Customer services

EnquiriesMedicines aboutregulations

Marketing newauthorisations, guidancevariations and procedureslicensing in place since 1 January 2021

guidance

ForWe enquirieshave relatingguidance toon ourMedicines: planninglicensing and proceduresapplications sincecollection, 1including Januaryinformation 2021,about seenew theapplications, emailpost-licensing, contactsadvertising, below.product information and fees.

ImportingRegulatory andinformation exportingservice (RIS) 

• To

  RIS checkacts as the suitabilitysingle ofmain yourpoint qualifications/professionalof bodycontact membership:for GDP.Inspectorate@mhra.gov.uk

• Queriesmarketing onauthorisation importingholders of investigationalmedicines medicaland productstheir (IMPs)representatives. fromIf approvalyou countries:cannot Completefind thisthe contactinformation formyou andneed on the website, email tous gmpinspectorate@mhra.gov.uk
• Queriesin onthe exportingfirst activeinstance substancesto manufacturedensure inyour therequest UK:is Completeappropriately thishandled: 

  New contactlicence formapplications: RIS.NA@mhra.gov.uk 

  Variations: variationqueries@mhra.gov.uk 

  Phone and(weekdays email9am to gmpinspectorate@mhra.gov.uk

5pm): 020 3080 7400 

MarketingOther authorisations,contacts: 

Queries variationson orphan medicines and licensingorphan guidance

• Instructionsdesignation: orphan@mhra.gov.uk 

  Queries on howpackaging toand applypatient forinformation anleaflets: patient.information@mhra.gov.uk

  Pharmacovigilance 

  We MHRA-allocatedhave companyguidance number,on forPharmacovigilance convertingprocedures. 

  General PDNsqueries toon UKpharmacovigilance PILs plpi@mhra.gov.ukprocedures: vigilanceservice@mhra.gov.uk

•  

  Queries on handlingUK ofqualified decentralisedperson andresponsible mutualfor recognitionpharmacovigilance procedures(QPPV), RIS.NA@mhra.gov.uk

• QueriesUK onpharmacovigilance orphansystem medicinesmaster file (PSMF) and orphanthe designationestablishment orphan@mhra.gov.ukof pharmacovigilance systems: gpvpinspectors@mhra.gov.uk
• . 

  Manufacturer and wholesale dealer licences (medicines) 

  Queries on convertingapplications centrallyfor authorisedlicences productsand toregistrations UKcovering marketingmanufacturing, authorisations:wholesaling, RIS.NA@mhra.gov.uk

• Queriesbrokering onand packagingimporting andof patientmedicines informationand leaflets:active patient.information@mhra.gov.uksubstances: pcl@mhra.gov.uk

. Contact is via email only.

MedicinesMHRA for childrenPortal 

• For

  Queries generalon enquiriesregistering aboutand paediatricsubmitting submissionsproduct includinglicence PIPapplications andusing waiverthe applications,MHRA modificationPortal, procedures,phone: and020 compliance3080 checks:7100 or ukpip@mhra.gov.ukemail portal.manager@mhra.gov.uk

• Submitting.

  Contact adetails coverfor letterSubmissions orPortal, finalPcL assessmentportal report:or paediatricstudies@mhra.gov.ukdevices queries

• General enquiriesare onfound medicineselsewhere foron children:this specialpopulationsunit@mhra.gov.uk

page.

PharmacovigilanceMHRA Submissions Portal 

• Guidance: Register to make submissions to the MHRA.

  For generaltroubleshooting enquiriesqueries abouton pharmacovigilanceregistering procedures:and vigilanceservice@mhra.gov.uksubmitting product applications using the Submissions Portal, email submissions@mhra.gov.uk

. Contact is via email only.

RegulatoryImporting and pharmacovigilance submissionsexporting 

• Queries

  We aroundhave UKguidance QPPV,for UK PSMFwholesalers and themanufacturers establishmenton ofhow pharmacovigilanceto systems:import gpvpinspectors@mhra.gov.uk

• Querieshuman aroundmedicines submissionincluding unlicensed medicines, how to apply for a licence and how much it costs. 

  To check the suitability of Typeyour IAqualifications/professional variations:body variationqueries@mhra.gov.ukmembership, email GDP.Inspectorate@mhra.gov.uk

. 

Medical

Queries devices

• Foron generalimporting deviceinvestigational queries:medical info@mhra.gov.uk
• Forproducts device(IMPs) registrationfrom queriesapproved :countries, device.registrations@mhra.gov.uk

NIBSC

• Informationcomplete aboutthe good interimmanufacturing arrangementspractice for(GMP) somecontact biologicalform and products:email cpb@nibsc.orgit to gmpinspectorate@mhra.gov.uk
• . 

