Art. 45

Any person applying for a licence in accordance with Article 44 paragraph 1 must prove that:

1. they have a licence to import medicinal products;
2. if these are ready-to-use medicinal products destined for the Swiss market, they have the corresponding authorisation;
3. they ensure the safe and lawful import of the medicinal products and accept responsibility for this;
4. the manufacturing and import of the medicinal products and wholesale trading in medicinal products are in conformity with the GMP rules described in Annex 1 and the GDP rules described in Annex 4;
5. in the case of blood and blood products for use in humans, in addition to letters a–d:

1. no pathogens or indication of the presence of pathogens can be detected,

2. each individual blood donation is analysed using tests that correspond to state-of-the-art scientific and technical knowledge,

3. blood and plasma are only imported unmixed, unless Swissmedic has exceptionally granted a licence to import mixed products,

4. the requirements in accordance with Article 27 paragraph 1 letter c and Articles 34, 35 and 37 are adhered to.