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

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.