Learn more about how the MHRA and National Institute for Health and Care Excellence (NICE) are collaborating to align decisions to get medicines to patients 3-6 months sooner. Our ambition is to achieve same time publication for marketing authorisation and NICE guidance, supported by information sharing, the integrated scientific advice service and aligned pathway.

Webinar recording: https://youtu.be/FVBVYTUc2Q4

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.  Read the guidance for a specific pathway for any extra information or steps that might be required. The pathway that is followed will depend on the type of application being made. 

Find out more about the different national and international procedures. 

2. Application process 

All UK marketing authorisation applications should be submitted through the MHRA Submissions Portal. Any questions about the Submissions Portal should be sent by email tosubmissions@mhra.gov.uk. 

The application should be submitted using the electronic Common Technical Document (eCTD).  

The pre-submission checklist (PDF, 129 KB, 7 pages) and the eAF and cover letter tool should be used to determine what documents and information to include in the application. If the correct documents and information are not submitted the application will not be validated. 

The MHRA check that eCTD submissions are technically valid using the Lorenz Docubridge validation tool which strictly aligns validation against the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) international standards and eCTD 3.2 regional requirements. It is recommended that a validation tool is used to check the submission.  

Electronic Common Technical Document (eCTD) submissions update

For more information on the standards visit:  

• ICH Official website  
• eSubmission: Projects (europa.eu)   

If there are any questions about submitting an application, please contact: 

ris.na@mhra.gov.uk. 

2.1 PL number 

If applying for a UK or Northern-Ireland, licence, then a PL number must be sought from the MHRA Portal  or by emailing  PLNumberAllocation@mhra.gov.uk  before you submit the application. 

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

• PLPL:: a an MA number for an application for a product to be licensed by the MHRA that covers the whole of the UK UK
• PLGBPLNI::  an MA number for an application for a product to be licensed by the the MHRA that forcovers theNorthern territoryIreland of(NI) Greatonly Britainas Only. the Noteterritorial thatapplication.
• PLGB: an MA numbernumbers with a PLGB prefix will not be issued onfrom or after 1 January 2025.  PLGB MA numbers already issued with a PLGB prefix can continue to be used andbut theauthorisation, licence,if oncegranted, granted  will cover the whole of the UK from 1 January 2025  2025.
• PLNI: a product licensed by the MHRA that covers Northern Ireland (NI) only as the territorial application. 

2.2 Active substance master files (ASMFs) 

ASMFs holders must submit dossiers to the MHRA. It is the MA applicant’s responsibility to make sure that the ASMF is submitted either before an application is submitted or at the same time.  Applications will not be valid without it. 

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

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

Certificates of Suitability (CEPs) continue to be acceptable in support of UK national authorisations. 

2.3 Summary of product characteristics (SmPC) 

The summary of product characteristics (SmPC) should be submitted to the MHRA in the correct format using the SPC template (MS Word Document, 36 KB). If this template is not used the submission will be rejected. The templates should not be altered in any way, other than inserting the relevant information. 

2.4 Established medicines 

For established active substance marketing authorisation applications (MAAs). 

2.4.1 Process for review 

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

Watch the webinar 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 MAA 

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

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

2.4.3 UK public assessment report (UKPAR) templates 

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

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

3. Providing a name for a medicine 

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

Applicants can find out more in guidance: Naming human medicines - GOV.UK 

4. Fast tracking a marketing authorisation 

Applications can be fast 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 for fast tracking your marketing authorisation you should email a letter of no more than 3 pages to RIS.NA@mhra.gov.uk. 

The letter should include: 

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

If an applicant wants the MHRA to fast track an application because of a shortage of supply of medicinal product, it is recommend this is discussed with DHSC by emailing  DHSCmedicinesupplyteam@dhsc.gov.uk before submitting the request. 

There is no additional fee for fast-tracking applications. 

5. Rejection 

Any submission that is incomplete because it does not meet the requirements set out in Regulation 50 and Schedule 8 of the Human Medicines Regulations 2012 (as amended) or does not meet the necessary technical requirements will be rejected. 

If a submission is rejected, the MHRA will 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 

Fees vary depending on the type and route of application. More information about the fees charged can be found in the guidance  MHRA fees. 

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

6.1 Purchase Orders (POs) 

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

6.2 Payments 

Once an application has been validated, applicants will receive an invoice so that a payment for the outstanding amount can be made. All invoices must be settled upon receipt. 

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