁴ The Agency shall de­scribe the in­form­a­tion and the doc­u­ments re­ferred to in para­graphs 1–3 in great­er de­tail.

⁵ The Fed­er­al Coun­cil shall stip­u­late:

a.

the re­quire­ments for or­gan­ising, car­ry­ing out and re­cord­ing the phar­ma­co­lo­gic­al and tox­ic­o­lo­gic­al tests re­ferred to in para­graph 2 let­ter a num­ber 2 and the con­trol pro­ced­ure, tak­ing in­to ac­count in­ter­na­tion­ally re­cog­nised guidelines and stand­ards;

b.

the lan­guages to be used for la­belling and in­form­a­tion leaf­lets.

The doc­u­ments re­lat­ing to a medi­cin­al product con­tain­ing at least one new act­ive sub­stance and au­thor­ised in ac­cord­ance with Art­icle 11 shall be pro­tec­ted for a peri­od of ten years.

¹ If a medicinal product is submitted with one or more known active substances, the correspondingdocumentationon new indications,modes of ad­min­is­tra­tion, dosage forms or dosages, or on its ap­plic­a­tion to a new tar­get an­im­al spe­cies shall be pro­tec­ted for a peri­od of three years.

² For a new indication, this period of protection shall be set by the Agency, on request, at 10 years if it is expected to bring a significant clinical benefit in comparison with existing therapies and if it is backed up by extensive clinical trials.

³ On re­quest, the Agency shall grant a ten-year doc­u­ment pro­tec­tion for a medi­cin­al product spe­cific­ally and ex­clus­ively for pae­di­at­ric use in ac­cord­ance with the pae­di­at­ric in­vest­ig­a­tion plan, provided that no doc­u­ment pro­tec­tion ex­ists for an­oth­er medi­cin­al product au­thor­ised by the Agency with the same act­ive sub­stance for the same spe­cif­ic pae­di­at­ric use.

⁴ In the case of an important orphan medicinal product, the Agency shall, on request, grant document protection for a period of fifteen years.

⁵ The Fed­er­al Coun­cil shall reg­u­late the de­tails.

¹ The ap­plic­a­tion for a mar­ket­ing au­thor­isa­tion for a medi­cin­al product which is es­sen­tially the same as a medi­cin­al product whose doc­u­ments are pro­tec­ted in ac­cord­ance with Art­icles 11a or 11b may be based on the res­ults of the phar­ma­co­lo­gic­al, tox­ic­o­lo­gic­al and clin­ic­al tests if:

a.

the hold­er of the mar­ket­ing au­thor­isa­tion for the medi­cin­al product with doc­u­ment pro­tec­tion provides writ­ten per­mis­sion; or

b.

the pro­tec­tion peri­od for the rel­ev­ant doc­u­ments has ex­pired.

² If the holder of the marketing authorisation does not agree, the granting of a marketing authorisation for an essentially identical medicinal product shall be permissible at the earliest on the first day after expiry of the period of protection for the medicinal product with document protection. A corresponding application for marketing authorisation may be submitted at the earliest two years before the end of the term of protection.

If a medi­cin­al product or pro­ced­ure is already au­thor­ised in a coun­try hav­ing equi­val­ent medi­cin­al product con­trol, the res­ults of tests car­ried out for this pur­pose shall be taken in­to ac­count.

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 As part of the au­thor­isa­tion pro­ced­ure for medi­cin­al products that are im­por­ted as par­al­lel im­ports, the Agency shall make pro­vi­sion for sim­pli­fied rules with re­gard to la­belling and the in­form­a­tion sup­plied about the medi­cin­al product.⁵⁷

¹ Ap­plic­a­tions for a mar­ket­ing au­thor­isa­tion un­der the sim­pli­fied au­thor­isa­tion pro­ced­ure must con­tain the fol­low­ing data and doc­u­ments for the fol­low­ing medi­cin­al products:

a.

Medi­cin­al products re­ferred to in Art­icle 14 para­graph 1 let­ter a^bis:

1.

the data and doc­u­ments re­ferred to in Art­icle 11 para­graphs 1 and 2 let­ter a num­bers 1–4; the data re­ferred to in Art­icle 11 para­graph 2 let­ter a num­ber 2 may be re­placed by a com­pil­a­tion of equi­val­ent sci­entif­ic evid­ence,

2.

proof of the mar­ket­ing au­thor­isa­tions of the for­eign com­par­at­or product;

b.

Medi­cin­al products re­ferred to in Art­icle 14 para­graph 1let­ter a^ter:

1.

the data and doc­u­ments re­ferred to in Art­icle 11 para­graphs 1 and 2 let­ter a num­bers 1, 3 and 4,

2.

an as­sess­ment of the risks,

3.

proof of 30 or 15 years of med­ic­al use;

c.

Medi­cin­al products re­ferred to in Art­icle 14 para­graph 1 let­ter a^quater:

1.

the data and doc­u­ments re­ferred to in Art­icle 11 para­graphs 1 and 2 let­ter a num­bers 1, 3 and 4,

2.

an as­sess­ment of the risks,

3.

the can­ton­al mar­ket­ing au­thor­isa­tion;

d.

Medi­cin­al products re­ferred to in Art­icle 14 para­graph 1 let­ter b: the data and doc­u­ments re­ferred to in Art­icle 11 para­graphs 1 and 2 let­ter a; the data re­ferred to in Art­icle 11 para­graph 2 let­ter a num­ber 2 may be re­placed by equi­val­ent data in ac­cord­ance with spe­cif­ic ther­apy ap­proaches, in par­tic­u­lar by bib­li­o­graph­ic­al evid­ence of ef­fic­acy and safety, or by evid­ence of use;

e.

Medi­cin­al products re­ferred to in Art­icle 14 para­graph 1 let­ter c^bis: the data and doc­u­ments re­ferred to in Art­icle 11 para­graphs 1 and 2 let­ter a; the data re­ferred to in Art­icle 11 para­graph 2 let­ter a num­ber 2 may be re­placed by bib­li­o­graph­ic­al evid­ence of ef­fic­acy and safety, or by evid­ence of use.

² Throughout the peri­od of mar­ket­ing au­thor­isa­tion of medi­cin­al products re­ferred to in para­graph 1 let­ter a, the fol­low­ing in­form­a­tion on the for­eign com­par­at­or product shall be sub­mit­ted to the Agency without be­ing re­ques­ted:

a.

all in­ter­na­tion­ally re­cor­ded safety sig­nals;

b.

all in­ter­im re­ports and fi­nal res­ults of the for­eign reg­u­lat­ory au­thor­ity.

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.

¹ The Agency shall grant a mar­ket­ing au­thor­isa­tion if the con­di­tions are ful­filled. It may at­tach con­di­tions and re­quire­ments to the au­thor­isa­tion.

² The mar­ket­ing au­thor­isa­tion is is­sued for the first time for a peri­od of five years. The Agency shall or­der a short­er peri­od of au­thor­isa­tion if:

a.

the au­thor­isa­tions are lim­ited in ac­cord­ance with Art­icle 9a; or

b.

this is ne­ces­sary for the pro­tec­tion of health.⁶¹

³ The au­thor­isa­tion of medi­cin­al products on the basis of a no­ti­fic­a­tion shall be val­id for an un­lim­ited peri­od.⁶²

⁴ …⁶³

¹ The Agency shall re­voke the au­thor­isa­tion for a medi­cin­al product if:

a.

it is not ac­tu­ally placed on the mar­ket with­in three years of the grant­ing of the au­thor­isa­tion;

b.

it is no longer ac­tu­ally on the mar­ket dur­ing a peri­od of three suc­cess­ive years after it has been placed on the mar­ket.

² The Fed­er­al Coun­cil may provide for ex­cep­tions from para­graph 1.

³ It may provide that, in the case of medi­cin­al products for severe ill­nesses, in­jur­ies or dis­ab­il­it­ies or of medi­cin­al products with a pae­di­at­ric in­dic­a­tion or for pae­di­at­ric use, the au­thor­isa­tion is re­voked be­fore the peri­od re­ferred to in para­graph 1 has ex­pired. It de­cides the dur­a­tion of such peri­ods and lays down the cri­ter­ia for re­voc­a­tion.⁶⁶

⁴ If the holder of the marketing authorisation intends to cease marketing a medicinal product authorised for apae­di­at­ric in­dic­a­tion or for pae­di­at­ric use for which they have ob­tained pro­tec­tion un­der Art­icle 11b para­graphs 3 and 4 of this Act or un­der Art­icle 140n or 140t of the Pat­ents Act of 25 June 1954⁶⁷, they shall pub­lish that in­ten­tion in an ap­pro­pri­ate form.⁶⁸

⁵ The hold­er of the mar­ket­ing au­thor­isa­tion must state in the pub­lic­a­tion that they will trans­fer the au­thor­isa­tion doc­u­ment­a­tion to third parties so they can ob­tain their own au­thor­isa­tion.⁶⁹

¹ A mar­ket­ing au­thor­isa­tion shall be re­newed upon ap­plic­a­tion if the au­thor­isa­tion re­quire­ments con­tin­ue to be met.

² As a rule, re­newed au­thor­isa­tions are val­id for an un­lim­ited peri­od. The Agency may, however, lim­it them, in par­tic­u­lar au­thor­isa­tions in ac­cord­ance with Art­icle 16 para­graph 2 let­ters a and b.

The Agency may re­view the au­thor­isa­tion at any time;it may ad­apt or re­voke the au­thor­isa­tion in the light of chan­ging cir­cum­stances.

¹ If the man­u­fac­ture of a medi­cin­al product re­quires spe­cial meas­ures to be taken, in par­tic­u­lar to guar­an­tee safety, then a re­lease au­thor­isa­tion must be ob­tained from the Agency for each batch be­fore dis­tri­bu­tion; the fore­go­ing is without pre­ju­dice to in­ter­na­tion­al agree­ments on batch re­lease re­cog­ni­tion.

² The Agency shall de­term­ine the cat­egor­ies of medi­cin­al products for which of­fi­cial batch re­lease is re­quired, as well as pro­ced­ure and the re­quire­ments to be ful­filled.

³ It shall pub­lish a list of medi­cin­al products which re­quire a batch re­lease for their dis­tri­bu­tion.

¹ A li­cence gran­ted by the Agency is re­quired by any per­son who pro­fes­sion­ally:

a.

im­ports ready-to-use medi­cin­al products in­ten­ded for dis­tri­bu­tion or dis­pens­ing;

b.

ex­ports ready-to-use medi­cin­al products in­ten­ded for dis­tri­bu­tion or dis­pens­ing;

c.

trades medi­cin­al products in for­eign coun­tries from Switzer­land, without their en­ter­ing Switzer­land;

d.

acts from Switzer­land as a broker or agent for medi­cin­al products.⁷²

² The Fed­er­al Coun­cil shall spe­cify the re­quire­ments for activ­it­ies un­der para­graph 1.⁷³

³ It may is­sue ex­emp­tions from the re­quire­ment of li­cence for:

a.

med­ic­al pro­fes­sion­als who work across bor­ders;

b.

in­ter­na­tion­al or­gan­isa­tions.

⁴ Goods stored in a cus­toms ware­house or a bon­ded ware­house shall be con­sidered to be im­por­ted.⁷⁴

⁵ The Fed­er­al Coun­cil may is­sue spe­cial reg­u­la­tions for goods in trans­it.

⁶ If an­oth­er State re­quests ex­port cer­ti­fic­ates and at­test­a­tions for the im­port­ing of medi­cin­al products, the Agency may is­sue such doc­u­ments to per­sons hold­ing an au­thor­isa­tion to ex­port.

¹ The li­cence shall be is­sued if:

a.

the ne­ces­sary tech­nic­al and op­er­a­tion­al con­di­tions are ful­filled;

b.

an ap­pro­pri­ate sys­tem of qual­ity as­sur­ance ex­ists.

² The li­cence shall also be is­sued to the ap­plic­ant who already pos­sesses a man­u­fac­tur­ing li­cence for medi­cin­al products. Fur­ther­more, the li­cence re­ferred to in Art­icle 18 para­graphs 1 let­ters b and c shall be is­sued to the ap­plic­ant already pos­sess­ing a li­cence for the im­port or whole­sale trade of medi­cin­al products.

