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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)听

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:听

New licence applications:鈥�RIS.NA@mhra.gov.uk听

痴补谤颈补迟颈辞苍蝉:鈥�variationqueries@mhra.gov.uk听

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

Other contacts:听

Queries on orphan medicines and orphan designation:鈥�orphan@mhra.gov.uk听

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

Pharmacovigilance听

We have guidance on Pharmacovigilance procedures.听

General queries on pharmacovigilance procedures:鈥�vigilanceservice@mhra.gov.uk听

Queries on UK qualified person responsible for pharmacovigilance (QPPV), UK pharmacovigilance system master file (PSMF) and the establishment of pharmacovigilance systems:鈥�gpvpinspectors@mhra.gov.uk.听

Manufacturer and wholesale dealer licences (medicines)听

Queries on applications for licences and registrations covering manufacturing, wholesaling, brokering and importing of medicines and active substances:鈥�pcl@mhra.gov.uk.

MHRA Portal听

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

MHRA Submissions Portal听

Guidance: Register to make submissions to the MHRA.

For troubleshooting queries on registering and submitting product applications using the Submissions Portal, email鈥�submissions@mhra.gov.uk.听听

Importing and exporting听

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.听

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

Queries on importing investigational medical products (IMPs) from approved countries, complete the鈥�鈥痑nd email it to鈥�gmpinspectorate@mhra.gov.uk.听

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

Medicines for children听

We have guidance on the legal requirements for children鈥檚 medicines.听听听

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

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

Clinical trials of medicines听

We have guidance on Clinical trials for medicines.听听

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听or email鈥�clintrialhelpline@mhra.gov.uk.

Report problems with medicines听or medical devices

You can submit a report through the for any suspected side effects听to a medicine听or suspected adverse incidents with a medical device.听

Defective medicines reporting centre听(DMRC)

贰尘补颈濒:鈥�dmrc@mhra.gov.uk.

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

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.听

Medicines enforcement听

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鈥�.

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

Medical devices regulation听

We have guidance on regulating medical devices.听

General device queries:鈥�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:鈥�devices.compliance@mhra.gov.uk.

Payment queries听

Guidance: Make a payment to MHRA - 51茶馆.

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

Accounts payable鈥�Accounts.Payable@mhra.gov.uk.听

The National Institute for Biological Standards and Control (NIBSC)

Information about interim arrangements for some biological products:鈥�cpb@nibsc.org.

Queries on biological reference materials:鈥�standards@nibsc.org.

Whistleblower referrals听

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.听

贰尘补颈濒鈥�whistleblower@mhra.gov.uk听or phone 07778 168204.

All other queries about potential illegal dealings should go to鈥�Medicines enforcement.听

Data protection听

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

Customer services听

If any of the information above does not answer your query, contact the Customer Experience Centre:鈥�info@mhra.gov.uk.

or phone (weekdays 9am to 5pm): 020 3080 6000听

or write to: MHRA听

10 South Colonnade听

Canary Wharf听

London E14 4PU听

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

News centre听

Media enquiries (including out of hours):听

Phone 020 3080 7651听or email鈥�newscentre@mhra.gov.uk.