Frequently asked questions relating to FMD covering: the background to FMD; progress in the UK; implications for community pharmacies.
Last updated 17th November 2016
Section 1: FMD background and definitions, key players and timelines
What is FMD?
The European Falsified Medicines Directive (commonly known as FMD) [2011/62/EU] has been brought in to address the issue of falsified medicines entering the legitimate medicines supply chain across Europe. Falsified medicines include those with little or no active ingredients, the wrong active ingredients, fake or tampered packaging, and those where products and/or packaging have been stolen for re-use or re-sale.
Although unlicensed internet sites have now become the main route for trading falsified medicines to the public, regulatory authorities continue to find and report falsified medicines in the supply chain. Such products pose an unacceptable risk to patients, as well as undermining confidence in the genuine products supplied by manufacturers, wholesalers and pharmacies.
Under the Directive, all new packs of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a unique identifier(UI) in the form of a 2D data matrix (barcode) and an anti-tamper device (ATD).
FMD aims to introduce a pan-European 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 a relevant National Medicines Verification System (NMVS) and pharmacies will be able to check the status of each pack during the dispensing process. The system will be notified of products known to have been recalled, withdrawn, stolen or tampered with. A European Medicines Verification System (EMVS) will act as a hub, linking the national systems together and allowing parallel trading of medicines to continue. Pharmacies will also have to check that the ATD is still intact.
Scanning and authentication of packs will come in to effect across Europe from Saturday 9th February 2019, following the publication of a Delegated Regulation [2016/161] which set out details for the unique identifiers, the national verification systems and the responsibilities of manufacturers, wholesalers and pharmacies.
Which other countries are doing this?
FMD will be introduced in 32 countries – the 28 (current) Member States of the EU, plus the four members of the European Free Trade Area (Iceland, Norway, Liechtenstein, Switzerland). 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.
What’s been done so far across Europe?
Policy work on FMD has been going on for around a decade, leading up to the adoption of the EU Directive in 2011. Pharmacy bodies, including the National Pharmacy Association and the Royal Pharmaceutical Society were involved in this through the Pharmaceutical Group of the European Union (PGEU), the European pharmacy association. Further work on technical details of serialisation and the verification systems saw the Delegated Regulation published in February 2016. It will come in to force across Europe from February 2019.
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.
Under the blueprint model, three companies have been chosen to bid for Blueprint Service Provider (BSP) contracts to run national medicines verification systems. These are Aegate, Arvarto and SolidSoft Reply. Each has experience in providing large-scale IT projects, including serialisation.
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.
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).
Unlicensed products, including specials and clinical trial supplies, are out-of-scope, but any licensed products being incorporated in to them (such as ingredients for specials) would have to be authenticated and decommissioned before they could be used.
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 used in UK]
- Batch number
- Expiry date
Because this information will be printed and encoded on every pack, it can also be used for some activities in pharmacy, such as stock re-ordering, stock rotation and accuracy checking.
How is the unique identifier used to authenticate products?
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 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)”. Pharmacies will need to have processes in place to deal with these situations, which could include making reports to regulatory bodies, if required.
What is the 10-day rule?
Before medicines are handed to patients, they need to be authenticated (ie, have their UI scanned and verified against the NMVS) and, if successfully verified, they are then decommissioned. This means that the product’s status in the NMVS is changed by the dispenser from “active” to “inactive – dispensed”. This prevents the same UI being authenticated by any other pharmacy (or dispensing entity). This process of decommissioning UIs is at the heart of FMD.
If for some reason the product is not then supplied to a patient, there is an opportunity to reverse the status of a decommissioned UI. This can only take place in the following circumstances [Article 22]:
- The reversal takes place in the same location as the original decommissioning (ie, within the same pharmacy)
- The reversal is done not more than 10 days after the decommissioning (commonly known as the “10-day rule”)
- The product has not expired
- The product has not been marked by the NMVS as recalled, withdrawn, stolen or intended for destruction
- The product has not been supplied to the public.
