Overview

The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service beforeto applyingsupport forprospective medicinesapplicants Marketingbefore Authorisations.submission of applications. This service aims to provide theappropriate best support possibleto forapplicants, prospectiveregardless applicants,of whicheverthe application routeroute.

This isguidance chosen.applies to:

• Initial Marketing Authorisation Applications (MAAs) for Innovative Medicines;
• Variation applications to introduce new indications; and
• Line extension applications.

CompaniesFor whothe arepurposes intendingof this guidance, Innovative Medicines refer to submitnew Marketingchemical Authorisationactive Applicationssubstances, all biological medicines (including biosimilars), medicines for Neworphan Activeindications, Substancesmedicines and/orfor Biologicalrare diseases, and products seeking conditional approval or approval under exceptional circumstances.

Applicants intending to submit such applications must notify the MHRA of their intended submission date in advance, as outlined below.

Applicants may also request a pre-submission meeting withto thesupport relevantpreparation teamsfor at-leasta 3planned monthssubmission. priorThese meetings are intended to support procedural and regulatory aspects and MHRA’s operational planning while providing an opportunity to introduce the intendedproduct applicationand date.planned submission approach to the MHRA.

Pre-submissionWhere advicea pre-submission meeting is not requested, but the MHRA deem it required, a servicepre-submission meeting is strongly advised prior to submission to ensure that providesappropriate stakeholdersexpertise withand theresources meansare in place and to understandidentify howany procedural or logistical issues that could affect the processhandling of compilingthe andapplication. submittingApplicants applicationsare andstrongly supportingencouraged evidenceto appliesattend forany theirpre-submission product/s.meeting Itrequested isby distinctthe fromMHRA. MHRAsFailure Scientificto Advicedo offering.so may increase the risk of validation issues or delayed validation and subsequent assessment of the application.

ThePre-submission relevantmeetings formsmay (below)identify canhigh-level beconsiderations downloaded,or filledareas inrequiring attention and returnedare intended to presubmission@mhra.gov.uksupport wheresubmission onereadiness. They do not constitute an assessment of the teamdata willpackage triageand thesemust not be used to seek confirmation on the relevantacceptability, area.adequacy, or sufficiency of specific scientific, clinical, or regulatory approaches.

The

Where processapplicants require MHRA views on the adequacy or acceptability of their data package, development programme or regulatory strategy, a formal Scientific Advice request should be submitted. For further information on scientific advice, please see Medicines: get scientific advice from the MHRA - GOV.UK.

Process and templatetemplates

ForApplications Internationalvia recognitionthe Direct National Route

Applicants intending to submit viaan theMAA, Internationala Recognitionnew Procedureindications havevariation or a line extension for an Innovative Medicine must notify the optionMHRA of requestingtheir pre-submissionintended advicesubmission fromdate theat MHRA,least through3 themonths relevantin formadvance belowby completing and returning the pre-submission notification form below to presubmission@mhra.gov.uk.

Pre-submission  TheseAdvice requestsForm will(MS beWord assessedDocument, and262 KB)

Applicants are strongly encouraged to request a pre-submission meeting from the MHRA by indicating this in the form.

Requests will eitherbe directconsidered toby the MHRA, which may direct applicants to relevant guidance, provide written adviceadvice, or offer a pre-submission meeting.

Pre-submissionIf Advicethere Formare -any Internationalquestions Recognitionor Procedurequeries (IRP) (MSon Wordthe Document,above 264documents KB)and process, please direct these to presubmission@mhra.gov.uk.

ForApplications Newvia Activethe SubstancesInternational and/orRecognition complexProcedure applications(IRP)

Applicants intending to submit Marketingan AuthorisationMAA, Applicationsa fornew Newindications Activevariation Substancesor and/ora Biologicalline productsextension mustfor notifyan theInnovative MHRAMedicine andvia requestthe aIRP pre-submissionroute meetingmust fromnotify the relevantMHRA teamsof at-leasttheir 3intended monthssubmission priordate toat theleast intended8 applicationweeks date.in Thisadvance canby becompleting donethe byonline downloading,IRP fillingeligibility inform and returningsubmitting the relevantoutcome form to presubmission@mhra.gov.ukRecognition@mhra.gov.uk.

