Contact the MHRA
How to contact the MHRA for specific services or enquiries.
Review the information below and choose the most relevant contact for your enquiry. Selecting the appropriate contact will speed up our response time in coming back to you.
Medicines regulations
Marketing authorisations, variations and licensing guidance
We have guidance on Medicines: licensing and applications collection, including information about new applications, post-licensing, advertising, product information and fees.
Regulatory information service (RIS)
RIS acts as the single main point of contact for marketing authorisation holders of medicines and their representatives. If you cannot find the information you need on the website, email us in the first instance to ensure your request is appropriately handled:
New licence applications: RIS.NA@mhra.gov.uk
Variations: variationqueries@mhra.gov.uk
Phone (weekdays 9am to 5pm): 020 3080 7400
Other contacts:
Queries on orphan medicines and orphan designation: orphan@mhra.gov.uk
Queries on packaging and patient information leaflets: patient.information@mhra.gov.uk
Pharmacovigilance
We have guidance on Pharmacovigilance procedures.
General queries on pharmacovigilance procedures: vigilanceservice@mhra.gov.uk
Queries on UK qualified person responsible for pharmacovigilance (QPPV), UK pharmacovigilance system master file (PSMF) and the establishment of pharmacovigilance systems: gpvpinspectors@mhra.gov.uk.
Manufacturer and wholesale dealer licences (medicines)
Queries on applications for licences and registrations covering manufacturing, wholesaling, brokering and importing of medicines and active substances: pcl@mhra.gov.uk.
MHRA Portal
Queries on registering and submitting product licence applications using the MHRA Portal, phone: 020 3080 7100 or email portal.manager@mhra.gov.uk.
MHRA Submissions Portal
Guidance: Register to make submissions to the MHRA.
For troubleshooting queries on registering and submitting product applications using the Submissions Portal, email submissions@mhra.gov.uk.
Importing and exporting
We have guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
To check the suitability of your qualifications/professional body membership, email GDP.Inspectorate@mhra.gov.uk.
Queries on importing investigational medical products (IMPs) from approved countries, complete the good manufacturing practice (GMP) contact form and email it to gmpinspectorate@mhra.gov.uk.
Queries on exporting active substances manufactured in the UK, complete the GMP contact form and email it to gmpinspectorate@mhra.gov.uk.
Medicines for children
We have guidance on the legal requirements for children’s medicines.
General queries on paediatric submissions including paediatric investigation plan (PIP) and waiver applications, modification procedures and compliance checks: ukpip@mhra.gov.uk.
Submitting a cover letter or final assessment report: paediatricstudies@mhra.gov.uk.
Clinical trials of medicines
We have guidance on Clinical trials for medicines.
If you are checking the status of a clinical trial submission, have a general clinical trial query or a technical query regarding an application you have submitted or plan to make, phone (weekdays 8:30am to 4:30pm) 020 3080 6456 or email clintrialhelpline@mhra.gov.uk.
Report problems with medicines or medical devices
You can submit a report through the Yellow Card Scheme for any suspected side effects to a medicine or suspected adverse incidents with a medical device.
Defective medicines reporting centre (DMRC)
Email: dmrc@mhra.gov.uk.
DMRC (office hours) 020 3080 6574 (8:45am to 4:45pm Monday to Friday).
DMRC (out of hours) 07795 641 532 (urgent outside of normal working hours, at weekends or on public holidays). Do not leave voicemail messages at this number during normal working hours as they will only be picked up out of hours.
Medicines enforcement
For queries on potential illegal dealings with medicines, email thebureau@mhra.gov.uk.
Members of the public or healthcare professionals can report suspected falsified medicines through the Yellow Card Scheme.
Other stakeholders can report suspected falsified medicines by email: fakemeds@mhra.gov.uk.
Medical devices regulation
We have guidance on regulating medical devices.
General device queries: info@mhra.gov.uk.
We have guidance on registering medical devices including user guides for our online registration service. For any queries, contact device.registrations@mhra.gov.uk.
Queries relating to compliance issues for medical devices: devices.compliance@mhra.gov.uk.
Payment queries
Guidance: Make a payment to MHRA - GOV.UK.
Accounts receivable: sales.invoices@mhra.gov.uk.
Accounts payable Accounts.Payable@mhra.gov.uk.
The National Institute for Biological Standards and Control (NIBSC)
Information about interim arrangements for some biological products: cpb@nibsc.org.
Queries on biological reference materials: standards@nibsc.org.
Whistleblower referrals
Contact the whistleblowing section if you are reporting on issues as an employee, ex-employee or third-party employee of the company or organisation in question.
Email whistleblower@mhra.gov.uk or phone 07778 168204.
All other queries about potential illegal dealings should go to Medicines enforcement.
Data protection
For all data protection queries: DataProtection@mhra.gov.uk.
Customer services
If any of the information above does not answer your query, contact the Customer Experience Centre: info@mhra.gov.uk.
or phone (weekdays 9am to 5pm): 020 3080 6000
or write to: MHRA
10 South Colonnade
Canary Wharf
London E14 4PU
To reproduce or re-use any MHRA material see our guidance on reproducing MHRA information.
News centre
Media enquiries (including out of hours):
Phone 020 3080 7651 or email newscentre@mhra.gov.uk.
Updates to this page
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The telephone numbers for both Accounts receivable and Accounts payable areas have been removed as they are no longer active. Updated contact numbers will be added in due course.
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Added Data Protection contact details
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Added information about COVID-19 and urgent regulatory flexibility enquiries over the Easter weekend.
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Added information about MHRA services and using email or telephone to contact us during the coronavirus (COVID-19) response period.
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Change of Accounts payable supplier contact phone numbers.
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Added a section on contacts for EU exit no deal enquiries.
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Added new contact details for Medical Devices.
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Added contact details for submission enquiries.
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Updated the contact information for the Clinical Trials helpline.
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Updated contact details
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Contact details for medicines enforcement updated.
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First published.