FMD Use and Learn Period in Ireland to End on Phased Basis from 31st January 2020
1st October 2019
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) continues to meet
regularly to monitor implementation of FMD in Ireland. Excellent progress has
been made in all sectors over the last few months:
All alerts generated in pharmacies, wholesalers and hospitals, upon scanning a pack during the use and learn period, are forwarded by the system to the IMVO, the HPRA and the manufacturers/MAHs so that they can be investigated, monitored and resolved.
The use and learn
period will end on a phased basis starting
from 31st 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.
What am I expected to
Advice issued in previous communications about ‘use and learn’ still applies:
Wholesalers, pharmacies and hospitals:
After the use and learn period ends, every single alert will have to be investigated and the risk of the pack being falsified must be ruled out before it can be supplied. It is therefore critical to ensure that all avoidable alerts are eliminated early before the use and learn period ends to minimise disruption for everyone, especially patients. To achieve this objective, all parties are requested to intensify efforts now to address issues that are causing alerts and errors, such as:
- Pack data for FMD packs not correctly uploaded by MAHs to the national system via EU Hub;
- Pharmacy, wholesaler and hospital FMD software issues leading to incorrect barcode data being sent to the national system;
- Scanners incorrectly configured;
- Simple mistakes during scanning such as:
- Trying to decommission when in verify mode;
- Decommissioning packs that are already decommissioned;
- Decommissioned packs being returned to wholesalers.
IMVO will work with all groups over the coming weeks to further raise awareness of how to identify and fix these problems. Furthermore, a national procedure will be finalised for managing alerts after use and learn, including detailed guidance on what each party needs to do to investigate and close out an alert. These guidelines will set out the roles and responsibilities of pharmacies, hospitals, wholesalers, MAHs, IMVO and the HPRA, so there is clarity for everyone after the use and learn period ends.
For further information
Queries re alerts: firstname.lastname@example.org
Queries re end-user registration/connection to national system: email@example.com
Telephone: +353 1 5715320
General FMD information: Click here
Reporting product defects: Click here
Telephone: +353 1 6764971
Falsified Medicines Directive FAQ: Click here
Telephone: +353 1 2184000
Support queries: firstname.lastname@example.org
Telephone: +372 611 90 44
24th June 2019
IMVO is delighted to announce the appointment of Dermot Byrne as Head of IT with IMVO. With experience built up over 25 years in commercial industry, across a range of roles, Dermot has managed both the technology and commercial aspects of business change and service delivery across the Irish, UK and US markets. He has held executive positions in renewable energy, payments, software solutions and consulting businesses. He has extensive experience in digital transformation, enterprise software development, business Intelligence, data analytics and IT security. Dermot holds a BSc. (Hons) Comp Sci from University College Dublin
8th May 2019
Decision to extend ‘use and learn’ phase
New FMD safety feature requirements came into effect on 9th February. 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 until 9th September 2019 to allow additional time for the system to stabilise. The situation will be reviewed again at that stage.
Progress since go live
Significant progress has been made on several fronts since 9th February:
It was anticipated that significant numbers of alerts would be generated by the verification system across Europe after go-live due to technical glitches and other teething problems as the system bedded in. Over 600,000 alerts have been generated in Ireland since 9th February. There are many root causes for these alerts including system bugs, data not uploaded or uploaded incorrectly by manufacturers, as well as actions related to the scanning of packs by pharmacies, hospitals and wholesalers, including scanner configuration issues, errors in how FMD systems handle barcode data, and the wrong type of barcode or non-FMD packs being scanned.
Across Europe, national medicines verification organisations (NMVOs) – including IMVO, the European Medicines Verification Organisation (EMVO), manufacturers/marketing authorisation holders (MAHs) and bodies representing end-users (pharmacies, hospitals and wholesalers) have been sharing knowledge and experience relating to alerts and how to eliminate them. Actions taken to address the known causes include bug fixes, the issuing of guidance on configuration of scanners and end-user systems, as well as contacts with end-users and manufacturers generating the largest numbers of alerts.
What will happen during the next phase of use and learn?