³ The com­pet­ent au­thor­ity shall veri­fy by in­spec­tion that the con­di­tions are ful­filled.

¹ Medi­cin­al products which have been au­thor­ised, or which are not sub­ject to au­thor­isa­tion, may be im­por­ted.

² The Fed­er­al Coun­cil may per­mit the im­port­ing of small quant­it­ies of non-au­thor­ised ready-to-use medi­cin­al products by:

a.

private in­di­vidu­als for their per­son­al use;

b.

med­ic­al pro­fes­sion­als.

^2bis It may al­low un­au­thor­ised, ready-to-use, non-pre­scrip­tion medi­cin­al products for which no al­tern­at­ive and equi­val­ent medi­cin­al product has been au­thor­ised to be im­por­ted in small quant­it­ies in ac­cord­ance with Art­icle 25 para­graph 1 let­ters b and c with­in the lim­its of their dis­pens­ing au­thor­ity.⁷⁵

³ It may:

a.

stip­u­late that the li­cence to im­port cer­tain medi­cin­al products re­quir­ing a spe­cif­ic con­trol for the pro­tec­tion of health be gran­ted in par­tic­u­lar cases by the Agency;

b.

re­strict or pro­hib­it the im­port­ing of cer­tain medi­cin­al products if cir­cum­stances sug­gest that they could be in­ten­ded for il­leg­al pur­poses or mis­use.

⁴ The Agency shall draw up a list of medi­cin­al products for which im­ports shall be re­stric­ted or pro­hib­ited.

¹ The ex­port of medi­cin­al products and their for­eign trade from Switzer­land shall be pro­hib­ited if:

a.

they are pro­hib­ited in the tar­get coun­try;

b.⁷⁶

cir­cum­stances sug­gest that they are in­ten­ded for il­leg­al pur­poses; or

c.⁷⁷

it is deemed that they are in­ten­ded for cap­it­al pun­ish­ment.

^1bis The Fed­er­al Coun­cil shall reg­u­late the re­quire­ments for the ex­port and for­eign trade of medi­cin­al products which could be used for cap­it­al pun­ish­ment. It shall take ac­count of the EU pro­vi­sions.⁷⁸

² The Fed­er­al Coun­cil may stip­u­late that in par­tic­u­lar cases the ex­port of medi­cin­al products which are not au­thor­ised in Switzer­land or in the tar­get coun­try is pro­hib­ited by the Agency or sub­ject to re­stric­tions.

³ The Agency shall draw up a list of medi­cin­al products for which ex­port shall be re­stric­ted or pro­hib­ited.

⁴ In par­tic­u­lar cases, it may grant ex­emp­tions from ex­port re­stric­tions or bans, in par­tic­u­lar if the au­thor­ity of the tar­get coun­try agrees to the im­port.

¹ Any per­son ex­port­ing ready-to-use medi­cin­al products, wheth­er pre-pack­aged or not, should provide the re­cip­i­ent, without be­ing asked, with the ap­pro­pri­ate ba­sic med­ic­al and phar­ma­ceut­ic­al in­form­a­tion.

² Any per­son ex­port­ing medi­cin­al products in­ten­ded for use in clin­ic­al tri­als must de­mand proof that the rules of good clin­ic­al tri­al prac­tice are ap­plied.

¹ Medi­cin­al products shall be clas­si­fied in­to cat­egor­ies ac­cord­ing to wheth­er or not they are sub­ject to pre­scrip­tion.

² A cat­egory of over-the-counter medi­cin­al products shall be cre­ated for which neither med­ic­al and phar­ma­ceut­ic­al nor pro­fes­sion­al cus­tom­er ad­vice is re­quired. Art­icles 24–27 and 30 do not ap­ply to this cat­egory.⁸⁰

³ The Fed­er­al Coun­cil shall lay down the clas­si­fic­a­tion cri­ter­ia.⁸¹

¹ The Agency shall cat­egor­ise each medi­cin­al product for which it has gran­ted a mar­ket­ing au­thor­isa­tion in ac­cord­ance with the cri­ter­ia laid down by the Fed­er­al Coun­cil. It shall take in­to ac­count the pro­fes­sion­al com­pet­ence of the pro­fes­sion­al groups en­titled to dis­pense medi­cin­al products.

² It shall re­view the cat­egor­isa­tion of medi­cin­al products peri­od­ic­ally or at the re­quest of the hold­er of the mar­ket­ing au­thor­isa­tion and ad­apt it to the state of the art in sci­ence and tech­no­logy.

¹ The fol­low­ing per­sons shall be en­titled to dis­pense pre­scrip­tion-only medi­cin­al products:

a.⁸³

phar­macists, on present­a­tion of a doc­tor’s pre­scrip­tion. They may dis­pense medi­cin­al products without a doc­tor’s pre­scrip­tion if they have dir­ect con­tact with the per­son con­cerned, if they doc­u­ment the product dis­pensed, and if:

1.

the medi­cin­al products and in­dic­a­tions have been des­ig­nated by the Fed­er­al Coun­cil, or

2.

the case is jus­ti­fied and ex­cep­tion­al;

b.⁸⁴

all oth­er med­ic­al pro­fes­sion­als in ac­cord­ance with the pro­vi­sions on pro-phar­macy and tak­ing ac­count of Art­icle 1 para­graph 3 let­ter c;

c. all duly trained pro­fes­sion­als, un­der the su­per­vi­sion of a per­son spe­cified in let­ters a and b.

^1bis The Fed­er­al Coun­cil shall de­term­ine the form and the scope of the doc­u­ment­a­tion ob­lig­a­tion pur­su­ant to para­graph 1 let­ter a.⁸⁵

² Pre­scrip­tion-only med­ic­ated food­stuffs for an­im­als may also, on present­a­tion of a pre­scrip­tion from a veter­in­ary sur­geon, be dis­pensed by per­sons li­censed to add medi­cin­al products to an­im­al food­stuffs.

³ The can­tons may li­cense the per­sons re­ferred to in Art­icle 25 para­graph 1 let­ter c, to use cer­tain pre­scrip­tion-only medi­cin­al products.

¹ The fol­low­ing shall be en­titled to dis­pense non-pre­scrip­tion medi­cin­al products:

a.

per­sons en­titled to dis­pense pre­scrip­tion medi­cin­al products;

b.⁸⁶

drug­gist hold­ing a fed­er­al dip­loma;

c.

all oth­er duly trained per­sons, with­in the lim­its of their right to dis­pense medi­cin­al products;

d.

all duly trained pro­fes­sion­als, un­der the su­per­vi­sion of per­sons re­ferred to in let­ters a and b.

² The Fed­er­al Coun­cil shall de­term­ine the cat­egor­ies of duly trained per­sons which are re­ferred to in para­graph 1 let­ter c.

³ The Agency shall de­term­ine the medi­cin­al products which may be dis­pensed by the per­sons re­ferred to in para­graph 1 let­ter c.⁸⁷

⁴ …⁸⁸

⁵ Sub­ject to the pro­vi­sions of para­graphs 2 and 3, the can­tons may grant to per­sons hold­ing a qual­i­fic­a­tion re­cog­nised by the can­ton the right to dis­pense cer­tain groups of medi­cin­al products, such as those per­tain­ing to com­ple­ment­ary medi­cine. The Agency must be in­formed of this.

¹ The re­cog­nised rules of phar­ma­ceut­ic­al and med­ic­al sci­ences must be re­spec­ted when pre­scrib­ing, dis­pens­ing and us­ing medi­cin­al products, and the prin­ciples of the cor­res­pond­ing ther­apy ap­proach must be re­spec­ted when pre­scrib­ing, dis­pens­ing and us­ing com­ple­ment­ary medi­cines without in­dic­a­tions. The Federal Council may specify these rules in more detail.⁹⁰

² A medi­cin­al product may only be pre­scribed if the state of health of the con­sumer or pa­tient is known.

^2bis The fol­low­ing prin­ciples and min­im­um re­quire­ments must be ob­served for the pre­scrip­tion of medi­cin­al products:

a.

The pre­scrip­tion meets the min­im­al re­quire­ments set by the Fed­er­al Coun­cil fol­low­ing con­sulta­tions with the med­ic­al pro­fes­sions con­cerned.

b.

The pre­scrip­tion shall be­come the prop­erty of the per­son for whom it was is­sued. The per­son should re­main free to de­cide wheth­er to re­ceive the pre­scribed product or to ob­tain a second opin­ion and to de­term­ine with which au­thor­ised pro­vider they want to re­deem the pre­scrip­tion. In the case of elec­tron­ic pre­scrip­tions, the choice of pro­vider should not be re­stric­ted by tech­nic­al obstacles.⁹¹

³The pre­scriber shall not in­flu­ence pa­tients in the choice of the per­son who sup­plies them with the medi­cin­al products if he or she de­rives a ma­ter­i­al be­ne­fit from do­ing so. The Fed­er­al Coun­cil may provide for ex­cep­tions.⁹²

⁴ Be­fore a pre­scrip­tion-only medi­cin­al product for hu­man use is dis­pensed, a per­son au­thor­ised to pre­scribe and dis­pense the product must in prin­ciple is­sue a pre­scrip­tion to the pa­tient. The pa­tient may de­cline to ac­cept the pre­scrip­tion.⁹³

¹ In prin­ciple, mail-or­der trade in medi­cin­al products is pro­hib­ited.

² A li­cence may only be is­sued un­der the fol­low­ing con­di­tions:

a.

there is a doc­tor’s pre­scrip­tion for the medi­cin­al product;

b.

no safety re­quire­ments op­pose it;

c.

ap­pro­pri­ate con­sulta­tion is guar­an­teed;

d.

suf­fi­cient med­ic­al su­per­vi­sion of the ef­fect of the medi­cin­al product is guar­an­teed.

³ The Fed­er­al Coun­cil shall reg­u­late the de­tails.

⁴ The can­tons shall is­sue the au­thor­isa­tion.

¹ Any per­son en­gaged in the whole­sale trade of medi­cin­al products must pos­sess a 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 li­cence shall also be is­sued if the ap­plic­ant already pos­sesses a man­u­fac­tur­ing or im­port li­cence for medi­cin­al products.

⁴ The com­pet­ent au­thor­ity shall veri­fy by in­spec­tion that the con­di­tions are ful­filled.

¹ Any per­son en­gaged in the whole­sale trade of medi­cin­al products must re­spect the re­cog­nised prin­ciples of good dis­tri­bu­tion prac­tice.

² The Fed­er­al Coun­cil shall spe­cify the re­cog­nised prin­ciples of good dis­tri­bu­tion prac­tice. In do­ing so, it shall take ac­count of in­ter­na­tion­ally re­cog­nised guidelines and stand­ards.

¹ Any per­son dis­pens­ing medi­cin­al products must pos­sess a can­ton­al li­cence.

² The li­cence shall be is­sued when the re­quired spe­cial­ist con­di­tions are met and there is a qual­ity as­sur­ance sys­tem in place which is ap­pro­pri­ate for the type and size of the es­tab­lish­ment.

³The can­tons may is­sue fur­ther re­quire­ments. They reg­u­late the man­dat­ory li­cens­ing pro­cess and carry out peri­od­ic­al in­spec­tions of re­tail es­tab­lish­ments and prac­tices.

¹ In prin­ciple, it shall be per­mit­ted to:

a.

ad­vert­ise all types of medi­cin­al products if the ad­vert­ising is dir­ec­ted ex­clus­ively at per­sons who pre­scribe or dis­pense them;

b.

ad­vert­ise non-pre­scrip­tion medi­cin­al products to the gen­er­al pub­lic.

² The Fed­er­al Coun­cil shall lay down the con­di­tions for the pub­lic­a­tion of price com­par­is­ons for pre­scrip­tion medi­cin­al products.

³ It may, in or­der to pro­tect health and pre­vent fraud, re­strict or pro­hib­it the ad­vert­ising of cer­tain medi­cin­al products or groups of medi­cin­al products and en­act reg­u­la­tions con­cern­ing cross-bor­der ad­vert­ising.

