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FMD Use and Learn Period in Ireland to continue into 2021

01st December 2020

The Safety Features Oversight Group (comprising IMVO, HPRA, PSI, Department of Health, HSE and Private Hospitals Association) continues to oversee progress with FMD implementation in Ireland. Because of the unique circumstances in which we find ourselves this year and the need to ensure that the medicines supply chain can cope with whatever challenges the Covid-19 situation and Brexit may bring over the next 2-3 months, the Group has decided that FMD will remain in a use and learn phase into 2021. In the meantime, the advice is as follows:

  1. Pharmacies, hospitals and wholesalers are expected to comply with their obligations under the Commission Delegated Regulation (EU) 2016/161 to scan packs and verify safety features during use and learn. The PSI and HPRA are monitoring compliance with this obligation.
    • If an alert or any other unexpected message is flagged when a pack is scanned, the pack should still be supplied to the patient in line with existing procedures, unless there is overriding concerns that a falsified medicine is involved.
    • If at any stage you have grounds for believing that a pack has been tampered 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 the link Medicine Quality Issue/Defect.
  2. If you have any queries about your FMD obligations, please contact either the PSI (Retail Pharmacy Businesses), HSE FMD project team (Email: FMD.support@hse.ie – public hospitals), HPRA (wholesalers, MAHs, manufacturers, parallel importers, parallel distributors).
  3. Parallel importers and parallel distributors should continue to comply with the guidance issued to them by the HPRA on 7 February 2020.
  4. Please contact IMVO if you have queries about your connection to the national system (including new locations, log in queries, change of FMD Software Provider, connection problems etc.) or want to follow up on specific alerts or scanning issues.

The Safety Features Oversight Group will closely monitor the situation over the coming weeks and new dates for ending the use and learn period will be notified in due course.