Barcode removal on UK medicine packs raises patient safety concerns

On 1 January 2025, new medicines rules under the Windsor Framework came into effect across the UK. The Framework was introduced to replace parts of the Northern Ireland Protocol and simplify how medicines move between Great Britain and Northern Ireland. Previously, Northern Ireland was required to follow the EU Falsified Medicines Directive (FMD), even after the rest of the UK left the EU. 

FMD was an EU safety regulation designed to prevent falsified medicines entering the supply chain. It required every prescription medicine pack to carry a unique serialised 2D GS1 DataMatrix and a tamper‑evident seal, enabling authenticity, batch and expiry information to be verified before dispensing. 

With FMD no longer applying anywhere in the UK, manufacturers supplying UK‑only packs are no longer required to include the FMD‑mandated GS1 DataMatrix 2D barcode. As a result, more medicines are now arriving in NHS organisations without the GS1 DataMatrix and in some cases without any product identifier at all, including the simple linear GTIN barcode that support accurate scanning, traceability and medicines safety. While regulatory alignment was the goal, the practical impact on patient care and safety is becoming increasingly clear.

Hospitals and pharmacy professionals have raised increasing concerns about the quality and consistency of barcode information on some UK‑only medicine packs. According to the MHRA Inspectorate, recent issues reported across the system include:

Barcode issues affect the entire medicines management process, from supply and dispensing to administration. 

Point of care scanning has become a cornerstone of safe medicines practice in many healthcare providers across the UK. By scanning the GS1 DataMatrix 2D barcode at the bedside, clinicians can confirm the five rights of medicines administration (the right patient, drug, dose, route and time) within seconds. 

Closed‑loop medication administration (CLMA) uses digital technologies to provide additional verification of the five rights. It forms a key component of closed‑loop medicines management, which relies on integrated digital systems to support and safeguard every stage of the medicines process. 

When a barcode is missing or cannot be scanned, this safety loop breaks and staff must revert to manual checks. This increases the risk of errors and extends the time required to complete tasks. Many medicines look alike, sometimes differing only in strength or presentation, so manual verification increases the likelihood of error. 

The impact extends beyond the point of care. Barcode failures can disrupt: 

• automated dispensing inventory management
• electronic patient records
• product recalls
• incident investigations
• audit and reporting
• clinical confidence in scanning systems 

Every failure results in workarounds that slow down workflows, increase cognitive load and reduce the reliability of systems designed to support safe, efficient care.

GS1 standards provide a globally recognised system for identifying medicines consistently and reliably. A GS1 DataMatrix encodes essential information — such as the GTIN, batch number and expiry date — in a format that clinical and supply chain systems can read instantly.

Although the Windsor Framework removes the legal requirement for EU serialisation on UK‑only packs, the clinical and operational value of GS1‑compliant DataMatrix barcodes remains unchanged. Without them, the NHS loses critical safety information, and the digital systems that support CLMA, stock control and recall management cannot function effectively. 

Healthcare leaders, including the UK’s chief pharmaceutical officers, have already encouraged manufacturers to continue applying 2D barcodes across all UK packs to maintain medicines safety and support the NHS’s digital ambitions.

The adoption of digital systems and technologies in medicines management has already delivered significant benefits across the NHS, from improving the accuracy of documentation to reducing medication administration errors. Barcode data captured at the point of care supports clinical decision‑making, strengthens audit trails and enables more effective recall responses. 

But these gains rely entirely on the data printed on each medicine pack. If a barcode is missing or inaccurate, the NHS cannot fully realise the benefits of digital medicines management or maintain the high level of safety that CLMA provides. 

To protect these advances, manufacturers supplying medicines to the UK should ensure their packs continue to carry GS1‑compliant DataMatrix barcodes that meet global best practice. Consistent, accurate data now will help protect patients and support the NHS as it continues its digital transformation.