About the Falsified Medicines Directive (FMD)

The original Falsified Medicines Directive (FMD) 2011/62/EU was published on 1^st July 2011 by the Council and Parliament of the European Union and contained measures aimed at improving the safety and security of medicine supply in Europe.

Entering into force on 1^st January 2013, the Directive set out three actionable objectives for achieving this aim: to 'Strengthen Good Manufacturing and Good Distribution Practices', improve the regulation and supervision of actors within the medicinal distribution chain, and ensure the integrity and authenticity of medicines – including associated safety features.

The safety features include the placement of an unique identifier (UI) to allow verification of medicines throughout the supply chain and the addition of a tamper evidence device (ATD – anti-tamper device) on each pack of prescribable medicine.

Delegated Regulation to the FMD (EU 2016/161)

The Delegated Regulation to the FMD was initially adopted in October, 2015 and published on 9^th February 2016.

The Delegated Regulation provides further technical details on the obligations on all stakeholders in the supply chain. These include the expectations on Marketing Authorisation Holders to add safety features to each pack of prescribable medicines and introduce a 'pan-European' verification system, which will enable those involved in the supply of medicines to verify and to determine the authenticity of that pack of medicines at the time of supply to patients.

Verification System

Stakeholders in the medicines distribution chain from across Europe will be expected to build and manage a pan-European verification system, which is flexible enough to be interoperable and implementable between national agencies, or systems.

This system will be governed by non-profit organisations, under the supervision of national authorities.

FMD aims to provide a system through which pharmacies and other "dispensing entities" can authenticate prescription medicines before they are handed to patients.

Manufacturers will upload valid UI codes to the European Medicines Verification System (EMVS) via the European Medicines Verification Organisation (EMVO) and supply chain stakeholders / pharmacies will be able to check the status of each pack at any point along the supply chain and during the dispensing process via their interface with appropriate National Medicines Verification Systems (NMVS) . The system will be notified of products known to have been recalled, withdrawn, stolen or tampered with. Read the EMVO Guideline for EMVO and NMVO stakeholder - recommendations for alert handling and prevention processes.

The European Medicines Verification System (EMVS) will act as a hub, linking the national systems together and allowing parallel trading of medicines to continue. Dispensing entities and in some cases wholesalers will also have to check that the ATD is still intact.

The development of the European and national verification systems is being led through a stakeholder model involving the five main sectors (or "constituencies") of the supply chain – research-based manufacturer, generic manufacturers, parallel traders, wholesalers and pharmacies – working alongside the European Commission and national competent authorities (Health Ministries and Regulators).

At a European level, the European Medicines Verification Organisation (EMVO) has been established by the European associations representing the five sectors. As well as establishing the central European Medicines Verification System (EMVS), which is now up and running, the EMVO has developed the blueprint model for national verification systems. This is designed to promote harmonisation and reduce costs.

National stakeholder associations across Europe are working to establish their own National Medicines Verification Organisations which will then invite the Blueprint Service Providers to tender to operate the NMVS. These are expected to be established during 2017, allowing pilot schemes to start.

The EMVO has developed a set of governing principles that all parties have agreed to. Some of the key principles relate to data security, including:

Data ownership is determined by the party who generates the data
Data in the system is not to be used to analyse the flow of products in the supply chain
The system allows for verification of products at any point but is not a "track-and-trace" system and does not give visibility of current or past locations of products
Manufacturers will not seek, and will not have access to, individual prescribing or patient profile information
Data is owned by the party that generates it, and it cannot be used or shared with other parties without explicit consent (other than for investigating suspected incidents of falsification). It is not possible for manufacturers to see where or when a pack is verified or dispensed. The EMVS is not intended as a "track-and-trace" system and it does not maintain any central log of where each and every pack of medicine is at any given time. It is based on a "book-end" model, with UI data being uploaded at the start by manufacturers and these being decommissioned or checked out one at a time during dispensing, predominantly by community pharmacies. What happens in between is not recorded, albeit the status of individual products can be checked.

Countries involved in FMD

FMD will be applicable in 32 countries – the 27 (current) Member States of the EU, plus the four members of the European Free Trade Area (Iceland, Norway, Liechtenstein, Switzerland) and Northern Ireland. Under the Delegated Regulation, Belgium, Greece and Italy have six-year derogations until 2025 as they already have verification systems in place. Belgium has already indicated that it will not take up its derogation.

National stakeholder associations across Europe have worked to establish their own National Medicines Verification Organisations.

What's in scope and out-of-scope?

Almost all prescription medicines with a Marketing Authorisation are in scope of FMD, with only a few specialist products, radionuclide kits and medicinal gases being out-of-scope. All non-prescription medicines are out-of-scope, with the exception of two omeprazole products (which were subject to falsification in the past).

