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–cbis 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