812.212.1MPLOFederal Council OrdinanceJan 1, 2019Original source
If the tests are carried out abroad, it must be proven that they comply with the state-of-the-art scientific and technological knowledge.
Swissmedic may specify technical requirements and particulars in relation to the tests and test procedures.
When tests are being carried out on blood or labile blood products intended for transfusion or to manufacture medicinal products, the rules of good practice must be adhered to in accordance with Annex 1 of the Ordinance of 29 April 20151on Microbiological Laboratories.