During the next phase of use & learn, efforts to eliminate avoidable errors will intensify across Europe. Here in Ireland, this will require co-operation between IMVO, pharmacies, hospitals, wholesalers and manufacturers/MAHs. It is expected that all parties will take whatever action they can to support this objective, including co-operating with alert investigations by IMVO and complying with guidance issued by IMVO and regulatory authorities such as the HPRA and PSI. IMVO will not be investigating individual alerts during this period but will continue to focus on trends and unusual events.
The instructions issued at the start of the use and learn period in February will continue to apply during this next phase, i.e:
National legislation including the provisions of Article 23 of the Delegated Regulation was introduced in February, however, offences for breaches of the legislation will not be commenced until after the use and learn phase.
What am I expected to do now?
Continue with the instructions as outlined at 2-4. above. Additional information obtained since the system went live that may be helpful is detailed below:
(See Figures 1 and 2 for more information on what an FMD pack looks like and what barcodes to scan/not scan)
Final reminder to register with IMVO / connect to national system if you haven’t already done so:
Continue with the instructions as outlined at 2-4. above. Additional information obtained since the system went live that may be helpful is detailed below.
(See Figures 1 and 2 for more information on what an FMD pack looks like and what barcodes to scan/not scan)
Final reminder to register with IMVO / connect to national system if you haven’t already done so:
Manufacturers / MAHs
Continue with the instructions as outlined at 1. above. Additional information obtained since the system went live that may be helpful is detailed below.
- Email: email@example.com
- Tel: +372 611 90 44
New medicines security features further protect supply chain for medicines
8th February 2019
A new national and European system, giving patients further protection from the threat of counterfeit medicines comes into effect tomorrow (Saturday 9th February 2019). Throughout Europe, medicine packs will have enhanced tamper-proof measures and will now carry a barcode with a unique serial number so that each pack can be scanned in a pharmacy. It will be checked against a central database to ensure the product is legitimate before handover to a patient. Established and managed by the Irish Medicines Verification Organisation (IMVO), the new national system provides an additional layer of security to protect the supply of medicines at pharmacy and patient level. Ireland is now in compliance with the EU Falsified Medicines Directive (FMD), which provides more safeguards and security to ensure Irish patients will continue to have absolute confidence in the medicines they receive from their pharmacy.
According to Pat O’Mahony, Chair, IMVO, “Setting up this advanced and robust verification system is a significant undertaking as a result of over three years of collaboration by the key Irish stakeholders including pharmaceutical manufacturers, parallel distributors, wholesalers as well as community and hospital pharmacists. Substantial work and investment has been required by everyone in the medicines supply chain to have the system up and running and in place as appropriate to the legislation coming into effect.
“Although there has been no risk or reported incidents at pharmacy level from counterfeit or falsified medicines in Ireland, other countries have had issues so this new system provides further security and protection for Irish patients now and into the future. Counterfeit medicines can pose serious risks to health, as there is no guarantee of their quality or safety,” he says.
The initiative has involved the collaboration of over 2,000 pharmacies, hospitals and wholesalers in Ireland who distribute dispense over 95 million prescription medicines every year, as well as the manufacturers who make the products. Each pharmacy now has a scanner to check each pack before it is dispensed to the patient. The scanner connects to a central database of prescription-only medicines manufactured, distributed and supplied for sale in Ireland.
Patients will see the new safety features appear on medicine packs as they come onto the market this year. Each pack will have a:
today, Minister for Health Simon Harris, TD, said: "The purpose of the regulation is
to improve patient safety and maintain confidence in the safety of medicines
supplied to patients. Nothing in the new regulations seeks to alter the existing
legal and regulatory responsibilities of persons authorised to place medicinal
products on the market or supply them to the public. It will apply to
manufacturers, wholesalers, pharmacy owners and pharmacists equally. This new
national system provides further security and protection for Irish and European
patients now and into the future.”
The system is based on providing an alert if the barcode is not identified when scanned. A clear protocol then follows to investigate these alerts, involving the location where the pack was scanned, the manufacturer, the Health Products Regulatory Authority (HPRA), the IMVO and its European counterpart, the European Medicines Verification Organisation (EMVO).
For the next number of months, medicine packs with and without the individual serial number will be available at the same time as the existing stocks are gradually replaced by new packs with safety features. There is also a period of time allowed to bed in the new system across the country so alerts will be monitored and managed without any impact on medicine supply during this ‘use and learn’ phase.
