Medicines and Healthcare products Regulatory Agency

List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.

Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function.

Relevant safety information for users of magnetic resonance imaging (MRI) equipment in clinical use.

Parallel import licences granted in 2026.

Expressions of interest are invited from AI-enabled medical device manufacturers and NHS provider organisations interested in participating in the London Region I MHRA Regulatory Sandbox.

Marketing authorisations granted in 2026.

Device qualification and classification of ambient voice technology-enabled products that are medical devices intended to be placed on the market, or put into service, in Great Britain.

Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.

The MHRA’s AI Airlock second phase ran between April 2025 and May 2026. This report does not constitute formal MHRA guidance.

Public Assessment Report on the safety review of the available data on the risk of dementia with the use of bladder anticholinergic medicines.

How the MHRA decides whether to approve a clinical investigation for medical devices.

How to notify the MHRA that you are going to undertake a clinical investigation of a medical device.

How to determine if you will need to undertake a clinical investigation of a medical device, or if it is exempt under the regulations.

Information about how we handle potential corporate conflicts of interest (COI) between different parts of the Agency.

Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.

How to comply with the regulatory requirements for manufacturing custom-made medical devices.

Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.

A list of authorised orphan medicinal products registered by the UK licensing authority.

Details of the organisations that are currently approved to undertake conformity assessments on medical devices.

Annual Report of the Human Medicines Regulations (2012) Advisory Bodies - the Commission on Human Medicines (CHM) and the British Pharmacopoeia Commission.

MHRA annual report and accounts 2025 to 2026.

Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.

How to use the procedure for medicines licensing applications.

This privacy notice describes how we collect and use your personal information, in accordance with the Data Protection Act and the General Data Protection Regulation.

UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.

Department of Health and Social Care and MHRA register of licensed wholesale distribution sites (human).

Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.

The MHRA register of licensed manufacturing sites: manufacturer specials - human (MS) and manufacturer specials authorisation - veterinary (MANSA) only.

Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.

List of sites granted a manufacturer or wholesale dealer licence.

The Medicines and Healthcare products Regulatory Agency (MHRA) published a review of the safety of albumins manufactured from UK-sourced plasma with respect to variant Creutzfeldt-Jakob disease (vCJD) risk in August 2023. A further review of the safety of five additional plasma derived medicinal products (Fibrinogen, Prothrombin Complex Concentrates (PCCs), C1 Esterase Inhibitor, Factor X and Protein C) manufactured from UK-sourced plasma with respect to vCJD risk has now been completed, with the results published in July 2026.

Goals agreed with the Medicines and Healthcare products Regulatory Agency to clarify how their actions should support economic growth.

Decisions made by MHRA on adverts reported to have breached the legislation on advertising medicines.

Which professions can act as an investigator, training and experience expectations, provision of medical support and delegation of activities.

Doxecitine and Doxribtimine in the treatment of paediatric and adult patients with thymidine kinase 2 deficiency (TK2d) with an age of symptom onset on or before 12 years.

The MHRA’s Innovation Office offers access to expert regulatory guidance for developers of innovative medicines and novel manufacturing processes that face regulatory challenges, uncertainties, or gaps in the current regulatory framework

This guidance explains the legal framework for labelling and packaging as described in UK legislation and gives best practice for producing medicines labelling and packaging.

Guidance for submitting changes to labels and Patient Information Leaflets (PILs) as a self-certification.

A regulator’s view on what the new UK Health Data Research Service must deliver.

Department of Health and Social Care and MHRA register of electronic export certificates (human).

This guidance sets out the warning statements which should appear on the label and/or in the leaflet of certain medicines.

This guidance sets out the legal framework for patient information leaflets as described in EU and national legislation and best practice in the area of information design.

We can provide access to world-class regulatory knowledge, expertise and experience from within the MHRA.

How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.

Provide innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.

Find out which COVID-19 test products have been approved.

This register contains all websites that are authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) to sell medicines online, in Northern Ireland.

Information about suspected side effects of e-cigarettes and how to report side effects.

Findings from the National Commission into the Regulation of AI in Healthcare's call for evidence and wider research and engagement activities.

Key insights of simulation workshops from the AI Airlock testing programme. You should note that these documents are not formal guidance.

Decisions made by MHRA on adverts reported to have breached the legislation on advertising medicines.

MHRA’s Public Sector Equality Duty report 2026 sets out progress on equality, diversity and inclusion across regulation, public engagement and workforce.

MHRA are seeking feedback on a proposed framework for rare disease therapies.

