News and Events

The Safety Features Oversight Group [1] has been reviewing plans to end the FMD use and learn period on a phased basis in light of the COVID-19 pandemic. The Group recognises that this crisis has placed considerable strain on all parties involved in the medicines supply chain in Ireland – pharmacies, hospitals, and wholesalers as well as manufacturers, MAHs and parallel importers/distributors – and acknowledges the excellent work being done by everyone to maintain the supply of medicines, while ensuring staff and public safety. The obligation to move towards full compliance with the Falsified Medicines Directive (FMD) remains, however, given the unique circumstances in which we find ourselves, it has been decided to delay plans previously notified to end the use and learn period for wholesalers in May and for pharmacies and hospitals in September.

IMVO is operating as normal and has been closely monitoring FMD activity on the ground over the last few weeks as well as liaising with other national medicines verification organisations to see how they are being impacted by COVID-19. IMVO is also continuing to work in the background to reduce the number of avoidable alerts due to manufacturer and system issues and to prepare for the end of use and learn.

The Safety Features Oversight Group will continue to closely monitor the situation over the next few weeks and new dates for ending the use and learn period will be notified in due course. In the meantime, the advice is as follows:

• If you have any queries about your FMD obligations, please contact the PSI (Retail Pharmacy Businesses), HSE FMD project team (public hospitals), HPRA (wholesalers, MAHs, manufacturers, parallel importers, parallel distributors).
• Parallel importers and parallel distributors should continue to comply with the guidance issued to them by the HPRA on 7th February.
• Please contact IMVO if you have queries about your connection to the national system (including new registrations, login queries, change of FMD software provider) or want to follow up on specific alerts or scanning issues.
• If at any stage you have grounds for believing that a pack has been interfered with or could be falsified, please report this to the HPRA, by email to qualitydefects@hpra.ie or using the HPRA’s online reporting system HPRA – Report an Issue (then select option – Medicine Quality Issue/Defect)

IMVO Queries re alerts: alert.support@imvo.ie Queries re end-user registration/connection to national system: registration@imvo.ie

Tel: +353 1 5715320

HPRA Queries: compliance@hpra.ie

Tel: +353 1 6764971

PSI Queries: info@psi.ie

Tel: +353 1 2184000

HSE FMD Project Team Queries re FMD: FMD.support@hse.ie

[1] Comprises Irish Medicines Verification Organisation (IMVO), Department of Health, Health Products Regulatory Authority (HPRA), Pharmaceutical Society of Ireland (PSI), Health Service Executive (HSE) and Private Hospitals Association (PHA).