IMVO advises that purchasing prescription-only
medicines from the internet or other unauthorised sources is illegal and there
is a high risk that these products are counterfeit, not safe for use, and do
not contain the active ingredient required to make the medicine work. When you
receive medicines from your pharmacist, always listen to their advice and
follow the steps outlined in the package leaflet.
For Further Information:
Weber Shandwick PR 01 679 8600
Siobhan Molloy / Jo Twamley 086 817 5066 / 085 143 8320
IMVO is a not-for-profit organisation established by the key stakeholders across the medicines supply chain in Ireland to manage the national medicines verification system for Ireland:
This new initiative is part of the European Commission’s Delegated Regulation (EU) 2016/161 on Safety Features on Medicinal Products for Human Use. The Delegated Regulation supplements the Falsified Medicines Directive 2011/161/EU, by setting out detailed rules for the safety features appearing on the packaging of medicinal products for human use.
IMVO is part of a European-wide network of national medicines verification organisations, all operating national databases connected together via an EU Hub managed by the European Medicines Verification Organisation. This advanced and robust verification system ultimately captures the data of all medicines legitimately manufactured and supplied across Europe.
Counterfeit medicinal products are now officially known as ‘falsified medicinal products’ under EU medicines legislation. Falsified medicines may contain ingredients which are of poor quality or in the wrong dose.
Pictured using the new system at Conefrey’s Care Plus Pharmacy, Pearse Street, Dublin 2, are Amy Brophy and her children Amelia and Tommy Andrews, Leonie Clarke, General Manager IMVO and pharmacist Tomás Conefrey.
Announcement of national approach to safety features implementation – initial ‘use and learn’ phase
5th February 2019
Following discussions at a national level between the Department of Health, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI), the HSE and Private Hospitals Association (PHA) stakeholder representatives and IMVO, it has been decided to adopt a pragmatic approach to the implementation of the Delegated Regulation (and the associated statutory instrument) after the go live date, to ensure the continuity of safe supply of medicines to patients while all parties gain a better understanding of the new system. This means that:
National legislation including the provisions of Article 23 of the Delegated Regulation will be introduced, however, the offences provided for in the Regulations will not be commenced for a period of time to let the new system bed in.
During this period, the alerts generated will be analysed by the Department of Health, IMVO, HPRA, PSI, HSE and the private hospital pharmacies to determine why they are occurring and develop appropriate protocols for their resolution. Manufacturers (and marketing authorisation holders (MAHs) will also be involved in the investigation of alerts generated against their products. The system will be reviewed again in three months’ time. This approach will ensure that medicines continue to be provided to patients without delay and also ensure that all stakeholders, manufacturers, wholesalers, pharmacists and other healthcare professionals work to build confidence in operating the new safety system.
Formal notification of this agreed national approach has been issued today to pharmacists, wholesalers, MAHs and manufacturers by the PSI and the HPRA. IMVO is very appreciative of the careful consideration given to the matter by the authorities in Ireland and we will continue to work closely with them over the coming months to maximise the learnings about the system during this ‘use and learn’ period.
Online registration for pharmacies and hospitals now open
IMVO is delighted to announce that online registration for pharmacies and hospitals is now open. This is an important milestone to assist pharmacies and hospitals in complying with new EU Falsified Medicines Directive (‘FMD’) requirements that come into effect on 9th February 2019. IMVO has contacted all community pharmacies and hospitals registered with the Pharmaceutical Society of Ireland with details of how to register. Registering with IMVO is a pre-requisite for connecting the system that community pharmacies and hospitals will use to scan barcodes, to the IMVO repository. For more information, include HSE updates, visit our pharmacies & hospitals page.
Wholesaler registration will commence shortly and wholesalers will receive a separate notification from IMVO.
First serialised pack decommissioned in Ireland
20th June 2018
Pictured scanning a pack in Moore’s Pharmacy are (L to R), Ciaran Mulligan, pharmacist/pharmacy owner, David Doyle IMVO, Robert Antal IMVO, Alan Reilly Irish Pharmacy Union and Leonie Clarke IMVO
We are delighted
to announce that the first serialised pack was decommissioned in Ireland in Moore’s Pharmacy
in Crumlin, Dublin, on 20th June. We believe this may have been the first pack
decommissioned in a community pharmacy anywhere in Europe using the ‘blueprint’ system model
. The pack scanned was
a J&J product and the system used was ezFMD provided by HE Clissmann.
