Any person drawing blood from persons for the purpose of transfusion or the manufacture of therapeutic products or for supply to a third party must possess an operating licence issued by the Agency.
The licence shall be issued if:
the necessary technical and operational conditions are fulfilled;
an appropriate system of quality assurance exists.
The Agency shall verify by inspection that the licensing conditions are fulfilled.
Establishments such as hospitals which only stock blood or blood products must possess a cantonal operating licence. The cantons shall lay down the conditions and the procedure for granting this licence. They shall carry out periodical inspections.
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