Combating Counterfeit Ozempic: The EU’s EMVS Steps Up
In a recent development, the European Medicines Agency (EMA) has flagged the presence of counterfeit Ozempic pens in the EU market. These counterfeit pens, originating from wholesalers in Austria and Germany, bear the German language labelling and packaging and possess batch numbers, 2D barcodes, and unique serial numbers identical to those found on genuine Ozempic packs.
Fortunately, the EU Medicines Verification System (EMVS) has played a crucial role in detecting these counterfeit pens. EMVS, an EU-wide electronic system, assigns a unique identifier (UI) to each medicinal product, enabling real-time verification of product authenticity and traceability throughout the distribution process. When the serial numbers of counterfeit Ozempic pens were scanned through EMVS, they were flagged as inactive, alerting authorities to a potential falsification.
The EMA has assured patients that there is no evidence of any counterfeit pens being dispensed from legitimate pharmacies. However, they are collaborating with EU medicines regulatory authorities and the police to investigate the matter thoroughly. Wholesalers and pharmacies in the affected countries have been warned, and parallel distributors across the EU have also been informed.
The German and Austrian regulatory authorities have taken further action by issuing statements of non-compliance with good distribution practices (GDP) to the wholesalers involved. These wholesalers failed to adhere to required procedures, including compliance with security measures, thereby contributing to the counterfeiting of Ozempic.
The increased demand for Ozempic, sometimes used off-label for weight loss, has led to shortages, possibly creating an opportunity for counterfeiters to exploit. The emergence of counterfeit Ozempic highlights the importance of EMVS in protecting patients from the dangers of falsified medicines.
As we strive for a safer pharmaceutical supply chain, the EMVS stands as a valuable tool, enabling real-time verification and traceability, and safeguarding patients from the perils of counterfeit drugs.
