Apply for a licence to market a medicine in the UK

1. Overview 

An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees This information is common to all procedures.procedures.  YouRead should read the guidance for youra specific pathway for any extra information or steps that might be required. The pathway that youis followfollowed will depend on your intended market and the type of application youbeing are making.made. 

Find out more about the different different national and international licensing procedures. 

2. Application processprocess 

YouAll should submit all UK andmarketing Greatauthorisation Britainapplications (England,should Scotlandbe andsubmitted Wales) national applications through the the MHRA Submissions submissionsPortal. portal.

IfAny you have any questions about the submissionsSubmissions portal,Portal should be sent by email tosubmissions@mhra.gov.uk.. 

YouThe application should submitbe yoursubmitted application using the the electronic Common Technical Document (eCTD)..  

Use the The pre-submission checklist (PDF, (PDF, 129 129KB, 7 KB,pages) 7and pages)the to help you with your application. You should also use our eAF and cover letter tool should be used to determine what informationdocuments youand needinformation to include in yourthe application. If youthe docorrect notdocuments includeand theinformation correctare informationnot yoursubmitted the application will not be validated.validated. 

WeThe MHRA check that eCTD submissions are technically valid using the Lorenz Docubridge validation tool which strictly aligns validation against ICHthe internationalInternational standardsCouncil andfor eCTDHarmonisation 3.2 regional requirements. We recommend that you use a validation tool to check your submission.

You can check the validation of yourTechnical submissionRequirements beforefor makingPharmaceuticals itfor usingHuman theUse LORENZ(ICH) eValidatorinternational Basicstandards validationand software for eCTD and3.2 more.regional Yourrequirements. MHRAIt agentis willrecommended usethat thea Lorenzvalidation docuBridgetool eCTDis toolused to technicallycheck validate the submission against ICH international standards, eCTD 3.2 EU regional requirements, once we receive it.  submission.  

For more information on the standards,standards see: visit:  

• ICH Official website

    

• eSubmission: Projects (europa.eu)

    

If youthere haveare any questions about submitting youran application, emailplease contact: 

ris.na@mhra.gov.uk.. 

2.1 PL numbernumber 

If you are applying for a UK,UK Great Britain or NorthernNorthern-Ireland, Ireland licence, youthen must get a PL number must be sought from the MHRA Submissions Portal  or by emailingemailing   PLNumberAllocation@mhra.gov.uk before  before you submit yourthe application.application. 

PleaseWhen requesting a PL number, please note the following prefixes and their definitions:definitions: 

• PL: a: a product licensed by the the MHRA that that covers the whole of the UK, coming into effect from 1 January 2025UK 
• PLNIPLGB: a: a product licensed by the MHRA for the territory of Great Britain Only.  Note that coversan NorthernMA Irelandnumber (NI)with onlya asPLGB prefix will not be issued on or after 1 January 2025.  PLGB MA numbers already issued continue to be used and the territoriallicence, application.once granted  will cover the whole of the UK from 1 January 2025  
• PLGBPLNI: a: a product licensed by the the MHRA that that covers GreatNorthern BritainIreland (GB)(NI) only as the territorial applicationapplication. 

2.2 Active substance master files (ASMFs)(ASMFs) 

ASMFs holders must submit theirdossiers dossier to the the MHRA. It is yourthe MA applicant’s responsibility to make sure youthat submit the the ASMF is submitted either before youan submitapplication youris applicationsubmitted or at the same time.time.  YourApplications application will not be valid without it.it. 

Submission of a new new ASMF and and any update to an an ASMF should should be made by the the ASMF holder holder using using MHRA Submissions. Submissions.Updated Ifversions youof haveASMFs anyshould questionsbe clearly distinguished from earlier versions with a version number or other code. Questions about the MHRA Submissions Submissions, portal, should be addressed by email to submissions@mhra.gov.uk.. 

ReadThe ourMHRA guidance onabout the the submission of ASMFs. is available at: Handling of Active Substance Master Files and Certificates of Suitability - GOV.UK (www.gov.uk) 

Certificates of suitabilitySuitability (CEPs) continue to be acceptable in support of UK and GB national authorisations.authorisations. 

2.3 Summary of product characteristics (SmPC)) 

YouThe must submit the summary of product characteristics (SmPC) toshould thebe submitted to the MHRA in in the correct format using the the SPC template (MS (MS Word Document,Document, 36 36KB). KB). If youthis dotemplate is not useused thisthe template your submission will be rejected. YouThe musttemplates should not alterbe thesealtered templates in any way, other than inserting the relevant information.information. 

2.4 Established medicines

medicines 

For established active substance marketing authorisation applications (MAAs).). 

2.4.1 Process for review

review 

To ensure applications are complete on initial assessment, or as soon after submission as possible, read thethe  guidance on the licensing process change for established medicines, effective from 1 March 2024.. 