Section 2: FMD progress in UK (including Brexit)
What’s been done so far in the UK?
In the UK, a National Medicines Verification Organisation was formally established under the name SecurMed UK in July 2016. It is governed by five voting directors, one from each of the sectors. Pharmacies are represented jointly by the National Pharmacy Association (NPA) and the Company Chemists Association (CCA), through a single director. SecurMed UK is expected to appoint its Blueprint Service Provider before the end of 2016.
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. Community pharmacy is closely involved with this Advisory Board and its many working groups.
What is the UK FMD Working Group for Community Pharmacy and what is its position on FMD?
In order to align the interests of community pharmacies, the UK FMD Working Group for Community Pharmacy has been formed, bringing together the main community pharmacy bodies and pharmacy negotiators. This Working Group receives regular updates from Department of Health and MHRA officials.
It has been active in preparing a communications plan and mapping the processes that will need to change within community pharmacies in order to implement FMD. Both pieces of work are being used to influence a forthcoming consultation by the Department of Health on proposals to change UK legislation.
The Community Pharmacy Working Group wants to achieve a solution for implementing FMD that will be straightforward, easy to use and which will have minimal impact on pharmacy working practices. It should also be implemented at minimum cost to pharmacy contractors.
The UK voted to leave the EU. Will we still have to do FMD?
FMD is the European approach to dealing with the rising global issue of falsified medicines. Like other major markets, including China and India, it involves individual serialisation of medicine packs and an associated authentication system.
The European Directive and the Delegated Regulation are binding on all EU and EEA Member States. Switzerland is also adopting FMD and pack serialisation. As it currently stands, it is likely that FMD scanning will come in to effect before the UK leaves the European Union. Any changes made to the UK’s Human Medicines Regulations 2012 to implement FMD would remain in place until the UK Government of the time decides to change them. Medicines regulation is not devolved and FMD will apply to the whole of the UK.
At present, the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA), the “national competent authorities” (NCAs) for the UK, have stated that they are continuing with work to implement FMD in the UK and this is “business as usual” for them.
Given the global nature of falsified medicines and the fact that the UK remains a major part of the pharmaceutical sector, we believe that the UK would have to adopt pack serialisation in order to maintain its reputation as a safe part of the medicines supply chain. At present, it seems likely that this would be the European FMD system.
How will this be enforced?
Enforcement of FMD in Member States is the responsibility of national competent authorities. In the UK this is the Department of Health, responsible for updating legislation and setting out penalties; the MHRA, responsible for enforcement for manufacturers and wholesalers; and the General Pharmaceutical Council, responsible for enforcement for community pharmacies, together with the Pharmaceutical Society of Northern Ireland. Pharmacists have a general duty to comply with prevailing medicines legislation while carrying out their professional work.
Levels of penalties have yet to be decided and will form part of the forthcoming consultation by the Department of Health on proposed changes to UK medicines legislation to fully implement FMD.
Will there be a consultation? Will there be an impact assessment?
Yes. The Department of Health plans to obtain the views of all sectors involved. The Department of Health and MHRA are currently collecting information to prepare an impact assessment looking at the various costs associated with implementing FMD in the UK. This has included visits to manufacturers, wholesalers and pharmacies. They are also preparing draft Regulations for changes to the Human Medicines Regulations 2012. Both the regulations and the impact assessment are expected to be put out for a public consultation in early 2017. The Community Pharmacy Working Group and pharmacy bodies will be responding and we will be encouraging pharmacy contractors and LPCs to be involved in the consultation process.
Section 3: FMD implications for community pharmacies
What will change for pharmacy contractors?
Community pharmacy contractors will be required to ensure that all their pharmacies are connected to the UK Medicines Verification System, including having updated software and hardware (scanners) as needed.
Standard operating procedures will need to be changed to ensure that all relevant prescription medicines are authenticated and decommissioned during the dispensing process, prior to hand-over to patients. Processes will be needed to deal with any unexpected results and with reverse decommissioning, where necessary.
