The Falsified Medicines Directive (2011/62/EU) ‘(FMD’) introduced new requirements from February 2019 for safety features on prescription medicines packaging, enabling the packs to be authenticated as genuine prior to supply to patients.
FMD has been in a ‘use and learn’ phase in Ireland since February 2019 due, in part, to the impact of Covid-19 and Brexit. The use and learn phase ended for wholesalers on 9th May 2022 and for pharmacies and hospitals for 30th May 2022. After these dates, pharmacies, hospitals and wholesalers may not supply packs that generate alerts when scanned unless the alert has been fully investigated and a root cause has been found and falsification ruled out.
Detailed guidance has been developed for pharmacies, hospitals, wholesalers on what to do next if there is an alert and is available on the IMVO website (www.imvo.ie).
For further information:
IMVO
Queries re alerts: alert.support@imvo.ie
Queries re end-user registration/connection to the IMVS: registration@imvo.ie
Tel: +353 1 5715320
Website: www.imvo.ie
IMVO’s service desk opening hours – Monday-Friday 8-8; Saturday 9-6; Sunday/public holidays 11-6
HPRA
Queries: compliance@hpra.ie
Website: http://www.hpra.ie/homepage/medicines/special-topics/falsified-medicines-legislation
Tel: +353 1 6764971
PSI
Queries: info@psi.ie
Website: https://www.thepsi.ie/gns/Pharmacy_Practice/FalsifiedMedicinesDirective.aspx
Tel: +353 1 2184000
HSE FMD Project Team
Queries re FMD: HSE.Support@ezfmd.com
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