Watch the webinar videos:videos: 

• MHRA established medicines licensing process change webinar, March 2024 (youtube.com)
• MHRA established medicines licensing process change update webinar, April 2024 (youtube.com) 

2.4.2 Checklists -– established active substance MAAs

MAA 

For established active substances within scope of the relevant checklist, wethe MHRA encourage applicants to submit thethe  following documents with the initial submissions. The main purpose of these checklists is to promote ‘right first time’ submissions.submissions. 

• Checklist and abstract for bioequivalence studies and/or biowaivers  
• Checklist for product information 

2.4.3 UK public assessment report (UKPAR) templates

templates 

The lay summary of the UK PAR forms are completed by the applicant of a national abridged applications onlyonly  following the request for further information (RFI) from the MHRA.. 

• Public Assessment Report (PAR) template - Full Dossier Reg 50 (8.3) (MS (MS Word Document,Document, 123 123 KB)KB) 
• Public Assessment Report (PAR) template - Generic Reg 51 (10.1) (MS (MS Word Document,Document, 114 114 KB)KB) 
• Public Assessment Report (PAR) template - Hybrid Reg 52 (10.3) (MS (MS Word Document,Document, 110 110 KB)KB) 
• Public Assessment Report (PAR) template - Bibliographic Reg 54 (10a) (MS (MS Word Document,Document, 97.3 97.3 KB)KB) 
• Public Assessment Report (PAR) template - Fixed Combination Reg 55 (10b) (MS (MS Word Document,Document, 94.8 94.8 KB)KB) 
• Public Assessment Report (PAR) template - Informed Consent Reg 56 (10c) (MS (MS Word Document,Document, 101 101 KB)KB) 

3. Providing a name for youra medicinemedicine 

The MHRA considers considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly.correctly. 

FindApplicants can find out more in ourguidance: namingNaming ofhuman medicines guidance (PDF,- 235 KB, 20 pages).GOV.UK 

Fast-track4. yourFast tracking a marketing authorisationauthorisation 

Applications can be fast-trackedfast tracked if there is compelling evidence of benefit in a public health emergency or if there is a shortage of supply of an essential medicine that has been verified by the Department of Health and Social Care (DHSC).). 

To make a request tofor fast-trackfast tracking your marketing authorisation,authorisation you should email a letter of no more than 3 pages to to RIS.NA@mhra.gov.uk.. 

The letter should include:include: 

• the justification for fast trackingtracking 
• a brief description of the major clinical properties of the productproduct 
• evidence supporting the claimed benefits of the product for the proposed indication(s)indication(s) 

If youan wantapplicant wants the MHRA to fast-trackfast yourtrack an application because of a shortage of supply weof recommendmedicinal youproduct, discussit is recommend this withis discussed with DHSC by by emailing  DHSCmedicinesupplyteam@dhsc.gov.uk. before submitting the request. 

There is no additional fee for fast-tracking applications.applications. 

Fees5. Rejection 

FeesAny varysubmission dependingthat onis incomplete because it does not meet the typerequirements set out in Regulation 50 and routeSchedule 8 of application.the FindHuman outMedicines moreRegulations about2012 (as amended) or does not meet the feesnecessary wetechnical chargerequirements inwill be rejected. 

If a submission is rejected, the MHRA feeswill email the reasons for the rejection. The complete application must then be resubmitted with the errors corrected. Do not send the corrected deficiencies by email. 

Applicants will not be charged if a submission fails technical validation. 

If applicants think a submission has been wrongly rejected, email ris.na@mhra.gov.uk.

6. Fees 

UseFees vary depending on the feestype calculatorand toroute workof outapplication. whatMore information about the feefees forcharged yourcan submissionbe willfound be.in the guidance  MHRA fees. 

FindYou can find out more about how to pay your fees in our guidance on making a payment to to MHRA.. 

6.1 Purchase ordersOrders (POs)(POs) 

It is yourthe applicant’s responsibility to make sure the invoices for your submissions are paid on time. If youran organisation operates a PO system, please make sure that the relevant PO is provided to the MHRA before before the invoice is issued.issued. 

Refusal to pay outstanding fees on the grounds that the PO is not provided on the invoice will not be accepted. The use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices.invoices. 

Payments6.2 Payments 

Once youran application has been validatedvalidated, youapplicants will receive an invoice so that you can make a payment for the outstanding amount.amount can be made. All invoices must be settled upon receipt.receipt. 

Penalty fees may be incurred for non-payment. Details of the penalties are explained in our feesour Fees regulations.Regulations. 

Non-payment may also result in suspension of any licence or authorisation, followed by legal proceedings for any unpaid amounts, as a debt due to the Crown.

Rejection