Written evidence from GS1 UK (MED0047)
Written evidence from GS1 UK (MED0047)
Introduction
GS1 UK is a not-for-profit body that sets and enables global standards in supply chains. Our standards are used 10 billion times per day, and form the basis of a global business language that identifies, captures and shares key information on products around the world – with the best known being barcodes.
In healthcare and medicines, GS1 standards enable the unique global identification of every person, every product and every place. GS1 standards are already in place in many healthcare settings, both NHS and private, and well-integrated though global supply chains.
We welcome the opportunity to respond to this call for evidence following issues relevant to our area of expertise being raised during Oral Evidence at the Select Committee on 15th October. Our response sets out how GS1 standards enable a safe and efficient supply chain, especially in relation to the digitisation of the medicines supply chain, traceability, and the operational and safety benefits of barcoding.
1. What are the causes of medicine supply chain issues in the UK? 1.1 A major cause of supply chain issues is the lack of end-to-end digital traceability and verification. Until January 2025, the UK was connected to the European Medicines Verification System (EMVS) via the EU Falsified Medicines Directive (EUFMD), which required manufacturers to introduce a unique identifier (UI)—a 2D data matrix barcode encoding a product code, unique serial number, batch number, and expiry date—on every pack. This enabled end-to-end verification and was a significant safeguard against falsified medicines.
1.2 Since the expiry of the UK’s connection to EMVS, there is no longer an end-to-end verification system in place for medicines in the UK supply chain. Further still, the placement of a 2D barcode is no longer compulsory, following MHRA guidance. This has negative impacts on:
2. What are the current and possible future threats facing the UK medicine supply chain?
2.1 The absence of a mandatory requirement for 2D barcodes (Data Matrix) on medicine packaging is a significant threat. Without these barcodes, medicines cannot be efficiently tracked or verified and are incompatible with advanced dispensing and stock management systems.
2.2 This increases the risk of counterfeit and falsified medicines entering the supply chain, as there is no longer a robust, digital means of verification at the point of dispensing or administration.
3. How do providers monitor stock levels and how effective is this? 3.1 Where GS1 standards are used, stock levels can be monitored efficiently through automated systems, supporting real-time tracking and inventory management. For example, the use of GS1 standards enables:
However, the lack of a mandatory barcode requirement means not all medicines are traceable, leading to gaps in monitoring and reduced efficiency.
4. To what extent is the Government able to predict supply chain issues before they occur?
4.1 Prediction is limited by the absence of a national, interoperable digital system. The lack of standardised, real-time data across the supply chain is a barrier to effective prediction and early intervention to prevent real-world consequences from supply chain issues.
4.2 Under the previous EUFMD regime, dispensers could check and verify a product against manufacturer-uploaded details in the EMVS. Currently, no such end-to-end verification method exists in the UK following withdrawal from the EU.
5. How can the monitoring of the medicine supply chain and prediction of potential supply chain issues be improved?
5.1 Reinstating mandatory 2D barcodes would enable real-time, end-to-end monitoring and improve steps towards verification. Developing a UK-wide digital verification system would then allow for the unique identification and tracking of every medicine, every patient, and every location within the healthcare system.
5.2 This would make it much more difficult for falsified medicines to enter the market, as they would also need to falsify matching batch numbers, expiry dates, manufacturer codes as well as GS1 standards / numbers. Even if this were possible, a duplication of details flag would be issued upon scanning on both the legitimate and falsified medicines in separate locations.
6. What impact do procurement policies have on supply chain resilience and how could these be improved?
6.1 Procurement policies that do not require digital traceability undermine supply chain resilience.
6.2 Policies should incentivise or mandate the use of global standards to ensure medicines are traceable throughout the supply chain. This could be improved by continuing to print 2D barcodes on medicines’ packaging, encoding, as a minimum, the GTIN, batch number, and expiry date, to maintain safety and operational benefits.
Recommendations
13 November 2025