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

¹ Fed­er­al and can­ton­al au­thor­it­ies, re­gion­al centres and third parties en­trus­ted with en­force­ment tasks may, to the ex­tent ne­ces­sary to ful­fil their du­ties un­der this Act, pro­cess the fol­low­ing sens­it­ive per­son­al data:¹⁴⁹

a.

data on health:

1.¹⁵⁰

for of­fi­cial mar­ket sur­veil­lance,

2.

to ex­er­cise vi­gil­ance in con­nec­tion with in­com­ing no­ti­fic­a­tions on ad­verse ef­fects and events and on qual­ity de­fects,

3.

to veri­fy clin­ic­al tri­als on the basis of in­com­ing no­ti­fic­a­tions and in­spec­tions, or

4.¹⁵¹

in con­nec­tion with ap­plic­a­tions for tem­por­ary au­thor­isa­tions as spe­cified in Art­icle 9b para­graph 1 and for ex­emp­tions for med­ic­al devices as spe­cified in Art­icle 46 para­graph 3 let­ter b;

b.

data on ad­min­is­trat­ive or crim­in­al pro­sec­u­tions and sanc­tions:

1.

with­in the frame­work of pro­ced­ures for grant­ing es­tab­lish­ment li­cences, or

2.

to as­sess wheth­er an in­vest­ig­at­or is qual­i­fied for con­duct­ing clin­ic­al tri­als.

² Sens­it­ive per­son­al data pur­su­ant to para­graph 1 let­ter a shall be made an­onym­ous wherever pos­sible.

³ The Fed­er­al Coun­cil shall is­sue im­ple­ment­ing pro­vi­sions on:

a.

re­spons­ib­il­ity for data pro­cessing;

b.

the scope of ac­cess rights for re­triev­al pro­ced­ures;

c.

the length of time the data is to be kept;

d.

the archiv­ing and de­struc­tion of data;

e.

data se­cur­ity.