Spare adrenaline nasal spray in schools: MHRA consultation

MHRA proposals for spare adrenaline nasal spray in schools

UK schools cannot yet buy and hold spare adrenaline nasal spray without a prescription. The MHRA opened a consultation on changing this on 19 October 2026, with responses due by 11:59pm on 14 December 2026 (consultation page). Until the law changes, the school exemption covers spare adrenaline auto-injectors only.

The MHRA announced the proposal as a UK-wide consultation, run jointly with the Department of Health in Northern Ireland. Its consultation document states the current position: supply to schools of self-administered adrenaline without a prescription "is currently limited to Adrenaline Auto-Injectors and does not extend to Adrenaline Nasal Sprays" (consultation document).

What the law allows now for spare auto-injectors

The exemption sits in Schedule 17 of the Human Medicines Regulations 2012. Two entries matter.

Part 1, paragraph 12 covers supply. A person who sells or supplies prescription-only medicines may supply a school with "(a) an inhaler containing salbutamol; or (b) an auto-injector containing adrenaline". The principal or head teacher must sign an order that gives the school's name, the purpose and the total quantity. The product is only for supplying or administering to pupils at the school in an emergency.

Administration is Part 3, paragraph 11. A person carrying on the business of a school "who is trained to administer the relevant medicine" may give an adrenaline auto-injector to a pupil at that school who is known to be at risk of anaphylaxis and needs it in an emergency. The Regulations don't define the training. The consultation document explains that consent is best practice, rather than a requirement in these Regulations.

The auto-injector wording came in on 1 October 2017, through SI 2017/715 and, in Northern Ireland, S.R. 2017/241. Salbutamol inhalers got the same kind of exemption from 1 October 2014.

The consultation page mentions schools in England, but the Schedule 17 exemption applies across the UK.

For injected medicines, there is also an administration restriction. Regulation 214(2) says only an appropriate practitioner, or someone acting on their directions, may parenterally administer a prescription-only medicine. There is a separate life-saving route. Regulation 238 lifts that restriction for medicines in Schedule 19 given to save life in an emergency, and Schedule 19 lists "Adrenaline 1:1000 up to 1mg for intramuscular use in anaphylaxis". In a March 2023 letter, the MHRA said this lets a school's auto-injector be used on someone the school did not know was at risk, but only in exceptional circumstances "that could not have been foreseen". That wording is about intramuscular adrenaline, so don't assume it carries over to a nasal spray.

What the consultation would change

The proposal would add adrenaline nasal sprays to the Schedule 17 school exemptions, next to auto-injectors. According to the consultation page and the consultation document:

• Schools could hold auto-injectors, nasal sprays or both. None would have to stock a particular product, brand or both device types.
• The safeguards stay. Adrenaline could only go to children known to be at risk of anaphylaxis, given by appropriately trained staff.
• Either device could be used in an emergency, whatever the pupil was prescribed. In the MHRA's words, a child prescribed an auto-injector "can safely be treated in an emergency with an Adrenaline Nasal Spray (and vice versa)".
• "School" keeps its regulation 213 meaning, broadly any institution providing primary education, secondary education or both.
• The MHRA also asks whether the law should use broader wording for self-administered adrenaline products that may come later.

The consultation document gives Part 2 of the Medicines and Medical Devices Act 2021 as the legal basis. Training, implementation timelines and schools' operational duties are outside the MHRA's remit and this consultation's scope. The Department of Health and Social Care will update its 2017 schools guidance for England and coordinate with the devolved governments.

Which nasal sprays are approved

The MHRA approved EURneffy 2 mg (ALK-Abelló A/S) on 18 July 2025 for adults and children weighing 30 kg or more. A 1 mg strength followed on 12 June 2026 for children aged 4 and over weighing 15 to 30 kg. So the approvals put 2 mg at 30 kg or more, while the consultation document says more than 30 kg for 2 mg and 15 to 30 kg for 1 mg. It names no brand. It does not say which strength a school should keep.

How the 2017 auto-injector guidance works today

The DHSC guidance on adrenaline auto-injectors in schools, published 20 September 2017, applies to all UK primary and secondary schools, independent schools included. Holding spares is optional under it. A spare is used only for pupils at risk who have medical authorisation and written parental consent, for when their own device is broken, out of date, misfired or wrongly given. The guidance covers pharmacy purchases, a register of eligible pupils, records of use and staff training. It does not cover spare nasal sprays.

Benedict's Law in England

In England, separate allergy-safety changes are under way. In March 2026 the Department for Education announced that schools would for the first time have to stock spare auto-injectors, train all staff in allergy awareness and keep an allergy policy. The change is named after Benedict Blythe. The MHRA's announcement reports that the first phase of requirements came into force in September 2026.

That does not mean the stocking duty has started. The statutory guidance Allergy safety in schools, published 6 July 2026, covers maintained schools, pupil referral units and academies in England. It says the stocking duty will come "through forthcoming Regulations", so it isn't in force yet. It also says nasal sprays cannot currently be stocked as spare devices. A school's spare auto-injector may be used if a pupil prescribed nasal adrenaline has anaphylaxis. Early years settings and FE colleges may not stock spare devices.

How to respond to the consultation

Responses go through the MHRA online survey only. The consultation page gives MHRACustomerServices@mhra.gov.uk for accessible formats. The MHRA wants views from people at risk of anaphylaxis, parents, carers, school staff, school nurses, healthcare professionals, and the public.

Suppliers cannot fill a school's order for a spare nasal spray under Schedule 17 until an amending instrument is made. The consultation gives no date for it, so watch for the government response after 14 December.

You can ask RegAffairs AI whether UK schools can keep spare adrenaline nasal sprays and read its cited answer on the current Schedule 17 text.