Commentaries: Art. 21

Any person applying for a licence to trade in foreign countries must prove that:
1. the facilities operate a system to ensure the pharmaceutical quality of medicinal products and that the company management and staff in the individual departments concerned take an active part in this system;
2. a Responsible Person in accordance with Article 23 is available;
3. the facilities are organised in an appropriate way;
4. a documentation system is available that comprises the working instructions, process descriptions and protocols of the relevant procedures involved in the activities;
5. due diligence is exercised as described in Article 22.
Swissmedic may specify further technical requirements and details.
The licence does not entitle the holder to issue manufacturing orders.