Ordinance
on Licensing in the Medicinal Products Sector
(Medicinal Products Licensing Ordinance, MPLO)


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Art. 31 Appropriate tests and test procedures

1 If the tests are car­ried out abroad, it must be proven that they com­ply with the state-of-the-art sci­entif­ic and tech­no­lo­gic­al know­ledge.

2 Swiss­med­ic may spe­cify tech­nic­al re­quire­ments and par­tic­u­lars in re­la­tion to the tests and test pro­ced­ures.

3 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 20159 on Mi­cro­bi­o­lo­gic­al Labor­at­or­ies.

9 SR 818.101.32

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