# Contact the MHRA Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/01fed06e-2619-4dd8-a8f6-5e60bfa0c32b Type: Detailed Guide Published: May 27, 2014 Updated: June 11, 2026 > This document provides a comprehensive contact directory for the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). It is designed to assist stakeholders in navigating the UK’s regulatory framework for medicines and medical devices by identifying the correct departments for specific enquiries, thereby improving response times. The guide covers a wide range of regulatory activities, including marketing authorizations, pharmacovigilance procedures, clinical trial submissions, and manufacturer licensing. While the provided text is a navigational guide rather than an enforcement report—and thus does not list specific inspection dates or violations—it outlines the required actions for entities seeking to remain compliant with UK law. Specifically, stakeholders are directed to use dedicated email addresses and portals for various tasks, such as reporting defective products through the Defective Medicines Reporting Centre (DMRC) or submitting suspected side effects via the Yellow Card Scheme. Additionally, the document provides specialized contact information for whistleblowers and reports of illegal dealings or falsified medicines. By following these established communication channels, companies ensure that their applications for licenses, variations, and safety reports are handled by the appropriate regulatory experts. The MHRA emphasizes that using these specific contacts is essential for the efficient processing of regulatory submissions and maintaining compliance within the UK healthcare market. --- ## Content 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 . Contact is via email only. 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 . Contact details for Submissions Portal , PcL portal or devices queries are found elsewhere on this page. 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 . Contact is via email only. 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 Notify the MHRA about a suspicious online seller using the Criminal Enforcement Unit reporting service. Check if a website selling medicines or medical devices is ‘Not Recommended’ 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 is by email only at device.registrations@mhra.gov.uk . Queries relating to compliance issues for medical devices contact is via email only at: 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 The Whistleblowing Section should be contacted by individuals raising concerns in their capacity as an employee, former employee, or third-party employee of the relevant company or organisation. Before making a referral, please review the published whistleblowing guidance . While referrals are welcomed, in most cases we are unable to provide updates on matters raised. Contact details Email: whistleblower@mhra.gov.uk Email contact is preferred wherever possible. Responses will be issued as soon as practicable. Telephone: 020 3080 6793 The telephone line is available between 10:00 and 15:00 Mon-Fri, subject to staff availability. If your call cannot be answered, please contact us by email. 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 . Enquiries related to Scotland, Wales, and Northern Ireland For enquiries relating to activity or regulatory matters in Scotland, Wales and Northern Ireland, please use the dedicated mailboxes below: Scotland: Scotland-support@mhra.gov.uk Wales: Wales-support@mhra.gov.uk Northern Ireland: NI-support@mhra.gov.uk News centre Media enquiries (including out of hours): Phone 020 3080 7651 or email newscentre@mhra.gov.uk .