  Queries on biologicalexporting referenceactive materials:substances standards@nibsc.org

Newsmanufactured centre

Pressin enquiriesthe (includingUK, outcomplete ofthe GMP hours):contact 020form and 3080email 7651

newscentre@mhra.gov.ukit to gmpinspectorate@mhra.gov.uk.

Access

Medicines consortium

for children 

ForWe morehave informationguidance pleaseon referthe tolegal ourrequirements accessfor consortiumchildren’s guidancemedicines..   

ForGeneral queries,queries oron topaediatric submitsubmissions anincluding expressionpaediatric ofinvestigation interestplan form,(PIP) contactand access-mhra@mhra.gov.ukwaiver applications, modification procedures and compliance checks: ukpip@mhra.gov.uk.. 

Accounts receivable

sales.invoices@mhra.gov.ukSubmitting a cover letter or final assessment report: paediatricstudies@mhra.gov.uk.

AccountsClinical payabletrials of medicines 

Accounts.Payable@mhra.gov.uk

We have guidance on Clinical trials offor 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:

Telephonemake, phone (weekdays 8:30am to 4:30pm):4:30pm) 020 3080 6456

6456 or email clintrialhelpline@mhra.gov.uk.

DefectiveReport medicinesproblems reportingwith centremedicines or medical devices

Email:You dmrc@mhra.gov.uk

Reportcan submit a defectivereport medicine 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)Friday). 

DMRC (out of hours) 07795 641 532 (urgent outside of normal working hours, at weekends or on public holidays)

Medicalholidays). devices

ForDo enquiriesnot relatingleave tovoicemail compliancemessages issuesat forthis medicalnumber devicesduring contact:normal Devices.compliance@mhra.gov.ukworking hours as they will only be picked up out of hours. 

Medicines enforcementenforcement 

EnquiriesNotify the MHRA about potentiala illegalsuspicious dealingsonline withseller medicinesusing the Criminal Enforcement Unit reporting service.

TelephoneCheck (weekdaysif 9ama towebsite 5pm):selling 020medicines 3080or 6330medical devices is ‘Not Recommended’

Email:For queries on potential illegal dealings with medicines, email thebureau@mhra.gov.uk.

ReportMembers of the public or healthcare professionals can report suspected falsified medicines viathrough the the Yellow Card Scheme.

Telephone:Other 020stakeholders 3080can 6330report /suspected 020falsified 3080medicines 6701

Email:by email: fakemeds@mhra.gov.uk.

ManufacturerMedical anddevices wholesale dealer licences (medicines)regulation 

EnquiriesWe abouthave applicationsguidance foron licencesregulating andmedical registrationsdevices. 

General coveringdevice manufacturing,queries: info@mhra.gov.uk.

We wholesaling,have brokeringguidance andon importingregistering ofmedical medicinesdevices andincluding activeuser substances

Email: pcl@mhra.gov.uk

MHRAguides medicinesfor portal

Forour enquiriesonline aboutregistration registeringservice. andFor submittingany productqueries, licencecontact is applicationsby usingemail MHRAonly portal.at device.registrations@mhra.gov.uk.

Telephone:Queries 020relating 3080to 7100

portal.manager@mhra.gov.uk

Regulatorycompliance informationissues servicefor (RIS)

RISmedical actsdevices ascontact theis singlevia mainemail pointonly ofat: devices.compliance@mhra.gov.uk.

Payment contactqueries 

Guidance: forMake marketinga authorisationpayment holdersto ofMHRA medicines- andGOV.UK.

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

TelephoneAccounts (weekdayspayable Accounts.Payable@mhra.gov.uk. 

The 9amNational toInstitute 5pm):for 020Biological 3080Standards 7400

and Control (NIBSC)

NewInformation licenceabout applicationsinterim :arrangements RIS.NA@mhra.gov.uk

Variations:for variationqueries@mhra.gov.uksome biological products: cpb@nibsc.org.

PLPIQueries (allon applicationbiological types):reference RIS.PLPI@mhra.gov.ukmaterials: standards@nibsc.org.

Whistleblower referralsreferrals 

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:question. Whilst whistleblower@mhra.gov.ukwe welcome referrals, please note that in most cases we cannot update whistleblowers on referrals they make to us; please review the published information about whistleblowing before contacting us.

Telephone:Email whistleblower@mhra.gov.uk or 07778168204phone 020 3080 6793.

All other enquiriesqueries about potential illegal dealings should go to to Medicines Enforcementenforcement.

DistanceData sellingprotection 

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

Customer services 

EnquiriesIf aboutany applicationsof andthe registrationsinformation forabove distancedoes sellingnot logoanswer your query, contact the Customer Experience Centre: info@mhra.gov.uk.

Email:or dsl@mhra.gov.ukphone (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. 

DataNews protectioncentre 

ForMedia allenquiries data(including protectionout enquiries,of contact:hours): 

Phone DataProtection@mhra.gov.uk020 3080 7651 or email newscentre@mhra.gov.uk.