The Department and the NHS Business Services Authority have not received a request from the General Medical Council for data relating to named services or individual prescribers of cannabis-based products for medicinal use. NHS England routinely liaises with relevant regulators and shares information to support the safe management and use of controlled drugs. In June 2026, NHS England met the General Medical Council to discuss prescribing of cannabis-based products for medicinal use and subsequently shared information, including details of named medical prescribers.

NHS England has also provided information relating to Care Quality Commission-registered services to the Care Quality Commission, as the regulator of health and social care services in England.

Unlicensed medicines, including unlicensed cannabis-based products for medicinal use in humans may be supplied, according to Regulation 167 of the Human Medicines Regulations 2012, when there is a special clinical need that cannot be met by licensed available medicines. The special need, clinical in nature, is determined by the prescriber responsible for the care of the individual patient. According to Regulation 167 of the Human Medicines Regulations 2012, the prescriber is a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber, or supplementary prescriber.

Clinical-need justifications submitted during the course of notifications to the Medicines and Healthcare products Regulatory Agency to import unlicensed medicines is part of normal clinical practice, which is monitored by the relevant professional healthcare regulator and the royal colleges.

The Department of Health and Social Care has worked closely with the Home Office and healthcare regulators in the development and implementation of the law change in 2018 to permit the prescribing of unlicensed cannabis-based products for medicinal use and their use in clinical research. These unlicensed medicines may be supplied under regulation 167 of the Human Medicines Regulations 2012 when there is a special clinical need that cannot be met by available licensed medicines. The special need is determined by the prescriber.

My Rt Hon. Friend, the Secretary of State for the Home Department, has commissioned the Advisory Council on the Misuse of Drugs (ACMD) to review the regulation of cannabis-based products for medicinal use. The review will consider the matters raised and assess whether the legislation has had the desired impact. The commission also asks the ACMD to identify any unintended consequences that were not anticipated at the time of implementation and offer recommendations on how to mitigate these, including any inhibiting effect that the availability of cannabis-based products for medicinal use through private prescriptions has had on the incentive to conduct clinical trials to develop safe, effective, and cost-effective products for use via the National Health Service. The ACMD report is expected by summer 2026, and the Government will carefully consider the report and its recommendations before taking any action.

Private medical clinics offering unlicensed medicines that are supplied to fulfil special clinical needs under regulation 167 of Human Medicines Regulations 2012, can advertise services or consultations but not medicinal products. The Medicines and Healthcare products Regulatory Agency (MHRA) has the power to investigate and take enforcement action when breaches, or suspected breaches, of medicines regulations are identified. One investigation concerning a cannabis-based product for medicinal use has been conducted since 1 January 2020, resulting in the company in question ceasing to advertise the product prior to any formal enforcement action.

The MHRA cannot comment on any cases where regulatory action is ongoing or planned, which may be prejudicial.

Following the approval of an adrenaline nasal spray by the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2025, the Government is considering whether any amendments to Schedule 17 of the Human Medicines Regulations 2012 are appropriate. Any changes to access arrangements would represent an amendment to the current regulatory framework and would require consideration of patient safety and appropriate clinical use. Should changes be proposed, a public consultation would be undertaken.

The National Institute of Health and Care Excellence (NICE) has been notified of the considerations being made by the Department in this area. NICE is not currently considering producing guidance on EURneffy. NICE will continue to monitor new evidence on this topic, in line with its usual processes. NICE has met with the National Institute for Health and Care Research which has agreed to explore whether research on this topic would be feasible and, if so, what research programme it might be suited to.

There are no restrictions on accessing information on how to use adrenaline devices, whether by a medical professional or member of the public. Guidance from the MHRA on their website and on YouTube includes information on the correct use of adrenaline auto-injectors and what to do in an emergency, with further information available at the following two links:

https://www.gov.uk/drug-safety-update/adrenaline-auto-injectors-aais-new-guidance-and-resources-for-safe-use

https://www.youtube.com/watch?v=4vNR5N1-iBw

The manufacturers of adrenaline devices also provide a range of training materials freely available to the public, including training devices without medication, guides on instructions for use, and video demonstrations.

An assessment, through a commissioned piece of user-research of homecare paper-based prescribing, was done during the COVID-19 pandemic. NHS England will use the information in this assessment to understand the issues in homecare, as well as to inform future improvement actions, particularly developing and adoption of the Electronic Prescription Service (EPS).

No assessment has been made of the impact of requirements under the Human Medicines Regulations 2012. The only advanced electronic signature (AES) is through EPS. Not many e-prescribing systems used in secondary care have the capability to meet this AES requirement.

Reforms to the Human Medicines Regulations 2012 are progressing under the Medicines and Medical Devices Act 2021. The Act supports the United Kingdom’s ambitions for the Life Sciences sector through regulations to increase innovation and support the development of new medical technologies. This includes placing the Early Access to Medicines Scheme on a statutory basis, supporting the continued safe deployment of COVID-19 and flu vaccines, and consulting on proposals for a new regulatory framework to enable innovative medicines to be manufactured and delivered at the point of care.

Through the Retained EU Law (Revocation and Reform) Bill, the Government is currently reviewing which retained European Union law should be repealed, reformed or preserved. The Government continues to work with a range of stakeholders to ensure that any such reforms maintain current standards in patient safety and public health. The Medicines and Healthcare products Regulatory Agency is participating in the review of all retained EU law within its responsibilities.