Applicants themay MHRAalso willrequest advisea onpre-submission themeeting mostby appropriatecompleting route for delivering the requiredPre-submission advice.

MHRAAdvice areForm also- requestingInternational thisRecognition formProcedure bebelow filledand outreturning forit newto indicationspresubmission@mhra.gov.uk. andRequests linewill extensionsbe atconsidered leastby 3the monthsMHRA, inwhich advancemay ofdirect submissionapplicants and sent to therelevant sameguidance, mailbox.provide Requestswritten foradvice, adviceor mayoffer bea requested,pre-submission however is not mandatory.meeting.

Pre-submission Advice Form - International Recognition Procedure (IRP) (MS (MS Word Document,Document, 262264 KB)KB)

If there are any questions or queries on the above document/s and process, please direct these to presubmission@mhra.gov.uk.

For ACCESS and Orbis procedures

Applicants intending to submit Marketingan AuthorisationMAA, Applicationsa fornew Newindications Activevariation Substancesor and/ora Biologicalline productsextension or applications for newan indicationsInnovative Medicine through the ACCESS work sharing initiative or the project ORBIS procedure, must also notify the relevant teams as through the pages below:

Access Consortium - GOV.UK (www.gov.uk)

Project Orbis - GOV.UK (www.gov.uk)

If there are any questions or queries on the above document/sdocument(s) and process, please direct these to presubmission@mhra.gov.uk.

Pre-submission meeting format

Pre-submission meetings are intended to support submission readiness by facilitating early regulatory dialogue on procedural, administrative and operational aspects of an application.

These meetings are not intended to review the scientific content of regulatory dossiers or detailed scientific data packages. Applicants should therefore not submit extensive briefing materials, full study reports or comprehensive scientific justifications. If scientific advice is required, a Scientific Advice Meeting should be requested (please see Medicines: get scientific advice from the MHRA - GOV.UK).

In pre-submission meetings, applicants should instead provide concise information in advance of the meeting to support effective discussion. This is limited to information necessary for understanding the proposed submission and does not require detailed argumentation. Proposed submission timelines and submission routes for the UK and other geographies should be included.

Applicants are required to submit the relevant pre-submission notification or meeting request form available on this page. This form provides the core administrative and product information required to support planning and scheduling of the meeting.

Applicants should also provide a concise presentation slide deck, typically consisting of 10-15 slides. The presentation should introduce the product, outline the proposed submission strategy, and highlight any key procedural or operational considerations relevant to submission readiness. It should also include specific regulatory points or regulatory questions intended for discussion at the meeting.

Additional supporting documentation is not routinely required. Where necessary, for example in cases involving complex regulatory pathways or novel product types, the MHRA may request limited additional information to support effective preparation for the meeting.

The MHRA will not routinely take formal minutes of pre-submission meetings. Applicants may take their own minutes and are encouraged to share them with the MHRA within 5 working days of the meeting. The MHRA will review the minutes and will not normally provide comments or amendments unless the MHRA considers that the minutes do not accurately reflect the discussion or that the applicant may have misunderstood the MHRA’s position. In these cases the MHRA will provide clarification.

Further information

For queries relating to information on other elements of MHRAsMHRA services, please contact the relevant colleagues who will be able to assist:

• For general MHRA enquiries, including for medical devices, contact info@mhra.gov.uk
• For medicines regulatory support on all other matters, contact ris.na@mhra.gov.uk
• For e-cigarettes support, visit E-cigarettes: regulations for consumer products - GOV.UK (www.gov.uk)