Falsified Medicines Directive: Medicines Authentication
FMD Latest Information (04 May 2023):
Alert Management
From February 2019 safety features have been required on prescription medicines packaging, enabling the packs to be authenticated as genuine prior to supply to patients. 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.
It is the responsibility of pharmacy owners and superintendent pharmacists to ensure that the legal requirements of FMD are being met within their pharmacies and that alerts are closed out in a timely manner. The IMVO have supports to assist you to resolve alerts: Alert Management - IMVO.
PSI Monitoring Compliance
The PSI is monitoring the performance of pharmacies and we will continue to engage, explain and encourage compliance with this legislation. We will engage directly with pharmacies and pharmacists where there is a concern as to their compliance.
Detailed guidance and ongoing support is available to pharmacies from the Irish Medicines Verification Organisation (IMVO), including what to do if there is an alert to be dealt with. The Irish Institute of Pharmacy and IMVO have recordings of webinars they have hosted and these may also be helpful. Communications from the PSI to pharmacists and pharmacies about their roles and responsibilities in line with this legislation are available below.
What are the Safety Features?
The Delegated Regulations require all EU pharma companies (originator companies, generic companies and parallel distributors) to place ‘safety features’ on the packaging of medicinal products which consist of:
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An anti-tamper device so the person supplying it can be sure it hasn’t been interfered with. (Such devices are already common on many medicines but will be mandatory for most medicines in future).
- A special 2D barcode containing information about the medicine, known as unique identifiers. Embedded in this barcode will be a product code, serial number, batch number and expiry.
The Delegated Regulation set an implementation deadline of 9 February 2019 and manufacturers must ensure medicines released to the Irish market after this date have the required safety features.
What must pharmacists and pharmacies do?
Under the Delegated Regulation ‘a person authorised or entitled to supply medicines to the public’ must verify the safety features on the packaging of medicinal products upon supply of the medicines.
All pharmacists and pharmacies have a legal obligation to check the safety features on the packaging of medicines and ensure that the following actions are taken before supply to patients:
- the unique identifier, contained in the 2D barcode, must be authenticated by scanning and decommissioning the product from the IMVO repository; and
- the anti-tamper device must be checked to ensure that it is intact.
Following the initial phased introduction of the legislation ('use and learn'), from Monday, 30 May 2022 packs cannot be supplied until the root cause of an alert has been established and falsification ruled out. Pharmacists must provide support for alert investigations, in particular, identifying if there is a root cause within the pharmacy.
To be able to scan and decommission the 2D barcode on a pack, pharmacies must have a scanner with associated software in place and be registered with the Irish Medicines Verification Organisation (IMVO) and connected to the Irish Medicines Verification System (IMVS).
The Irish Medicines Verification Organisation (IMVO) has been established to manage the medicines verification system for Ireland. All pharmacies, wholesalers, MAHs and manufacturers are required to register with the IMVO.
IMVO has produced guidance for pharmacists on the implementation of FMD requirements which is available on the IMVO website, including details of introductory webinars for pharmacists. IMVO has also made the webinars available for download and has provided additional guidance to pharmacists on where to go for support, and has sent out guidance on scanning to all pharmacies. This includes a video on how to scan correctly as well as details of how to check that your scanner is configured correctly and if not, how to fix it.
Depending on your requirements, support is available from the IMVO, or by contacting your pharmacy's FMD software provider.
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 and not supply the pack. The HPRA’s online reporting system (select the online form 'Medicine Quality Issue/Defect') should be used or email qualitydefects@hpra.ie.
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A pragmatic, phased approach to the implementation of the legislation was taken with a 'use and learn' phase from February 2019 to May 2022.
The following prerequisites have been defined by the Safety Features Oversight Group* to ensure that end-users and marketing authorisation holders (MAHs) are ready for the end of use and learn, minimising disruption for them and for patients:
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Alert rate at 0.05% or lower, i.e., alerts generated by pharmacies, hospitals and wholesalers (‘end-users’), as a % of the total number of end-user scans**;
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All end-users scanning packs in accordance with their obligations under the Commission Delegated Regulation on Safety Features (EU) 2016/161 as amended;
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Avoidable alerts minimised by addressing issues with scanners, software, MAH data and procedural errors;
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Clear instructions available for all parties on what to do if there is an alert, including clear responsibilities for deciding if packs may be supplied or not, i.e., alert handling guidance in place;
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Fast efficient process for communication between parties;
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Clarity on impact of Brexit on supply chain/alerts;
Capacity of end-users to deal with alerts in face of challenges of COVID-19;
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European Medicines Verification System has the capacity to cope with COVID-19 vaccines and treatments.
