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The Royal Pharmaceutical Society (RPS) has called for mandatory 2D barcodes on medicines packs.
In a statement published on 18 February 2026, the RPS said: “Members have raised concerns that 2D barcodes are no longer being printed on all medicines that are destined for the UK supply chain.”
It added that there is “no assurance or process that verifies that the information on the barcode is accurate” — for example, ensuring Global Trade Item Numbers (GTINs) are not reused, and that the details of the medicine, such as name and strength, are represented accurately by the barcode.
“Barcode errors, duplication or absence can lead to the wrong medicine or wrong dose reaching patients, with potentially fatal consequences.
“[The] RPS joins the call from NHS England for regulatory changes to mandate 2D barcodes on UK medicines packaging and include GTIN information in the licensing process for medicines,” the statement continued.
The Society has called on manufacturers and market authorisation holders to voluntarily include 2D barcodes, ahead of any proposed regulatory change.
Under the EU Falsified Medicines Directive (FMD), medicine packs are required to feature a 2D barcode containing a unique serial number alongside a product code, batch number and expiry date.
However, since the UK withdrew from the EU in 2020, the FMD has no longer applied. The previous government committed to establishing a UK version of the scheme, but no consultation on this has yet taken place.
In June 2025, the four UK chief pharmaceutical officers wrote an open letter to pharmaceutical companies, stressing “the importance of continuing to print 2D barcodes on medicines’ packaging, encoding, as a minimum, the GTIN, batch number and expiry date”.
In October 2025, pharmacists launched a petition to make accurate GTIN barcodes mandatory in all MHRA-licensed medicines, following reports of growing problems with barcode data errors and missing 2D barcodes on UK medicine packs.
The issue was highlighted by several ‘Class 4 medicines defect notifications’ during 2025 that were linked to barcode or labelling problems, including fexofenadine hydrochloride tablets in August 2025 and simvastatin tablets in July 2025.
In November 2025, Henrietta Hughes, patient safety commissioner for England, warned that barcode errors on medicines “pose critical patient safety risks”.
Hughes told The Pharmaceutical Journal on 19 February 2026: “Correct labelling of medication is vital to reduce the risk harms to patients.
“I am calling for a consistent method of identification, compatible with the increasing use of automated systems to keep people safe.”
Claire Anderson, president of the RPS, said: “Accurate 2D barcodes on medicines are fundamental to patient safety. When packs do not include a GTIN, batch number and expiry date, pharmacy teams cannot reliably scan and verify medicines, increasing the risk of errors and undermining digital safety systems.”
David Watson, executive director of patient access at the Association of the British Pharmaceutical Industry (ABPI), said: “The industry recognises the concerns raised that barcodes are not currently required on medicine packs, but there is a need for further discussion with all parties on the future of medicine packaging and digitalisation of supply data in the UK, to ensure we continue to have a system that protects patient safety and supports the NHS.”
Mark Samuels, chief executive of Medicines UK, said: “While we appreciate 2D barcoding’s potential benefits, the government and regulators must recognise today’s tough environment for off-patent medicines, which comprise 85% of all NHS prescriptions. Prices for these medicines are at record lows, so extra costs further strain supply resilience and exacerbate shortages.”
“Before the UK left the FMD scheme, manufacturers sought explicit confirmation from the government on whether to maintain the barcoding machinery. We were told more than once that the machinery could be scrapped, so it is unreasonable to expect manufacturers to repurchase it.
“If the government wishes to proceed, it must be accompanied by moving away from the need for patient information leaflets (PILs) in UK packs. Regulation should be modernised, with marketing authorisation holders providing PILs in electronic form for every pack placed on the market, and paper copies supplied at the point of dispensing only upon request by patients.
“Crucially, the same barcodes previously used for FMD should be enabled for patients and healthcare professionals to scan via mobile phone to access the electronic PIL,” he said.
A spokesperson for the MHRA commented: “MHRA does not regulate GTIN codes and the management of these are not within our remit; however, [we] recognise the value to the supply chain and healthcare professionals of barcoding.
“We are actively engaged with healthcare professionals and stakeholders on this topic,” they added.
“MHRA are also contributing to the government response to the House of Lords Public Services Committee Medicines Security inquiry report.
“We continue to engage with stakeholders and contribute to the ongoing conversation relating to GTIN codes, proportionate regulatory responses and their application.”
