News

Update on Plans for Ending FMD Use and Learn in Ireland

30th April 2020

The Safety Features Oversight Group [1] 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.                                                                               

Update on Plans for Ending Safety Features Use and Learn in Ireland on Phased Basis from 2nd March 2020

7th February 2020

Following on from previous communications about plans to end the use and learn period on a phased basis, the Safety Features Oversight Group¹ has now agreed that this will be done in the following phases starting from 2nd March 2020: 

1. The Safety Features Oversight Group comprises the 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).
2. For the purposes of this communication, a ‘primary wholesaler’ is considered to be the wholesaler that first receives stock into Ireland from a wholesaler or manufacturer in another EU member state and supplies it to the Irish market, or the wholesaler that receives stock directly from an Irish manufacturer and supplies it to the Irish market.
3. i.e. all wholesale distribution authorisation (WDA) holders, including pharmacies that carry out wholesaling activities.

Further information: 

IMVO

Website: www.imvo.ie

Queries re alerts: alert.support@imvo.ie

Queries re end-user registration/connection to national system: registration@imvo.ie

Tel: +353 1 5715320

HPRA

Website:

- General FMD information: https://www.hpra.ie/homepage/medicines/special-topics/falsified-medicines-legislation

- Reporting product defects: https://www.hpra.ie/homepage/about-us/report-an-issue

Queries: compliance@hpra.ie

Tel: +353 1 6764971 

PSI

Website: https://www.thepsi.ie/gns/Pharmacy_Practice/FalsifiedMedicinesDirective.aspx

Queries: info@psi.ie

Tel: +353 1 2184000 

HSE

Queries re FMD implementation in public hospitals and clinics: FMD.support@hse.ie 

EMVO

(for manufacturer queries relating to EU Hub & uploading of data)

Website: www.emvo-medicines.eu

Support queries: helpdesk@emvo-medicines.eu

Tel: +32 2 657 00 08

FMD Use and Learn Period in Ireland to End on Phased Basis from 31st January 2020

1st October 2019

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) continues to meet regularly to monitor implementation of FMD in Ireland. Excellent progress has been made in all sectors over the last few months: 

For further information

IMVO

Website:                           www.imvo.ie

Queries re alerts:                       alert.support@imvo.ie

Queries re end-user registration/connection to national system:  registration@imvo.ie

Telephone:                          +353 1 5715320

HPRA

Website:                           HPRA

General FMD information:                    Click here

Reporting product defects:                     Click here

Queries:                            compliance@hpra.ie

Telephone:                          +353 1 6764971

PSI

Website:                           PSI

Falsified Medicines Directive FAQ:                 Click here

Queries:                           info@psi.ie

Telephone:                             +353 1 2184000

EMVO

Website:                           EMVO

Support queries:                         helpdesk@emvo-medicines.eu

Telephone:                          +372 611 90 44

• The vast majority of pharmacies, hospitals and wholesalers have registered with the Irish Medicines Verification Organisation (IMVO) and are connected to the national system.
• Almost 11.3 million scans of packs of medicines have taken place in Irish pharmacies, hospitals and wholesalers since February and the number of scans is growing weekly.
• Barcode data for over 180 million packs has been uploaded to the national system by manufacturers. The number of packs bearing 2D barcodes in pharmacies will increase quickly as these packs work their way through the supply chain.
• Extensive analysis of alerts is taking place across Europe, resulting in greater understanding of their root causes and the rollout of initiatives to reduce the number of alerts being generated. These initiatives are taking effect and the rate of alerts vs scans continues to fall in and now stands at 3.5% in Ireland (down from a high of 20%).

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:

• The vast majority of pharmacies, hospitals and wholesalers have registered with IMVO and are connected to the national system.
• Between 50,000 and 60,000 thousand scans are taking place daily in Irish pharmacies, hospitals and wholesalers and this number is growing week on week.
• Barcode data for over 100 million packs has been uploaded to the national system by manufacturers. The number of packs bearing 2D barcodes in pharmacies will increase over the coming weeks and months as these packs work their way through the supply chain.
• Extensive analysis of alerts is taking place across Europe, resulting in greater understanding of their root causes and the rollout of initiatives to reduce the number of alerts being generated.

