Regulator seeks views on reclassification of pain medication

The MHRA is consulting on making Nuromol, a medicine that contains ibuprofen and paracetamol, available without the need to visit a pharmacy.

Dr Sarah Branch, Director of Vigilance and Risk Management of Medicines at the MHRA, said:

Every response received will help us gain a better picture of whether people think Nuromol can be made available safely without the need to visit a pharmacy.

We want to hear from as many people as possible, and therefore we urge people to respond to our consultation and let us know their views.

Nuromol is used for the temporary relief of mild to moderate pain associated with migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, pain of non-serious arthritis, cold and flu symptoms, sore throat, and fever when paracetamol or ibuprofen alone have not provided adequate pain relief. If reclassified it will be available in a pack of 6 tablets.

While most people can take paracetamol, ibuprofen isn’t suitable for everyone and it is important that people do not exceed the recommended dose or take more than one paracetamol product at once. We would like to hear from anyone who may be affected by this proposed change in classification .

The MHRA welcomes views from the public and stakeholders on whether this product should become a general sale medicine (available in shops such as supermarkets as well as from pharmacies). At present it is only available for purchase in pharmacies, under the supervision of a pharmacist. The MHRA is committed to making medicines easier to access, where it is safe to do so. Therefore, it is vital that we hear what people have to say on this consultation.

The Commission on Human Medicines advises the government on the safety, quality and effectiveness of medicines and vaccines. They have advised that it is safe for this product to potentially be made available as a general sales product.

The Nuromol consultation is open until 3 June 2021.

Notes to Editor

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. 

MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health and Social Care. 

The Medicines and Healthcare products Regulatory Agency is responsible for protecting and improving the health of millions of people every day through the effective regulation of all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care. 

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