The Chief Pharmaceutical Inspector (GIF) has published two decisions regarding the well-known diabetes drug – Ozempic. In one case, it withdraws one of the series from circulation throughout the country, and in the other it prohibits the marketing of three more series.
The Chief Pharmaceutical Inspector made a decision on the immediate enforceability of the drug Ozempic from the Danish manufacturer Novo Nordisk A/S.
Ozempic 1mg solution for injection in pre-filled pen; 3 pens 3 ml + 12 needles lot number: MP5E511, expiry date: 07/2025 for packages with serial number (SN): 1946483405690
On the other hand marketing ban throughout the country applies to:
Ozempic 1mg solution for injection in pre-filled pen; 3 3 ml pens + 12 needles
batch number: MP5E511, expiry date: 07/2025 for packages with a serial number (SN): 1946483405690 batch number: NP5G866, expiry date: 12/2025 for packages with a serial number (SN): 1946483405690 batch number: NP5G866, expiry date validity: 12/2025 for packaging with serial number (SN): 1031002838555
Withdrawal and ban on the sale of Ozempic. Justification
“On October 5 and 10, 2023, the Chief Pharmaceutical Inspector received two reports of counterfeiting of the medicinal product Ozempic 1mg solution for injection in a pen; 3 3 ml pens + 12 needles. The reports concerned two batches of the product in question with numbers MP5E511, expiry date: 07/2025, NP5G866, expiry date: 12/2025,” GIF said in a statement.
It was further stated that “unit packages of the medicinal product indicated above identified as counterfeit were discovered in the legal supply chain in Great Britain and Germany. 200 packages for batch number MP5E511 were found to be counterfeit due to their marking with an identical serial number (SN ): 1946483405690. The responsible entity, i.e. Novo Nordisk A/S, based in Denmark, confirmed the forgery.
The inspector states that “then 1,300 unit packages were identified for the series with the number NP5G866, which were marked with an identical serial number (SN): 1946483405690. All the counterfeit packages had German labels. Another information from the German authority indicated that the unit packages for the series were forged No. NP5G866, which were marked with serial number (SN): 1031002838555”.
GIF conducted an investigation which revealed that Ozempic 1mg solution for injection in a pen; 3 3 ml pens + 12 needles are traded in the territory of the Republic of Poland in the series number MP5E511. The NP5G866 series has not been subject to such trade so far. The authority also determined that packaging with serial number 1946483405690 has not yet appeared in PLMVS (European Medicines Verification System) system alerts.
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