Commentaries: Art. 27

Any person applying for a licence to collect blood for transfusion or the manufacture of medicinal products in accordance with Article 34 TPA must prove that:
1. the conditions described in Article 3 have been fulfilled;
2. the Responsible Person fulfils the conditions of Articles 5 and 6 and has a university degree in medicine or a life science and the scientific and medical experience needed to collect blood;
3. blood is collected in compliance with the GMP rules described in Annex 1;
4. due diligence is exercised as described in Articles 28–38.
Swissmedic may specify further technical requirements and details.