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

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.