News Category: Regulatory news
The Safety Features Oversight Group continues to oversee progress with implementation of the Falsified Medicines Directive (FMD) in Ireland.
The Safety Features Oversight Group has been made aware of an issue regarding FMD alerts received when scanning four batches of French packs of Utrogestan products supplied as exempt medicinal products (EMPs) in Ireland.
If pharmacies scan and receive alerts for these four Utrogestan batches, they may supply the packs to patients under their existing procedures, unless they have overriding concerns that a falsified medicine is involved.
The alerts have been caused, in part, by decommissioning transactions that took place in another country, and there is no evidence that the products have been falsified.
If a pharmacist has reason to believe that the packaging has been interfered with, based on their examination of the anti-tamper device on the pack, they must report their concern to the HPRA (as a suspected quality defect via the usual reporting mechanisms) and not supply the pack.