¹ Ad­vert­ising shall be deemed un­law­ful:

a.

if it is mis­lead­ing or con­trary to pub­lic or­der and mor­al­ity;

b.

if it may in­cite an ex­cess­ive, ab­us­ive or in­ap­pro­pri­ate use of medi­cin­al products;

c.⁹⁶

if it is for medi­cin­al products which may not be placed on the mar­ket na­tion­ally or can­ton­ally.

² Ad­vert­ising dir­ec­ted at the gen­er­al pub­lic shall be deemed un­law­ful for medi­cin­al products which:

a.

may only be sup­plied on a pre­scrip­tion;

b.

con­tain nar­cot­ic or psy­cho­trop­ic sub­stances as re­ferred to in the Nar­cot­ics Act of 3 Oc­to­ber 1951⁹⁷;

c.

may not, on ac­count of their com­pos­i­tion and their in­ten­ded use, be used without the in­ter­ven­tion of a doc­tor for the ne­ces­sary dia­gnos­is, pre­scrip­tion or treat­ment;

d.

are fre­quently the ob­ject of ab­use or which lead to an ad­dic­tion or de­pend­ence.

¹ Any­one 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.

¹ An im­port li­cence is re­quired for each in­di­vidu­al batch of im­por­ted blood and blood products. Stor­age in a cus­toms ware­house shall be deemed to be im­port­ing.

² The Fed­er­al Coun­cil may make pro­vi­sion for ex­emp­tions from an im­port li­cence if all danger to per­sons is ex­cluded.

¹ The hold­er of the li­cence re­ferred to in Art­icle 34 para­graph 1 must veri­fy that the donor is fit to give blood.

² Per­sons ex­cluded from donat­ing blood shall be those:

a.

whose health could suf­fer from the ex­trac­tion of blood;

b.

whose blood may trans­mit patho­gens.

³ The Fed­er­al Coun­cil shall lay down the re­quire­ments re­lat­ing to the donor’s fit­ness to give blood, the com­pet­ence to es­tab­lish this fit­ness and the data which must be re­cor­ded at the time of the blood dona­tion.

¹Any op­er­a­tions re­lat­ing to blood and labile blood products, in par­tic­u­lar the ex­trac­tion, man­u­fac­ture, pro­cessing, stor­age and the pla­cing on the mar­ket, must be con­duc­ted in ac­cord­ance with the prin­ciples of qual­ity man­age­ment and the re­cog­nised prin­ciples of good man­u­fac­tur­ing prac­tice in the hand­ling of blood and blood products.

² Blood and labile blood products as well as as­so­ci­ated blood samples must be la­belled such that they can be un­am­bigu­ously iden­ti­fied at any time.

³ The Fed­er­al Coun­cil shall spe­cify the re­cog­nised rules of good man­u­fac­tur­ing prac­tice. In do­ing so, it shall take ac­count of in­ter­na­tion­ally re­cog­nised guidelines and stand­ards.

¹ Donated blood must be tested for the pres­ence or signs of patho­gens and ex­am­in­a­tions must be car­ried out in or­der to guar­an­tee com­pat­ib­il­ity.

² The Fed­er­al Coun­cil shall spe­cify:

a.

for which patho­gens or which signs of their pres­ence the blood should be tested;

b.

the pro­ced­ure to be fol­lowed when a test res­ult is pos­it­ive;

c.

the ex­am­in­a­tions to be car­ried out in or­der to guar­an­tee com­pat­ib­il­ity;

d.

the reg­u­la­tions con­cern­ing the ex­e­cu­tion of tests.

³ It may grant ex­emp­tions to the ob­lig­a­tion to test in the case of auto­log­ous trans­fu­sions.

¹ Any per­son hand­ling blood or blood products must:

a.

re­cord all of the pro­cesses which are im­port­ant for safety;

b.

main­tain the re­cords in such a man­ner as to be able to trace the data back to the per­son who donated or re­ceived the blood;

² For each ex­trac­tion of blood, the fol­low­ing shall in par­tic­u­lar be re­cor­ded:

a.

the sur­name, first name and the date of birth of the blood donor;

b.

the date on which the blood was taken;

c.

the test res­ults and their in­ter­pret­a­tion.

³ For a per­son ex­cluded from donat­ing blood, the fol­low­ing shall be re­cor­ded:

a.

the sur­name, first name and the date of birth;

b.

the date and the reas­ons for ex­clu­sion.

⁴ For a per­son to whom blood or blood products are to be ad­min­istered, the fol­low­ing shall be re­cor­ded:

a.

the sur­name, first name and the date of birth;

b.

the date of ad­min­is­tra­tion;

c.

the la­belling and the ori­gin of the blood or blood products.

⁵ The Fed­er­al Coun­cil shall reg­u­late the de­tails. In par­tic­u­lar, it may grant ex­emp­tions from the ob­lig­a­tion to re­cord in the case of auto­log­ous blood dona­tions.

¹ The in­form­a­tion re­cor­ded un­der Art­icle 39 and all im­port­ant doc­u­ments must be archived for 30 years.⁹⁹

² The Fed­er­al Coun­cil shall reg­u­late the de­tails. In par­tic­u­lar, it may:

a.

make pro­vi­sion for the trans­fer to the Agency, or the archiv­ing, of the re­cords re­ferred to in Art­icle 39 and any im­port­ant doc­u­ments, should the es­tab­lish­ment cease its activ­ity pri­or to the ex­piry of the archiv­ing peri­od;

b.

grant ex­emp­tions from the ob­lig­a­tion to archive in the case of auto­log­ous trans­fu­sions.

The Fed­er­al Coun­cil may pre­scribe ad­di­tion­al safety pre­cau­tions; in par­tic­u­lar it may de­term­ine that the pro­ced­ures for the re­mov­al or the in­ac­tiv­a­tion of pos­sible patho­gens may only be ap­plied after the Agency has giv­en au­thor­isa­tion.

¹ A medi­cin­al product may only be pre­scribed or sup­plied for an an­im­al if the pre­scriber knows the an­im­al or live­stock.

² If the medi­cin­al product is in­ten­ded for pro­duc­tion an­im­als, the pre­scriber must also know the state of health of the an­im­al.

³ The Fed­er­al Coun­cil may pro­hib­it the pre­scrip­tion and dis­pens­ing of medi­cin­al products or the ap­plic­a­tion of medi­cin­al products that need no au­thor­isa­tion in ac­cord­ance with Art­icle 9 para­graph 2 for pro­duc­tion an­im­als. It may also re­strict the pre­scrip­tion, dis­pens­ing or ap­plic­a­tion of these products.¹⁰⁰

¹ The Fed­er­al Coun­cil may provide for meas­ures to re­duce an­ti­mi­cro­bi­al res­ist­ance, in par­tic­u­lar:

a.

meas­ures to re­duce an­ti­bi­ot­ic con­sump­tion and pro­mote an­im­al health;

b.

re­quire­ments for the train­ing and fur­ther edu­ca­tion of veter­in­ari­ans and live­stock hold­ers.

² It may also re­strict or pro­hib­it the use of cer­tain an­ti­bi­ot­ic agents in veter­in­ary medi­cine in ac­cord­ance with for­eign reg­u­la­tions if this ap­pears ne­ces­sary for the ef­fect­ive treat­ment of pa­tients.

Any per­son who im­ports or ex­ports, dis­trib­utes or dis­penses veter­in­ary medi­cin­al products or ad­min­is­ters or al­lows them to be ad­min­istered to pro­duc­tion an­im­als must keep a re­cord of in­com­ings and out­go­ings of such medi­cin­al products and archive the sup­port­ing doc­u­ments.

The Fed­er­al Coun­cil may im­pose meas­ures for en­force­ment on the can­tons and ob­lige them to in­form the com­pet­ent fed­er­al of­fice of the en­force­ment meas­ures taken and the test res­ults.

¹ A med­ic­al device used in ac­cord­ance with its in­ten­ded use must not en­danger the health of the user, the con­sumer, the pa­tient or a third party. The in­ten­ded per­form­ance must be demon­strated.¹⁰²

² Any per­son pla­cing a med­ic­al device on the mar­ket must be able to prove that the device sat­is­fies the fun­da­ment­al re­quire­ments.

³ The Fed­er­al Coun­cil shall lay down the re­quire­ments that med­ic­al devices must sat­is­fy. In par­tic­u­lar it shall lay down:

a¹⁰³.

the fun­da­ment­al safety and per­form­ance re­quire­ments;

b.

the rules of their clas­si­fic­a­tion;

c.

the lan­guages used for the product in­form­a­tion;

d.¹⁰⁴

the product la­belling.

⁴ The Agency shall, in con­sulta­tion with the State Sec­ret­ari­at for Eco­nom­ic Af­fairs, des­ig­nate tech­nic­al stand­ards and com­mon spe­cific­a­tions which are ap­pro­pri­ate for giv­ing con­crete form to the fun­da­ment­al re­quire­ments. It shall des­ig­nate, as far as pos­sible, in­ter­na­tion­ally har­mon­ised stand­ards. It shall pub­lish in the Fed­er­al Gaz­ette the titles of the des­ig­nated tech­nic­al stand­ards and com­mon spe­cific­a­tions, also in­dic­at­ing the ref­er­ences or where they may be ob­tained.¹⁰⁵

⁵ The Fed­er­al Coun­cil shall lay down the re­quire­ments for med­ic­al devices in­ten­ded for use in clin­ic­al tri­als.

⁶ It may provide for the re­lax­a­tion of re­quire­ments for med­ic­al devices pro­duced and used only with­in health in­sti­tu­tions.¹⁰⁶

⁷ It may provide for the per­miss­ib­il­ity of re­pro­cessing and fur­ther use of single-use devices. It shall spe­cify the rel­ev­ant con­di­tions.¹⁰⁷

¹ Any per­son pla­cing a med­ic­al device on the mar­ket must be able to prove that it has been sub­mit­ted to the pre­scribed pro­ced­ures for as­sess­ing con­form­ity.

² The Fed­er­al Coun­cil shall reg­u­late the pre­scribed pro­ced­ures for as­sess­ing con­form­ity. In par­tic­u­lar it shall lay down:

a.

the types of pro­ced­ures;

b.

the med­ic­al devices for which an au­thor­ity for as­sess­ing con­form­ity must be en­lis­ted;

c.

the doc­u­ments re­quired and the length of time for which they should be archived.

³ It may:

a.

re­quire clin­ic­al tri­als for cer­tain med­ic­al devices, which will form an in­teg­ral part of the proof of con­form­ity;

b.

per­mit ex­emp­tions from the con­form­ity as­sess­ment for cer­tain med­ic­al devices or med­ic­al device groups.¹⁰⁸

¹ The man­u­fac­turer must re­gister med­ic­al devices in the in­form­a­tion sys­tem spe­cified in Art­icle 62c or in the European data­base on med­ic­al devices (Eu­damed). It must also en­sure that a unique device iden­ti­fi­er is as­signed to the med­ic­al device.

² The Fed­er­al Coun­cil shall define the mod­al­it­ies for re­gis­tra­tion and for device iden­ti­fic­a­tion. It may provide for ex­emp­tions from the ob­lig­a­tions spe­cified in para­graph 1.

³ It may reg­u­late the ob­lig­a­tions in­cum­bent on the oth­er eco­nom­ic op­er­at­ors con­cerned and on health in­sti­tu­tions in con­nec­tion with re­gis­tra­tion and device iden­ti­fic­a­tion. It may, in par­tic­u­lar, provide for an ob­lig­a­tion to re­cord and store the unique device iden­ti­fi­ers of the devices ac­quired or sup­plied in cer­tain cat­egor­ies.

⁴ The fol­low­ing are deemed to be eco­nom­ic op­er­at­ors:

a.

the man­u­fac­tur­ers;

b.

the per­sons au­thor­ised to rep­res­ent man­u­fac­tur­ers with headquar­ters abroad (au­thor­ised rep­res­ent­at­ives);

c.

the im­port­ers;

d.

the dis­trib­ut­ors;

e.

the nat­ur­al and leg­al per­sons who com­bine med­ic­al devices in or­der to place them on the mar­ket in the form of a sys­tem or a pro­ced­ure pack;

f.

the nat­ur­al and leg­al per­sons who ster­il­ise devices as spe­cified in let­ter e be­fore they are placed on the mar­ket.