According to Leonie Clarke, IMVO Project Manager “IMVO is delighted that Ireland continues to be at the forefront of rolling out the European Medicines Verification System and we applaud everyone involved in reaching this important milestone. We are particularly appreciative of the support of all the pharmacies, hospitals, wholesalers, manufacturers and IT software providers who have volunteered to take part in our pilot.”
First serialised pack verified in Ireland
30th May 2018
We are delighted to announce that the first serialised pack was verified in Ireland by PCO Manufacturing on 30th May, using their wholesaler connection to the Irish Medicines Verification System and the EasyFMD system supplied by Quick Pharm Solutions. Ireland was amongst the first five countries in Europe to start scanning of serialised packs using a live connection to the national medicines verification system.
According to Leonie Clarke, IMVO Project Manager “IMVO congratulates PCO on this significant achievement and looks forward to many more packs being verified and decommissioned in Ireland over the coming months.”
Irish Medicines Verification System goes live
10th April 2018
We are delighted to announce that the Irish Medicines Verification System (IMVS) has been connected today to the production environment of the EU Hub. Reaching this important milestone means that IMVO can start its pilot and thus the implementation of the IT system to support the safety feature provisions of the EU Falsified Medicines Directive. Together with Germany, Slovenia, Denmark and Sweden, Ireland is among the first countries to go live in Europe.
Minister for Health, Simon Harris, TD, launches IMVO
24th July 2017
Pictured at the launch of IMVO was Minister for Health, Simon Harris TD with Professor Pat O’Mahony, Chairperson IMVO and Karene Moynan, managing pharmacist, Roche’s Allcare Pharmacy, Greystones.
A unique new not-for-profit organisation – the Irish Medicines Verification Organisation (IMVO) - has been established by the key players in the medicines supply chain in Ireland - pharmaceutical manufacturers, wholesalers, parallel distributors, and community pharmacists - as part of an EU-wide series of measures to tackle the growing problem of fake or ‘falsified’ medicines.
To set the problem in context, over 650,000 dosage units of falsified and other illegal medicines bought over the Internet were detained coming into Ireland in 2016, according to the Health Products Regulatory Authority (HPRA). To date, there have been no reports of falsified medicines being distributed through legitimate channels in Ireland, eight such cases were detected in the UK between 2011 and 2015 so the risk cannot be ignored.
To tackle this threat, new EU legislation will require all prescription medicine packs to carry a special barcode containing a serial number and other details which will be used to check that the pack is legitimate. Before supplying the medicine to a patient, the pharmacist will scan the barcode to check the data against a central database managed by IMVO. If the pack details are not found in the database, an alert will be generated and an investigation will take place to find out if the pack is fake. These new requirements come into effect from February 2019 and pharmacists and pharmaceutical manufacturers and wholesalers, individually and through IMVO, are already working to ensure that all the necessary systems are in place by then.
Pictured with Minister for Health, Simon Harris TD are a number of IMVO’s directors: from left Darragh O’Loughlin (IPU), Professor Pat O’Mahony, Chairperson IMVO, Jeffrey Walsh (Medicines for Ireland), Orlaith Brennan (IPHA) and Paul Reilly (PDF).
Speaking at the launch of IMVO, the Minister for Health, Simon Harris, TD, said “The stakeholders involved in IMVO are to be congratulated for coming together to oversee this important initiative which will help to protect Irish patients from the threat of falsified medicines. I am delighted to see that as a result of their efforts, Ireland is amongst the leading countries in Europe in terms of progress made to date on this project.”
IMVO’s chairperson, Professor Pat O’Mahony, commented: “Implementing these requirements by the 2019 deadline is a significant challenge for pharmaceutical manufacturers, parallel distributors, wholesalers and pharmacists but the organisations who represent them in IMVO are committed to building on progress to date and working towards meeting this deadline.”
EMVO – Training video about the On-boarding Partner Portal
28th March 2017
The European Medicines Verification Organisation (EMVO) has released a new training video for pharmaceutical manufacturers and marketing authorisation holders to provide guidance on how to onboard to the EU Hub through the On-Boarding Partner Portal. This video and other information are available on the onboarding section of the EMVO website.