812.212.1MPLOFederal Council OrdinanceJan 1, 2019Original source
Any person applying for a licence to perform brokerage or agency activities must prove that:
the facilities operate a functioning quality assurance system and that the company management and staff in the individual departments concerned take an active part in this system;
a Responsible Person in accordance with Article 26 is available;
the facilities are organised in an appropriate way;
a documentation system is available that comprises the working instructions, process descriptions and protocols of the relevant procedures;
due diligence is exercised as described in Article 25.
Swissmedic may specify further technical requirements and details.
The licence does not entitle the holder to issue manufacturing orders.
0 commentaries
No commentaries are available for this article yet.