The Safety Features Oversight Group  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:
Tel: +353 1 5715320
HPRA Queries: firstname.lastname@example.org
Tel: +353 1 6764971
PSI Queries: email@example.com
Tel: +353 1 2184000
HSE FMD Project Team Queries re FMD: FMD.firstname.lastname@example.org
 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).