A Serious Shortage Protocol is an additional tool to manage and mitigate medication shortages and may be used in the exceptional and rare situation when other measures have been exhausted or are likely to be ineffective.

As the explanatory memorandum of the amending Statutory Instrument acknowledges, protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients. For example, such protocols would not be suitable for medicines that need to be prescribed by brand for clinical reasons, such as biological medicines. In these cases, patients would always be referred to the prescriber for any decision about their treatment before any therapeutic or generic alternative is supplied.

The proposed changes to the Human Medicines Regulation 2012 will be subject to the affirmative resolution procedure in accordance with paragraph 1(1) of Schedule 7 to the European Union (Withdrawal) Act 2018 for it to be exercisable in the United Kingdom. The Statutory Instrument will be laid before Parliament very soon.

Community pharmacists have an important role in ensuring that patient get the medicines they need. If a serious shortage protocol is in place they can dispense an alternative but only as prescribed in the protocol.

A protocol would increase the transparency of communication across the health system and reduce confusion amongst patients and prescribers as the protocol will give prescribers clarity about what will happen in the event a prescription only medicine is unavailable.

A protocol would support the quality of care delivered by the National Health Service. In particular, in a situation with multiple large shortages, serious shortages protocols can have an important role in reducing delays in getting patients their medicines and freeing up general practitioners’ time.

The serious shortage protocol provisions would enable retail pharmacies to provide a generic medicine when the brand has been prescribed but only if there is a serious shortage of that particular branded medicine and only if the protocol, developed with and signed off by clinicians, allows for the substitution. This is not automatic generic substitution of branded medicines by retail pharmacies which is currently not allowed and the Department has no plans to change this.

The legal provisions will clarify that a serious shortage is a serious shortage in the opinion of Ministers.

A protocol is only one of the tools that can be used to manage shortages. The Department has well-established governance processes for managing shortages in collaboration with manufacturers and suppliers, clinicians and the National Health Service and the Medicines and Healthcare products Regulatory Agency. A protocol would only be introduced in case of a serious shortage, if it would help manage the supply situation and if clinicians think it is appropriate, after discussion with the manufacturer and/or marketing authorisation holder.

Whether a serious shortage protocol is issued is a decision by Ministers but that decision would be taken after discussion with the manufacturer and/or marketing authorisation holder. Manufacturers are not the primary party to establish which products are listed as being in serious shortage.

An impact assessment will be published alongside the Statutory Instruments when they are laid in Parliament.

As part of the preparations for a ‘no deal’ exit from the European Union, the Department developed proposals for and informally consulted with the relevant stakeholder representative bodies on a power to modify the application of the Human Medicines Regulation 2012 to deal with serious shortages in the event of a ‘no deal’ exit. This power can only be used in the case of a ‘no deal’ exit from the EU, only have effect until two years after exit day and only apply in the case of a serious shortage where one but not the only significant factor contributing to the shortage is the withdrawal of the United Kingdom from the EU.

The legal provisions will clarify that a serious shortage is a serious shortage in the opinion of Ministers.

A serious shortage protocol would only be introduced in case of a serious shortage, if it would help manage the supply situation and if clinicians think it is appropriate. A protocol is only one of the tools that can be used to manage shortages. The Department manages shortages in collaboration with manufacturers and suppliers, the National Health Service and the Medicines and Healthcare products Regulatory Agency and will continue to do so. For each shortage the Department assesses the risk to patients and decides what tools to use to mitigate the impact on patients which could include a serious shortage protocol. The triggers for considering a protocol and the protocol itself will be different depending on the medicines and the supply situation, including whether alternatives are available.

The legal provisions will clarify that a serious shortage is a serious shortage in the opinion of Ministers.

Any serious shortage protocol would be developed with and signed off by clinicians. Only if clinicians deem it appropriate, an alternative quantity, strength, pharmaceutical form or medicine can be dispensed in line with the protocol. Each protocol would clearly set out what alternative can be dispensed by the retail pharmacy, under what circumstances, for which patients and during which period.

As part of the preparations for a ‘no deal’ exit from the European Union, the Department developed proposals for and informally consulted with the relevant stakeholder representative bodies on a power to modify the application of the Human Medicines Regulation 2012 to deal with serious shortages in the event of a ‘no deal’ exit. This power can only be used in the case of a ‘no deal’ exit from the EU, only have effect until two years after exit day and only apply in the case of a serious shortage where one but not the only significant factor contributing to the shortage is the withdrawal of the United Kingdom from the EU.

The legal provisions will clarify that a serious shortage is a serious shortage in the opinion of Ministers.

The Medicines and Healthcare products Regulatory Agency (MHRA) ran a four-week public consultation on changes to the Human Medicines Regulations 2012 in preparation for the United Kingdom’s withdrawal from the European Union in the event of a ‘no deal’, from 4 October to 1 November 2018.

Preparations to ensure the UK will be ready for EU exit in all scenarios, including a potential ‘no deal’ outcome, requires contigency legislation to be made before 29 March 2019 to allow for an orderly exit. There was no statutory obligation to consult on these changes, but the MHRA applied the principles of best practice and consulted stakeholders publicly for as long as was feasible. This public consultation followed informal consultation with industry and the third sector on the proposed changes.