Swiss wholesale license holder must tighten their audit practices towards suppliers from countries outside of the EU.
Foreign pharmaceuticals trade from Switzerland
Entities active in Switzerland in international trading of pharmaceuticals are required to apply for and to maintain a Swiss wholesale license or a special Swiss foreign trade license with the competent supervisory authority Swissmedic. A license is required even if there is no physical flow of goods within the Swiss territory.
The rationale for the license requirement is to ensure that all pharmaceuticals distributed by entities active in Switzerland comply with the EU GDP regulations guaranteeing high standards even abroad.
Tightened regulatory requirements
Swissmedic reports in a press release of recent cases where Swiss entities distributed abroad pharmaceuticals that turned out to be counterfeits. These products were sourced from suppliers in countries that do not have regulations equivalent to the EU GDP standards.
Therefore, Swissmedic communicated that it expects Swiss license holders to tighten their audit practices in relation to suppliers of finished pharmaceuticals from non-EU countries.
In particular, Swissmedic reminds license holders that they must verify that their suppliers are fully compliant with all EU GDP requirements, meaning that in addition to a document review, the license holder must carry out an in-depth audit of the supplier. Moreover, the license holder must have detailed knowledge of the local regulations and be able to reconstruct the supply chain of finished pharmaceuticals through all steps up to the marketing authorization holder.
Detailed information on all Swiss regulatory requirements in relation to licenses can be found online (in English) in the Swiss Therapeutic Products Act, the Swiss Medicinal Products Licensing Ordinance and in the relevant technical interpretation by Swissmedic (“Legal requirements and mandatory due diligence by Swiss firms wishing to engage in foreign trade with medicinal products from Switzerland”).
Swissmedic also specifically announces that it will take all appropriate administrative and criminal measures against any violation of the law by non-compliant foreign trade license holders, including ordering recalls and withdrawing licenses if appropriate.
Need for action
We recommend reviewing if the internal policies and procedures comply with the tightened regulatory practice in relation to non-EU suppliers.