Publication Schemes are a guide to the information routinely published by the public authority, and are designed to make available as much information as possible, without the need for a direct request being made.
The MHRA has adopted the Information Commissioner’s Model Publication Scheme which can be viewed in the following section:
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MHRA Model Publication Scheme
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The 7 'Classes' of information |
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Who we are and what we do |
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Our policies and procedures |
Who we are and what we do
This section explains MHRA’s work, structure and responsibilities, and that of its Ministers, Senior personnel and staff
› About us
Roles and responsibilities
› The MHRA's aims and objectives
› MHRA’s main areas of activity
Organisational structure
High Level organisation chart of the MHRA, and details of the new structure
› Organisational chart
Details of the responsibilities of our ten Divisions
› Our Divisions
Information about legislation relevant to MHRA’s functions
This section helps describe how the MHRA regulates
› How we regulate
Further information on how we regulate medicines and medical devices is available in this publication
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'Medicines & Medical Devices Regulation: What you need to know'
(831Kb)
UK medicines regulation
› How we regulate medicines
Medical Devices Regulations
› How we regulate devices
Lists of and information about organisations the MHRA works with
The MHRA is an agency of The Department of Health
› Department of Health (external link)
The MHRA also works closely with other health bodies
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How we relate to other healthcare agencies
The MHRA is also fully engaged in relevant international activities
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Our international activities
MHRA Ministers, Permanent Secretaries, Chief Executives, management board members and senior executives
Ministers: Biographies of the DH ministers whose responsibilities include the MHRA
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Our Ministers
Permanent Secretary: Answerable to the Secretary of State and Parliament for the way the Department is run
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Permanent Secretary (external link)
Agency Board: Primarily responsible for advising on the strategic development of the Agency and ensuring that targets set out in the Business Plan are met
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Agency Board
Executive Board: Primary responsibilities are to ensure the strategic direction set by the Agency Board is implemented and reflected in the day-to-day operations of the Agency; Agency's targets are met; principles of good governance are followed; the Agency is well managed financially; appropriate human resources (HR) policies are followed; and the culture of the Agency enables it to meet its aims and objectives.
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Executive Board
Locations of, and contact details for, the authority
Contact details for MHRA and its Regional Offices, together with information regarding specific types of enquiry
› Contact us
Specific enquiries by MHRA Division: This section provides contact details for specific enquiries by MHRA Divisions.
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Specific enquiries by MHRA Division
What we spend and how we spend it
The Medicines and Healthcare products Regulatory Agency operates as a trading fund in accordance with the requirements of the Government Trading Funds Act 1973 and the Medicines and Healthcare products Regulatory Agency Trading Fund Order 2003. The trading fund was established on 1 April 2003.
Trading Funds were introduced as a means of financing trading operations of a government department which, hitherto, have been carried out on Vote. They are self-accounting units that have greater freedom, than other government departments, in managing their own financial and management activities.
Pay and grading structures
› MHRA Pay and Grading structures (10Kb)
What are our priorities and how are we doing
MHRA Framework document:
› MHRA Framework Document - February 2010 (370Kb)
Strategic plans
› MHRA Corporate plans
› MHRA Communications Strategy
Annual business plan
› MHRA annual business plans
Annual report
MHRA Annual Reports and Accounts (includes any relevant Internal and external organisation performance reviews, Service standards, Public service agreements, reports to parliament etc.)
› MHRA Annual Reports and Accounts
Inspection reports
This section outlines the areas of regulatory responsibility that require MHRA to carry out inspections on a variety of different establishments. There are a great many inspections conducted each year which typically culminate in the production of a report. When complete, these reports can be requested using the Freedom of Information Act, and will be disclosed pending consideration of any relevant exemptions contained in the Act:
› FOI request form
Medicines - Inspection and standards
› Inspection and standards
Devices - The Devices Division also carries out a range of enforcement activities involving inspections, although most do not require the production of a formal report document upon completion
› Enforcement policy - Compliance inspection and action - Your rights
Impact assessments
Impact Assessments are an essential part of the development and delivery of policy, providing an assessment of the costs, benefits and risks of a proposal on businesses, charities or the voluntary sector. They identify and assess the regulatory and non-regulatory option, and determine whether the benefits justify the costs.
Impact Assessments (where required) are an integral of the consultation process, and MHRA Impact Assessment can be found included in the consultation documents:
› Consultations
More detailed information regarding Impact Assessments and “Better Regulation” in general can be found on the Department for Business, Enterprise & Regulatory Reform website:
› Public Sector Impact Assessments (external link)
Statistics produced in accordance with departmental requirements
› MHRA Annual Statistics
How we make decisions
Major policy proposals and decisions
› Policy development and delivery
Public consultations
The MHRA formally consults organisations representing public and professional interests, trade associations and industry on proposed statutory changes and other matters of importance these consultations are given the prefix, 'MLX'. We also consult on valid applications to change the legal status (prescription only, pharmacy or general sale list) of medicines; these consultations are given the prefix, 'ARM' (applications to reclassify medicines)
› Consultations
This section also provides the background information for major policy proposals and decisions taken by MHRA.
