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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)Ìý

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:Ìý

New licence applications: RIS.NA@mhra.gov.ukÌý

³Õ²¹°ù¾±²¹³Ù¾±´Ç²Ô²õ: variationqueries@mhra.gov.ukÌý

Phone (weekdays 9am to 5pm): 020 3080 7400Ìý

Other contacts:Ìý

Queries on orphan medicines and orphan designation: orphan@mhra.gov.ukÌý

Queries on packaging and patient information leaflets: patient.information@mhra.gov.uk

PharmacovigilanceÌý

We have guidance on Pharmacovigilance procedures.Ìý

General queries on pharmacovigilance procedures: vigilanceservice@mhra.gov.ukÌý

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.Ìý

Manufacturer and wholesale dealer licences (medicines)Ìý

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 PortalÌý

Queries on registering and submitting product licence applications using the MHRA Portal, phone: 020 3080 7100Ìýor email portal.manager@mhra.gov.uk.

Contact details for Submissions Portal, PcL portal or devices queries are found elsewhere on this page.

MHRA Submissions PortalÌý

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.ÌýContact is via email only.

Importing and exportingÌý

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.Ìý

To check the suitability of your qualifications/professional body membership, email GDP.Inspectorate@mhra.gov.uk.Ìý

Queries on importing investigational medical products (IMPs) from approved countries, complete the  and email it to gmpinspectorate@mhra.gov.uk.Ìý

Queries on exporting active substances manufactured in the UK, complete the  and email it to gmpinspectorate@mhra.gov.uk.

Medicines for childrenÌý

We have guidance on the legal requirements for children’s medicines.ÌýÌýÌý

General queries on paediatric submissions including paediatric investigation plan (PIP) and waiver applications, modification procedures and compliance checks: ukpip@mhra.gov.uk.Ìý

Submitting a cover letter or final assessment report: paediatricstudies@mhra.gov.uk.

Clinical trials of medicinesÌý

We have guidance on Clinical trials for medicines.ÌýÌý

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 6456Ìýor email clintrialhelpline@mhra.gov.uk.

Report problems with medicinesÌýor medical devices

You can submit a report through the for any suspected side effectsÌýto a medicineÌýor suspected adverse incidents with a medical device.Ìý

Defective medicines reporting centreÌý(DMRC)

·¡³¾²¹¾±±ô: dmrc@mhra.gov.uk.

DMRC (office hours) 020 3080 6574 (8:45am to 4:45pm Monday to Friday).Ìý

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.Ìý

Medicines enforcementÌý

Notify the MHRA about a suspicious online seller using theÌý

Check if a website selling medicines or medical devices isÌý

For queries on potential illegal dealings with medicines, emailÌýthebureau@mhra.gov.uk.

Members of the public or healthcare professionals can report suspected falsified medicines through the .

Other stakeholders can report suspected falsified medicines by email: fakemeds@mhra.gov.uk.

Medical devices regulationÌý

We have guidance on regulating medical devices.Ìý

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, contactÌýis 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 queriesÌý

Guidance: Make a payment to MHRA - °Ç¸ç³Ô¹Ï.

Accounts receivable: sales.invoices@mhra.gov.uk.

Accounts payable Accounts.Payable@mhra.gov.uk.Ìý

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 referralsÌý

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 .

Data protectionÌý

For all data protection queries: DataProtection@mhra.gov.uk.

Customer servicesÌý

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 6000Ìý

or write to: MHRAÌý

10 South ColonnadeÌý

Canary WharfÌý

London E14 4PUÌý

To reproduce or re-use any MHRA material see our guidance on reproducing MHRA information.Ìý

Enquiries related toÌýScotland, 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 centreÌý

Media enquiries (including out of hours):Ìý

Phone 020 3080 7651Ìýor email newscentre@mhra.gov.uk.