¹ The man­u­fac­turer must pro­duce tech­nic­al doc­u­ment­a­tion.

² The tech­nic­al doc­u­ment­a­tion must be such as to per­mit an as­sess­ment of the con­form­ity of the med­ic­al device with the re­quire­ments of this Act. In par­tic­u­lar, it shall also con­tain in­form­a­tion and data on post-mar­ket sur­veil­lance.

³ The man­u­fac­turer must keep the tech­nic­al doc­u­ment­a­tion up to date.

⁴ The Fed­er­al Coun­cil shall spe­cify for what med­ic­al devices what data and in­form­a­tion must be in­cluded in the tech­nic­al doc­u­ment­a­tion, and how this doc­u­ment­a­tion must be made avail­able.

¹ The man­u­fac­turer must es­tab­lish and main­tain a qual­ity man­age­ment sys­tem which is ap­pro­pri­ate to the risk class and type of med­ic­al device and en­sures com­pli­ance with the re­quire­ments of this Act.

² The qual­ity man­age­ment sys­tem shall in­clude, in par­tic­u­lar, a risk man­age­ment sys­tem and a post-mar­ket sur­veil­lance sys­tem.

¹ The eco­nom­ic op­er­at­ors shall dis­close to the com­pet­ent au­thor­ity, on re­quest:

a.

all eco­nom­ic op­er­at­ors from whom they have ac­quired a med­ic­al device;

b.

all eco­nom­ic op­er­at­ors to whom they have sup­plied a med­ic­al device;

c.

all health in­sti­tu­tions or health pro­fes­sion­als to whom they have sup­plied a med­ic­al device.

² The Fed­er­al Coun­cil shall spe­cify for how long the in­form­a­tion has to be kept.

¹ The man­u­fac­turer or the au­thor­ised rep­res­ent­at­ive must have suf­fi­cient fin­an­cial cov­er­age to com­pensate for dam­age caused by de­fect­ive med­ic­al devices.

² The au­thor­ised rep­res­ent­at­ive shall be jointly and sev­er­ally li­able with the man­u­fac­turer vis-à-vis the in­jured party.

¹ The Fed­er­al Coun­cil may:

a.

make pro­vi­sion for man­dat­ory no­ti­fic­a­tion for the pla­cing on the mar­ket of cer­tain med­ic­al devices;

b.

make pro­vi­sion for man­dat­ory li­cens­ing for the pla­cing on the mar­ket of cer­tain med­ic­al devices, in par­tic­u­lar for in vitro dia­gnostics;

c.

make pro­vi­sion for an ob­lig­a­tion for eco­nom­ic op­er­at­ors and con­form­ity as­sess­ment bod­ies to use Eu­damed or the in­form­a­tion sys­tem spe­cified in Art­icle 62c.

² It shall reg­u­late:

a.

the ad­di­tion­al ob­lig­a­tions of eco­nom­ic op­er­at­ors and health in­sti­tu­tions, in par­tic­u­lar con­cern­ing the re­gis­tra­tion of the man­u­fac­tur­ers and the in­form­a­tion to be provided in con­nec­tion with im­plant­able med­ic­al devices;

b.

the re­quire­ments for the man­u­fac­tur­ers’ and au­thor­ised rep­res­ent­at­ives’ per­sons re­spons­ible for reg­u­lat­ory com­pli­ance, and their oth­er ob­lig­a­tions.

¹ For the pro­tec­tion of health, the Fed­er­al Coun­cil may, for cer­tain med­ic­al devices:

a.

make pro­vi­sion that they can only be dis­pensed on a med­ic­al pre­scrip­tion;

b.

lay down the ne­ces­sary tech­nic­al and op­er­a­tion­al con­di­tions or a man­dat­ory no­ti­fic­a­tion for their dis­pens­ing and use;

c.

at­tach to the dis­pens­ing of products the con­di­tion that the devices con­cerned must be trace­able between their man­u­fac­ture and their use and vice versa.

² Art­icle 26 ap­plies by ana­logy to med­ic­al devices.¹¹⁵

¹ Any per­son who uses a med­ic­al device com­mer­cially or who uses it on a third party shall be ob­liged to take all the ne­ces­sary meas­ures for the main­ten­ance of such device to en­sure the con­tin­ued per­form­ance and the safety of the med­ic­al device.

² The Fed­er­al Coun­cil may:

a.

spe­cify the type of main­ten­ance re­quired for cer­tain med­ic­al devices or cer­tain classes of med­ic­al devices;

b.

reg­u­late the pro­ced­ure for prov­ing that the ob­lig­a­tion of main­ten­ance and the re­l­at­ive re­quire­ments have been ful­filled;

c.

make the main­ten­ance de­pend­ent upon the tech­nic­al con­di­tions.

¹ If re­quired for the pro­tec­tion of health, the Fed­er­al Coun­cil may re­strict or pro­hib­it the im­port or ex­port of cer­tain med­ic­al devices.

² If an­oth­er state re­quests ex­port cer­ti­fic­ates and at­test­a­tions for med­ic­al devices which are to be im­por­ted, the Agency may, on re­quest, is­sue these doc­u­ments to the man­u­fac­turer or to the au­thor­ised rep­res­ent­at­ive with a re­gistered of­fice in Switzer­land.¹¹⁶

³ Any­one ex­port­ing a med­ic­al device to a state with which Switzer­land has con­cluded an agree­ment un­der in­ter­na­tion­al law for the mu­tu­al re­cog­ni­tion of con­form­ity as­sess­ments and pro­ced­ures for med­ic­al devices must be able to demon­strate that the fun­da­ment­al re­quire­ments re­ferred to in Art­icle 45 para­graph 2 are ful­filled.¹¹⁷

The Fed­er­al Coun­cil may, in or­der to pro­tect health and pre­vent fraud, re­strict or pro­hib­it the ad­vert­ising of cer­tain med­ic­al devices and en­act reg­u­la­tions con­cern­ing cross-bor­der ad­vert­ising.

¹ The Agency shall pub­lish the Phar­ma­co­poeia.

² It shall in­volve the in­ter­ested parties in the draft­ing of the Phar­ma­co­poeia. In par­tic­u­lar, it shall call upon ex­perts and work­ing groups.

³ It shall par­ti­cip­ate in the de­vel­op­ment of the European Phar­ma­co­poeia (Phar­ma­co­poeia Euro­paea) in ac­cord­ance with in­ter­na­tion­al con­ven­tions and trans­pose it in­to fed­er­al law. It may en­act ad­di­tion­al reg­u­la­tions val­id for Switzer­land (Phar­ma­co­poeia Hel­vetica).

⁴The Phar­ma­co­poeia shall be pub­lished sep­ar­ately from the Of­fi­cial Com­pil­a­tion of Fed­er­al Le­gis­la­tion. The Fed­er­al Coun­cil shall reg­u­late the de­tails of pub­lic­a­tion and in par­tic­u­lar shall stip­u­late the lan­guages in which it shall be pub­lished.

For clin­ic­al tri­als of thera­peut­ic products in hu­mans, the Hu­man Re­search Act of 30 Septem­ber 2011¹¹⁹ ap­plies in ad­di­tion to the pro­vi­sions of this Act.

¹ Clin­ic­al tri­als of thera­peut­ic products re­quire au­thor­isa­tion from the Agency in ad­vance.

² Ex­emp­ted from man­dat­ory au­thor­isa­tion are clin­ic­al tri­als in­volving au­thor­ised medi­cin­al products used in ac­cord­ance with the product in­form­a­tion.¹²¹

³ The Fed­er­al Coun­cil may:

a.

for oth­er tri­als, grant an ex­emp­tion from man­dat­ory au­thor­isa­tion or spe­cify man­dat­ory no­ti­fic­a­tion;

b.

for clin­ic­al tri­als of veter­in­ary thera­peut­ic products, spe­cify man­dat­ory au­thor­isa­tion or no­ti­fic­a­tion;

c.¹²²

make modi­fic­a­tions to clin­ic­al tri­als sub­ject to man­dat­ory au­thor­isa­tion.

⁴ As part of the au­thor­isa­tion pro­ced­ure, the Agency shall veri­fy:

a.

in the case of medi­cin­al products, wheth­er they com­ply with the rules of Good Man­u­fac­tur­ing Prac­tice and of medi­cin­al product safety;

b.

in the case of med­ic­al devices, wheth­er:

1.

the med­ic­al devices meet the re­quire­ments spe­cified in Art­icle 45, in­so­far as com­pli­ance with these re­quire­ments is not the sub­ject of the clin­ic­al tri­al,

2.

the risks as­so­ci­ated with a med­ic­al device are duly con­sidered in the clin­ic­al tri­al,

3.

the in­form­a­tion on the med­ic­al device is in line with cur­rent sci­entif­ic know­ledge and is cor­rectly in­dic­ated in the pro­tocol.¹²³

⁵ …¹²⁴

⁶ The Fed­er­al Coun­cil shall reg­u­late the au­thor­isa­tion pro­ced­ure. It may define the re­quired form of the ap­plic­a­tion and stip­u­late that the sub­mis­sion of ap­plic­a­tions, cor­res­pond­ence and the pub­lic­a­tion of de­cisions must be ef­fected elec­tron­ic­ally.¹²⁵

⁷ …¹²⁶

⁸ In is­su­ing reg­u­la­tions in ac­cord­ance with para­graphs 3 and 6, the Fed­er­al Coun­cil shall have re­gard to the re­cog­nised in­ter­na­tion­al reg­u­la­tions.¹²⁷

¹ For each medi­cin­al product, a pae­di­at­ric in­vest­ig­a­tion plan shall be drawn up with a view to its mar­ket­ing au­thor­isa­tion which sets out the re­quire­ments for the de­vel­op­ment of the medi­cin­al product in pae­di­at­rics and which must be sub­mit­ted to the Agency.

² The Fed­er­al Coun­cil shall reg­u­late:

a.

the pro­ced­ure;

b.

the re­quire­ments for the pae­di­at­ric in­vest­ig­a­tion plan in ac­cord­ance with the EU pro­vi­sions.

³ It may waive the ob­lig­a­tion to pre­pare a pae­di­at­ric in­vest­ig­a­tion plan, in par­tic­u­lar for medi­cin­al products for the treat­ment of dis­eases that oc­cur only in adults. It may provide for a pae­di­at­ric in­vest­ig­a­tion plan as­sessed by a for­eign au­thor­ity to be taken in­to ac­count.

¹ The Agency may at any time carry out an in­spec­tion to de­term­ine wheth­er the con­duct of the clin­ic­al tri­al meets the re­quire­ments spe­cified in this Act and in the Hu­man Re­search Act of 30 Septem­ber 2011¹³⁰.

² The Fed­er­al Coun­cil may, hav­ing re­gard to re­cog­nised in­ter­na­tion­al reg­u­la­tions, spe­cify no­ti­fic­a­tion and in­form­a­tion re­quire­ments, con­cern­ing in par­tic­u­lar:

a.

the com­ple­tion or dis­con­tinu­ation of a clin­ic­al tri­al;

b.

ad­verse events ob­served in con­nec­tion with a clin­ic­al tri­al;

c.

in­cid­ents oc­cur­ring dur­ing the con­duct of a clin­ic­al tri­al which may af­fect the safety or health of the par­ti­cipants or call in­to ques­tion the ac­quis­i­tion of re­li­able and ro­bust data.

³ It shall reg­u­late the no­ti­fic­a­tion pro­ced­ure and the ex­change of in­form­a­tion. It may stip­u­late that no­ti­fic­a­tion and the ex­change of in­form­a­tion must be ef­fected elec­tron­ic­ally.

¹ Per­sons who pre­scribe, dis­pense, use or pur­chase for this pur­pose pre­scrip­tion medi­cin­al products, and or­gan­isa­tions em­ploy­ing such per­sons shall not claim, be prom­ised or ac­cept any un­due ad­vant­age for them­selves or for the be­ne­fit of a third party. Sim­il­arly, it is for­bid­den to of­fer, prom­ise or grant an un­due ad­vant­age to any such per­son or or­gan­isa­tion for their be­ne­fit or for the be­ne­fit of a third party.

