Ordinance
on Clinical Trials
with the exception of
Clinical Trials of Medical Devices¹
(Clinical Trials Ordinance, ClinO)

¹ This Or­din­ance reg­u­lates:

a.⁵

the re­quire­ments for the con­duct of:

1.⁶

clin­ic­al tri­als with medi­cin­al products, in­clud­ing com­bin­a­tions un­der Art­icle 2 para­graph 1 let­ters f and g of the Med­ic­al Devices Or­din­ance of 1 Ju­ly 2020 (MedDO)⁷, or trans­plant products,

2.

clin­ic­al tri­als with …⁸ products un­der Art­icle 2a para­graph 2 TPA⁹,

3.

clin­ic­al tri­als of trans­plant­a­tion,

4.

clin­ic­al tri­als that are not clin­ic­al tri­als un­der num­bers 1 to 3;

b.

the au­thor­isa­tion and no­ti­fic­a­tion pro­ced­ures for clin­ic­al tri­als;

c.

the du­ties and re­spons­ib­il­it­ies of re­search eth­ics com­mit­tees (eth­ics com­mit­tees), the Swiss Agency for Thera­peut­ic Products (the Agency) and the Fed­er­al Of­fice of Pub­lic Health (the FOPH) in con­nec­tion with the au­thor­isa­tion and no­ti­fic­a­tion pro­ced­ures;

d.

the re­gis­tra­tion of clin­ic­al tri­als and pub­lic ac­cess to the re­gistry.

² The fol­low­ing ap­ply:

a.¹⁰

for clin­ic­al tri­als with med­ic­al devices un­der Art­icle 1 MedDO und Art­icle 1 of the Or­din­ance of 4 May 2022¹¹ on In Vitro Dia­gnost­ic Med­ic­al Devices: the Or­din­ance of 1 Ju­ly 2020¹² on Clin­ic­al Tri­als with Med­ic­al Devices;

b.

for clin­ic­al tri­als of xeno­trans­plant­a­tion: the Xeno­trans­plant­a­tion Or­din­ance of 16 March 2007¹³ ap­plies.¹⁴

In this Or­din­ance:

a.

clin­ic­al tri­al means a re­search pro­ject in­volving in­di­vidu­als that pro­spect­ively as­signs them to un­der­go a health-re­lated in­ter­ven­tion in or­der to study its ef­fects on health or on the struc­ture and func­tion of the hu­man body;

b.

health-re­lated in­ter­ven­tion means a pre­vent­ive, dia­gnost­ic, thera­peut­ic, pal­li­at­ive or re­hab­il­it­at­ive meas­ure in­vest­ig­ated in a clin­ic­al tri­al;

c.

min­im­al risks and bur­dens means risks and bur­dens, which, in terms of in­tens­ity and qual­ity, and tak­ing in­to ac­count the vul­ner­ab­il­ity of the par­ti­cipants and the spe­cif­ic cir­cum­stances, will have only a slight and tem­por­ary im­pact on the par­ti­cipants’ health; in par­tic­u­lar, min­im­al risks and bur­dens may be as­so­ci­ated with:

1.

sur­veys and ob­ser­va­tions,

2.

peri­pher­al ven­ous or ca­pil­lary blood sampling and skin punch biopsies of lim­ited ex­tent,

3.

re­mov­ing or col­lect­ing bod­ily sub­stances without in­vas­ive in­ter­ven­tions, in par­tic­u­lar, saliva, ur­ine and stool samples,

4.

tak­ing swabs,

5.

mag­net­ic res­on­ance ima­ging scans without a con­trast me­di­um, ul­tra­sound ex­am­in­a­tions or elec­tro­grams,

6.¹⁶

ex­am­in­a­tions us­ing ion­ising ra­di­ation, provided that the ef­fect­ive dose is be­low 5 mSv per re­search pro­ject and per per­son con­cerned and:

–

the medi­cin­al product used is au­thor­ised or ex­empt from au­thor­isa­tion, or

–

the devices un­der Art­icle 1 MedDO¹⁷ bear con­form­ity mark­ings and no con­trast me­di­um is used;

d.

spon­sor means a per­son or in­sti­tu­tion headquartered or rep­res­en­ted in Switzer­land that takes re­spons­ib­il­ity for or­gan­ising a clin­ic­al tri­al, and in par­tic­u­lar for the ini­ti­ation, man­age­ment and fin­an­cing of the tri­al in Switzer­land;

e.

in­vest­ig­at­ormeans a per­son re­spons­ible in Switzer­land for the con­duct of a clin­ic­al tri­al and for the pro­tec­tion of the par­ti­cipants at the tri­al site; an in­vest­ig­at­or who takes re­spons­ib­il­ity for or­gan­ising a clin­ic­al tri­al in Switzer­land is also a spon­sor.

¹ The spon­sor and the in­vest­ig­at­or, and the oth­er per­sons in­volved in the clin­ic­al tri­al, shall main­tain sci­entif­ic in­teg­rity. In par­tic­u­lar, it is pro­hib­ited:

a.

to falsi­fy, fab­ric­ate or sup­press re­search res­ults;

b.

to fail to dis­close con­flicts of in­terest at the plan­ning stage, in the au­thor­isa­tion pro­ced­ure, or when con­duct­ing or pub­lish­ing re­search;

c.

to im­pede or pre­vent re­search activ­it­ies without good reas­on;

d.

to pre­vent or sanc­tion the ex­pos­ure of sci­entif­ic mis­con­duct.

² The ap­plic­able guidelines are the Prin­ciples and Pro­ced­ures for In­teg­rity in Sci­entif­ic Re­search is­sued by the Swiss Academies of Arts and Sci­ences, as spe­cified in An­nex 1 num­ber 1. In jus­ti­fied cases, oth­er re­cog­nised sci­entif­ic in­teg­rity guidelines of equi­val­ent stand­ing may be used.

The spon­sor and the in­vest­ig­at­or of a clin­ic­al tri­al shall en­sure sci­entif­ic qual­ity. In par­tic­u­lar:

a.

they shall define a re­search ques­tion based on the cur­rent state of sci­entif­ic know­ledge;

b.

they shall use an ap­pro­pri­ate sci­entif­ic meth­od­o­logy; and

c.

they shall en­sure the avail­ab­il­ity of the re­sources re­quired for the clin­ic­al tri­al and provide the ne­ces­sary in­fra­struc­ture.

¹ Clin­ic­al tri­als must be con­duc­ted in ac­cord­ance with the rules of Good Clin­ic­al Prac­tice, as spe­cified in An­nex 1 num­ber 2.

² A clin­ic­al tri­al covered by Chapter 4 may be con­duc­ted in ac­cord­ance with oth­er rules which are re­cog­nised in the spe­cialty in ques­tion, provided that the pro­tec­tion of par­ti­cipants and data qual­ity and se­cur­ity are guar­an­teed.

³ The meas­ures and pre­cau­tions re­quired in ac­cord­ance with the rules of Good Clin­ic­al Prac­tice must be ad­ap­ted to the ex­tent of the risks to which par­ti­cipants are ex­posed. De­pend­ing on the ex­tent of these risks, there may be cer­tain de­vi­ations from the rules of Good Clin­ic­al Prac­tice. Any de­vi­ations must be re­cor­ded in the pro­tocol. The pro­tec­tion of the par­ti­cipants and data qual­ity and se­cur­ity must be guar­an­teed in all cases.

¹ The clin­ic­al tri­al in­vest­ig­at­or must:

a.

be ad­equately trained in Good Clin­ic­al Prac­tice and have the pro­fes­sion­al know­ledge and ex­per­i­ence re­quired for the clin­ic­al tri­al; and

b.

be con­vers­ant with the leg­al re­quire­ments for clin­ic­al tri­als or be able to en­sure com­pli­ance by call­ing in ap­pro­pri­ate ex­pert­ise.

² In ad­di­tion, the in­vest­ig­at­or in a clin­ic­al tri­al of medi­cin­al products, products un­der Art­icle 2a para­graph 2 TPA or trans­plant­a­tion must be en­titled to prac­tise the med­ic­al pro­fes­sion in­de­pend­ently.¹⁸

³ For clin­ic­al tri­als covered by Chapter 4, a per­son without med­ic­al qual­i­fic­a­tions may also serve as an in­vest­ig­at­or, provided that this per­son is en­titled to prac­tise in­de­pend­ently the pro­fes­sion spe­cific­ally qual­i­fy­ing him or her to con­duct the clin­ic­al tri­al.¹⁹

⁴ The oth­er per­sons con­duct­ing the clin­ic­al tri­al must have the pro­fes­sion­al know­ledge and ex­per­i­ence ap­pro­pri­ate to the activ­it­ies in ques­tion.

