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

¹ A li­cence from the Agency shall be re­quired by those who:²⁶

a.

man­u­fac­ture medi­cin­al products;

b.

add medi­cin­al products to an­im­al feed.

² The Fed­er­al Coun­cil reg­u­lates ex­emp­tions from the li­cence re­quire­ment. In par­tic­u­lar, it may:

a.²⁷

make the man­u­fac­ture of medi­cin­al products un­der Art­icle 9 para­graph 2 let­ters a–c^bis sub­ject to a man­dat­ory can­ton­al li­cence or re­port­ing re­quire­ment;

b.

ex­empt from the li­cence re­quire­ment live­stock hold­ers who add medi­cin­al products to an­im­al feed in­ten­ded for their own live­stock.

³ It may provide for a licence requirement in accordance with the corresponding internationally recognised requirements for the manufacture of certain categories of pharmaceutical excipients which present an increased risk to patients.²⁸