² The fol­low­ing are not re­garded as un­due ad­vant­ages:

a.

ad­vant­ages of mod­est value which are of rel­ev­ance to med­ic­al or phar­ma­ceut­ic­al prac­tice;

b.

sup­port for re­search, edu­ca­tion and train­ing, provided that cer­tain cri­ter­ia are met;

c.

com­pens­a­tion for equi­val­ent ser­vices in re­turn, in par­tic­u­lar for those provided in con­nec­tion with or­ders and de­liv­er­ies of thera­peut­ic products;

d.

price dis­counts or re­funds gran­ted on med­ic­al pur­chases, provided they have no in­flu­ence on the choice of treat­ment.

³ The Fed­er­al Coun­cil shall reg­u­late the de­tails. It may ex­tend the ap­plic­ab­il­ity of para­graphs 1 and 2 to oth­er cat­egor­ies of thera­peut­ic products.

¹ All dis­counts and re­bates gran­ted on pur­chases of medi­cin­al products shall be shown on the re­ceipts and in­voices and in the ac­counts of both the selling and the pur­chas­ing per­sons and or­gan­isa­tions and shall be dis­closed to the com­pet­ent au­thor­it­ies on re­quest.

² The Fed­er­al Coun­cil shall reg­u­late the de­tails.

³ It may provide for ex­cep­tions to the re­quire­ment laid down in para­graph 1 in the case of thera­peut­ic products with a low risk po­ten­tial.

¹ The Agency and the oth­er au­thor­it­ies en­trus­ted with the en­force­ment of this Act shall mon­it­or, with­in the lim­its of their powers, wheth­er the man­u­fac­ture, dis­tri­bu­tion, dis­pens­ing and main­ten­ance of, and claims re­lat­ing to thera­peut­ic products are law­ful. For this pur­pose, they may carry out an­nounced and un­an­nounced in­spec­tions.¹³⁵

² The Agency shall veri­fy the thera­peut­ic products placed on the mar­ket. It shall veri­fy that the medi­cin­al products con­form to the mar­ket­ing au­thor­isa­tion and that the med­ic­al devices sat­is­fy the leg­al re­quire­ments.

³ The Agency shall be re­spons­ible for mon­it­or­ing the safety of thera­peut­ic products. To this ef­fect, it shall in par­tic­u­lar col­lect the no­ti­fic­a­tions re­ferred to in Art­icle 59, eval­u­ate them, and take the ne­ces­sary ad­min­is­trat­ive meas­ures.

⁴ The Agency and the oth­er au­thor­it­ies en­trus­ted with the im­ple­ment­a­tion of this Act may take samples, re­quest es­sen­tial in­form­a­tion and doc­u­ments, and ask for any help ne­ces­sary for this pur­pose. Neither the samples nor any oth­er kind of help will be com­pensated for.¹³⁶

⁵ In the course of their mon­it­or­ing ser­vices, the can­tons shall no­ti­fy the Agency or the Fed­er­al Of­fice of Pub­lic Health (FOPH) in ac­cord­ance with their re­spect­ive re­spons­ib­il­it­ies of any events, find­ings or com­plaints. The Agency or the FOPH shall take the ne­ces­sary ad­min­is­trat­ive meas­ures. The can­tons may also take the ne­ces­sary ad­min­is­trat­ive meas­ures in the case of a ser­i­ous dir­ect threat to health.¹³⁷

¹ Any per­son man­u­fac­tur­ing or dis­trib­ut­ing ready-to-use thera­peut­ic products must put in place a sys­tem of no­ti­fic­a­tion. He must no­ti­fy the Agency of any ad­verse event or re­ac­tion which:

a.

is or may be at­trib­ut­able to the thera­peut­ic product it­self, its use or to in­cor­rect la­belling or in­struc­tions;

b.

may en­danger or dam­age the health of the con­sumer, of the pa­tient, of a third party or of the treated an­im­als.

² Any per­son man­u­fac­tur­ing or dis­trib­ut­ing thera­peut­ic products must fur­ther­more no­ti­fy the Agency of any qual­ity de­fects and any fur­ther find­ings and as­sess­ments which could in­flu­ence the basis of eval­u­ation.

³ Any per­son who pro­fes­sion­ally dis­penses thera­peut­ic products or ad­min­is­ters them to hu­mans or an­im­als or who is en­titled to do so as med­ic­al per­son­nel must no­ti­fy the Agency of any ser­i­ous and pre­vi­ously un­known ad­verse ef­fects and in­cid­ents, ob­ser­va­tions of oth­er ser­i­ous and pre­vi­ously un­known facts or qual­ity de­fectsthat are of significance for drug safety.¹³⁸

3^bis Any per­son who man­u­fac­tures or places on the mar­ket thera­peut­ic products must re­port to the Agency any sus­pi­cion of il­leg­al trad­ing in thera­peut­ic products by third parties that come to its know­ledge in con­nec­tion with its activ­it­ies, its products or their com­pon­ents.¹³⁹

⁴ Con­sumers, pa­tients and their or­gan­isa­tions as well as in­ter­ested third parties, may no­ti­fy the Agency for ad­verse events and re­ac­tions with thera­peut­ic products.

⁵ The no­ti­fic­a­tions re­ferred to in para­graphs 1–3 shall be made in ac­cord­ance with the re­cog­nised rules of good vi­gil­ance prac­tice.¹⁴⁰

⁶ The Fed­er­al Coun­cil shall define the re­cog­nised rules of good vi­gil­ance prac­tice. It shall take in­to ac­count in­ter­na­tion­ally re­cog­nised guidelines and stand­ards.¹⁴¹

⁷ Em­ploy­ees of per­sons and or­gan­isa­tions who man­u­fac­ture, dis­trib­ute, pre­scribe or dis­pense thera­peut­ic products are en­titled to no­ti­fy the com­pet­ent au­thor­it­ies of ob­ser­va­tions that in­dic­ate a vi­ol­a­tion of the pro­vi­sions of this Act.¹⁴²

¹ The Agency is re­spons­ible for in­spec­tions car­ried out in Switzer­land sub­ject to the re­ser­va­tions of Art­icles 30 and 34 para­graph 4.

² It is re­spons­ible for the in­spec­tions spe­cified in Art­icles 6, 19 and 28 in the fol­low­ing sec­tors:

a.

im­mun­o­lo­gic­al medi­cin­al products;

b.

blood and blood products;

c.

rarely used pro­ced­ures which re­quire very spe­cif­ic and spe­cial­ised know­ledge.

³ It shall del­eg­ate the in­spec­tions re­ferred to in Art­icles 6, 19 and 28 in all oth­er sec­tors to the can­ton­al in­spect­or­ates in­so­far as they sat­is­fy the re­quire­ments of fed­er­al le­gis­la­tion and in­ter­na­tion­al law ap­plic­able in Switzer­land.

⁴ It may in­volve the can­ton­al in­spect­or­ates in, or ask them to carry out in­spec­tions with­in its area of com­pet­ence.

⁵ The can­tons may in­volve re­gion­al or oth­er can­ton­al in­spect­or­ates or the Agency in, or ask them to carry out the in­spec­tions re­ferred to in para­graph 3.

Per­sons re­spons­ible for the ex­e­cu­tion of this Act are ob­liged to main­tain pro­fes­sion­al secrecy.

¹ If there is an over­rid­ing le­git­im­ate in­terest in pre­serving the secrecy of the data col­lec­ted in ac­cord­ance with this Act, the com­pet­ent au­thor­ity must treat such data as con­fid­en­tial.

² The Fed­er­al Coun­cil may de­term­ine the data which are dis­closed by the com­pet­ent au­thor­ity.

¹ The Agency and the Fed­er­al Of­fice for Cus­toms and Bor­der Se­cur­ity (FO­CBS), after weigh­ing up the in­terests, are en­titled on a case-by-case basis to dis­close con­fid­en­tial data col­lec­ted in ac­cord­ance with this Act to the hold­er of an op­er­at­ing li­cence or of a mar­ket­ing au­thor­isa­tion for medi­cin­al products or to any per­son who places a med­ic­al device on the mar­ket, in­clud­ing sens­it­ive per­son­al data in ac­cord­ance with Art­icle 5 let­ter c num­ber 5 of the Data Pro­tec­tion Act of 25 Septem­ber 2020¹⁴⁹, provided this meas­ure is re­garded as ne­ces­sary in or­der to un­cov­er or com­bat sus­pec­ted il­leg­al trad­ing in thera­peut­ic products.¹⁵⁰

² Per­son­al data re­lat­ing to pa­tients may not be dis­closed.

¹ The Agency, to ful­fil its tasks, shall op­er­ate a med­ic­al devices in­form­a­tion sys­tem; this shall serve in par­tic­u­lar to en­sure the safety of med­ic­al devices, as well as vi­gil­ance and sur­veil­lance.

² The in­form­a­tion sys­tem shall con­tain data as spe­cified in Art­icle 62a which is ne­ces­sary for the sur­veil­lance of med­ic­al devices and the con­duct of no­ti­fic­a­tion and au­thor­isa­tion pro­ced­ures for clin­ic­al tri­als in ac­cord­ance with this Act.

³ The data re­ferred to in para­graph 2 may be auto­mat­ic­ally aligned with Eu­damed.

⁴ Any data re­ferred to in para­graph 2 which is not sens­it­ive may be pub­lished with due pro­tec­tion of pro­fes­sion­al con­fid­en­ti­al­ity and trade secrets.

⁵ The Fed­er­al Coun­cil shall reg­u­late:

a.

the struc­ture and data cata­logue;

b.

the ac­cess rights;

c.

the or­gan­isa­tion­al and tech­nic­al meas­ures ne­ces­sary to en­sure data pro­tec­tion and data se­cur­ity;

d.

the stor­age peri­od.

¹ The fed­er­al and can­ton­al au­thor­it­ies re­spons­ible for en­for­cing this Act shall en­sure mu­tu­al dis­clos­ure of the data in­so­far as this is ne­ces­sary for en­for­cing this Act.

² The Fed­er­al Coun­cil may make pro­vi­sion for the dis­clos­ure of data to oth­er au­thor­it­ies or or­gan­isa­tions should this be ne­ces­sary for the en­force­ment of this Act.

³ It may make pro­vi­sion for the Agency to dis­close data to oth­er fed­er­al au­thor­it­ies if this is ne­ces­sary for the en­force­ment of fed­er­al le­gis­la­tion re­lat­ing to health.¹⁵²

¹ The fed­er­al au­thor­it­ies re­spons­ible for the en­force­ment of this Act may dis­close in­form­a­tion which is not pub­licly ac­cess­ible to the for­eign au­thor­it­ies and in­sti­tu­tions re­spons­ible for the en­force­ment of thera­peut­ic product reg­u­la­tions and to in­ter­na­tion­al or­gan­isa­tions, provided that it is en­sured that:

a.

the re­quest­ing body is bound by of­fi­cial secrecy and uses the in­form­a­tion re­ceived ex­clus­ively in an ad­min­is­trat­ive pro­ced­ure in con­nec­tion with the en­force­ment of thera­peut­ic product reg­u­la­tions and does not pass it on to third parties;

b.

only in­form­a­tion re­quired for the en­force­ment of thera­peut­ic product reg­u­la­tions is trans­mit­ted;

c.

no man­u­fac­tur­ing or trade secrets are dis­closed, un­less the trans­mis­sion of such in­form­a­tion is re­quired to avert an im­me­di­ate and ser­i­ous risk to hu­man life or health.

² They may dis­close per­son­al data, in­clud­ing data on health and on ad­min­is­trat­ive or crim­in­al pro­ceed­ings or sanc­tions, if le­gis­la­tion in the state con­cerned guar­an­tees ad­equate pro­tec­tion of the pri­vacy of the data sub­ject. In the ab­sence of such le­gis­la­tion, the data may only be dis­closed if:

a.

suf­fi­cient safe­guards, in par­tic­u­lar con­trac­tu­al clauses, en­sure an ad­equate level of pro­tec­tion;

b.

the data sub­ject has con­sen­ted in the spe­cif­ic case;

c.

ser­i­ous risks to health can thereby be aver­ted in the spe­cif­ic case;

d.

dis­clos­ure is re­quired in the spe­cif­ic case in or­der to pro­tect the life or the phys­ic­al in­teg­rity of the data sub­ject; or

e.

in the spe­cif­ic case, there is a pos­sib­il­ity that il­leg­al traffic or oth­er ser­i­ous vi­ol­a­tions of this Act may be re­vealed as a res­ult.