¹ In ad­di­tion to the points spe­cified in Art­icle 16 para­graph 2 HRA, the per­sons con­cerned must re­ceive in­form­a­tion on:

a.

pos­sible al­tern­at­ives to the in­ter­ven­tion un­der in­vest­ig­a­tion, if the clin­ic­al tri­al is ex­pec­ted to of­fer a dir­ect be­ne­fit;

b.

the ef­fort in­volved and the ob­lig­a­tions arising from par­ti­cip­a­tion;

c.

their right to with­hold or to re­voke their con­sent without giv­ing reas­ons and without suf­fer­ing any dis­ad­vant­ages in re­la­tion to their med­ic­al treat­ment;

d.

the con­sequences of re­voc­a­tion of con­sent for their sub­sequent med­ic­al treat­ment, and for fur­ther use of the per­son­al data and bio­lo­gic­al ma­ter­i­al col­lec­ted up to this point;

e.

their right to re­ceive in­form­a­tion at any time in re­sponse to fur­ther ques­tions re­lat­ing to the clin­ic­al tri­al;

f.

their right to be in­formed of res­ults con­cern­ing their health, and their right to forgo such in­form­a­tion or to des­ig­nate a per­son who is to take this de­cision for them;

g.

the meas­ures en­vis­aged to cov­er any dam­age arising from the clin­ic­al tri­al, in­clud­ing the pro­ced­ure in the event of a claim;

h.

the spon­sor and the main sources of fin­an­cing for the clin­ic­al tri­al;

i.

oth­er points rel­ev­ant to their de­cision on par­ti­cip­a­tion.

² If the in­ten­tion ex­ists to make fur­ther use for re­search of bio­lo­gic­al ma­ter­i­al sampled or health-re­lated per­son­al data col­lec­ted in the clin­ic­al tri­al, the per­sons con­cerned must also re­ceive in­form­a­tion on the points spe­cified in Art­icles 28–32 of the Hu­man Re­search Or­din­ance of 20 Septem­ber 2013²⁰.

³ The in­form­a­tion may be provided in stages. It may be ad­di­tion­ally presen­ted in a non-tex­tu­al form.

⁴ Ap­pro­pri­ate meas­ures must be taken to en­sure that the per­sons con­cerned have un­der­stood the es­sen­tial ele­ments of the in­form­a­tion provided.

¹ In in­di­vidu­al cases, in­form­a­tion may be provided and con­sent giv­en in a non‑writ­ten form if:

a.

the per­son con­cerned, for phys­ic­al or cog­nit­ive reas­ons, can­not read or can­not write; and

b.

the in­vest­ig­at­or fur­nishes proof of the pro­vi­sion of in­form­a­tion and con­sent, spe­cific­ally by means of writ­ten con­firm­a­tion by wit­nesses, or by a re­cord­ing of verbal con­sent.

² In in­di­vidu­al cases, the re­quire­ment to provide in­form­a­tion in writ­ten form may be waived if:

a.

this could only be im­ple­men­ted with dis­pro­por­tion­ate ef­fort, giv­en the lan­guage skills of the per­son con­cerned; and

b.

an in­de­pend­ent qual­i­fied trans­lat­or is called in to provide or­al in­form­a­tion and gives writ­ten con­firm­a­tion there­of.

¹ If con­sent is re­voked, the bio­lo­gic­al ma­ter­i­al and health‑re­lated per­son­al data of the per­son con­cerned must be an­onymised after data eval­u­ation has been com­pleted.

² An­onymisa­tion of the bio­lo­gic­al ma­ter­i­al and per­son­al data may be dis­pensed with if:

a.

the per­son con­cerned ex­pressly re­nounces this right when re­vok­ing con­sent; or

b.

it is es­tab­lished at the be­gin­ning of the clin­ic­al tri­al that an­onymisa­tion is not pos­sible and the per­son con­cerned, hav­ing been ad­equately in­formed of this fact, con­sen­ted to par­ti­cip­ate.

³ Per­sons re­vok­ing con­sent must be offered any fol­low-up care re­quired to pro­tect their health.

¹ Ex­empt from li­ab­il­ity in re­la­tion to clin­ic­al tri­als un­der Art­icle 19 para­graph 1 HRA shall be any per­son who proves that the dam­age is at­trib­ut­able to:

a.

the ad­min­is­tra­tion of an au­thor­ised medi­cin­al product used in ac­cord­ance with the pre­scrib­ing in­form­a­tion;

b.

the ad­min­is­tra­tion of an au­thor­ised medi­cin­al product, if this is re­cog­nised as stand­ard in guidelines pre­pared in ac­cord­ance with in­ter­na­tion­ally ac­cep­ted qual­ity cri­ter­ia;

c.²¹

the use of a product un­der Art­icle 2a para­graph 2 TPA that has been re­por­ted pur­su­ant to Art­icle 6 para­graph 3 MedDO²² in its ver­sion of 1 Janu­ary 2002²³ in ap­plic­a­tion of Art­icle 108 para­graph 1 let­ter b MedDO and used in ac­cord­ance with the in­struc­tions;

d.

the use of some oth­er health-re­lated in­ter­ven­tion which is re­cog­nised as stand­ard in guidelines pre­pared in ac­cord­ance with in­ter­na­tion­ally ac­cep­ted qual­ity cri­ter­ia.

² Also ex­empt from li­ab­il­ity un­der Art­icle 19 para­graph 1 HRA shall be any per­son who proves that the ex­tent of the dam­age is no great­er than would be ex­pec­ted in the cur­rent state of sci­entif­ic know­ledge and:

a.

com­par­able dam­age could also have oc­curred if the in­jured party had un­der­gone stand­ard ther­apy for the dis­ease; or

b.

in the case of acutely life-threat­en­ing dis­eases for which no stand­ard ther­apy ex­ists.

The lim­it­a­tion peri­od for com­pens­a­tion claims in re­spect of dam­age:

a.

at­trib­ut­able to the use of ion­ising ra­di­ation is gov­erned by Art­icle 40 of the Ra­di­olo­gic­al Pro­tec­tion Act of 22 March 1991²⁴;

b.

at­trib­ut­able to the use of ge­net­ic­ally mod­i­fied or­gan­isms is gov­erned by Art­icle 32 of the Gene Tech­no­logy Act of 21 March 2003²⁵.

Ex­empt from li­ab­il­ity cov­er­age re­quire­ments are:

a.

dam­age ex­empt from li­ab­il­ity in ac­cord­ance with Art­icle 10;

b.

Cat­egory A clin­ic­al tri­als (Art. 19 para. 1, Art. 20 para. 1, Art. 49 para. 1 and Art. 61 para. 1) in­volving meas­ures for sampling of bio­lo­gic­al ma­ter­i­al or col­lec­tion of health-re­lated per­son­al data which en­tail only min­im­al risks and bur­dens.

¹ The li­ab­il­ity cov­er­age re­quire­ments can be ful­filled:

a.

by tak­ing out in­sur­ance; or

b.

by provid­ing se­cur­ity of equi­val­ent value.

² The policy value shall be set in ac­cord­ance with An­nex 2.

³ The li­ab­il­ity cov­er­age must cov­er dam­age oc­cur­ring up to ten years after the com­ple­tion of the clin­ic­al tri­al.

¹ Can­cel­la­tion of the in­sur­ance policy by the in­sur­ance com­pany is not per­miss­ible after the oc­cur­rence of the in­sured event.

² With­in the frame­work of the in­sur­ance cov­er­age, the in­jured party or leg­al suc­cessor has a dir­ect claim against the in­sur­ance com­pany. Ob­jec­tions can­not be raised on the basis of the in­sur­ance policy or the In­sur­ance Policies Act of 2 April 1908²⁶.

³ If the in­sur­ance com­pany is sub­ject to ac­tion un­der para­graph 2, it shall have a right of re­course against the in­sured party.

⁴ Para­graphs 1–3 ap­ply mu­tatis mutandis if se­cur­ity of equi­val­ent value is provided in ac­cord­ance with Art­icle 13 para­graph 1 let­ter b.

¹ The spon­sor and the in­vest­ig­at­or must, when plan­ning or con­duct­ing a clin­ic­al tri­al in an emer­gency situ­ation, take any meas­ures ne­ces­sary to en­sure that:

a.

the con­sent of the per­son con­cerned can be ob­tained post hoc as soon as pos­sible;

b.

in the case of a clin­ic­al tri­al in­volving chil­dren or ad­oles­cents, the con­sent of the leg­al rep­res­ent­at­ive can be ob­tained as soon as pos­sible, if this is re­quired in ac­cord­ance with Art­icles 22 and 23 HRA;

c.

in the case of a clin­ic­al tri­al in­volving adults per­man­ently lack­ing ca­pa­city, the con­sent of the per­son au­thor­ised to act as a rep­res­ent­at­ive can be ob­tained as soon as pos­sible, if no state­ment of wishes for­mu­lated in a state of ca­pa­city is avail­able.

² The pro­ced­ure for ob­tain­ing post hoc con­sent must be defined in the pro­tocol.

¹ If a per­son who was in­cluded in a clin­ic­al tri­al in an emer­gency situ­ation dies be­fore it has been pos­sible to ob­tain con­sent or re­fus­al in ac­cord­ance with Art­icle 15, the bio­lo­gic­al ma­ter­i­al and the health-re­lated per­son­al data col­lec­ted may only be used if this per­son has con­sen­ted, in an ad­vance dir­ect­ive or oth­er­wise, to the use of such ma­ter­i­al and health-re­lated data for re­search pur­poses.

² In the ab­sence of a state­ment of wishes as spe­cified in para­graph 1, use is per­miss­ible if con­sent is giv­en by the next of kin or a des­ig­nated trus­ted per­son. Con­sent is gov­erned by Art­icle 8 of the Trans­plant­a­tion Act.

¹ The bio­lo­gic­al ma­ter­i­al sampled and the health-re­lated per­son­al data col­lec­ted dur­ing a clin­ic­al tri­al in an emer­gency situ­ation may only be eval­u­ated when con­sent has been ob­tained in ac­cord­ance with Art­icle 15 or 16.

