Swissmedic has been informed by the Brazilian Health Regulatory Agency ANVISA that Brazil has suspended all imports of medicinal products from three Turkish wholesalers:
- ANKARA TURKELI ECZA DEPOSU LTD.STI
- POROS PHARMA
- KAREN ILAC ECZA DEPOSU ITHALAT IHRACAT A.S.
The reason for this is the export of falsified units of Defibrotide (batch 0126), Soliris (batches 1000706, 1003254) and Harvoni (batches 22VMYA12, 61264902) from Turkey to Brazil. One of the abovementioned Soliris batches was also obtained from Turkey and sold to Brazil by a Swiss wholesaler (see below for link).
Accordingly, Swiss companies are also not permitted to supply medications obtained from the abovementioned Turkish wholesalers to Brazil (also via third parties).
Swissmedic expects holders of a licence to distribute medicinal products to take this information into account when verifying and qualifying their suppliers. They are responsible for taking all the necessary measures to ensure they obtain and distribute only high-quality medicinal products from qualified sources.