³ In par­tic­u­lar, the fol­low­ing data may be dis­closed:

a.

res­ults of mar­ket sur­veil­lance;

b.

in­spec­tion re­ports;

c.

in­form­a­tion on clin­ic­al tri­als;

d.

in­form­a­tion from vi­gil­ance;

e.

in­form­a­tion on au­thor­isa­tions;

f.

in­form­a­tion on con­form­ity as­sess­ment bod­ies.

⁴ The Agency is en­titled to dis­close the fol­low­ing in­form­a­tion to the World Health Or­gan­iz­a­tion via its Glob­al Phar­ma­covi­gil­ance Data­base, in con­nec­tion with no­ti­fic­a­tions and re­gis­tra­tions of ad­verse re­ac­tions to medi­cin­al products:

a.

in­form­a­tion which is not pub­licly ac­cess­ible and per­son­al data re­lat­ing to health, to­geth­er with the data sub­ject’s ini­tials, sex and year of birth;

b.

a re­port on the ad­verse re­ac­tions.

¹ Com­pet­ent for­eign au­thor­it­ies shall, on no­ti­fy­ing the Agency, be en­titled to in­spect Swiss es­tab­lish­ments op­er­at­ing in the thera­peut­ic products sec­tor provided that:

a.

the in­spec­tion has the sole pur­pose of veri­fy­ing com­pli­ance with reg­u­la­tions on thera­peut­ic products;

b.

the res­ults of the in­spec­tion are used solely in ad­min­is­trat­ive pro­ceed­ings in con­nec­tion with the en­force­ment of reg­u­la­tions on thera­peut­ic products;

c.

the es­tab­lish­ment con­cerned con­sents to the in­spec­tion; and

d.

the for­eign au­thor­ity in­forms the Agency of the res­ults by provid­ing it with the in­spec­tion re­port in an of­fi­cial Swiss lan­guage or in Eng­lish.

² The Agency may ac­com­pany the for­eign au­thor­ity dur­ing its in­spec­tion.

³ It may in con­sulta­tion with the com­pet­ent au­thor­it­ies carry out in­spec­tions of es­tab­lish­ments abroad that op­er­ate in the thera­peut­ic products sec­tor, if this is re­quired to guar­an­tee the pro­tec­tion of health. In ad­di­tion, it may par­ti­cip­ate in in­spec­tions car­ried out by com­pet­ent for­eign au­thor­it­ies.¹⁵⁵

The com­pet­ent fed­er­al and can­ton­al au­thor­it­ies are en­titled to pro­cess per­son­al data as part of the im­ple­ment­a­tion of their du­ties un­der this Act with re­gard to meas­ures to re­duce an­ti­bi­ot­ic res­ist­ance in veter­in­ary medi­cine.

¹ The Fed­er­al Food Safety and Veter­in­ary Of­fice (FS­VO) op­er­ates an in­form­a­tion sys­tem to mon­it­or an­ti­bi­ot­ic sales, an­ti­bi­ot­ic con­sump­tion and an­ti­bi­ot­ic res­ist­ance (An­ti­bi­ot­ics In­form­a­tion Sys­tem).

² The An­ti­bi­ot­ics In­form­a­tion Sys­tem is part of the joint cent­ral in­form­a­tion sys­tem along the food chain of the Fed­er­al Of­fice for Ag­ri­cul­ture (FO­AG) and the FS­VO.

³ The costs of set­ting up and op­er­at­ing the An­ti­bi­ot­ics In­form­a­tion Sys­tem are borne by the fed­er­al gov­ern­ment.

¹ The An­ti­bi­ot­ics In­form­a­tion Sys­tem con­tains per­son­al data in­clud­ing:

a.

the quant­ity of medi­cin­al products con­tain­ing an­ti­mi­cro­bi­al agents dis­trib­uted to the per­sons en­titled to dis­pense them;

b.

the data on pre­scrip­tion, dis­pens­ing and use of medi­cin­al products con­tain­ing an­ti­mi­cro­bi­al agents in ac­cord­ance with the in­struc­tions for use and the of­fi­cial pre­scrip­tion form;

c.

the name and ad­dress of the dis­pens­ing per­son or prac­tice;

d.

the name of the live­stock hold­er to whom the medi­cin­al product is dis­pensed;

e.

the date of dis­pens­ing.

² The An­ti­bi­ot­ics In­form­a­tion Sys­tem ob­tains:

a.

data from oth­er ap­plic­a­tions of the joint cent­ral in­form­a­tion sys­tem along the food chain as re­ferred to in Art­icle 64cpara­graph 2;

b.

per­son­al data from the Re­gister of Med­ic­al Pro­fes­sions in ac­cord­ance with Art­icles 51–54 of the Med­ic­al Pro­fes­sions Act of 23 June 2006¹⁵⁷.

¹ As part of their stat­utory du­ties, the fol­low­ing au­thor­it­ies may pro­cess data on­line in the An­ti­bi­ot­ics In­form­a­tion Sys­tem:

a.

the FS­VO: to com­pile an­ti­bi­ot­ics sales and con­sump­tion stat­ist­ics, to mon­it­or the an­ti­bi­ot­ic res­ist­ance situ­ation and to guar­an­tee the en­force­ment of the le­gis­la­tion;

b.

the can­ton­al en­force­ment au­thor­it­ies: to ful­fil their tasks in their re­spect­ive areas of re­spons­ib­il­ity.

² In or­der to ful­fil their stat­utory du­ties, the fol­low­ing au­thor­it­ies or per­sons may re­trieve data on­line from the An­ti­bi­ot­ics In­form­a­tion Sys­tem:

a.

the FS­VO and the can­ton­al en­force­ment au­thor­it­ies: dis­tri­bu­tion, pre­scrip­tion, dis­pens­ing and ap­plic­a­tion data;

b.

the FS­VO: dis­tri­bu­tion, pre­scrip­tion, dis­pens­ing and ap­plic­a­tion data to ful­fil the tasks as­signed to it in ac­cord­ance with the Ag­ri­cul­ture Act of 29 April 1998¹⁵⁸;

c.

live­stock hold­ers: data con­cern­ing them­selves;

d.

veter­in­ari­ans and oth­er per­sons sub­ject to the ob­lig­a­tion to re­port un­der Art­icle 64flet­ter h: data con­cern­ing them and data which they have re­por­ted.

The Fed­er­al Coun­cil reg­u­lates the fol­low­ing for the An­ti­bi­ot­ics In­form­a­tion Sys­tem:

a.

the struc­ture and data cata­logue, in­clud­ing the part used by the can­tons;

b.

the re­spons­ib­il­it­ies for data pro­cessing;

c.

the ac­cess rights un­der Art­icle 64e, in par­tic­u­lar their scope;

d.

the or­gan­isa­tion­al and tech­nic­al meas­ures ne­ces­sary to en­sure data pro­tec­tion and data se­cur­ity;

e.

the co­oper­a­tion pro­ced­ure with the can­tons;

f.

stor­age and de­struc­tion peri­ods;

g.

archiv­ing;

h.

the re­port­ing ob­lig­a­tions of per­sons who mar­ket, pre­scribe, dis­pense and use an­ti­bi­ot­ics; live­stock hold­ers are ex­empt from the ob­lig­a­tion to re­port;

i.

ob­tain­ing data on the veter­in­ary pro­fes­sion from the Re­gister of Med­ic­al Pro­fes­sions in ac­cord­ance with Art­icles 51–54 of the Med­ic­al Pro­fes­sions Act of 23 June 2006¹⁵⁹.

The can­tons that use the An­ti­bi­ot­ics In­form­a­tion Sys­tem for their own en­force­ment pur­poses are ob­liged to is­sue equi­val­ent data pro­tec­tion pro­vi­sions for their own areas and to des­ig­nate a body to mon­it­or com­pli­ance with these pro­vi­sions.

¹ The Agency and oth­er au­thor­it­ies en­trus­ted with en­for­cing this Act shall levy fees for the li­cences, con­trols and the ser­vices that they provide. Fur­ther­more, the Agency may levy fees for the re­ceipt of no­ti­fic­a­tions.

² It shall levy a su­per­vi­sion fee on the mar­ket­ing au­thor­isa­tion hold­ers for the fin­an­cing of costs it in­curs in the field of medi­cin­al products which are not covered by fees in ac­cord­ance with para­graph 1 or by pay­ments from the Con­fed­er­a­tion in ac­cord­ance with Art­icle 77 para­graph 2a.¹⁶¹

³ The su­per­vi­sion fee shall be levied on the ex-fact­ory price of the au­thor­ised ready-to-use medi­cin­al products sold in Switzer­land. The max­im­um fee is 1.5 per cent of the ex-fact­ory price. The in­come from the fee may not ex­ceed a total of 1 per cent of the pro­ceeds from all medi­cin­al products sold in the re­spect­ive levy year.¹⁶²

⁴ The Fed­er­al Coun­cil shall reg­u­late the de­tails of the su­per­vi­sion fee, in par­tic­u­lar the fee rate ap­plic­able to the in­di­vidu­al price cat­egor­ies.¹⁶³

⁵ The Agency Coun­cil shall set its fees in ac­cord­ance with para­graph 1 in the Agency’s Fees Or­din­ance. The Fees Or­din­ance shall be sub­mit­ted to the Fed­er­al Coun­cil for ap­prov­al.¹⁶⁴

⁶ The Fed­er­al Coun­cil may, un­der the stra­tegic ob­ject­ives, re­quest that the Agency re­lin­quish all or part of the fees for cer­tain li­cences, pro­vi­sions of ser­vice or con­trols.¹⁶⁵

¹ The Agency and the oth­er au­thor­it­ies en­trus­ted with the en­force­ment of this Act may with­in their jur­is­dic­tion take all ad­min­is­trat­ive meas­ures ne­ces­sary to en­force this Act.¹⁶⁶

² In par­tic­u­lar they may:¹⁶⁷

a.

raise ob­jec­tions and set an ap­pro­pri­ate time peri­od for restor­ing the state of law;

b.

sus­pend or re­voke li­cences and mar­ket­ing au­thor­isa­tions;

c.

close down es­tab­lish­ments;

d.

seize, hold in of­fi­cial stor­age or des­troy thera­peut­ic products which en­danger health or which do not con­form to the reg­u­la­tions of this Act;

e.

pro­hib­it the dis­tri­bu­tion, dis­pens­ing, im­port, ex­port and for­eign trade from Switzer­land of thera­peut­ic products, or­der their im­me­di­ate re­call from the mar­ket, or or­der the pub­lic­a­tion of re­com­mend­a­tions of con­duct to pre­vent dam­age;

f.

seize, hold in of­fi­cial stor­age, des­troy or pro­hib­it the use of il­leg­al ad­vert­ising me­dia, and pub­lish the pro­hib­i­tion at the ex­pense of the re­spons­ible parties;

g.

tem­por­ar­ily or per­man­ently pro­hib­it the ad­vert­ising of a spe­cif­ic thera­peut­ic product in the event of ser­i­ous or re­peated in­fringe­ments of the pro­vi­sions of this Act, and pub­lish the pro­hib­i­tion at the ex­pense of the re­spons­ible parties.