² In ex­cep­tion­al cases, the bio­lo­gic­al ma­ter­i­al and the health-re­lated per­son­al data may be eval­u­ated be­fore con­sent has been ob­tained if:

a.

the bio­lo­gic­al ma­ter­i­al is only util­is­able for a lim­ited peri­od; or

b.

this is ne­ces­sary for the sake of the par­ti­cipants’ safety and health.

³ If con­sent to par­ti­cip­ate in a clin­ic­al tri­al in an emer­gency situ­ation is with­held post hoc, the bio­lo­gic­al ma­ter­i­al and the health-re­lated per­son­al data must be des­troyed.

⁴ If the valid­ity of the clin­ic­al tri­al or its res­ults is com­prom­ised in es­sen­tial re­spects by the de­struc­tion of the bio­lo­gic­al ma­ter­i­al and the health-re­lated per­son­al data, the use there­of in the clin­ic­al tri­al is per­miss­ible in spite of re­fus­al of con­sent. The bio­lo­gic­al ma­ter­i­al and the health-re­lated per­son­al data must be an­onymised without delay. The right to dis­sent of the per­son con­cerned is re­served.

⁵ If it is fore­see­able that ma­ter­i­al or data may be eval­u­ated be­fore con­sent has been ob­tained, in ac­cord­ance with para­graph 2, or used in spite of re­fus­al of con­sent, in ac­cord­ance with para­graph 4, this must be stated in the pro­tocol.

¹ Any per­son who stores health-re­lated per­son­al data in con­nec­tion with a clin­ic­al tri­al must take ap­pro­pri­ate op­er­a­tion­al and or­gan­isa­tion­al meas­ures to pro­tect it, and in par­tic­u­lar:

a.

re­strict the hand­ling of the health-re­lated per­son­al data to those per­sons who re­quire this data to ful­fil their du­ties;

b.

pre­vent un­au­thor­ised or ac­ci­dent­al dis­clos­ure, al­ter­a­tion, de­le­tion and copy­ing of the health-re­lated per­son­al data;

c.

doc­u­ment all pro­cessing op­er­a­tions which are es­sen­tial to en­sure trace­ab­il­ity.

² Any per­son who stores bio­lo­gic­al ma­ter­i­al in con­nec­tion with a clin­ic­al tri­al must, in par­tic­u­lar:

a.

com­ply with the prin­ciples set out in para­graph 1 mu­tatis mutandis;

b.

en­sure that the tech­nic­al re­quire­ments are met for ap­pro­pri­ate stor­age of the bio­lo­gic­al ma­ter­i­al;

c.

make avail­able the re­sources re­quired for stor­age.

¹ Clin­ic­al tri­als of medi­cin­al products come un­der Cat­egory A if the medi­cin­al product is au­thor­ised in Switzer­land and its use:

a.

is in ac­cord­ance with the pre­scrib­ing in­form­a­tion;

b.

is in an in­dic­a­tion or dosage dif­fer­ent from that spe­cified in the pre­scrib­ing in­form­a­tion, but in ac­cord­ance with the fol­low­ing cri­ter­ia:

1.

the in­dic­a­tion is with­in the same dis­ease group of the In­ter­na­tion­al Clas­si­fic­a­tion of Dis­eases (ICD), as spe­cified in An­nex 1 num­ber 3,

2.

the dis­ease in ques­tion is self-lim­it­ing and the dosage of the medi­cin­al product is lower than that spe­cified in the pre­scrib­ing in­form­a­tion; or

c.

is re­cog­nised as stand­ard in guidelines pre­pared in ac­cord­ance with in­ter­na­tion­ally ac­cep­ted qual­ity cri­ter­ia.

² Clin­ic­al tri­als of medi­cin­al products come un­der Cat­egory B if the medi­cin­al product:

a.

is au­thor­ised in Switzer­land; and

b.

is not used as spe­cified in para­graph 1.

³ They come un­der Cat­egory C if the medi­cin­al product is not au­thor­ised in Switzer­land.

⁴ In jus­ti­fied cases, a clin­ic­al tri­al of a medi­cin­al product au­thor­ised in Switzer­land may be as­signed to a dif­fer­ent cat­egory if this is pos­sible or ne­ces­sary with re­gard to medi­cin­al product safety or pro­tec­tion of the par­ti­cipants’ safety and health.

¹ Clin­ic­al tri­als of products un­der Art­icle 2a para­graph 2 TPA come un­der Cat­egory A if:

a.

the product that is un­der in­vest­ig­a­tion has been re­por­ted pur­su­ant to Art­icle 6 para­graph 3 MedDO²⁸ in its ver­sion of 1 Janu­ary 2002²⁹ in ap­plic­a­tion of Art­icle 108 para­graph 1 let­ter b MedDO; and

b.

it is used in ac­cord­ance with the in­struc­tions.

² They come un­der Cat­egory C if:

a.

das product that is un­der in­vest­ig­a­tion has not been re­por­ted pur­su­ant to Art­icle 6 para­graph 3 MedDO in its ver­sion of 1 Janu­ary 2002 in ap­plic­a­tion of Art­icle 108 para­graph 1 let­ter b MedDO;

b.

the product that is un­der in­vest­ig­a­tion is not used in ac­cord­ance with the in­ten­ded pur­poses spe­cified in the in­struc­tions; or

c.

use of the product that is un­der in­vest­ig­a­tion is pro­hib­ited in Switzer­land.

For clin­ic­al tri­als of trans­plant products, the pro­vi­sions of this Or­din­ance con­cern­ing clin­ic­al tri­als of medi­cin­al products ap­ply mu­tatis mutandis.

¹ For the pur­poses of this Or­din­ance, clin­ic­al tri­als of gene ther­apy are tri­als in which ge­net­ic in­form­a­tion is in­tro­duced in­to so­mat­ic cells (so­mat­ic gene ther­apy).

² For the pur­poses of this Or­din­ance, clin­ic­al tri­als of ge­net­ic­ally mod­i­fied or­gan­isms are tri­als of medi­cin­al products con­tain­ing ge­net­ic­ally mod­i­fied or­gan­isms as defined in the Re­lease Or­din­ance of 10 Septem­ber 2008³⁰, and in par­tic­u­lar rep­lic­a­tion-com­pet­ent vir­uses.

³ For the pur­poses of this Or­din­ance, clin­ic­al tri­als of patho­gen­ic or­gan­isms are tri­als of medi­cin­al products con­tain­ing patho­gen­ic or­gan­isms as defined in the Re­lease Or­din­ance.

⁴ For clin­ic­al tri­als of gene ther­apy and for clin­ic­al tri­als of ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms, the pro­vi­sions of this Or­din­ance con­cern­ing clin­ic­al tri­als of medi­cin­al products ap­ply mu­tatis mutandis.

¹ The in­vest­ig­at­or and the spon­sor may sim­ul­tan­eously sub­mit ap­plic­a­tions to the re­spons­ible eth­ics com­mit­tee and to the Agency.

² The re­spons­ible eth­ics com­mit­tee and the Agency shall in­form each oth­er about mat­ters re­lat­ing to the re­view areas spe­cified in Art­icle 25 and in Art­icle 32, and shall co­ordin­ate their as­sess­ments.

¹ The in­vest­ig­at­or shall sub­mit to the re­spons­ible eth­ics com­mit­tee the ap­plic­a­tion doc­u­ments spe­cified in An­nex 3 for re­view.

² The eth­ics com­mit­tee may re­quest ad­di­tion­al in­form­a­tion.

³ The spon­sor may sub­mit the ap­plic­a­tion in­stead of the in­vest­ig­at­or. In this case, the spon­sor as­sumes the ob­lig­a­tions of the in­vest­ig­at­or as spe­cified in Art­icles 28 and 29 and also the no­ti­fic­a­tion and re­port­ing ob­lig­a­tions vis-à-vis the re­spons­ible eth­ics com­mit­tee. The ap­plic­a­tion doc­u­ments must be co-signed by the in­vest­ig­at­or.

