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Self-administered injectable medicines should be considered for reclassification as Pharmacy (P) medicines, the chief executive of PAGB, which represents over-the-counter medicine manufacturers, has said.
For most medicines, manufacturers can apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for reclassification of their products. Current regulatory frameworks mean these products “cannot even be considered for reclassification in the UK, regardless of any evidence supporting their safe use”, Michelle Riddalls said in a statement issued on 7 October 2026.
Speaking at the AESGP Switch Day conference, held in Brussels, Belgium, on 7 October 2026, Riddalls said that PAGB is “calling for changes to medicines legislation, including the criteria that determine prescription-only medicine status, so that self-administered injectable medicines can be considered for pharmacy reclassification, where supported by evidence”.
In the UK, all self-administered injectables are prescription-only medicines. A reclassification to P status would mean an injectable product could be purchased from a pharmacy in the presence of a pharmacist.
Riddalls told The Pharmaceutical Journal: “Our proposal would only cover self-injectables where it would be safe to do so. Therefore, there are certain medicines that would still need to be administered via a healthcare professional which would remain out of scope.”
She added: “We want to see the opportunity for all types of self-injectable medicines to make a reclassification application, if the company have the appropriate benefit risk data to support a submission. It remains the decision of the company to make any application to the MHRA should they wish to do so.
“The key issue is that, under the current legislation, such applications cannot be made as a matter of principle. This means that, even where robust evidence exists to support the safe and effective use of a medicine through a pharmacy route, there is currently no mechanism for that evidence to be considered through a reclassification application.”
Examples of these kind of products, Riddalls said, “could include adrenaline for life-threatening allergic reactions (epi-pens), GLP1s or Vitamin B12.
“However, it is important to be clear that this would not constitute an automatic or blanket change. Each medicine would need to be thoroughly assessed by the MHRA, with appropriate evidence and suitable risk-minimisation measures in place, before any approval could be made.”
Rachel Brucoli, deputy director of established medicines licensing at the MHRA, said: “Patient safety is our top priority. While many injectable medicines can be self-administered by patients, that does not automatically mean they are suitable to be supplied without a prescription.
“We support innovation and appropriate reclassification where robust evidence demonstrates that access can be widened safely.
“We remain open to further evidence and constructive engagement. Any proposal to change the current legislative framework would require careful consideration of the evidence, patient safety, and the potential impact on patients and the wider healthcare system, alongside appropriate stakeholder engagement and consultation.”
