Brokering of medicinal products via sales platforms
Broker and agency activities
The Therapeutic Products Act (TPA) does not generally permit the sale of medicinal products by mail order. Furthermore a licence is required to distribute medicinal products. With the revision of the therapeutic products legislation as of 1 January 2019, the TPA now explicitly recognises broker and agency activities as "distribution" activities.
This innovation enshrines in law Swissmedic’s existing practice of making such activities dependent on the issuing of a Swissmedic licence. The specific provisions governing these activities are set out in the Medicinal Products Licensing Ordinance (MPLO).
They impose a clear requirement to obtain a licence from Swissmedic for broker and agency activities between wholesalers and/or manufacturers or from wholesalers to retailers.
Direct sales (online platforms) to end customers
However, activities that do not involve brokering medicinal products to another licensed facility but are provided direct to a final customer (patient) are deemed to be medicinal products dispensing. Such activities are subject to the relevant cantonal licences.
Any sales platform that wants to undertake activities of this kind must ensure that both it and its contracted partners (the companies or individuals who offer medicinal products for sale on the platform) possess all cantonal licences explicitly required to distribute medicinal products via a sales platform.
Swissmedic hereby calls on the operators of sales platforms to verify that their activities are legally compliant, and, if necessary, to apply for the necessary licences without delay. Anyone who has not submitted a suitably documented application for a licence to carry out broker or agency activities or who does not hold the necessary cantonal licences must ensure that no medicinal products are brokered or offered for sale on their platform.
Platform operators will be held responsible for any medicinal products offered for sale on their platforms.