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

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.