Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he plans to allow inhalers to be sold over the counter without a prescription.

At present, inhalers used for conditions such as asthma and chronic obstructive pulmonary disease are authorised as prescription-only medicines (POM). This classification reflects the clinical need for a healthcare professional to confirm diagnosis, advise on correct inhaler technique, determine appropriate dosing, monitor treatment response, and detect any adverse reactions. The prescription requirement also supports the systematic recording of use and helps prevent inappropriate or excessive use.

It is also important to note that inhalers themselves are not a class of medicine per se but a delivery device for a range of medicines.

If a manufacturer or marketing authorisation holder wishes to pursue POM to pharmacy medicine reclassification for any type of medicine or their mode of delivery, the appropriate route is to submit a major reclassification application to the Medicines and Healthcare products Regulatory Agency (MHRA). This is a formal dossier that must present a robust evidential case in support of reclassification.

The MHRA publishes guidance on the requirements for reclassification applications, including what constitutes a “major” reclassification. The MHRA is open to early dialogue with sponsors to clarify expectations and help focus application efforts via the provision of scientific advice. Until such an application is received and assessed under the statutory framework, the prescription requirement remains in place.

Should a comprehensive dossier be submitted, the MHRA will consider it in line with its public-health mandate. The MHRA remains open to innovations that improve patient access and convenience, provided they uphold safety, clinical outcomes, and quality of care.