Non-commercial sample packs, clinical trial supplies and unlicensed products, including specials, are out-of-scope, but any licensed products being incorporated in to them (such as ingredients for specials, or commercial packs used in clinical trials) would have to be verified and decommissioned.

Medical devices are out-of-scope, but the European Commission is expected to publish an updated Medical Devices Regulation in early 2017 that would come in to force in 2020.

What information is encoded in the unique identifier?

Each individual pack of a prescription medicine will need to carry a unique identifier (UI) encoded via a 2D data matrix (barcode). If the pack size permits it, the pack will also carry the same information in human-readable text, printed adjacent to the 2D-code where possible.

The unique identifier will consist of ^{Article 4}:

Product code: the name, common name, pharmaceutical form, strength, pack size and pack type
Serial number: randomised numeric or alphanumeric sequence of up to 20 characters
National reimbursement number: national identifying code, if required by Member State ^{note: unlikely to be included in the 2D barcode in the UK}
Batch number
Expiry date

Because this information will be printed and encoded on every pack, it can also be used for some activities, such as stock re-ordering, stock rotation and accuracy checking, for example in wholesalers and pharmacies.

How the unique identifiers will be used to authenticate medicines

Pharmacies and wholesalers who have a pack in their possession will be able to scan the UI and send this information to their National Medicines Verification System. The NMVS will send back the current status of the product. If the status is "active" then the product can be supplied or dispensed in the normal way, as long as the anti-tamper device is also undamaged (unless it is required to be broken in order to assemble or prepare the medicine).

If the NMVS sends back a message that the pack is "inactive", then it cannot be supplied to a patient. We expect that the system will also indicate why the pack is inactive, such as "already been dispensed", "recalled", "withdrawn", "stolen", "locked (temporarily inactive during investigations)". Dispensing entities will need to have processes in place to deal with these situations, which could include making reports to regulatory bodies, if required.

System Data and Costs

The transactional data that is input and generated within the system will belong to the stakeholders which generate it and access to it by other stakeholders will be unavailable except for the purpose of verification or via standard reports. The costs for the implementation of the safety features and operational verification system for the Delegated Regulation of the FMD will be as follows:

Manufacturers must pay the costs associated with the addition of pack safety features - coding of medicines and tamper evidence devices.
Manufacturers and Market Authorisation Holders will be responsible for funding the European and national levels of the verification system.
Individual stakeholders will be expected to pay for their own installations associated with interfacing with the verification system e.g. wholesalers, pharmacies.

FMD Delegated Regulation in the UK

In the UK, the principal associations representing the various stakeholders in the supply chain are:

ABPI – Association of the British Pharmaceutical Industry
BAEPD – British Association of the European Pharmaceutical Distributors
BGMA – British Generics Association
CCA – Company Chemist Association
HDA – Healthcare Distribution Association
NPA – National Pharmacy Association

Each have worked closely and collaboratively to create the UK medicine verification organisation – SecurMed UK – under the supervision of the Competent Authorities - the Medicines and Healthcare products Regulatory Agency (MHRA) and Department of Health (DH).

The stakeholder associations have agreed a Memorandum of Understanding which captures the principles of their collaboration and their intention of establishing a UK Medicines Verification Organisation (UKMVO) and UK Medicines Verification System (UKMVS) which aligns and interfaces with the European Medicines Verification Organisation (EMVO) and the European Medicines Verification System (EMVS) respectively.

The Department of Health has established an FMD Implementation Advisory Board bringing together a wide range of stakeholders from right across the whole of the medicines supply chain and the many health professionals who supply medicines to the public. ABPI is closely involved with this Advisory Board and its many working groups.

Many of the principle associations involved in the set-up of SecurMed UK have their own working groups focusing on the requirements of its members. ABPI has the FMD Task and Finish group which reports to the Supply Chain Work-stream. Pharmacy associations for example have the UK FMD Working Group for Community Pharmacy, bringing together the main community pharmacy bodies and pharmacy negotiators.

Brexit

Now that the UK has left the EU and the Transition Period ends on 31st December 2020, some regulatory requirements will no longer apply. However, certain EU legislation will continue to have effect in Northern Ireland under the Northern Ireland Protocol.

FMD in GB

• The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 Statutory Instrument outlines changes to regulations around the use of medicines in the UK.

• The requirements placed on all actors in the GB supply chain from 9 February 2019, by virtue of the Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regarding the safety features aspects of the Falsified Medicines Directive are removed by this instrument, according to the Explanatory Memorandum (Article 7.32)

• The EU legislation requires that the Unique Identifier on medicines coming from the EU be decommissioned (made inactive) on export from the EU to a third country (Article 22 – EU Delegated Regulation).

• There will be no obligations on the GB supply chain to affix safety features or to scan packs of medicines however, packs that already have FMD safety features will continue to be accepted in the GB, provided that they are in line with other GB packaging requirements.

