Background and definitions, key players and timelines

This page was last updated on 17th January 2019

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 and Switzerland). Under the Delegated Regulation, Belgium, Greece and Italy have six-year derogations until 2025 as they already have verification systems in place.

What’s been done previously 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 community pharmacy association. Further work on technical details of serialisation and the verification systems saw the Delegated Regulation published in February 2016.

The development of the European and national verification systems has been led through a stakeholder model involving the five main sectors (or “constituencies”) of the supply chain – research-based manufacturers, 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) – the European hub – 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 were 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. Since the start of the process Aegate has withdrawn from the market.

National stakeholder associations across Europe have worked to establish their own National Medicines Verification Organisations (in the UK this is SecurMed UK) which then invited the Blueprint Service Providers to tender to operate the NMVS.

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 into 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 separate changes are being made to regulation of medical devices.

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:

  • 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
  • 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 the National Medicines Verification System – the UK hub. The UK hub 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-tampering device is also undamaged (unless it is required to be broken in order to assemble or prepare the medicine).

If the UK hub sends back a message that the pack is “inactive”, then it cannot be supplied to a patient. 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 difference between verification and decommissioning?

Verification: A medicine can be scanned to verify it is in the UK hub and that it is not marked as dispensed, expired or recalled. This can be done at any point the medicine is in stock and does not change the status of the medicine in the UK hub. Wholesalers will do this using an ad hoc, risk-based approach, e.g. if a medicine comes from a different supplier than usual or if a medicine is returned by a pharmacy.

Decommissioning: When supplying a medicine to a member of the public, the medicine will be scanned to verify it is in the UK hub and that it is not marked as dispensed, expired or recalled. Decommissioning causes the status of the medicine to be marked as “inactive – dispensed”, meaning if the same number is scanned again, it will be flagged to the person scanning it. Community pharmacies must do this for all relevant medicines dispensed or supplied.

What are recommissioning and the 10-day rule?

Before medicines are handed to patients, they need to be verified and decommissioned. This means that the product’s status in the UK hub 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 (recommissioning). This can only take place in the following circumstances:

  • The recommissioning takes place in the same location as the original decommissioning (i.e. within the same pharmacy)
  • The recommissioning is done not more than 10 days after the decommissioning
  • The product has not expired
  • The product has not been marked by the UK hub as recalled, withdrawn, stolen or intended for destruction
  • The product has not been supplied to the public.

If a decommissioned product is not collected by the patient and it is not possible to recommission it, e.g. it is more than 10 days after decommissioning, the legislation says the product cannot be returned to stock or supplied to another patient, so it will have to be disposed of.

What do tamper-evident seals look like?

This is a seal which allows visual verification of whether the packaging of a medicine has been tampered with. It will be either a foil or plastic seal, similar to that on many medicines currently.

What happens if the UK Brexits without a deal (a “hard-Brexit”)?

If Brexit happens without an agreement with the other member states of the European Union, the UK hub’s connection to the European hub (where all the UI data is uploaded by manufacturers etc.) will be suspended at some point, which will prevent the UK hub operating. In this circumstance, the legal obligations to comply with FMD would be removed by the Government for all actors in the UK supply chain.

The MHRA has also stated that packs containing the FMD safety features would still be accepted in the UK, provided that they are in line with other UK packaging requirements. In the interests of public safety, Government will evaluate the options for a future UK falsified medicines regulatory framework, taking into account the investment already made by stakeholders.