A programme to help decision making across the lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations.

The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.

Information on Medicines and Healthcare products Regulatory Agency spending over £25,000.

We are seeking views on proposed updates to the definition of Gene therapy medicinal products to better reflect advances in science and manufacturing.

Decisions made by MHRA on adverts reported to have breached the legislation on advertising medicines.

Patient factsheet providing information on respiratory syncytial virus (RSV) and RSV vaccination.

The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.

MHRA achievements and highlights for 2025/26 and key projections for 2026/2027.

Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.

Information to help comply with ICH guidelines, if you are running clinical trials in the UK.

Information on practical arrangements for notification, what should and should not be classified as a “serious breach” and what must be reported.

Information about Clinical Trials Regulations outlining expanded enforcement provisions, offences, and compliance requirements for sponsors and investigators.

How to respond to the GCP inspection report findings, increase awareness of the GCP Inspectors’ expectations and aid formulation of an acceptable response.

This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.

Further explanatory guidance for Diagnostic Radiopharmaceutical (RP) Investigation Medicinal Products (IMPs) and Good Manufacturing Practice (GMP) requirements.

Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.

Fees payable to the MHRA from 2025.

The minutes of the ministerial annual accountability review of the Medicines and Healthcare products Regulatory Agency (MHRA).

Marketing authorisations granted in 2025.

Triheptanoin used to treat long-chain fatty acid oxidation disorders (LC-FAOD), a group of rare inherited disorders, in adults and children of all ages.

Decisions made by MHRA on adverts reported to have breached the legislation on advertising medicines.

By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.

This guidance sets out the expectations for environmental risk assessments (ERAs) for medicinal products in the UK.

Detailing the information you need to provide the MHRA when you notify us of your clinical investigation plans.

How to make sure that you are providing the statistical data required as part of a clinical investigation of your medical device.

How to carry out the biological safety evaluation, which is required before undertaking a clinical investigation for a medical device.

How to make sure your clinical investigation will meet the MHRA's requirements for medical devices.

MHRA transactions over £500 made using the government procurement card (GPC).

Meningitis is a serious infection that can develop quickly and affect people of all ages

Information on the other regulatory bodies responsible for e-cigarette and vape products.

This consultation invites views on proposals for recognising CE marked medical devices in Great Britain.

MHRA's Improving Patient Information project aims to modernise how medicines product information is delivered, making it more accessible, trusted, and future-ready.

Extra information for the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) Integrated Scientific Advice (ISA) service.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.

Recommendations from the independent Expert Advisory Group to the MHRA on the use of paclitaxel balloon catheters and stents to treat peripheral arterial disease.

The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeutics.

MHRA invites current and former suppliers to join Risk Ledger and complete a security profile to strengthen supply chain cyber security.

Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).

Transitional arrangements and timelines for acceptance of CE marked medical device in Great Britain.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.

This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.

Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.

Parallel import licences granted in 2025.

Report of the Isotretinoin Implementation Advisory Expert Working Group regarding recommendations to strengthen the safe use of isotretinoin, the acne medicine commonly known by brand names Roaccutane and Reticutan.

Public Assessment Report on the review of the implementation of the recommendations of the Commission on Human Medicines Isotretinoin Expert Working Group and Isotretinoin Implementation Advisory Expert Working Group.

Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.

Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).

A step-by-step guide on using the MORE Platform for Submissions of device related incidents.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Public Assessment Report on improving information regarding addiction, dependence, withdrawal, and tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs.

Details and statistics on the import of unlicensed medicines from March 2014 onwards.

A research report on attitudes regarding identifying and reporting harms associated with the use of DMHT and awareness of the MHRA Yellow Card Scheme.

The MHRA is consulting with UK stakeholders to gather feedback and comments on an international guideline on the assessment and control of extractables and leachables.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

A paper outlining MHRA’s intentions to make it quicker and easier to get rare disease therapies tested, manufactured and approved in the UK.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

We are seeking feedback on our new draft guideline on individualised mRNA cancer immunotherapies, a new type of cancer treatment being tested in clinical trials. This will help us to clarify and streamline pathways for bringing these therapies through to patients, without compromising on robust safety principles.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Consultation on proposals to update the MHRA's statutory fees to ensure they continue to recover their costs.

The MHRA is consulting with UK stakeholders to gather feedback and comments on a revised international guideline, M4Q(R2).

The MHRA is consulting with UK stakeholders to gather feedback and comments on ICH E20, a new international guideline.

The MHRA is inviting members of the public to provide their views on proposed changes to the regulatory framework for medical devices.