The re­spons­ible eth­ics com­mit­tee shall re­view:

a.

the com­plete­ness of the ap­plic­a­tion;

b.

the cat­egor­isa­tion re­ques­ted;

c.

the in­form­a­tion in­ten­ded for re­gis­tra­tion in ac­cord­ance with Art­icle 64;

d.

the pro­tocol with re­gard to:

1.

the sci­entif­ic rel­ev­ance of the top­ic (Art. 5 HRA), the suit­ab­il­ity of the chosen sci­entif­ic meth­od­o­logy and com­pli­ance with Good Clin­ic­al Prac­tice,

2.

the ra­tio between the likely risks and bur­dens and the ex­pec­ted be­ne­fits (Art. 12 para. 2 HRA),

3.

the meas­ures taken to min­im­ise risks and bur­dens, and for the pro­tec­tion and fol­low-up of par­ti­cipants (Art. 15 HRA), in­clud­ing pre­cau­tion­ary meas­ures in the hand­ling of per­son­al data,

4.

the need to in­volve per­sons, and in par­tic­u­lar per­sons who are par­tic­u­larly vul­ner­able (Art. 11 HRA),

5.

the cri­ter­ia for the se­lec­tion of par­ti­cipants,

6.

the pro­posed pro­ced­ure for provid­ing in­form­a­tion and ob­tain­ing con­sent, in­clud­ing the ap­pro­pri­ate­ness of the peri­od for re­flec­tion,

7.

the ap­pro­pri­ate­ness of the re­mu­ner­a­tion for par­ti­cipants,

8.

com­pli­ance with sci­entif­ic in­teg­rity re­quire­ments;

e.

the com­plete­ness of the doc­u­ment­a­tion for re­cruit­ment, in­form­a­tion and con­sent, and its com­pre­hens­ib­il­ity, es­pe­cially with re­gard to the pos­sible in­volve­ment of par­tic­u­larly vul­ner­able per­sons;

f.

the guar­an­tee­ing of the right to com­pens­a­tion in the event of dam­age (Art. 20 HRA);

g.

the ad­equacy of the know­ledge and ex­per­i­ence of the in­vest­ig­at­or and of the oth­er per­sons con­duct­ing the clin­ic­al tri­al, in re­la­tion to the dis­cip­line con­cerned and the con­duct of a clin­ic­al tri­al;

h.

the suit­ab­il­ity of the in­fra­struc­ture at the tri­al site;

i.

the fin­an­cing of the clin­ic­al tri­al and the agree­ments between the spon­sor, third parties and the in­vest­ig­at­or con­cern­ing the al­loc­a­tion of tasks, re­mu­ner­a­tion and pub­lic­a­tion;

j.

for Cat­egory A clin­ic­al tri­als of medi­cin­al products or products un­der Art­icle 2a para­graph 2 TPA cap­able of emit­ting ion­ising ra­di­ation: ad­di­tion­ally, com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and the dose es­tim­a­tion;

k.

for in­vest­ig­a­tions in­volving ra­di­ation sources³¹: ad­di­tion­ally, com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and the dose es­tim­a­tion, in cases where an opin­ion does not have to be sought from the FOPH in ac­cord­ance with Art­icle 28;

l.

oth­er areas, where this is ne­ces­sary to as­sess the pro­tec­tion of par­ti­cipants.

¹ The eth­ics com­mit­tee shall ac­know­ledge re­ceipt of the ap­plic­a­tion with­in 7 days and no­ti­fy the in­vest­ig­at­or of any form­al de­fi­cien­cies in the ap­plic­a­tion doc­u­ments.

² It shall reach a de­cision with­in 30 days of ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments.

³ If the eth­ics com­mit­tee re­quests ad­di­tion­al in­form­a­tion in ac­cord­ance with Art­icle 24 para­graph 2, the clock shall be stopped un­til this in­form­a­tion has been re­ceived.

⁴ It shall in­form the Agency of its de­cision in the case of Cat­egory B and C clin­ic­al tri­als.

¹ The co­ordin­at­ing in­vest­ig­at­or shall sub­mit the ap­plic­a­tion for mul­ti­centre clin­ic­al tri­als to the lead com­mit­tee in ac­cord­ance with Art­icle 47 para­graph 2 HRA. The spon­sor may sub­mit the ap­plic­a­tion in­stead of the co­ordin­at­ing in­vest­ig­at­or; Art­icle 24 para­graph 3 ap­plies mu­tatis mutandis.

² The co­ordin­at­ing in­vest­ig­at­or is the per­son re­spons­ible in Switzer­land for co­ordin­a­tion of the in­vest­ig­at­ors re­spons­ible at the in­di­vidu­al tri­al sites.

³ The lead com­mit­tee shall ac­know­ledge re­ceipt of the ap­plic­a­tion with­in 7 days and at the same time no­ti­fy the co­ordin­at­ing in­vest­ig­at­or wheth­er the ap­plic­a­tion doc­u­ments are form­ally in or­der.

⁴ At the re­quest of the lead com­mit­tee, the co­ordin­at­ing in­vest­ig­at­or shall sub­mit the re­quired num­ber of cop­ies of the ap­plic­a­tion doc­u­ments spe­cified in An­nex 3 to the eth­ics com­mit­tees re­spons­ible at the oth­er tri­al sites (eth­ics com­mit­tees con­cerned). These shall re­view the loc­al con­di­tions and in­form the lead com­mit­tee of their as­sess­ment with­in 15 days.

⁵ The lead com­mit­tee shall reach a de­cision with­in 45 days of ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion. It shall in­form the eth­ics com­mit­tees con­cerned of its de­cision and the Agency in the case of Cat­egory B and C clin­ic­al tri­als.

¹ In the case of in­vest­ig­a­tions in­volving ra­di­ation sources, the in­vest­ig­at­or shall ad­di­tion­ally sub­mit to the re­spons­ible eth­ics com­mit­tee the doc­u­ments spe­cified in An­nex 3 num­ber 5. Sub­ject to the pro­vi­sions of the fol­low­ing para­graphs, the au­thor­isa­tion pro­ced­ure is gov­erned by Art­icles 24–27 and 29.

² The in­vest­ig­at­or shall ad­di­tion­ally sub­mit to the FOPH the ap­plic­a­tion doc­u­ments spe­cified in An­nex 3 num­ber 6, in­form­ing the eth­ics com­mit­tee at the same time, if the ef­fect­ive dose per per­son, tak­ing the un­cer­tainty factor in­to ac­count, is more than 5 mSv per year and:

a.

a ra­dio­phar­ma­ceut­ic­al is used which is not au­thor­ised in Switzer­land;

b.

a ra­dio­phar­ma­ceut­ic­al is used which is au­thor­ised in Switzer­land, and the in­ter­ven­tion in ques­tion is not a routine nuc­le­ar medi­cine ex­am­in­a­tion; or

c.

some oth­er ra­dio­act­ive source³² is used.

³ The FOPH shall de­liv­er an opin­ion for the eth­ics com­mit­tee on com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and on the dose es­tim­a­tion.

⁴ The eth­ics com­mit­tee shall grant au­thor­isa­tion if:

a.

the re­quire­ments covered by Art­icle 25 are met; and

b.

the FOPH has raised no ob­jec­tions to the clin­ic­al tri­al.

⁵ It shall reach a de­cision with­in 45 days of ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments. It shall in­form the FOPH of its de­cision.

¹ Sig­ni­fic­ant changes to an au­thor­ised clin­ic­al tri­al must be au­thor­ised by the eth­ics com­mit­tee be­fore be­ing im­ple­men­ted. Ex­empt from this re­quire­ment are meas­ures which have to be taken im­me­di­ately in or­der to pro­tect the par­ti­cipants.

² The in­vest­ig­at­or shall sub­mit to the eth­ics com­mit­tee any ap­plic­a­tion doc­u­ments spe­cified in An­nex 3 which are af­fected by the change. At the same time, the in­vest­ig­at­or shall provide in­form­a­tion on the reas­ons for the change.

³ The fol­low­ing are con­sidered to be sig­ni­fic­ant changes:

a.

changes af­fect­ing the par­ti­cipants’ safety and health, or their rights and ob­lig­a­tions;

b.

changes to the pro­tocol, and in par­tic­u­lar changes based on new sci­entif­ic know­ledge which con­cern the tri­al design, the meth­od of in­vest­ig­a­tion, the en­d­points or the form of stat­ist­ic­al ana­lys­is;

c.

a change of tri­al site, or con­duct­ing the clin­ic­al tri­al at an ad­di­tion­al site; or

d.

a change of spon­sor, co­ordin­at­ing in­vest­ig­at­or or in­vest­ig­at­or re­spons­ible at a tri­al site.

⁴ The eth­ics com­mit­tee shall reach a de­cision on sig­ni­fic­ant changes with­in 30 days. Art­icle 26 ap­plies mu­tatis mutandis.

⁵ If a site at which a clin­ic­al tri­al is to be ad­di­tion­ally con­duc­ted does not lie with­in the re­spons­ib­il­ity of the eth­ics com­mit­tee which gran­ted au­thor­isa­tion, the pro­ced­ure is gov­erned by Art­icle 27mu­tatis mutandis.

⁶ Oth­er changes must be no­ti­fied to the eth­ics com­mit­tee in the an­nu­al safety re­port spe­cified in Art­icle 43.

Cat­egory A clin­ic­al tri­als are ex­emp­ted from the re­quire­ment for au­thor­isa­tion from the Agency as spe­cified in Art­icle 54 para­graph 1 TPA.

¹ The spon­sor shall sub­mit to the Agency the ap­plic­a­tion doc­u­ments spe­cified in An­nex 4 for re­view.

² The Agency may re­quest ad­di­tion­al in­form­a­tion.

¹ For clin­ic­al tri­als of medi­cin­al products, the Agency shall re­view:

a.

the com­plete­ness of the ap­plic­a­tion;

b.

the safety of the medi­cin­al product, and in par­tic­u­lar the pre­clin­ic­al and clin­ic­al phar­ma­co­logy, tox­ic­o­logy, for­mu­la­tion and phar­ma­cokin­et­ics, and the pro­posed dosage and in­dic­a­tion;

c.

the risk as­sess­ment and risk man­age­ment based on the medi­cin­al product safety data;

d.

the qual­ity of the medi­cin­al product and com­pli­ance with Good Man­u­fac­tur­ing Prac­tice (GMP);

e.

oth­er areas, where this is ne­ces­sary to as­sess the safety or qual­ity of the medi­cin­al product.