Who will pay for this (in pharmacy)?
The EU Delegated Regulation [2016/161] makes it clear that the costs of establishing the repositories system (ie, the European and national verification systems and their governing bodies) is to be borne by manufacturers (ie, research-based companies, generic manufacturers and parallel traders). It is expected that this will be done through a licensing arrangement linked to the right to upload data to the national repositories.
Community pharmacies (and wholesalers) will be required to pay for any “physical scanning equipment” that is required for reading unique identifiers [Article 32]. They will also have to pay for any software upgrades that are required to connect with their national verification system and to make use of the data they receive (ie, the status of UIs they have scanned).
The pharmacy negotiators are represented on the UK FMD Working Group and are working hard for a pragmatic solution that recognises the additional costs and impacts that FMD could have on community pharmacies and their suppliers.
Where and when do I have to scan?
Pharmacies will be required to authenticate products, which means visually checking the anti-tamper device and performing a verification and decommissioning scan, “at the time of supplying it to the public”. There is still a debate about what this actually means (eg, what is the definition of supply? Can checking the ATD and scanning barcodes be done separately?). However, it means that the FMD process must have been completed at the point the medicine is released to the patient or their representative. One way of doing this efficiently, where more than one product is involved, is to used and aggregated barcode on the bag label (see “What is an aggregated code?”)
Will I still be able to use split packs?
Yes. Packs that are going to be split will have their ATD checked and be decommissioned at the point at which they are first opened [Article 28]. The remainder of the pack can be dispensed without further checking at a future point as it will have already been decommissioned.
Will I still be able to do MDS?
Yes. Packs will have to be checked and decommissioned before they are opened to be repacked in MDS trays.
What happens if ATD gets broken? What if I need to break the ATD to assemble a medicine?
If you need to open a pack, either to split the quantity or to prepare or label the product, you will need to check the ATD and decommission the pack before it is opened. The pack can then be dispensed and supplied to patients in the normal way, including in MDS trays.
When checking the anti-tamper device at the time of dispensing, pharmacy staff will be looking to see that the product does not appear to have been tampered with. This will depend on the nature of the device or format used to seal or secure the packaging. Products with packaging where the anti-tamper device has clearly been broken cannot be supplied to patients (unless this was done by the dispenser as part of the process of assembling the medicine).
Wholesalers have to verify products that are returned to them, including inspecting anti-tamper devices. It is unlikely that they would accept back products which have broken anti-tamper devices.
What happens if the pack doesn’t have a 2D barcode?
It is likely that there will still be packs without 2D barcodes in the supply chain when the requirements for authentication under the Falsified Medicines Directive come in to effect in February 2019. These packs will still be able to be dispensed and supplied but they will not be required to be decommissioned.
Some packs are already appearing with 2D barcodes (as well as linear barcodes) as manufacturers and packagers change over in advance of the FMD requirements. Further discussions will be needed on how these packs will be handed by national medicines verification systems.
What’s an aggregated code?
Using aggregated codes is one way in which the FMD process could be made more efficient within pharmacies, especially when dispensing multiple medicines for the same patient.
During the dispensing process you could link information from the UIs of all of the packs for that patient together. This could be linked to a single aggregated code printed on the bag label. When the bag is being handed to the patient or their representative, the bag-label barcode would be scanned and this would trigger the decommissioning of all the packs in a single operation, avoiding having to empty the bag out in front of the patient and scanning each one individually. This is technically possible but discussions are ongoing with PMR suppliers to see if this is feasible.
Will I still be able to use PI products?
Yes. Parallel traded products will have to re-packaged and re-labelled for the intended country of use. This will include applying a new unique identifier and 2D barcode (linked at batch level to the original UI) and replacing the ATD if it has been broken. They will then be treated in the same way as a pack originally manufactured for the UK market. Note that the position of parallel traded products after the UK leaves the EU has yet to be clarified.