Annual Report of the Human Medicines Regulations 2012 Advisory Bodies - the Commission on Human Medicines (CHM) and the British Pharmacopoeia Commission.

MHRA annual report and accounts 2024 to 2025.

MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.

The MHRA is consulting with UK stakeholders to gather feedback and comments on a new international guideline for the appropriate inclusion and/or retention of pregnant and/or breast-feeding individuals in clinical trials of medicines.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Public Assessment Report on the review of risk minimisation for fluoroquinolone antibiotics.

These reports outline the MHRA’s Corporate and Business Plans, detailing the agency's strategic direction over the next three years.

Information on Medicines and Healthcare products Regulatory Agency spending over £25,000.

MHRA transactions over £500 made using the government procurement card (GPC).

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

We invite feedback on the clarity and wording of our new draft guideline on the use of external control arms based on real-world data to support regulatory decisions.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

The ICH Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) GCP guideline. The MHRA represents the Pharmaceutical Inspection Co-operation Scheme (PIC/s) in the EWG.

The ICH Expert Working Group (EWG) for ICH M13B has been drafting the second guideline in the series which describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment for orally administered immediate-release solid oral dosage forms.

MHRA transactions over £500 made using the government procurement card (GPC).

MHRA transactions over £500 made using the government procurement card (GPC).

MHRA transactions over £500 made using the government procurement card (GPC).

The Medicines and Healthcare products Regulatory Agency opinion on the regulatory status of products containing CBD.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

EAMS scientific opinion issued to KalVista Pharmaceuticals Limited for Sebetralstat in the treatment of hereditary angioedema (HAE) attacks in adult and adolescents aged 12 years and older.

Public Assessment Report on the removal of the indication for post-operative pain for modified-release opioids.

A list of Great Britain Product Licence (PLGB) numbers for the grandfathering of centrally authorised product (CAP) marketing authorisations (MAs).

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

MHRA performance metrics for clinical trials and established medicines assessment.

Public Assessment Report on managing reproductive risks in male patients under 55 taking valproate.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Progress made in delivering the Patient Involvement Strategy, October 2021 - January 2025.

The ICH Expert Working Group for ICH M15 (EWG) has been drafting the ICH M15 MIDD guideline. The MHRA attended the EWG meetings and participated in the drafting group.

Marketing authorisations granted in 2024

Parallel import licences granted in 2024

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 20 September 2022 and 5 May 2023.

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 1 June 2021 and 19 November 2021.

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 3 December 2021 and 29 March 2022.

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 13 April 2022 and 25 August 2022.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 10 May 2021 to 25 May 2021.

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 13 January 2021 to 15 February 2021.

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 25 February 2021 to 6 April 2021.

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 25 August 2020 to 28 November 2020.

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 12 April 2021 to 4 May 2021.

Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 7 December 2020 to 3 January 2021.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

The Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies.

The MHRA’s strategy for Improving Safety Communications for 2024 to 2027.

MHRA 2024-2027 Data Strategy sets out our five strategic themes for data and digital technology.

Public Assessment Report of review of results of a post-authorisation safety study on paternal exposure to valproate.

Consultation on the ICH E2D(R1) guidelines on General principles on plan, design, and analysis of pharmacoepidemiological studies that utilise real-world data for safety assessment of medicines.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Information for healthcare professionals and the public about the Pfizer/BioNTech's bivalent vaccines

Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.

Annual Report of the Human Medicines Regulations 2012 Advisory Bodies - the Commission on Human Medicines (CHM) and the British Pharmacopoeia Commission.

MHRA annual report and accounts 2023 to 2024.

Lists of products using derogations under the European Commission Directive 2022/642

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Public Assessment Report of review of Topiramate safety data and expert advice on management of risks.

Medicines that were granted a positive opinion under the early access to medicines scheme (EAMS) which has now expired.

A list of centrally authorised product (CAP) bridging mechanism products registered by the UK Licensing Authority.

A research report on attitudes to digital mental health technology.

Implementing the Artificial Intelligence (AI) White Paper principles.

Public Assessment Report of review of Finasteride safety data and expert advice on management of risks.

Information for healthcare professionals and the public on Moderna's bivalent vaccines. Information on the original Spikevax COVID-19 vaccine can found on a separate page (link below)

Information for healthcare professionals and the public about the adapted Spikevax XBB.1.5 vaccine

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

Describes the working relationship between the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA).

The Medicines and Healthcare Products Regulatory Agency (MHRA) have launched a public consultation to propose reclassification of Codeine Linctus to prescription-only medicine.

