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FMD use and learn period ends in Ireland May 2022
From Department of Health
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This information may be out of date. Please see here for updated information on FMD Use and Learn Period
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 on 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, a root cause has been found and falsification ruled out.
Detailed guidance has been developed for pharmacies, hospitals and wholesalers as to what to do if an alert occurs. This is available on the IMVO website.
For further information see:
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 to Friday 8-8; Saturday 9-6; Sunday/public holidays 11-6
Queries: compliance@hpra.ie
Tel: +353 1 6764971
Queries: info@psi.ie
Tel: +353 1 2184000
Queries re FMD: HSE.Support@ezfmd.com
The National Safety Features Oversight Group comprising of the Irish Medicines Verification Organisation (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) continues to oversee progress with FMD implementation in Ireland. FMD has been in a ‘use and learn’ phase for pharmacies, hospitals and wholesalers in this country since February 2019 due, in part, to the impact of Covid-19 and Brexit.
The National Safety Features Oversight Group following consultation with all relevant stakeholders, has now agreed a plan for ending use and learn on a phased basis concluding at the end of Q1 2022. Further information can be found on the IMVO website
Key Stakeholders will work together as a priority to ensure Ireland meets its obligations under this important Directive.
Further to the below, the National Safety Features Oversight Group comprising the Irish Medicines Verification Organisation (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 decided that the use and learn period will be further extended to allow additional time for the system to stabilise and to ensure that everyone is ready when it becomes mandatory to investigate and close out all alerts before supplying the packs.
The Use and Learn Period will end on a phased basis starting from 31 January 2020.
Planning for the end of ‘use and learn’ will continue over the coming weeks. The Safety Features Oversight Group, taking into account all relevant factors, will determine the different phases and communicate details to affected parties.
Further information can be found on the IMVO website: https://www.imvo.ie/news-events/news
On Saturday 09th February the European Commission’s Delegated Regulation (EU) 2016/161 on Safety Features on Medicinal Products for Human Use, came into operation across Europe. The Delegated Regulation supplements the Falsified Medicines Directive 2011/62/EU, by setting out detailed rules for the safety features appearing on the packaging of medicinal products for humans. During this time, the system in Ireland has been in ‘use and learn’ phase to ensure the continuity of safe supply of medicines to patients while all parties gained a better understanding of the new system.
The National Safety Features Oversight Group comprising the Irish Medicines Verification Organisation (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 since go live on 9th February. Taking all factors into account, the group has decided that the use and learn period will be further extended to allow additional time for the system to stabilise and to ensure that everyone is ready when it becomes mandatory to investigate and close out all alerts before supplying the packs. The use and learn period will end on a phased basis, and a detailed plan as to how this will be done, including dates, will be published at the end of September.
In the meantime, pharmacies, hospitals, wholesalers and manufacturers/MAHs are asked to continue following the instructions given to them when the use and learn period was last extended in May - Please see full details provided in the below document.
