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


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Art. 19 Licensing conditions

1 The li­cence shall be is­sued if:

a.
the ne­ces­sary tech­nic­al and op­er­a­tion­al con­di­tions are ful­filled;
b.
an ap­pro­pri­ate sys­tem of qual­ity as­sur­ance ex­ists.

2 The li­cence shall also be is­sued to the ap­plic­ant who already pos­sesses a man­u­fac­tur­ing li­cence for medi­cin­al products. Fur­ther­more, the li­cence re­ferred to in Art­icle 18 para­graphs 1 let­ters b and c shall be is­sued to the ap­plic­ant already pos­sess­ing a li­cence for the im­port or whole­sale trade of medi­cin­al products.

3 The com­pet­ent au­thor­ity shall veri­fy by in­spec­tion that the con­di­tions are ful­filled.

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