³ They may or­der thera­peut­ic products from a per­son un­der a fic­ti­tious name if:

a.

they sus­pect that the per­son is man­u­fac­tur­ing, im­port­ing or ex­port­ing thera­peut­ic products il­leg­ally or pla­cing them on the mar­ket il­leg­ally; and

b.

pre­vi­ous en­quir­ies have been un­suc­cess­ful or fur­ther en­quir­ies would oth­er­wise be fu­tile or would be dis­pro­por­tion­ately dif­fi­cult.¹⁶⁸

⁴ The cus­toms au­thor­it­ies shall be en­titled to hold back ship­ments of thera­peut­ic products at the bor­der, in a free port or in a cus­toms ware­house if they sus­pect that the re­cip­i­ent or sender in Switzer­land is in breach of the pro­vi­sions gov­ern­ing the im­port, man­u­fac­ture, pla­cing on the mar­ket or ex­port of thera­peut­ic products with the con­tents of the ship­ment.¹⁶⁹

⁵They may call in the en­force­ment au­thor­it­ies. The lat­ter shall make any fur­ther en­quir­ies and take the ne­ces­sary meas­ures. In par­tic­u­lar, they may ask postal ser­vice pro­viders for the name and ad­dress of the hold­er of a post of­fice box. In this case, the pro­viders are ob­liged to provide in­form­a­tion.¹⁷⁰

⁶ The en­force­ment au­thor­it­ies shall in­form the per­sons con­cerned at the latest after the com­ple­tion of the pro­ced­ure of:

a.

the or­der un­der a fic­ti­tious name;

b.

the re­quest for in­form­a­tion and the reas­on for it.¹⁷¹

¹ The Agency shall en­sure that the pub­lic is in­formed of oc­cur­rences spe­cific­ally re­lat­ing to thera­peut­ic products which en­danger health, and shall is­sue ap­pro­pri­ate re­com­mend­a­tions. It shall pub­lish in­form­a­tion of gen­er­al in­terest about the thera­peut­ic products sec­tor, in par­tic­u­lar re­gard­ing au­thor­isa­tion and re­voc­a­tion de­cisions as well as about find­ings with­in the frame­work of mar­ket sur­veil­lance.¹⁷²

^1bisThe pro­fes­sion­al in­form­a­tion con­tains all the act­ive sub­stances and ex­cipi­ents of a medi­cin­al product.¹⁷³

² The com­pet­ent fed­er­al of­fices may in­form the pub­lic on the cor­rect use of thera­peut­ic products for the pur­pose of pro­tect­ing health and com­bat­ing the ab­use of such products.

³ The mar­ket­ing au­thor­isa­tion hold­ers, rep­res­ent­at­ives of the in­ter­ested med­ic­al pro­fes­sions, per­sons with in­de­pend­ent dis­pens­ing rights in ac­cord­ance with Art­icle 25 and pa­tients or their as­so­ci­ations shall jointly main­tain an in­sti­tu­tion in the form of a found­a­tion which op­er­ates an elec­tron­ic re­gister with the leg­ally pre­scribed in­form­a­tion on medi­cin­al products in the hu­man and veter­in­ary fields.¹⁷⁴

⁴ The in­sti­tu­tion shall pub­lish in the elec­tron­ic re­gister re­ferred to in para­graph 3 in a suit­able and struc­tured form the full and up-to-date in­form­a­tion on medi­cin­al products of the mar­ket­ing au­thor­isa­tion hold­ers at their ex­pense. A simple re­gister with the full and up-to-date in­form­a­tion on medi­cin­al products shall be pub­licly ac­cess­ible and free of charge for all.¹⁷⁵

⁵ The mar­ket­ing au­thor­isa­tion hold­ers shall provide the in­sti­tu­tion with the leg­ally pre­scribed in­form­a­tion on the medi­cin­al products in the form in­ten­ded for this pur­pose. If the mar­ket­ing au­thor­isa­tion hold­ers fail to com­ply with this ob­lig­a­tion, the in­sti­tu­tion shall struc­ture the in­form­a­tion at their ex­pense.¹⁷⁶

⁶ The in­sti­tu­tion shall es­tab­lish, with the in­volve­ment of the in­sti­tu­tion and the per­sons with in­de­pend­ent dis­pens­ing rights in ac­cord­ance with Art­icle 25, the re­quire­ments as to the scope and struc­ture of the data re­ferred to in para­graph 4 and their sup­ply in ac­cord­ance with para­graph5. It shall, as far as pos­sible, take in­to ac­count the rel­ev­ant in­ter­na­tion­al stand­ards.¹⁷⁷

⁷ The com­pet­ent fed­er­al au­thor­it­ies may make fur­ther of­fi­cially pub­lished in­form­a­tion ac­cess­ible via the re­gister ser­vice.¹⁷⁸

⁸ If the in­sti­tu­tion does not ful­fil its task, the Agency shall pub­lish the leg­ally pre­scribed in­form­a­tion on medi­cin­al products at the ex­pense of the mar­ket­ing au­thor­isa­tion hold­ers in the form of an elec­tron­ic re­gister. The Agency may del­eg­ate the cre­ation and op­er­a­tion of the re­gister to third parties.¹⁷⁹

⁹ As soon as it has re­ceived an ap­plic­a­tion for mar­ket­ing au­thor­isa­tion for a medi­cin­al product, the Agency shall pub­lish the in­dic­a­tion, the act­ive sub­stances in the medi­cin­al product and the name and ad­dress of the ap­plic­ant, provided the pub­lic­a­tion does not con­flict with any in­terests of secrecy worth pro­tect­ing.¹⁸⁰

¹ In or­der to im­prove safety in the use of medi­cin­al products in pae­di­at­rics, the Fed­er­al Coun­cil may al­low for the col­lec­tion, har­mon­isa­tion, eval­u­ation and pub­lic­a­tion of data re­lat­ing to the pre­scrip­tion, sup­ply and use of medi­cin­al products.

² The Confederation may arrange for a database to be established and operated by third parties for this purpose. This database may not contain personal data.

³ The Fed­er­al Coun­cil:

a.

shall spe­cify the ba­sic re­quire­ments for the con­tent, op­er­a­tion and qual­ity of the data­base and reg­u­late the con­di­tions for the ac­cess to and use of the data;

b.

de­term­ines the en­tity re­spons­ible for man­aging the data­base and may au­thor­ise the same to gath­er in­form­a­tion in an­onymised form from med­ic­al pro­fes­sion­als.

⁴ The op­er­at­ors in ac­cord­ance with para­graph 2 shall guar­an­tee the in­ter­op­er­ab­il­ity of this data­base with the re­gister in ac­cord­ance with Art­icle 67.

⁵ The Federal Council may extend the activities under paragraphs 1 and 2 to include further specific population groups. It may provide for the establishment of advisory committees or the consultation of experts.

¹ The Fed­er­al Coun­cil may, tak­ing in­to ac­count in­ter­na­tion­ally re­cog­nised reg­u­la­tions, provide that the res­ults of clin­ic­al tri­als car­ried out with a view to de­vel­op­ing a medi­cin­al product for hu­man use shall be pub­lished after the au­thor­isa­tion de­cision.

² For this pur­pose, the Con­fed­er­a­tion may op­er­ate a data­base or have it op­er­ated by third parties. This data­base may not con­tain any data that would al­low any ref­er­ence to per­sons par­ti­cip­at­ing in clin­ic­al tri­als.

³ The Fed­er­al Coun­cil:

a.

des­ig­nates the au­thor­ity re­spons­ible for main­tain­ing the data­base;

b.

spe­cifies the du­ties and pro­ced­ure with re­gard to pub­lic­a­tion;

c.

de­term­ines the con­tent and form of the res­ults to be pub­lished;

d.

de­term­ines the re­quire­ments for the con­tent and op­er­a­tion of the data­base;

e.

reg­u­lates the ac­cess to and use of the data.

¹ The Con­fed­er­a­tion shall run the Agency with the co­oper­a­tion of the can­tons.

² The Agency is an in­sti­tu­tion un­der pub­lic law with its own leg­al per­son­al­ity.

³ It is autonom­ous in its or­gan­isa­tion and man­age­ment; it may use its fund­ing as it sees fit and shall keep its own ac­counts.

⁴ It may call upon private in­di­vidu­als to per­form cer­tain tasks.

⁵ It may ap­point ad­vis­ory com­mit­tees and ex­perts.

¹ The Agency shall ac­com­plish the tasks as­signed to it un­der this Act and oth­er fed­er­al acts.¹⁸⁴

^1bis The Fed­er­al Coun­cil may, against pay­ment, del­eg­ate oth­er tasks to the Agency which are closely re­lated to the tasks as­signed to it by law and which do not im­pair its per­form­ance.¹⁸⁵

² The Agency may, in re­turn for pay­ment, provide ser­vices to oth­er au­thor­it­ies and in­ter­na­tion­al or­gan­isa­tions with­in the scope of its tasks un­der this Act, provided that such ser­vices do not jeop­ard­ise the in­de­pend­ence of the Agency.¹⁸⁶

³ The Fed­er­al Coun­cil may ask the Agency to par­ti­cip­ate in the draft­ing of le­gis­la­tion in the thera­peut­ic products sec­tor.

⁴ The Agency is the na­tion­al cent­ral and con­tact point pur­su­ant to Art­icles 17 para­graph 3 and 22 para­graph 2 of the Coun­cil of Europe Con­ven­tion of 28 Oc­to­ber 2011¹⁸⁷ on the coun­ter­feit­ing of med­ic­al products and sim­il­ar crimes in­volving threats to pub­lic health. It shall main­tain con­tacts with the des­ig­nated con­tact points in oth­er coun­tries.¹⁸⁸

¹ The Fed­er­al Coun­cil shall ap­prove the Agency’s stra­tegic ob­ject­ives for a peri­od of four years at the re­com­mend­a­tion of the Agency Coun­cil.

² Ad­just­ments which be­come ne­ces­sary on the basis of the an­nu­al re­view by the Agency Coun­cil shall be sub­mit­ted to the Fed­er­al Coun­cil for re­view.

¹ The gov­ern­ing bod­ies of the Agency are:

a.

the Agency Coun­cil;

b.

the Man­age­ment Board;

c.

the aud­it­or.

² No per­son may be­long to more than one of these bod­ies.

³ The Fed­er­al Coun­cil may re­move one or more mem­bers of the Agency Coun­cil for good cause.

¹ The mem­bers of the Agency Coun­cil shall dis­close their ves­ted in­terests to the Fed­er­al Coun­cil pri­or to their elec­tion.

² Any per­son who re­fuses to dis­close their ves­ted in­terests shall not be eli­gible for elec­tion as a mem­ber.

³ The mem­bers of the Agency Coun­cil shall im­me­di­ately no­ti­fy the Fed­er­al De­part­ment of Home Af­fairs of any change in their ves­ted in­terests dur­ing their term of of­fice.

⁴ The Agency shall up­date the re­gister and pub­lish the ves­ted in­terests.

⁵ Pro­fes­sion­al secrecy with­in the mean­ing of the Crim­in­al Code¹⁹² shall re­main re­served.

⁶ A mem­ber of the Agency Coun­cil may be re­moved if they have not fully dis­closed their ves­ted in­ter­ested at the time of the elec­tion or if they have not re­por­ted changes in their ves­ted in­terests dur­ing their term of of­fice, and if they fail to do so even after be­ing re­ques­ted to do so by the Fed­er­al Of­fice of Home Af­fairs.

¹ The Agency Coun­cil shall com­prise a max­im­um of sev­en mem­bers.

² On the basis of a pro­file of re­quire­ments, the Fed­er­al Coun­cil shall elect the mem­bers of the Agency Coun­cil and ap­point one of these mem­bers as chair­per­son. The can­tons have the right to pro­pose three mem­bers.

³ The elec­tion shall be for a term of four years. Re-elec­tion is pos­sible for two fur­ther terms of of­fice.

¹ The Agency Coun­cil is the stra­tegic body of the Agency and safe­guards its in­terests. It has the fol­low­ing du­ties:

a.

It draws up the Agency’s stra­tegic ob­ject­ives, sub­mits them to the Fed­er­al Coun­cil for ap­prov­al and re­views them an­nu­ally.

b.

It sub­mits an an­nu­al re­port to the Fed­er­al Coun­cil on the achieve­ment of the stra­tegic ob­ject­ives. It sub­mits to the Fed­er­al Coun­cil the re­port of the Swiss Fed­er­al Audit Of­fice on an audit of the Agency as part of fin­an­cial su­per­vi­sion.

c.

It pro­poses to the Fed­er­al Coun­cil the amount of com­pens­a­tion to be paid by the Con­fed­er­a­tion for ser­vices rendered pur­su­ant to Art­icle 69.

d.

It is­sues the reg­u­la­tions of the or­gan­isa­tion of the Agency.

e.

It is­sues is own rules of pro­ced­ure and shall in par­tic­u­lar lay down the rules on re­cus­al.

f.

