EMA says verification system revealed fake Ozempic

The European Medicines Agency (EMA) has added its own voice to warnings of falsified versions of Novo Nordisk’s diabetes medicine Ozempic.

The counterfeit self-injector pens, which have German language labelling and packaging, originated from wholesalers in Austria and Germany, according to the EU regulator, and have batch numbers, 2D barcodes and unique serial numbers from genuine Ozempic packs.

They have been found in EU countries as well as in the UK, according to an alert issued this morning.

“In the EU, each medicine pack has a unique 2D barcode and serial number so that it can be tracked in an EU-wide electronic system,” said the EMA.

“When the packs of the falsified Ozempic were scanned, the serial numbers were shown to be inactive, thereby alerting operators to a potential falsification,” it added.

The EU Medicines Verification System (EMVS) went live across Europe on February 9, 2019, and protects patients from the risk of falsified medicines through an end-to-end verification of medicinal packs, with each checked at the pharmacy level.

“There is no evidence that any falsified pens have been dispensed to patients from legal pharmacies and there are no reports of harm to patients in relation to the falsified medicine,” said the EMA.

“The issue is currently being investigated by EU medicines regulatory authorities and the police,” it added, noting that wholesalers and pharmacies in the affected countries have been warned along with parallel distributors across the EU.

Meanwhile, the German and Austrian regulatory authorities have issued statements of non-compliance with good distribution practices (GDP) to the concerned wholesalers in their countries for not following required procedures, including compliance with security measures/

The falsification has emerged following an increase in demand for Ozempic, sometimes used off-label for weight loss, which has led to shortages.