² For Cat­egory B clin­ic­al tri­als of medi­cin­al products cap­able of emit­ting ion­ising ra­di­ation, it shall ad­di­tion­ally re­view com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and the dose es­tim­a­tion.

³ For clin­ic­al tri­als of products un­der Art­icle 2a para­graph 2 TPA, it shall re­view:

a.

the com­plete­ness of the ap­plic­a­tion;

b.

the re­quire­ments spe­cified in Art­icle 54 para­graph 4 let­ter b TPA.

¹ The Agency shall ac­know­ledge re­ceipt of the ap­plic­a­tion with­in 7 days and no­ti­fy the spon­sor of any form­al de­fi­cien­cies in the ap­plic­a­tion doc­u­ments.

² It shall reach a de­cision with­in 30 days of ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments.

³ If a medi­cin­al product or product un­der Art­icle 2a para­graph 2 TPA is to be used in per­sons for the first time or man­u­fac­tured in a new pro­cess, this dead­line may be ex­ten­ded by a max­im­um of 30 days. The Agency shall in­form the spon­sor of the ex­ten­ded dead­line.

⁴ If the Agency re­quests ad­di­tion­al in­form­a­tion in ac­cord­ance with Art­icle 31 para­graph 2, the clock shall be stopped un­til this in­form­a­tion has been re­ceived.

⁵ The Agency shall in­form the re­spons­ible eth­ics com­mit­tee and oth­er com­pet­ent can­ton­al au­thor­it­ies of its de­cision.

¹ Sig­ni­fic­ant changes to an au­thor­ised clin­ic­al tri­al must be au­thor­ised by the Agency be­fore be­ing im­ple­men­ted. Ex­empt from this re­quire­ment are meas­ures which have to be taken im­me­di­ately in or­der to pro­tect the par­ti­cipants.

² The spon­sor must sub­mit to the Agency any ap­plic­a­tion doc­u­ments spe­cified in An­nex 4 which are af­fected by the change. At the same time, the spon­sor shall provide in­form­a­tion on the reas­ons for the change.

³ The fol­low­ing are con­sidered to be sig­ni­fic­ant changes:

a.

changes to the medi­cin­al product or product un­der Art­icle 2a para­graph 2 TPA, or to its ad­min­is­tra­tion or use;

b.

changes based on new pre­clin­ic­al or clin­ic­al data which may af­fect product safety; or

c.

changes con­cern­ing the pro­duc­tion of the medi­cin­al product or product un­der Art­icle 2a para­graph 2 TPA which may af­fect product safety.

⁴ The Agency shall reach a de­cision with­in 30 days after re­ceipt of the com­plete ap­plic­a­tion doc­u­ments af­fected by the change. Art­icle 33 ap­plies mu­tatis mutandis.

⁵ Oth­er changes which af­fect the doc­u­ments sub­mit­ted to the Agency must be no­ti­fied to the Agency as quickly as pos­sible.

¹ For Cat­egory B and C clin­ic­al tri­als of gene ther­apy and for clin­ic­al tri­als of ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms as defined in Art­icle 22, the doc­u­ments spe­cified in An­nex 4 num­ber 4 must be sub­mit­ted to the Agency.

² Be­fore grant­ing au­thor­isa­tion, the Agency shall seek opin­ions from the Swiss Ex­pert Com­mit­tee for Biosafety (SECB), the Fed­er­al Of­fice for the En­vir­on­ment (FOEN) and the FOPH.

³ In ad­di­tion to the areas spe­cified in Art­icle 32, it shall re­view wheth­er the qual­ity and bio­lo­gic­al safety of the product are guar­an­teed with re­gard to the par­ti­cipants and to hu­man health and the en­vir­on­ment.

⁴ It shall grant au­thor­isa­tion if:

a.

the SECB has con­firmed the qual­ity and bio­lo­gic­al safety of the product with re­gard to the par­ti­cipants and to hu­man health and the en­vir­on­ment; and

b.

no ob­jec­tions to the clin­ic­al tri­al have been raised by the FOPH or by the FOEN, based on the as­sess­ment of the en­vir­on­ment­al data.

⁵ The Agency shall grant au­thor­isa­tion with­in 60 days of ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments. The Agency shall in­form the com­pet­ent fed­er­al and can­ton­al au­thor­it­ies of its de­cision.

⁶ Au­thor­isa­tions shall re­main val­id for the dur­a­tion of the clin­ic­al tri­al, but for no longer than five years after they are gran­ted.

⁷ The Agency, the FOPH and the FOEN shall jointly is­sue guidelines on as­sess­ment of risks to hu­man health and the en­vir­on­ment.

¹ For Cat­egory B and C clin­ic­al tri­als of medi­cin­al products or products un­der Art­icle 2a para­graph 2 TPA cap­able of emit­ting ion­ising ra­di­ation, the doc­u­ments spe­cified in An­nex 4 num­ber 5 must ad­di­tion­ally be sub­mit­ted to the Agency.

² In the case of Cat­egory C clin­ic­al tri­als, the Agency shall seek an opin­ion from the FOPH be­fore grant­ing au­thor­isa­tion. The FOPH shall re­view com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and the dose es­tim­a­tion.

³ The Agency shall grant au­thor­isa­tion if:

a.

the re­quire­ments covered by Art­icle 32 are met; and

b.

the FOPH has raised no ob­jec­tions to the clin­ic­al tri­al.

⁴ The Agency shall reach a de­cision on Cat­egory C clin­ic­al tri­als with­in 60 days of ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments. It shall in­form the FOPH of its de­cision.

⁵ In the case of Cat­egory C clin­ic­al tri­als, it shall trans­mit to the FOPH dir­ectly after re­ceipt:

a.

the fi­nal re­port spe­cified in Art­icle 38 para­graph 3 in­clud­ing all in­form­a­tion of rel­ev­ance for ra­di­olo­gic­al pro­tec­tion, and in par­tic­u­lar a ret­ro­spect­ive par­ti­cipant dose es­tim­a­tion, un­less stip­u­la­tions to the con­trary have been made by the FOPH;

b.

the re­ports spe­cified in Art­icle 41 para­graph 2 and Art­icle 42 para­graph 1.

¹ If im­me­di­ate safety and pro­tect­ive meas­ures have to be taken dur­ing the con­duct of a clin­ic­al tri­al, the in­vest­ig­at­or shall no­ti­fy the eth­ics com­mit­tee of these meas­ures, and of the cir­cum­stances ne­ces­sit­at­ing them, with­in 7 days.

² In the case of clin­ic­al tri­als of products un­der Art­icle 2a para­graph 2 TPA, this no­ti­fic­a­tion shall be made with­in 2 days.

³ For Cat­egory B and C clin­ic­al tri­als, the no­ti­fic­a­tions spe­cified in para­graphs 1 and 2 shall be made to the Agency. This ob­lig­a­tion rests on the spon­sor.

¹ The in­vest­ig­at­or shall no­ti­fy the eth­ics com­mit­tee of the com­ple­tion of the clin­ic­al tri­al in Switzer­land with­in 90 days. Com­ple­tion of a clin­ic­al tri­al is marked by the last par­ti­cipant’s fi­nal fol­low-up vis­it, in the ab­sence of pro­vi­sions to the con­trary in the pro­tocol.

² The in­vest­ig­at­or shall no­ti­fy the eth­ics com­mit­tee of the dis­con­tinu­ation or in­ter­rup­tion of the clin­ic­al tri­al with­in 15 days. In the no­ti­fic­a­tion, the reas­ons for the dis­con­tinu­ation or in­ter­rup­tion shall be stated.

³ The in­vest­ig­at­or shall sub­mit a fi­nal re­port to the eth­ics com­mit­tee with­in a year after com­ple­tion or dis­con­tinu­ation of the clin­ic­al tri­al, un­less a longer peri­od is spe­cified in the pro­tocol.

⁴ If a mul­ti­centre clin­ic­al tri­al is dis­con­tin­ued or in­ter­rup­ted at one of the tri­al sites, the co­ordin­at­ing in­vest­ig­at­or shall also no­ti­fy the re­spons­ible eth­ics com­mit­tee con­cerned in ac­cord­ance with para­graph 2.

⁵ For Cat­egory B and C clin­ic­al tri­als, the no­ti­fic­a­tions and re­ports spe­cified in para­graphs 1–3 shall be made to the Agency. These ob­lig­a­tions rest on the spon­sor.

¹ If, in the course of a Cat­egory C clin­ic­al tri­al of medi­cin­al products, ad­verse events which are not to be clas­si­fied as ser­i­ous oc­cur in par­ti­cipants, they must be doc­u­mented by the in­vest­ig­at­or in a stand­ard­ised man­ner.

² Ad­verse events oc­cur­ring in the course of a Cat­egory B clin­ic­al tri­al must be doc­u­mented in a stand­ard­ised man­ner, if this is en­vis­aged in the pro­tocol or was re­ques­ted by the au­thor­it­ies re­spons­ible for au­thor­isa­tion.

³ For Cat­egory A clin­ic­al tri­als, there is no ob­lig­a­tion to doc­u­ment ad­verse events.

⁴ The defin­i­tion of ad­verse events is gov­erned by the rules of Good Clin­ic­al Prac­tice as spe­cified in An­nex 1 num­ber 2.