It pre­pares and ap­proves a busi­ness re­port for each fin­an­cial year and sub­mits it to the Fed­er­al Coun­cil for ap­prov­al. At the same time, it sub­mits a re­quest to the Fed­er­al Coun­cil for dis­charge and for the ap­pro­pri­ation of any profit. It pub­lishes the busi­ness re­port after ap­prov­al.

g.

It de­cides on the es­tab­lish­ment, amend­ment and ter­min­a­tion of the em­ploy­ment re­la­tion­ship with the ex­ec­ut­ive dir­ect­or. The es­tab­lish­ment and ter­min­a­tion of the em­ploy­ment re­la­tion­ship re­quire the ap­prov­al of the Fed­er­al Coun­cil.

h.

It de­cides on the es­tab­lish­ment, amend­ment and ter­min­a­tion of the em­ploy­ment re­la­tion­ship of the oth­er mem­bers of the Man­age­ment Board at the re­quest of the ex­ec­ut­ive dir­ect­or.

i.

It ful­fils oth­er du­ties in the thera­peut­ic products sec­tor which the Fed­er­al Coun­cil as­signs to it.

j.

It su­per­vises the Man­age­ment Board and en­sures that the in­tern­al con­trol sys­tem and risk man­age­ment are ap­pro­pri­ate for the Agency.

k.

It en­acts the pro­vi­sions re­ferred to in Art­icle 82 para­graph 2.

l.

It ap­proves the busi­ness plan and the budget.

m.

It con­cludes the af­fil­i­ation agree­ment with the Fed­er­al Pen­sion Fund (PUB­LICA) and sub­mits it to the Fed­er­al Coun­cil for ap­prov­al.

n.

It reg­u­lates the com­pos­i­tion, elec­tion pro­ced­ure and or­gan­isa­tion of the joint body for the pen­sion fund.

o.

It is­sues reg­u­lat­ory pro­vi­sions which guar­an­tee the in­de­pend­ence of the ex­perts ap­poin­ted by the Agency.

² The mem­bers of the Agency Coun­cil shall ful­fil their du­ties and ob­lig­a­tions with all due care and shall safe­guard the in­terests of the Agency in good faith. The Agency Coun­cil shall take or­gan­isa­tion­al pre­cau­tions to safe­guard the in­terests of the Agency and to pre­vent con­flicts of in­terest.

¹ The Man­age­ment Board is the op­er­at­ive body of the Agency. It is headed by an ex­ec­ut­ive dir­ect­or.

² The Man­age­ment Board has the fol­low­ing du­ties:

a.

to con­duct busi­ness;

b.

to is­sue ad­min­is­trat­ive or­ders as provided for in the reg­u­la­tions of the or­gan­isa­tion;

c.

to pre­pare the basis for the de­cisions of the Agency Coun­cil and re­port to it reg­u­larly and without delay in the event of spe­cial in­cid­ents;

d.

to rep­res­ent the Agency in con­tacts with the out­side world;

e.

to is­sue the busi­ness plan and the budget and sub­mit the same to the Agency Coun­cil for ap­prov­al;

f.

to de­cide on es­tab­lish­ment, amend­ment and ter­min­a­tion of the em­ploy­ment re­la­tion­ship of Agency staff; the fore­go­ing is without pre­ju­dice to Art­icle 72a para­graph 1 let­ter h;

g.

to carry out the tasks not as­signed to any oth­er Agency body.

¹ The Agency shall em­ploy its staff un­der pub­lic law. In jus­ti­fied cases, con­tracts may be con­cluded in ac­cord­ance with the Code of Ob­lig­a­tions¹⁹⁹.

² The Agency Coun­cil is­sues the Agency’s staff reg­u­la­tions sub­ject to ap­prov­al by the Fed­er­al Coun­cil.²⁰⁰

³ With re­gard to the salar­ies of the mem­bers of the Man­age­ment Board and oth­er per­sons who are re­mu­ner­ated in a com­par­able way, and with re­gard to the oth­er con­trac­tu­al con­di­tions agreed with these per­sons, Art­icle 6a para­graphs 1–5 of the Fed­er­al Per­son­nel Act of 24 March 2000²⁰¹ ap­ply by ana­logy.²⁰²

⁴ The Fed­er­al Coun­cil shall de­term­ine the com­pens­a­tion of the mem­bers of the Agency Coun­cil. Art­icle 6a para­graphs 1–5 of the Fed­er­al Per­son­nel Act ap­ply to the re­mu­ner­a­tion of the mem­bers of the Agency Coun­cil and to the oth­er con­trac­tu­al con­di­tions agreed with these per­sons.²⁰³

¹ Em­ploy­ees shall no­ti­fy the pro­sec­u­tion au­thor­it­ies, their su­per­i­ors, the Agency Coun­cil or the Swiss Fed­er­al Audit Of­fice of any felony or mis­de­mean­our which they have dis­covered or has been re­por­ted to them in the course of their of­fi­cial du­ties.

² The ob­lig­a­tions to no­ti­fy arising from oth­er fed­er­al acts are re­served.

³ The ob­lig­a­tion to no­ti­fy does not ap­ply to per­sons en­titled to re­fuse to testi­fy or give evid­ence un­der Art­icles 113 para­graph 1, 168 and 169 of the Crim­in­al Pro­ced­ure Code²⁰⁵.

⁴ Em­ploy­ees are en­titled to re­port to their su­per­i­ors, the Agency Coun­cil or the Swiss Fed­er­al Audit Of­fice any oth­er ir­reg­u­lar­it­ies dis­covered or re­por­ted to them in the course of their of­fi­cial du­ties.

⁵ Any per­son who has sub­mit­ted a no­ti­fic­a­tion or a re­port in good faith or who has test­i­fied as a wit­ness may not be dis­ad­vant­aged in their pro­fes­sion­al status as a con­sequence.

¹ The Agency shall pro­cess, on pa­per and in one or more in­form­a­tion sys­tems, em­ploy­ee data for the ful­fil­ment of its tasks in ac­cord­ance with this Act, in par­tic­u­lar for:

a.

de­term­in­ing per­son­nel re­quire­ments;

b.

meet­ing per­son­nel re­quire­ments through staff re­cruit­ment;

c.

wage and salary ac­count­ing, pre­par­a­tion of per­son­nel re­cords, so­cial in­sur­ance no­ti­fic­a­tions;

d.

de­vel­op­ment and long-term re­ten­tion of staff;

e.

main­ten­ance and im­prove­ment of staff qual­i­fic­a­tions;

f.

plan­ning, man­age­ment and con­trol through data ana­lys­is, bench­mark­ing, re­port­ing and plan­ning of meas­ures.

² It may pro­cess the fol­low­ing per­son­nel data ne­ces­sary for the ful­fil­ment of its tasks as spe­cified in para­graph 1, in­clud­ing sens­it­ive per­son­al data:

a.

per­son­al de­tails;

b.

in­form­a­tion on the health situ­ation in re­la­tion to fit­ness for work;

c.

in­form­a­tion on per­form­ance and po­ten­tial, and on per­son­al and pro­fes­sion­al de­vel­op­ment;

d.

data re­quired for par­ti­cip­a­tion in the en­force­ment of so­cial in­sur­ance law;

e.

pro­ced­ur­al doc­u­ments and de­cisions by au­thor­it­ies re­lat­ing to work.

³ It shall be re­spons­ible for data pro­tec­tion and se­cur­ity.

⁴ It may pass on data to third parties if a leg­al basis for this ex­ists, or if writ­ten con­sent has been giv­en by the data sub­ject.

⁵ It shall is­sue im­ple­ment­ing pro­vi­sions on:

a.

the ar­chi­tec­ture, or­gan­isa­tion and op­er­a­tion of the in­form­a­tion sys­tems;

b.

the pro­cessing of data, in par­tic­u­lar the col­lec­tion, stor­age, archiv­ing and de­struc­tion there­of;

c.

data pro­cessing per­mis­sions;

d.

data cat­egor­ies in ac­cord­ance with para­graph 2;

e.

data pro­tec­tion and se­cur­ity.

⁶ It may provide for the dis­clos­ure of non-sens­it­ive data through re­triev­al pro­ced­ures. It shall is­sue im­ple­ment­ing pro­vi­sions for this pur­pose.

The staff of the Agency are in­sured by the Fed­er­al Pen­sion Fund.

¹ The Con­fed­er­a­tion and the can­tons may al­loc­ate an in­terest-free en­dow­ment fund to the Agency.

² The Agency shall fin­ance its ex­pendit­ure, in par­tic­u­lar, from:

a.²¹⁰

fed­er­al re­mu­ner­a­tion for tasks re­ferred to in Art­icle 69 para­graph 1, where these are not covered by charges and fees;

b.

charges and fees re­ferred to in Art­icle 65;

c.

charges for ser­vices provided to oth­er au­thor­it­ies and in­ter­na­tion­al or­gan­isa­tions re­ferred to in Art­icle 69 para­graph 2.

^2bis The fol­low­ing tasks and activ­it­ies of the Agency shall be fully fin­anced from fed­er­al re­mu­ner­a­tion:

a.

le­gis­la­tion;

b.

en­force­ment of crim­in­al pro­vi­sions;

c.

sur­veil­lance of med­ic­al devices.²¹¹

³ The task-spe­cif­ic use of the funds re­ferred to in para­graph 2 let­ters a and b and the ad­just­ments to be made in the event of over- or un­der­fin­an­cing of the tasks and activ­it­ies re­ferred to in para­graph 2^bis shall be de­term­ined with­in the frame­work of the ap­prov­al of stra­tegic ob­ject­ives.²¹²

⁴The fines and in­come from sanc­tions shall go to the Con­fed­er­a­tion.

¹ The fin­an­cial state­ments of the Agency shall present its fin­an­cial po­s­i­tion and per­form­ance in ac­cord­ance with the ac­tu­al cir­cum­stances.

² The ac­count­ing fol­lows the gen­er­al prin­ciples of ma­ter­i­al­ity, com­plete­ness, com­pre­hens­ib­il­ity, con­sist­ency and gross present­a­tion, and is based on gen­er­ally ac­cep­ted stand­ards.

³ The ac­count­ing and valu­ation rules de­rived from the ac­count­ing prin­ciples must be dis­closed in the an­nex.

⁴ The Fed­er­al Coun­cil may is­sue ac­count­ing reg­u­la­tions for the Agency.

¹ The an­nu­al re­port con­tains the an­nu­al ac­counts, the con­firm­a­tion of audit of the an­nu­al ac­counts and the fin­an­cial re­port.

² The an­nu­al ac­counts con­sist of the bal­ance sheet, the in­come state­ment and the an­nex.

³ The an­nu­al ac­counts shall be audited by the aud­it­or.

¹ If re­serves are formed, they shall serve to fin­ance fu­ture in­vest­ments by the Agency and cov­er any losses.

² Should the re­serves ex­ceed the amount of an an­nu­al budget, the charges and fees shall be re­duced.

¹ At the re­quest of the Agency, the Fed­er­al Fin­ance Ad­min­is­tra­tion may man­age its li­quid as­sets as part of its cent­ral treas­ury.

² The Fed­er­al Fin­ance Ad­min­is­tra­tion may grant the Agency loans at mar­ket in­terest rates to en­sure that it is able to pay.

³ The Fed­er­al Fin­ance Ad­min­is­tra­tion and the Agency shall agree on the de­tails of this co­oper­a­tion.

¹ The re­spons­ib­il­it­ies of the Agency, its gov­ern­ing bod­ies, staff and agents are gov­erned, sub­ject to para­graph 2, by the Gov­ern­ment Li­ab­il­ity Act of 14 March 1958²¹⁸.

² The Agency and its agents shall be li­able only if:

a.

they breach im­port­ant of­fi­cial ob­lig­a­tions;

b.

dam­age is not at­trib­ut­able to a breach of duty by an agent.

¹ The Agency shall be ex­empt from all fed­er­al, can­ton­al and com­mun­al taxes.

² This shall be without pre­ju­dice to the fed­er­al law gov­ern­ing:

a.

value ad­ded tax on re­mu­ner­a­tions;

b.

with­hold­ing tax and stamp du­ties.