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: 

1. All medicinal products released by MAHs for the Irish market since 9^th February should bear the safety features as required i.e. a tamper proof seal (anti-tamper device) and 2D barcode.
2. Wholesalers, pharmacies and hospitals must scan all medicines bearing the safety features and if an alert or any other unexpected message is flagged, should continue to supply packs to patients in accordance with their existing procedures, unless they have overriding concerns that a falsified medicine is involved.
3. All alerts generated in pharmacies, wholesalers and hospitals, upon scanning a pack during the ‘use and learn’ phase are forwarded by the system to the IMVO, the HPRA and the manufacturers/MAHs so that they can be investigated and monitored.
4. Notwithstanding the above, if a pharmacist or wholesaler has reason to believe that packaging has been interfered with, based on their examination of the anti-tampering device on the pack, they must report their concern to the HPRA (as a suspected quality defect via the usual reporting mechanisms) and not supply the pack. 

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? 

Pharmacies/ hospitals

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:

• Check that your scanner is correctly configured. If unsure, contact the supplier of the scanner or IMVO for further guidance (email: info@imvo.ie or 01-5715320).
• Start scanning if you haven’t already done so but only scan FMD packs. Do NOT scan the following as doing so is likely to generate alerts:

(See Figures 1 and 2 for more information on what an FMD pack looks like and what barcodes to scan/not scan)

• Make sure your FMD system is set in the correct mode when scanning, e.g. ‘supply’, not verification, if you want to decommission the pack.
• Co-operate with requests for information from IMVO when they are investigating alerts. 

Final reminder to register with IMVO / connect to national system if you haven’t already done so:

• See IMVO website for details of how to register.
• If you have registered with IMVO but not yet connected your FMD system to the national system, you must do so as soon as possible using the technical details that were emailed by IMVO after your registration application was processed. Contact your FMD system provider for support with this step.

Wholesalers

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.

• Check that your scanner is correctly configured. If unsure, contact the supplier of the scanner or IMVO for further guidance (email: info@imvo.ie or 01-5715320).
• Start scanning if you haven’t already done so but only scan FMD packs. Do NOT scan the following as doing so is likely to generate alerts.

(See Figures 1 and 2 for more information on what an FMD pack looks like and what barcodes to scan/not scan)

• Make sure your FMD system is set in the correct mode when scanning, e.g. ‘supply’, not verification, if you want to decommission the pack.
• Co-operate with requests for information from IMVO when they are investigating alerts.
• Consider scanning (with the scanner set to ‘verification’ mode) one pack from each incoming batch to verify that all is in order. Remember to set the scanner back to ‘supply’ mode when going to decommission packs. If the verification scan flags an issue relating to the data, it would be helpful if feedback can be provided to the relevant manufacturer/MAH, so they can take action to correct the problem.

Final reminder to register with IMVO / connect to national system if you haven’t already done so:

• See IMVO website for details of how to register.
• If you have registered with IMVO but not yet connected your FMD system to the national system, you must do so as soon as possible using the technical details that were emailed by IMVO after your registration application was processed. 

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.

• Ensure that data is correctly uploaded to the EU Hub for serialised packs.

    - Email:   helpdesk@emvo-medicines.eu

    - Tel:       +372 611 90 44

• Co-operate with requests for information from IMVO when they are investigating alerts.
• See HPRA website for MAH-specific information about alerts and quality defect reporting obligations.
• If you have any queries about alerts generated in the Irish system, please contact IMVO (email: alert.support@imvo.ie).

Figure 1

Figure 2

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.

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:

• Barcode (2D matrix barcode) containing data unique to that pack; and
  
• Anti-tamper device to provide assurances that the pack has not been interfered with, e.g. glued flap, sticky seal, plastic break-seal.
  

Speaking 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

Notes to Editors

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:

• Association of Pharmaceutical Parallel Distributors (www.aippd.ie) which represents active parallel importers in Ireland.
  
• Irish Pharmaceutical Healthcare Association (www.ipha.ie) which represents the international research-based pharmaceutical industry in Ireland.
  
• Irish Pharmacy Union (www.ipu.ie) which is the representative and professional body for community pharmacists in Ireland.
  
• Medicines for Ireland (www.medicinesforireland.ie) which represents Irish-based manufacturers and suppliers of generic OTC, biosimilars and hybrid medicines.
  
• Pharmaceutical Distributors Federation Ireland which represents full-line pharmaceutical wholesalers.
  

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

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

31st October 2018  

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

Minister for Health, Simon Harris, TD, launches IMVO

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.

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.