¹ If, in the course of a clin­ic­al tri­al, ser­i­ous ad­verse events oc­cur in par­ti­cipants, the in­vest­ig­at­or must doc­u­ment these in a stand­ard­ised man­ner and no­ti­fy the spon­sor with­in 24 hours after they be­come known. Events which are not to be re­por­ted ac­cord­ing to the pro­tocol are ex­emp­ted.

² In the ab­sence of pro­vi­sions to the con­trary in the pro­tocol, the in­vest­ig­at­or shall no­ti­fy the re­spons­ible eth­ics com­mit­tee of a fatal ser­i­ous ad­verse event oc­cur­ring at a tri­al site in Switzer­land with­in 7 days.

³ In the case of a mul­ti­centre clin­ic­al tri­al, the co­ordin­at­ing in­vest­ig­at­or shall also re­port events as spe­cified in para­graph 2 to the re­spons­ible eth­ics com­mit­tee con­cerned with­in the same peri­od.

⁴ The defin­i­tion of ser­i­ous ad­verse events is gov­erned by the rules of Good Clin­ic­al Prac­tice as spe­cified in An­nex 1 num­ber 2.

¹ If, in the course of a clin­ic­al tri­al, a sus­pec­ted un­ex­pec­ted ser­i­ous ad­verse re­ac­tion oc­curs in par­ti­cipants, the in­vest­ig­at­or must doc­u­ment this in a stand­ard­ised man­ner and no­ti­fy the spon­sor with­in 24 hours after it be­comes known.

² The in­vest­ig­at­or shall no­ti­fy the re­spons­ible eth­ics com­mit­tee of a fatal sus­pec­ted un­ex­pec­ted ser­i­ous ad­verse re­ac­tion oc­cur­ring in Switzer­land with­in 7 days, and of any oth­er sus­pec­ted un­ex­pec­ted ser­i­ous ad­verse re­ac­tion with­in 15 days.

³ If, in the case of a mul­ti­centre clin­ic­al tri­al, a sus­pec­ted un­ex­pec­ted ser­i­ous ad­verse re­ac­tion oc­curs at one of the tri­al sites, the co­ordin­at­ing in­vest­ig­at­or shall also no­ti­fy the re­spons­ible eth­ics com­mit­tee con­cerned in ac­cord­ance with para­graph 2, with­in the same peri­od.

⁴ For Cat­egory B and C clin­ic­al tri­als, the no­ti­fic­a­tions spe­cified in para­graph 2 shall also be made to the Agency. This ob­lig­a­tion rests on the spon­sor. For Cat­egory A clin­ic­al tri­als, the spon­sor is sub­ject to the no­ti­fic­a­tion re­quire­ments spe­cified in Art­icle 59 para­graphs 1 and 2 TPA.

⁵ The defin­i­tion of a sus­pec­ted un­ex­pec­ted ser­i­ous ad­verse re­ac­tion is gov­erned by the rules of Good Clin­ic­al Prac­tice as spe­cified in An­nex 1 num­ber 2.

¹ The in­vest­ig­at­or shall, with­in 7 days, no­ti­fy the re­spons­ible eth­ics com­mit­tee of the fol­low­ing:

a.

ser­i­ous ad­verse events which oc­cur in par­ti­cipants in Switzer­land in the course of a Cat­egory C clin­ic­al tri­al of products un­der Art­icle 2a para­graph 2 TPA and where it can­not be ex­cluded that the events are at­trib­ut­able:

1.

to the product un­der in­vest­ig­a­tion, or

2.

to an in­ter­ven­tion un­der­taken in the clin­ic­al tri­al;

b.

de­fi­cien­cies in the product un­der Art­icle 2a para­graph 2 TPA un­der in­vest­ig­a­tion that could have led to ser­i­ous ad­verse events if suit­able ac­tion had not been taken, in­ter­ven­tion had not been made, or cir­cum­stances had been less for­tu­nate.

² If, in the case of a mul­ti­centre clin­ic­al tri­al at one of the tri­al sites, ser­i­ous ad­verse events or de­fi­cien­cies oc­cur de­fi­cien­cies in the product un­der Art­icle 2a para­graph 2 TPA un­der in­vest­ig­a­tion, the co­ordin­at­ing in­vest­ig­at­or shall also no­ti­fy the re­spons­ible eth­ics com­mit­tee con­cerned.

³ For a Cat­egory C clin­ic­al tri­al, the no­ti­fic­a­tions spe­cified in para­graph 1 shall also be made to the Agency. This ob­lig­a­tion rests on the spon­sor. In ad­di­tion, the spon­sor shall no­ti­fy the Agency of any events oc­cur­ring or de­fi­cien­cies in the product un­der Art­icle 2a para­graph 2 TPA un­der in­vest­ig­a­tion ob­served abroad. In the case of a Cat­egory A clin­ic­al tri­al, the spon­sor is sub­ject to the re­port­ing re­quire­ments spe­cified in Art­icle 15 para­graph 1 MedDO³⁵ in its ver­sion of 1 Janu­ary 2002³⁶ in ap­plic­a­tion of Art­icle 103 para­graph 2 MedDO.

⁴ The defin­i­tion of ser­i­ous ad­verse events and de­fi­cien­cies in products un­der Art­icle 2a para­graph 2 TPA is gov­erned by the rules of Good Clin­ic­al Prac­tice as spe­cified in An­nex 1.

¹ Once a year, the in­vest­ig­at­or shall present to the re­spons­ible eth­ics com­mit­tee a list of events and de­fi­cien­cies in the product un­der Art­icle 2a para­graph 2 TPA un­der in­vest­ig­a­tion and ad­verse re­ac­tions as spe­cified in Art­icles 40–42 and, on this basis, shall sub­mit a re­port on their sever­ity and caus­al re­la­tion­ship to the in­ter­ven­tion, and on the safety of par­ti­cipants (an­nu­al safety re­port, ASR).³⁷

² In the case of clin­ic­al tri­als also con­duc­ted abroad ac­cord­ing to the same pro­tocol, the events and de­fi­cien­cies in the product un­der Art­icle 2a para­graph 2 TPA un­der in­vest­ig­a­tion and ad­verse re­ac­tions oc­cur­ring abroad must also be in­cluded in the list and the re­port.³⁸

³ For Cat­egory B and C clin­ic­al tri­als, re­ports as spe­cified in para­graphs 1 and 2 must also be sub­mit­ted to the Agency. This ob­lig­a­tion rests on the spon­sor.

¹ In clin­ic­al tri­als in­volving medi­cin­al products or products un­der Art­icle 2a para­graph 2 TPA cap­able of emit­ting ion­ising ra­di­ation, and in in­vest­ig­a­tions us­ing ra­di­ation sources, the in­vest­ig­at­or shall as­sess com­pli­ance with the dose guid­ance value in ac­cord­ance with Art­icle 45 of the Ra­di­olo­gic­al Pro­tec­tion Or­din­ance of 26 April 2017⁴⁰.

² If the per­mit­ted dose guid­ance value is ex­ceeded at any time, the in­vest­ig­at­or shall no­ti­fy the re­spons­ible eth­ics com­mit­tee with­in sev­en work­ing days of it be­com­ing known.

³ In the case of Cat­egory B and C clin­ic­al tri­als with medi­cin­al products or products un­der Art­icle 2a para­graph 2 TPA that emit ion­ising ra­di­ation, no­ti­fic­a­tion in ac­cord­ance with para­graph 2 must also be giv­en to the Agency. This ob­lig­a­tion rests on the spon­sor.

⁴ The re­spons­ible eth­ics com­mit­tee and the Agency may ob­tain spe­cial­ist ad­vice from the FOPH in or­der to as­sess the dose cal­cu­la­tion or the dose es­tim­a­tion and to de­cide what fur­ther meas­ures are re­quired.

⁵ With­in a year of the com­ple­tion or dis­con­tinu­ation of a clin­ic­al tri­al which in­cluded in­vest­ig­a­tions in­volving ra­dio­act­ive sources, the in­vest­ig­at­or shall sub­mit to the FOPH a fi­nal re­port in­clud­ing all in­form­a­tion of rel­ev­ance for ra­di­olo­gic­al pro­tec­tion, and in par­tic­u­lar a ret­ro­spect­ive par­ti­cipant dose es­tim­a­tion.

⁶ The re­port­ing re­quire­ments in ac­cord­ance with para­graph 5 do not ap­ply in the case of routine nuc­le­ar medi­cine ex­am­in­a­tions in­volving au­thor­ised ra­dio­phar­ma­ceut­ic­als.

⁷ With­in the frame­work of the opin­ion de­livered in ac­cord­ance with Art­icle 28, or on re­quest, the FOPH may spe­cify fur­ther ex­emp­tions from the re­port­ing re­quire­ments in ac­cord­ance with para­graph 5.

¹ The spon­sor must re­tain all data re­lat­ing to the clin­ic­al tri­al un­til the ex­piry date of the last batch sup­plied of the medi­cin­al product un­der in­vest­ig­a­tion or of the last product un­der Art­icle 2a para­graph 2 TPA man­u­fac­tured, but at least for ten years after the com­ple­tion or dis­con­tinu­ation of the clin­ic­al tri­al. In the case of products un­der Art­icle 2a para­graph 2 TPA that can be im­planted, the re­ten­tion peri­od amounts to a min­im­um of 15 years.⁴¹

² The in­vest­ig­at­or must re­tain all doc­u­ments re­quired for the iden­ti­fic­a­tion and fol­low-up of par­ti­cipants, and all oth­er ori­gin­al data, for at least ten years after the com­ple­tion or dis­con­tinu­ation of the clin­ic­al tri­al. In the case of products un­der Art­icle 2a para­graph 2 TPA that can be im­planted, the re­ten­tion peri­od amounts to a min­im­um of 15 years.⁴²

³ For clin­ic­al tri­als of trans­plant products and for clin­ic­al tri­als of blood and blood products, the re­ten­tion re­quire­ments are gov­erned by Art­icle 40 para­graph 1 TPA.