• The MHRA is encouraging companies to retain the tamper evidence device on packs supplied to the UK

• In the interests of public safety, the Government will evaluate the options for a future UK falsified medicines framework, considering the investment already made by stakeholders.

FMD in NI

• Under the Northern Ireland Protocol (NIP), medicines in NI will be governed by EU rules and regulations. However, these rules are to be enforced by the UK’s medicines regulator, the MHRA.

• As a result of the NIP, the Falsified Medicines Directive will continue to apply and FMD ‘safety feature’ requirements will continue in NI from 1 January 2021. Packs with a marketing authorization (MA) valid in NI will require a unique identifier and a tamper evident device on each pack.

• The unique identifiers on packs with MA valid in NI (including UK-wide MAs) supplied from the EEA will not require decommissioning when exported to the UK until the 31 December 2021, according to MHRA guidance. The active unique identifiers on these packs should be decommissioned in NI at the time of dispense.

Pharmacies and Wholesalers in Great Britain

The ‘safety features’ elements of the EU Falsified Medicines Directive (FMD, 2011/62/EU) and Delegated Regulation (2016/161) cease to have effect in Great Britain from 31st December 2020. This means that pharmacies (and other end users such as wholesalers, hospitals and others handling or supplying medicines) will no longer be required by law to verify and decommission unique identifiers on prescription medicine packs.

• End users in Great Britain will be disconnected automatically from the UK National Medicines Verification System (UKMVS) run by SecurMed UK. This means that it will no longer be possible to verify and authenticate packs from 1st January 2021. Pharmacy operators and system suppliers need to check that any integrated pharmacy systems with FMD functions are no longer actively connecting to or seeking a response from the UKMVS after the end of 2020. Stand-alone FMD systems can simply be turned off.

• Integrated pharmacy systems can still use batch details, expiry dates or product details (GTINs) from packs’ 2D barcodes while these packs are still in circulation. However, pack serial numbers no longer have any function. These packs remain valid and can be dispensed for as long as they are still in date.

• SecurMed UK will continue to provide end user registration and necessary support up to 31st December 2020 for end users in Great Britain.

Pharmacies and Wholesalers in Northern Ireland

Under the terms of the Northern Ireland Protocol, part of the UK’s Withdrawal Agreement with the EU, FMD will still apply in Northern Ireland, for at least four years (until the NI Protocol is due to be reviewed).

• End users in Northern Ireland will remain connected to the UKMVS. They need to continue to verify and decommission any packs with the FMD safety features (unique identifiers and anti-tamper devices) in line with the requirements of relevant EU and UK medicines legislation.

• SecurMed UK will continue to provide end user registration and necessary support to enable Northern Ireland end users to decommission packs with FMD identifier features in to 2021 and beyond.

The UK participated in discussions with the EU to agree a phased implementation of medicines regulations in Northern Ireland, under the NI Protocol, by 1 Jan 2022. The UK published a statement, agreed with the EU, on 5 Nov 2020 confirming a 12-month phased implementation of the Falsified Medicines Directive and regulatory importation requirements for medicines moving from GB to NI.

Work is continuing with the EU to agree operational specifics.

MHRA Guidance can be found at https://www.gov.uk/guidance/supplying-medicines-to-northern-ireland-from-1-january-2021.

Future national falsified medicines system

The Medicines and Medical Devices Bill (progressing through Parliament) would enable the Government to make regulations aimed at preventing falsified medicines from entering the medicine supply chain. This could include establishing a national system based on the unique identification of individual packs that enables medicines to be authenticated and identified if tampered with. The Government will have to consult with industry stakeholders, including pharmacy organisations, before introducing any new Regulations. No timetable has been set by the Government for consultation.

Enforcement

Enforcement of FMD in Member States is the responsibility of national competent authorities. In the UK, including NI this is the Department of Health, responsible for updating legislation and setting out penalties; the MHRA, responsible for enforcement for manufacturers and wholesalers,, with the Pharmaceutical Society of Northern Ireland responsible for enforcement for community pharmacies.

Milestones

Incorporation of SecurMed UK

SecurMed UK is the UK Medicines Verification Organisation and has been incorporated by the principle representative supply chain stakeholder associations as required by the Falsified Medicines Directive and associated Delegated Regulation (EU) 2016/16.

It has the aim of delivering the UK Medicines Verification System, with a national repository, linked to other European national repositories, via a European hub which will enable the verification of prescription medicines at the time of supply to UK patients.

The obligations on SecurMed UK and other National Medicines Verification Organisations are captured in Article 37 of the Delegated Regulation - Obligations of legal entities establishing and managing a repository which is part of the repositories' system.

Resources and links

A list of useful resources produced by the ABPI, EFPIA, MHRA and others is available to view.

Further information

For more details, please contact Dr Rick Greville.