During the use and learn period, pharmacies, hospitals and wholesalers must scan packs where obliged to do so and if an alert or any other unexpected message is flagged, should continue to supply packs to patients in accordance with their existing procedures, unless they have overriding concerns that a falsified medicine is involved
The Safety Features Oversight Group comprising the IMVO, the Department of Health, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI), the Health Service Executive (HSE) and the Private Hospitals Association (PHA) has been closely monitoring progress with the implementation of the IMVS since it went live on 9th February 2019. In order to allow time for it to stabilise, the system has been in a use and learn phase since then and this will be ended on a phased basis over the coming months.
During the use and learn period:
- All medicinal products released for the Irish market since 9th February 2019 must bear the safety features as required i.e. a tamper proof seal (anti-tamper device) and 2D barcode.
- During the use and learn period, pharmacies, hospitals and wholesalers must scan packs where obliged to do so and if an alert or any other unexpected message is flagged, should continue to supply packs to patients in accordance with their existing procedures, unless they have overriding concerns that a falsified medicine is involved.
- All alerts generated in pharmacies, wholesalers and hospitals, upon scanning a pack during the use and learn phase, are forwarded by the system to IMVO, the HPRA and the manufacturers/MAHs so that they can be investigated and monitored.
- Notwithstanding the above, if a pharmacist or wholesaler has reason to believe that packaging has been interfered with, based on their examination of the anti-tampering 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.