¹ The Agency is en­titled to in­spect all clin­ic­al tri­als of medi­cin­al products, products un­der Art­icle 2a para­graph 2 TPA or trans­plant products.

² If the Agency car­ries out in­spec­tions, it shall in­form in ad­vance the re­spons­ible eth­ics com­mit­tee and oth­er com­pet­ent can­ton­al and fed­er­al au­thor­it­ies. They may par­ti­cip­ate in the in­spec­tion.

³ The Agency’s powers are gov­erned by Art­icle 62 of the Medi­cin­al Products Au­thor­isa­tion Or­din­ance of 14 Novem­ber 2018⁴³.

⁴ The Agency may ad­di­tion­ally carry out in­spec­tions abroad at the spon­sor’s ex­pense, if this is ne­ces­sary to as­sess the clin­ic­al tri­al con­duc­ted in Switzer­land. The spon­sor must be in­formed in ad­vance.

⁵ The Agency shall in­form the re­spons­ible eth­ics com­mit­tee and oth­er com­pet­ent can­ton­al and fed­er­al au­thor­it­ies of the res­ults of the in­spec­tion.

The Agency may re­voke or sus­pend the au­thor­isa­tion gran­ted or make the con­tinu­ation of the clin­ic­al tri­al sub­ject to ad­di­tion­al con­di­tions, in par­tic­u­lar if:

a.

the safety or health of par­ti­cipants is at risk, par­tic­u­larly as a res­ult of in­ad­equate product safety or man­u­fac­tur­ing de­fects;

b.

the qual­ity of the data col­lec­ted is poor;

c.

the clin­ic­al tri­al is not con­duc­ted in ac­cord­ance with the ap­plic­a­tion doc­u­ments ap­proved by the Agency or by the eth­ics com­mit­tee;

d.

the au­thor­isa­tion and no­ti­fic­a­tion re­quire­ments have not been com­plied with.

¹ The re­spons­ible eth­ics com­mit­tee, the Agency and the oth­er com­pet­ent can­ton­al au­thor­it­ies shall co­ordin­ate in ad­vance the of­fi­cial meas­ures to be taken.

² The right is re­served to take meas­ures which have to be ordered without delay in or­der to pro­tect the safety or health of the per­sons con­cerned. The eth­ics com­mit­tees and the oth­er com­pet­ent fed­er­al and can­ton­al au­thor­it­ies shall im­me­di­ately in­form each oth­er about such meas­ures.

¹ A clin­ic­al tri­al of the trans­plant­a­tion of hu­man or­gans, tis­sues and cells comes un­der Cat­egory A if the trans­plant­a­tion to be in­vest­ig­ated is re­cog­nised as stand­ard in guidelines pre­pared in ac­cord­ance with in­ter­na­tion­ally ac­cep­ted qual­ity cri­ter­ia.

² A clin­ic­al tri­al of the trans­plant­a­tion of hu­man or­gans, tis­sues and cells comes un­der Cat­egory C if the trans­plant­a­tion to be in­vest­ig­ated is not re­cog­nised as stand­ard as spe­cified in para­graph 1.

³ Clin­ic­al tri­als of the trans­plant­a­tion of em­bryon­ic and foet­al tis­sues and cells come un­der Cat­egory C.

¹ The in­vest­ig­at­or and the spon­sor may sim­ul­tan­eously sub­mit ap­plic­a­tions to the re­spons­ible eth­ics com­mit­tee and to the FOPH.

² The re­spons­ible eth­ics com­mit­tee and the FOPH shall in­form each oth­er about mat­ters re­lat­ing to the re­view areas spe­cified both in Art­icle 25 and in Art­icle 53, and shall co­ordin­ate their as­sess­ments.

For the pro­ced­ure for the au­thor­isa­tion of clin­ic­al tri­als of trans­plant­a­tion by the re­spons­ible eth­ics com­mit­tee, Art­icles 24–29 ap­ply mu­tatis mutandis.

Cat­egory A clin­ic­al tri­als are ex­emp­ted from the re­quire­ment for au­thor­isa­tion from the FOPH spe­cified in Art­icle 36 para­graph 1 of the Trans­plant­a­tion Act.

For clin­ic­al tri­als of trans­plant­a­tion, the FOPH shall re­view:

a.

the com­plete­ness of the ap­plic­a­tion;

b.

the ori­gin of the or­gans, tis­sues or cells used in the clin­ic­al tri­al;

c.

com­pli­ance with the re­quire­ments of the trans­plant­a­tion le­gis­la­tion, par­tic­u­larly with re­gard to the du­ties of care in the hand­ling of or­gans, tis­sues and cells, and the al­loc­a­tion of or­gans;

d.

the avail­ab­il­ity of the au­thor­isa­tions re­quired in ac­cord­ance with the Trans­plant­a­tion Act;

e.

oth­er areas, where this is ne­ces­sary to as­sess the safety and qual­ity of the or­gans, tis­sues or cells used.

¹ The spon­sor shall sub­mit to the FOPH the ap­plic­a­tion doc­u­ments spe­cified in An­nex 4 for re­view.

² The FOPH may re­quest ad­di­tion­al in­form­a­tion.

³ For the pro­ced­ure and dead­lines, Art­icle 33 ap­plies mu­tatis mutandis.

¹ Sig­ni­fic­ant changes to an au­thor­ised clin­ic­al tri­al must be au­thor­ised by the FOPH be­fore be­ing im­ple­men­ted. Ex­empt from this re­quire­ment are meas­ures which have to be taken im­me­di­ately in or­der to pro­tect the par­ti­cipants.

² The spon­sor must sub­mit to the FOPH any ap­plic­a­tion doc­u­ments spe­cified in An­nex 4 which are af­fected by the change. At the same time, the spon­sor shall provide in­form­a­tion on the reas­ons for the change.

³ The fol­low­ing are con­sidered to be sig­ni­fic­ant changes:

a.

new sci­entif­ic know­ledge, based in par­tic­u­lar on new pre­clin­ic­al or clin­ic­al data, which af­fects the as­sess­ment of the safety of the or­gans, tis­sues or cells used; or

b.

changes re­lat­ing to the ori­gin, the tests to be per­formed or the stor­age of the or­gans, tis­sues or cells used.

⁴ Also con­sidered sig­ni­fic­ant in the case of clin­ic­al tri­als of the trans­plant­a­tion of em­bryon­ic or foet­al tis­sues and cells are changes which may af­fect the safety of the par­ti­cipants.

⁵ The FOPH shall reach a de­cision with­in 30 days of re­ceipt of the com­plete set of ap­plic­a­tion doc­u­ments af­fected by the change. Art­icle 33 ap­plies mu­tatis mutandis.

⁶ Oth­er changes which af­fect doc­u­ments sub­mit­ted to the FOPH must be no­ti­fied to the FOPH as quickly as pos­sible.

¹ The FOPH shall grant au­thor­isa­tion if, in ad­di­tion to Art­icle 53, the re­quire­ments spe­cified in Art­icle 34 of the Trans­plant­a­tion Or­din­ance of 16 March 2007⁴⁴ are met.

² It shall grant au­thor­isa­tion with­in 60 days or, in the case of sig­ni­fic­ant changes, with­in 30 days after re­ceipt of the com­plete ap­plic­a­tion doc­u­ments.

³ For clin­ic­al tri­als of the trans­plant­a­tion of em­bryon­ic or foet­al tis­sues and cells, Art­icles 35, 36 and 38 of the Trans­plant­a­tion Or­din­ance ad­di­tion­ally ap­ply.

¹ For no­ti­fic­a­tions and re­port­ing in the case of clin­ic­al tri­als of trans­plant­a­tion, Art­icles 37–41, 43 and 44 ap­ply mu­tatis mutandis.⁴⁵

² The ob­lig­a­tions which must be ful­filled un­der these pro­vi­sions vis-à-vis the Agency are to be ful­filled, for clin­ic­al tri­als of trans­plant­a­tion, vis-à-vis the FOPH.

³ For clin­ic­al tri­als of trans­plant­a­tion, the du­ties of the spon­sor and the in­vest­ig­at­or con­cern­ing doc­u­ment­a­tion, trace­ab­il­ity and re­ten­tion of re­cords are gov­erned by Art­icles 34 and 35 of the Trans­plant­a­tion Act.

¹ The FOPH may carry out in­spec­tions at any time and in­spect all doc­u­ments and data re­lat­ing to a clin­ic­al tri­al of trans­plant­a­tion. It may re­quest the can­ton­al au­thor­it­ies or third parties to carry out in­spec­tions.

² Oth­er powers and du­ties of co­oper­a­tion are gov­erned by Art­icle 63 para­graphs 2 and 3 and Art­icle 64 of the Trans­plant­a­tion Act.

