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

¹ The fed­er­al au­thor­it­ies re­spons­ible for the en­force­ment of this Act may dis­close in­form­a­tion which is not pub­licly ac­cess­ible to the for­eign au­thor­it­ies and in­sti­tu­tions re­spons­ible for the en­force­ment of thera­peut­ic product reg­u­la­tions and to in­ter­na­tion­al or­gan­isa­tions, provided that it is en­sured that:

a.

the re­quest­ing body is bound by of­fi­cial secrecy and uses the in­form­a­tion re­ceived ex­clus­ively in an ad­min­is­trat­ive pro­ced­ure in con­nec­tion with the en­force­ment of thera­peut­ic product reg­u­la­tions and does not pass it on to third parties;

b.

only in­form­a­tion re­quired for the en­force­ment of thera­peut­ic product reg­u­la­tions is trans­mit­ted;

c.

no man­u­fac­tur­ing or trade secrets are dis­closed, un­less the trans­mis­sion of such in­form­a­tion is re­quired to avert an im­me­di­ate and ser­i­ous risk to hu­man life or health.

² They may dis­close per­son­al data, in­clud­ing data on health and on ad­min­is­trat­ive or crim­in­al pro­ceed­ings or sanc­tions, if le­gis­la­tion in the state con­cerned guar­an­tees ad­equate pro­tec­tion of the pri­vacy of the data sub­ject. In the ab­sence of such le­gis­la­tion, the data may only be dis­closed if:

a.

suf­fi­cient safe­guards, in par­tic­u­lar con­trac­tu­al clauses, en­sure an ad­equate level of pro­tec­tion;

b.

the data sub­ject has con­sen­ted in the spe­cif­ic case;

c.

ser­i­ous risks to health can thereby be aver­ted in the spe­cif­ic case;

d.

dis­clos­ure is re­quired in the spe­cif­ic case in or­der to pro­tect the life or the phys­ic­al in­teg­rity of the data sub­ject; or

e.

in the spe­cif­ic case, there is a pos­sib­il­ity that il­leg­al traffic or oth­er ser­i­ous vi­ol­a­tions of this Act may be re­vealed as a res­ult.

³ In par­tic­u­lar, the fol­low­ing data may be dis­closed:

a.

res­ults of mar­ket sur­veil­lance;

b.

in­spec­tion re­ports;

c.

in­form­a­tion on clin­ic­al tri­als;

d.

in­form­a­tion from vi­gil­ance;

e.

in­form­a­tion on au­thor­isa­tions;

f.

in­form­a­tion on con­form­ity as­sess­ment bod­ies.

⁴ The Agency is en­titled to dis­close the fol­low­ing in­form­a­tion to the World Health Or­gan­iz­a­tion via its Glob­al Phar­ma­covi­gil­ance Data­base, in con­nec­tion with no­ti­fic­a­tions and re­gis­tra­tions of ad­verse re­ac­tions to medi­cin­al products:

a.

in­form­a­tion which is not pub­licly ac­cess­ible and per­son­al data re­lat­ing to health, to­geth­er with the data sub­ject’s ini­tials, sex and year of birth;

b.

a re­port on the ad­verse re­ac­tions.