Letters requesting a set of regulators to update their strategic approach to AI, with the intention of increasing the transparency around how they are implementing the AI Regulation White Paper proposals.

Annual reports of the Advisory Board on the Registration of Homeopathic Products and the Herbal Medicines Advisory Committee.

This is a consultation on a statutory instrument to amend the Human Medicines Regulations 2012 to remove the provision which provides the legal basis to the European Commission Decision Reliance Procedure (ECDRP).

The MHRA is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices.

Public Assessment Report of review of valproate safety data and expert advice on management of risks.

The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.

MHRA annual report and accounts 2022 to 2023.

This People Strategy sets out the agency’s five core priorities over the next three years.

These equality objectives set out how the Medicines and Healthcare products Regulatory Agency (MHRA) will comply with the public sector equality duty.

The Medicines and Healthcare products Regulatory Agency (MHRA) became a full member of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in May 2022 and is consulting with UK stakeholders on the ICH E6 (R3) Good Clinical Practice (GCP) guidelines to compile feedback to ICH.

Guidance in relation to Regulation 238 of the Human Medicines Regulations 2012

Public consultation on proposals to allow pharmacists to dispense prescription medicines in original packaging, in particular those containing sodium valproate.

Progress made in delivering the Patient Involvement Strategy, October 2021 - September 2022.

Access Consortium Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition

Putting patients first: a new era for our agency

Annual Report of the Human Medicines Regulations 2012 Advisory Bodies - the Commission on Human Medicines (CHM) and the British Pharmacopoeia Commission

MHRA annual report and accounts 2021 to 2022

This document contains the MHRA annual report and accounts 2020 to 2021.

Seeks views on proposed changes to the Human Medicines Regulations and the Medicines Act.

Information for the public about lateral flow devices (LFDs) provided by NHS Test and Trace

We’re looking for views from patients and the public on how we engage with them.

Change approved following detailed review of additional stability data

Statement from Dr June Raine, MHRA Chief Executive, following the Joint Committee on Vaccination and Immunisation's new advice

Following suspensions by some countries of the COVID-19 Vaccine AstraZeneca over suspected blood clots, the MHRA confirms that the benefits of the vaccine in preventing COVID-19 far outweigh the risks. People should still go and get their COVID-19 vaccine when asked to do so.

Expert Working Group concludes there is currently insufficient evidence to establish a link between use of ibuprofen and susceptibility to contracting COVID-19 or the worsening of its symptoms.

There is no evidence from clinical or epidemiological studies that treatment with ACE-I or ARBs might worsen COVID-19 infection.

We are asking for views on a new draft version on our guidance for users, carers and staff on the safe use of bed rails.

The final report from the Scottish independent review of the use, safety and efficacy of transvaginal mesh implants.

MHRA is asking for feedback on proposals to change the legal classification of Ibuprofen Seven Plus 200mg/5ml Oral Suspension

An interim report from the NHS England-led vaginal mesh working group on mesh used to treat stress urinary incontinence (SUI) and pelvic organ prolapse.

An interim report from the Scottish independent review of the use, safety and efficacy of transvaginal mesh implants.

The MHRA is asking for feedback on a proposal to allow wider access to naloxone for the purpose of saving life in an emergency.

This report makes recommendations on whether to regulate practitioners of herbal medicine and the products they use to keep the public safe.

This consultation welcomes views on proposals to allow paramedics involved in maritime and coastguard agency contracted helicopter search and rescue operations to use medicines under patient group directions.

MHRA is asking for feedback on proposals to reclassify Soleve Sunburn Relief Cutaneous Emulsion from pharmacy to general sales list.

MHRA seeks views on the listing of prescription medicines exempted from the safety feature and non-prescription medicines that must bear the safety feature (MLX387).

This consultation welcomes views on proposals to revoke ‘The Clinical Thermometers (EEC Requirements) Regulations 1993’ by November 2014.

MHRA is seeking views on the reclassification of Galpharm Period Pain Relief 250mg Gastro-Resistant Tablets from pharmacy to general sale list.

The MHRA is seeking views on the reclassification from pharmacy to general sale list of Nurofen Express 400mg Oral Powder.

The MHRA is seeking views on the proposal on the introduction of tell-and-do variations for a specific subset of parallel import licences.

The MHRA is undertaking a public consultation on the continued availability of diclofenac as a Pharmacy (P) medicine.

The Department of Health and the MHRA are seeking views on this proposal by the European Commission.