Guidance
Contact MHRA
How to contact MHRA for specific services or enquiries.
Customer Services
10 South Colonnade
Canary Wharf
London
E14 4PU
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Main Telephone (weekdays 9:00 -17:00): 020 3080 6000
Fax: 0203 118 9803
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To to reproduce or re-use any MHRA material see our guidance.
No deal Brexit enquiries
For enquiries relating to the Agency’s planning and procedures in a no deal scenario, see the below email contacts.
Please view the relevant no deal guidance before getting in touch.
Importing and exporting
- To check the suitability of your qualifications/professional body membership: GDP.Inspectorate@mhra.gov.uk
- Queries on importing of investigational medical products (IMPs) from approval countries: gmpinspectorate@mhra.gov.uk
- Queries on exporting active substances manufactured in the UK: gmpinspectorate@mhra.gov.uk
Marketing authorisations, variations and licensing guidance
- Instructions on how to apply for an MHRA-allocated company number, for converting PDNs to UK PILs: plpi@mhra.gov.uk
- Queries on handling of decentralised and mutual recognition procedures: RIS.NA@mhra.gov.uk
- Queries on orphan medicines and orphan designation: orphan@mhra.gov.uk
- Queries on converting centrally authorised products to UK marketing authorisations: IPU.enquiries@mhra.gov.uk
- Queries on packaging and patient information leaflets: patient.information@mhra.gov.uk
Medicines for children
- For general enquiries about paediatric submissions including 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
- General enquiries on medicines for children: specialpopulationsunit@mhra.gov.uk
Pharmacovigilance
- For general enquiries about pharmacovigilance procedures: pharmacovigilanceservice@mhra.gov.uk
Regulatory and pharmacovigilance submissions
- Setting up a company administrator on MHRA Submissions: submissions@mhra.gov.uk
- Queries about the ICSR/SUSAR process: E2B.support@mhra.gov.uk
- Queries around UK QPPV, UK PSMF and the establishment of pharmacovigilance systems: qpvpinspectors@mhra.gov.uk
- Queries around submission of Type IA variations: variationqueries@mhra.gov.uk
Medical devices
- For general device queries: devices.regulatory@mhra.gov.uk
- For device registration queries : device.registrations@mhra.gov.uk
NIBSC
- Information about interim arrangements for some biological products: cpb@nibsc.org
- Queries on biological reference materials: standards@nibsc.org
News centre
Press enquiries: 020 3080 7651
Out of hours: 07770 446 189
Accounts receivable
Telephone: 020 3080 6533
Accounts payable
Suppliers:
- A to F – 0203 080 7166
- G to L – 0203 080 6720
- M to Z – 0203 080 7111
Clinical trials of 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:
Telephone (weekdays 8:30-16:30): 020 3080 6456
Defective medicines reporting centre
Email: dmrc@mhra.gov.uk
Report a defective medicine through the Yellow Card Scheme
DMRC (office hours) 020 3080 6574 (08:45 to 16:45 Monday to Friday)
DMRC (out of hours) 07795 641 532 (urgent outside of normal working hours, at weekends or on public holidays)
Medical Devices
For medical device enquiries relating to:
- Regulatory advice
- Classification or borderline
- Clinical investigations for devices
Contact: devices.regulatory@mhra.gov.uk
For enquiries relating to compliance issues for medical devices contact: Devices.compliance@mhra.gov.uk
Medical devices adverse incident centre
Enquiries about reporting adverse incidents involving medical devices
Telephone: 020 3080 7080
Report a problem with a medical device via the Yellow Card Scheme
Medicines enforcement
Enquiries about potential illegal dealings with medicines
Telephone (weekdays 9:00-17:00): 020 3080 6330
Telephone (out-of-hours emergency): 020 3080 6701
Email: casereferrals@mhra.gov.uk
Report suspected counterfeit medicines via the Yellow Card Scheme.
Telephone: 020 3080 6330
Email: counterfeit@mhra.gov.uk
Manufacturer and wholesale dealer licences (medicines)
Enquiries about applications for licences and registrations covering manufacturing, wholesaling, brokering and importing of medicines and active substances
Telephone: 020 3080 6844
Email: pcl@mhra.gov.uk
MHRA medicines portal helpdesk
Telephone: 020 3080 7100
Regulatory information service (RIS)
RIS acts as the single main point of contact for marketing authorisation holders of medicines and their representatives.
Telephone (weekdays 9:00 -17:00): 020 3080 7400
New licence applications : RIS.NA@mhra.gov.uk
Variations: variationqueries@mhra.gov.uk
PLPI (all application types): RIS.PLPI@mhra.gov.uk
Whistleblower referrals
Please 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
Telephone: 020 3080 6447
All other enquiries about potential illegal dealings should go to Medicines Enforcement.
Distance Selling Logo
Enquiries about applications and registrations for Distance Selling Logo
Email: dsl@mhra.gov.uk
Telephone: 0203 080 6096
Submission enquiries
Enquiries to our Information Processing Unit about how to send regulatory submissions to the agency and validation issues.
Email IPUenquiries@mhra.gov.uk
Last updated 10 September 2019 + show all updates
- Change of Accounts payable supplier contact phone numbers.
- Added a section on contacts for EU exit no deal enquiries.
- Added new contact details for Medical Devices.
- Added contact details for submission enquiries.
- Updated the contact information for the Clinical Trials helpline.
- Updated contact details
- Contact details for medicines enforcement updated.
- First published.