¹ The FOPH may re­voke or sus­pend the au­thor­isa­tion gran­ted or make the con­tinu­ation of the clin­ic­al tri­al sub­ject to ad­di­tion­al con­di­tions, par­tic­u­larly if:

a.

it has reas­on to as­sume that the re­quire­ments are no longer met, the doc­u­ments spe­cified in Art­icle 54 have been changed without due no­ti­fic­a­tion hav­ing been made, or the tri­al is not be­ing con­duc­ted in ac­cord­ance with these doc­u­ments;

b.

such meas­ures are ne­ces­sit­ated by new in­form­a­tion con­cern­ing safety or the sci­entif­ic basis.

² For the co­ordin­a­tion of meas­ures and the ex­change of in­form­a­tion between the FOPH, the re­spons­ible eth­ics com­mit­tee and oth­er com­pet­ent can­ton­al au­thor­it­ies, Art­icle 48 ap­plies mu­tatis mutandis.

This Chapter ap­plies to clin­ic­al tri­als which are neither tri­als of medi­cin­al products, products un­der Art­icle 2a para­graph 2 TPA or trans­plant products nor tri­als of trans­plant­a­tion.

¹ A clin­ic­al tri­al comes un­der Cat­egory A if the health-re­lated in­ter­ven­tion in­vest­ig­ated:

a.

en­tails only min­im­al risks and bur­dens; or

b.

is re­cog­nised as stand­ard in guidelines pre­pared in ac­cord­ance with in­ter­na­tion­ally ac­cep­ted qual­ity cri­ter­ia.

² A clin­ic­al tri­al comes un­der Cat­egory B if the health-re­lated in­ter­ven­tion in­vest­ig­ated:

a.

en­tails more than min­im­al risks and bur­dens; and

b.

is not re­cog­nised as stand­ard as spe­cified in para­graph 1 let­ter b.

The pro­vi­sions which ap­ply mu­tatis mutandis are:

a.

for the au­thor­isa­tion pro­ced­ure for clin­ic­al tri­als, Art­icles 24–29;

b.

for the no­ti­fic­a­tion of safety and pro­tect­ive meas­ures, Art­icle 37 para­graph 1;

c.

for no­ti­fic­a­tion and re­port­ing upon com­ple­tion, dis­con­tinu­ation or in­ter­rup­tion of a clin­ic­al tri­al, Art­icle 38 para­graphs 1–4;

d.

for re­port­ing on the safety of par­ti­cipants, Art­icle 43 para­graphs 1 and 2;

e.

for data re­ten­tion re­quire­ments, Art­icle 45 para­graph 2.

¹ If, in the course of a clin­ic­al tri­al, ser­i­ous ad­verse events oc­cur in par­ti­cipants in Switzer­land, and it can­not be ex­cluded that the events are at­trib­ut­able to the in­ter­ven­tion un­der in­vest­ig­a­tion, the in­vest­ig­at­or must doc­u­ment them in a stand­ard­ised man­ner. In ad­di­tion, the in­vest­ig­at­or shall re­port these events:

a.

to the spon­sor with­in 24 hours after they be­come known; and

b.

to the re­spons­ible eth­ics com­mit­tee with­in 15 days.

² A ser­i­ous ad­verse event is defined as any event which:

a.

re­quires in­pa­tient treat­ment not en­vis­aged in the pro­tocol or ex­tends a cur­rent hos­pit­al stay;

b.

res­ults in per­man­ent or sig­ni­fic­ant in­ca­pa­city or dis­ab­il­ity;

c.

is life-threat­en­ing or res­ults in death; or

d.

causes a con­gen­it­al an­om­aly or birth de­fect.

³ If ne­ces­sary in or­der to guar­an­tee par­ti­cipants’ safety and health, fur­ther ad­verse events which must be doc­u­mented or re­por­ted are to be des­ig­nated in the pro­tocol or at the re­quest of the re­spons­ible eth­ics com­mit­tee.

⁴ If, in the case of a mul­ti­centre clin­ic­al tri­al, ser­i­ous ad­verse events oc­cur at one of the tri­al sites, the co­ordin­at­ing in­vest­ig­at­or shall also re­port the events as spe­cified in para­graphs 1 and 3 to the re­spons­ible eth­ics com­mit­tee con­cerned, with­in the same peri­od.⁴⁶

¹ For an au­thor­ised clin­ic­al tri­al, the spon­sor must re­gister the data spe­cified in An­nex 5 num­ber 1:

a.

in a primary re­gistry⁴⁷ re­cog­nised by the World Health Or­gan­iz­a­tion (WHO); or

b.

in the re­gistry of the U.S. Na­tion­al Lib­rary of Medi­cine⁴⁸.

² The spon­sor shall ad­di­tion­ally enter the data spe­cified in An­nex 5 num­ber 2 in the sup­ple­ment­ary fed­er­al data­base, us­ing a Swiss na­tion­al lan­guage.

³ The data must be entered in the form au­thor­ised by the re­spons­ible eth­ics com­mit­tee.

¹ The re­gis­tra­tion spe­cified in Art­icle 64 must be per­formed be­fore the clin­ic­al tri­al is con­duc­ted, sub­ject to the pro­vi­sions of para­graph 2.

² Clin­ic­al tri­als in which the medi­cin­al product un­der in­vest­ig­a­tion is be­ing ad­min­istered to adult per­sons for the first time (Phase I clin­ic­al tri­als) must be re­gistered no later than one year after the com­ple­tion of the clin­ic­al tri­al.

³ The spon­sor must up­date the data entered in ac­cord­ance with the re­quire­ments of the re­gistry in ques­tion, as spe­cified in Art­icle 64 para­graph 1, but at least once a year.

The spon­sor is re­spons­ible for the ac­cur­acy and com­plete­ness of the data entered.

¹ Pub­lic ac­cess to in­form­a­tion on clin­ic­al tri­als con­duc­ted in Switzer­land shall be guar­an­teed by a portal provid­ing ac­cess to one or more re­gis­tries.

² The portal shall en­able in par­tic­u­lar:

a.

link­ing of data in the sup­ple­ment­ary fed­er­al data­base to data in the ap­proved re­gistry, as spe­cified in Art­icle 64 para­graph 1;

b.

search­ing for clin­ic­al tri­als by keywords.

³ The op­er­a­tion of the portal and of the sup­ple­ment­ary fed­er­al data­base shall be guar­an­teed by the co­ordin­a­tion of­fice spe­cified in Art­icle 10 of the HRA Or­gan­isa­tion Or­din­ance of 20 Septem­ber 2013⁴⁹.

The Fed­er­al De­part­ment of Home Af­fairs may up­date An­nexes 1–5 in ac­cord­ance with in­ter­na­tion­al or tech­nic­al de­vel­op­ments. It shall un­der­take up­dates which may give rise to tech­nic­al bar­ri­ers to trade in con­sulta­tion with the Fed­er­al De­part­ment of Eco­nom­ic Af­fairs, Edu­ca­tion and Re­search.

The fol­low­ing Or­din­ances shall be re­pealed:

1.

Or­din­ance of 14 June 1993⁵⁰ on the Waiver of Pro­fes­sion­al Con­fid­en­ti­al­ity in Med­ic­al Re­search;

2.

Or­din­ance of 17 Oc­to­ber 2001⁵¹ on Clin­ic­al Tri­als of medi­cin­al products, in vitro dia­gnost­ic med­ic­al devices or com­bin­a­tions un­der Art­icle 2 let­ters f–h MedDO;

3.

HIV Stud­ies Or­din­ance of 30 June 1993⁵².

The amend­ment of oth­er le­gis­la­tion is reg­u­lated in An­nex 6.

¹ Clin­ic­al tri­als of thera­peut­ic products and trans­plant products and tri­als of trans­plant­a­tion which were au­thor­ised be­fore 1 Janu­ary 2014 are con­sidered to be Cat­egory C clin­ic­al tri­als.

² Oth­er au­thor­ised clin­ic­al tri­als are con­sidered to be Cat­egory B clin­ic­al tri­als.

³ On re­quest, the au­thor­ity which au­thor­ised the clin­ic­al tri­al be­fore 1 Janu­ary 2014 may as­sign the clin­ic­al tri­al to a dif­fer­ent cat­egory. In this case, the li­ab­il­ity, cov­er­age, no­ti­fic­a­tion, re­port­ing and doc­u­ment­a­tion re­quire­ments are gov­erned by the new law.

⁴ The re­spons­ible eth­ics com­mit­tee shall make the de­cision spe­cified in para­graph 3 ac­cord­ing to the sim­pli­fied pro­ced­ure spe­cified in Art­icle 6 of the HRA Or­gan­isa­tion Or­din­ance of 20 Septem­ber 2013⁵³.

⁵ The as­sess­ment of sig­ni­fic­ant changes is gov­erned by the new law.

The re­spons­ible eth­ics com­mit­tee shall make a de­cision on ap­plic­a­tions con­cern­ing clin­ic­al tri­als not sub­ject to au­thor­isa­tion un­der ex­ist­ing law, sub­mit­ted in ac­cord­ance with Art­icle 67 para­graph 2 HRA, with­in six months after ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments.

The spon­sor of an au­thor­ised clin­ic­al tri­al which is not com­pleted with­in a year after the com­mence­ment of the HRA must, with­in six months, enter the data spe­cified in An­nex 5 num­ber 1 in a re­gistry, as spe­cified in Art­icle 64 para­graph 1.

This Or­din­ance enters in­to force on 1 Janu­ary 2014.