Minutes, reports and papers provided for consideration at senior-level meetings
Agency Board Minutes, agendas and supporting documents on request subject to any relevant FOI exemptions
› Agency Board Minutes
Executive Board Minutes, agendas and supporting documents on request subject to any relevant FOI exemptions
› Executive Board Minutes
Other Committees
Medicines advisory bodies
› Medicines advisory bodies
Devices Committees
› Devices Committees
Independent Scientific Advisory Committee for MHRA database research (ISAC)
The ISAC is a non-statutory expert advisory body established in 2006 to provide advice on research related requests to access data from the Yellow Card Scheme and the General Practice Research Database.
› Independent Scientific Advisory Committee for MHRA database research (ISAC)
Supporting documents (subject to any relevant FOI exemptions) can be requested from the FOI officer:
stephen.wilson@mhra.gsi.gov.uk
Or alternatively by writing to:
Stephen Wilson,
Medicines and Healthcare products Regulatory Agency,
5 Magenta,
151 Buckingham Palace Road,
Victoria,
London, SW1W 9SZ
Our policies and procedures
Policies and procedures for conducting Agency business (internal communications guidance, criteria used for decision-making, internal instructions, manuals and guidelines)
This is a list of the MHRA’s internal Standard Operational Procedures (SOPs) documents, which explain various policies governing Agency business, including policies and procedures for delivering our services
› MHRA list of Standard Operational Procedures (111Kb)
Policies and procedures for recruiting and employing staff
› MHRA Recruitment Procedures (32431Kb)
Customer service
The Civil Service Code: a concise statement of the role and responsibilities of civil servants
› The Civil Service Code (external link)
MHRA complaints procedure: The MHRA operates formal procedures for dealing with complaints about the Agency's administrative services (not licensing and enforcement decisions)
› How to make a complaint
Records management and personal data policies
› MHRA Records Management Policy (7956Kb)
› MHRA Data Protection Policy (7245Kb)
Charging regimes and policies
The information we produce is Crown copyright unless otherwise stated (which we control under a delegation of authority from the Controller of Her Majesty’s Stationery Office (HMSO)). Terms and conditions of use, and an explanation of charges and policies relating to re-use of information can be found here
› Crown Copyright
Lists and Registers
Asset registers and Information Asset Register (IAR)
The IAR aims to cover the information held including databases, old sets of files, recent electronic files, collections of statistics, research etc, concentrating on information resources that have not yet been, or will not be formally published. MHRA entries are contained within the Department of Health IAR and are prefixed “MHRA” if searched for by “title” or “identifier”. Some of these assets may be subject to exemptions contained in the FOIA.
› DH Information Asset Register (external link)
Disclosure logs
MHRA’s Freedom of Information Disclosure Log
› Information disclosures under the FOI Act
The services we offer
Regulatory responsibilities
The MHRA regulates a wide range of materials from medicines and medical devices to blood and therapeutic products/services derived from tissue engineering.
› What we regulate
These regulatory responsibilities extend to a range of services, delivered online, for public authorities, industry, organisations and members of the public
› Online services
Services for which the MHRA is entitled to recover a fee, together with those fees
This section details the fees payable for the regulation of medicines, including herbal and homeopathic medicines, and blood establishments and blood banks.
› Fees for medicines, blood establishements and blood banks
› Medical Devices – Clinical trials
› Medical Devices – Designation of Notified Bodies
› Medical Devices – Class I Device registrations
The General Practice Research Database: The GPRD is the world's largest computerised database of anonymised medical records from primary care. It is the largest and most comprehensive source of data of its kind and is used worldwide for research by the pharmaceutical industry, clinical research organisations, regulators, government departments and leading academic institutions.
› General Practice Research Database (GPRD) (external link)
Government department circulars
› Department of Health circulars (and other publications) (external link)
Leaflets, booklets and newsletters
Publications section: MHRA produces a range of publications, most of which are aimed at healthcare professionals or people working in the device or pharmaceutical industries. Some are available in full-text as pdf documents.
› Publications
Advice and guidance
A wide range of MHRA publications providing guidance to the industry on the regulation of devices and medicines.
› Regulatory guidance
This section provides information and advice for consumers including the risks of buying products over the Internet, advice on buying herbal medicines and medical devices and what we are doing to combat the problem of counterfeit products.
› Advice and information for consumers
Consumer oriented publications
› Consumer publications
Media releases
This section provides list details of new items added to the site as well as a full archive of our press releases. It also includes our Press Office contacts and a photo and image library of downloadable images suitable for print output.
› Press releases