Will this mean that I get paid for (exactly) what I scan?
The Delegated Regulation gives Member States the flexibility to use information derived from unique identifiers for the purposes of reimbursement, pharmacovigilence and pharmacoepidemiology [Article 39]. At present, we do not expect that the Department of Health will be using this flexibility for the purposes of pharmacy reimbursement, particularly because the UK does not have an established system of national reimbursement numbers.
Will I have to link scans/UIs to patient records on PMR?
There is not a specific requirement within the Delegated Regulation to record or link unique identifiers to particular patients. No patient-specific information will be captured or stored within the repositories system, including the national verification systems.
The Department of Health may include this within its forthcoming consultation but we do not believe that it is something that would start at the same time as scanning for authentication in 2019. However, it remains possible that it may be introduced at a later date in order to improve pharmacovigilence and product recalls. There would need to be considerable discussion about how the costs of such an upgrade would be met.
Who can see/use FMD information in the pharmacy?
As FMD will affect dispensing, all pharmacy staff involved in the dispensing process would need to be trained to follow FMD protocols on verification/ decommissioning of products. It is expected that dispensing software/PMRs will be updated so that they ask for and receive the live status of product unique identifiers during the prescription assembly process.
Will manufacturers and wholesalers be able to see data on products I have dispensed?
No. The Delegated Regulation makes clear that all parties that are connected to the repositories system, including manufacturers, wholesalers and pharmacies, have sole responsibility, ownership and access to any data that they generate. This data is not shared with any other parties.
The only exception is the status (“active”/“inactive”) of products’ UIs, which is available to any party that has a relevant pack in their possession.
Each national medicines verification system will maintain an audit trail of when and where product information was uploaded and access, and where and when UIs are decommissioned. This data cannot be shared with other parties, other than with the express written permission of the data owner. The only exception is when there is an investigation in to an incident of potential falsification.
Can I still sell data to IMS?
Pharmacy contractors will be able to sell dispensing data generated by their PMR systems in the normal way, but it is likely that commercial restrictions will be placed on the use of individual pack data derived from the FMD system, in line with the data ownership rules outlined above.
Do PMR suppliers know that this is coming? Who is speaking to them?
Yes. FMD data interfaces with current PMR systems will form an integral part of how this process works in practice. PMR suppliers are aware of current FMD progress and will be more involved once the Blueprint Service Provider for the UK has been selected. This will allow technical capabilities to be discussed. PMR suppliers have been kept informed by the Department of Health, SecurMed UK and the Community Pharmacy Working Group.
Will my Wholesaler decommission for me? Can I scan when I receive the stock?
This is highly unlikely. Decommissioning within pharmacies has to occur “at the time of supplying it to the public” [Article 22]. This means that decommissioning needs to occur in the process as close to the patient as possible. Decommissioning when stock is received would not fulfil this criterion. In addition once decommissioned, stock can only be re-commissioned within 10 days (see “10-day rule”). This would mean that anything decommissioned more than 10 days ago could not be returned to the wholesaler.
Wholesalers can decommission products for a range of healthcare professionals, public service bodies and other organisations that use or supply medicines as an occasional part of their work [Article 23], but community and hospital pharmacies are specifically excluded from this.
I have a Wholesale Dealer’s Authorisation. What does this mean for me?
Not only will you have to abide by the regulations for pharmacies but you will need to abide by the regulations for wholesalers as well. This will involve numerous different steps and we recommend that you read the Delegated Regulation [2016/161] as soon as possible to ensure that you will be familiar with the rules you will have to work to.
Will I still be able to return products to my wholesaler?
This will depend upon your wholesaler’s terms and conditions, but in general, as long as the stock has not be decommissioned and the anti-tamper device is still intact, we currently expect the returns process to be unaltered. Wholesalers will have to verify the status of any products returned to them, so products that do not have an “active” status would not be accepted back.