* Comprising 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).
**The following are excluded when calculating the % alert rate as they have no impact on Irish end-users - alerts generated by MAH transactions and alerts from intermarket transactions (IMTs), i.e. alerts on Irish packs generated by end-users in other markets.
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Under the EU directive, hospitals are considered “Healthcare Institutions” and are required to verify the safety features on medicinal products. The Directive provides for healthcare institutions to scan and decommission products at an earlier point to assist with local logistical arrangements. The HSE is leading centrally on the introduction of the Falsified Medicines Directive in public hospitals. The HSE has a central contact point and ask anyone affected by FMD to send your questions / concerns to: FMD.support@hse.ie. The Private Hospitals Association has also been working with the Department of Health stakeholder group to prepare the private hospitals for introduction of FMD: info@privatehospitals.ie.
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Irish Medicines Verification Organisation (IMVO)
The Irish Medicines Verification Organisation (IMVO) has been established to manage the medicines verification system for Ireland and the vast majority of pharmacies, wholesalers, MAH’s and manufacturers have registered with the IMVO. IMVO have contacted all pharmacies with details of how to register with the IMVO and connect to the national repository system. Further information is available on the IMVO website, including details of introductory webinars for pharmacists. IMVO has also made the webinars available for download and has provided additional guidance to pharmacists on where to go for support. The IMVO has sent out guidance on scanning to all pharmacies. This includes a video on how to scan correctly as well as details of how to check that your scanner is configured correctly and if not, how to fix it.
Queries on alerts: alert.support@imvo.ie
Queries on end-user registration/connection to national system: registration@imvo.ie Tel: +353 1 5715320
Health Products Regulatory Authority (HPRA) The HPRA website has information and updates about the Falsified Medicines Directive, relevant to its stakeholders.
Queries: compliance@hpra.ie Tel: +353 1 6764971
Health Service Executive (HSE)
For pharmacies in public hospitals and clinics, the HSE has established a project team to co-ordinate the Falsified Medicines Directive implementation across the health services, and will be managing communications within the HSE. The HSE's October Newsletter contains useful updates on their preparations for the Falsified Medicines Directive.
Queries to FMD Project Team: FMD.support@hse.ie
PSI - the pharmacy regulator
Queries: info@psi.ie
Tel: +353 1 2184000
The Irish Pharmacy Union (IPU)
The IPU continues to assist its members in getting ready for FMD and has published articles, reports and frequently asked questions providing more information on the Falsified Medicines Directive on its website (IPU Member access).
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It is the responsibility of pharmacy owners and superintendent pharmacists to ensure that the legal requirements of FMD are being met within their pharmacies to ensure the continuity of safe supply of medicines to patients.
The Department of Health and the PSI are consulting on improving FMD compliance in pharmacies and are drafting legislation to invoke regulatory enforcement measures.
S.I. No. 270 of Medicinal products (safety features on packaging) Regulations 2022 was signed into legislation by the Minister of Health on 1 June 2022. This legislation makes verification and decommission of medicinal products a legal requirement.
The Delegated Regulations on Safety Features came into effect across Europe on 9 February 2019. Irish legislation giving effect to Commission Delegated Regulation (EU) 2016/161 commenced on 8 February 2019.
The Commission Delegated Regulation (EU) 2016/161 (‘Delegated Regulation’) was published by the Commission in February 2016. This legislation sets out detailed rules for the safety features appearing on the packaging of medicinal products for human use. It supplements the Directive and sets out exactly what manufacturers, wholesalers and persons authorised to supply medicines to the public need to do to ensure that the medicines supplied to patients are authentic.
The publication of the Delegated Regulation was accompanied by the publication of documents including a Q&A document from the EU Commission.
In 2011, the European Commission published a new directive, 2011/62/EU, known as the Falsified Medicines Directive which amends EU Directive 2001/83/EC on Human Medicinal Products. The purpose of this Directive is to introduce a coordinated and IT-enabled system of measures across Europe designed to protect the medicines supply chain against the risk of falsified (or counterfeit) medicines. These measures are intended to enhance patient safety by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines and by introducing new rules to, more rigorously, regulate the supply chain.
The Falsified Medicines Directive (2011/62/EU) is a patient safety initiative that introduced new requirements to prevent falsified medicines from entering the medicines supply chain.
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You can review PSI communications to pharmacists on FMD below: