Commentaries: Art. 46

The application for a licence to import individual batches must be submitted to Swissmedic together with the necessary documentation.
The licence is valid for one month.
The applicant must ensure that the licence is presented to the customs office at the time when the medicinal products are imported.
On customs clearance, the customs office shall discharge the licence and forward it to Swissmedic.
In the absence of a licence to import individual batches in accordance with Article 44 paragraph 1, medicinal products are refused entry at the border and reported to Swissmedic.