International trade with wholesalers outside the EU

Licence holders required to check suppliers more rigorously


Events in recent years have prompted Swissmedic to demand that licence holders check suppliers more rigorously when trading in finished medicinal products sourced from third parties. This applies to finished products from countries outside the EU that do not have equivalent GDP requirements and to products sourced via wholesalers in such countries.

In the last four years, for example, there have been ten cases of Swiss wholesalers distributing foreign presentations of medicinal products procured from Turkish wholesalers that later turned out to be falsifications. Swissmedic published one of these cases in September 2020 to raise awareness among market players (see link).

So far, the Swiss market has not been directly affected by falsified medicines, since the products in question were destined for sale abroad. However, the EU discovered that falsified medicinal products had made their way into distribution channels within the Union via parallel imports delivered by such suppliers.

Swiss licence holders must ensure that suppliers with wholesale licences from countries that do not apply the same GDP rules as Switzerland and the EU are fully qualified. In particular, they must verify that suppliers comply fully with all EU GDP requirements, which means conducting an in-depth audit in addition to a document review. Qualification also demands detailed knowledge of the legal situation at the supplier’s location.

In connection with this, licence holders are expected to be able to reconstruct the entire supply chain for a finished medicinal product as far as the authorisation holder and to verify the legality of the supply chain at each of its steps. If there are any doubts, or if anything is unclear, it is essential to request information directly from the authorisation holder in question.

Swiss wholesalers who are suspected of trading in falsified products will be officially investigated and may be faced with a batch recall involving publication or even with revocation of their establishment licence as part of administrative proceedings. Depending on the matter in question, administrative penal proceedings may also be initiated. Checking more rigorously on suppliers from countries with no equivalent GDP requirements thus not only benefits patient safety but is in licence holders’ interests too.