Guidance

Apply for a licence to market a medicine in the UK

An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.

From:
Medicines and Healthcare products Regulatory Agency
Published
18 December 2014
Last updated
11 December 2024 — See all updates

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 to[email protected]. 

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.  

For more information on the standards visit:  

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

[email protected]. 

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  [email protected]  before you submit the application. 

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

  • PL: a product licensed by the MHRA that covers the whole of the UK 
  • PLGB: a product licensed by the MHRA for the territory of Great Britain Only.  Note that an MA number with a PLGB prefix will not be issued on or after 1 January 2025.  PLGB MA numbers already issued continue to be used and the licence, once granted  will cover the whole of the UK from 1 January 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 [email protected]. 

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: 

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. 

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. 

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 [email protected]. 

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  [email protected] 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 [email protected].

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.

Updates to this page

Published 18 December 2014
Last updated 11 December 2024 + show all updates

  1. - Added section numbers and document overview   - Updated all sections for clarity and removal of outdated territorial information - Updated links to further guidance documents  

  2. Added a new webinar video on the established medicines licensing process

  3. Added details of Lorenz Docubridge validation tool.

  4. Edited to add Youtube tutorial for Established Medicines licensing process

  5. Details about new process changes which are being introduced for applications for  “Established Medicines”.

  6. Updated to add further guidance on obtaining a PL number for applications

  7. Added link to Fees Calculator.

  8. Added 'Checklist and abstract for bioequivalence studies and/or biowaivers' and 'Checklist for product information', for established active substance MAAs within scope.

  9. Added links to pages providing further information on some of the procedures.

  10. Following the end of the transition period, published information on new procedures for obtaining a marketing authorisation in the UK, Great Britain (England, Scotland and Wales) or Northern Ireland.

  11. Updated content to reflect that the UK cannot act as a Reference Members State (RMS) for approval of marketing authorisations in decentralised and mutual recognition licensing procedures during the transition period.

  12. The DHSC contact for fast-tracking a licence has changed.

  13. Inserted text - Request for Information (RFI)... Under 'Ways to make your submission'

  14. Updated email address and naming to Department of Health and Social Care

  15. Removed link to Excel spreadsheet list of products.

  16. Added spreadsheet under "types of application" heading

  17. Added a link to the User Guide for the electronic application form.

  18. Updated contact information for Department of Health for advice when seeking to fast-track an application due to a shortage of supply of essential medicines.

  19. New fees calculator.

  20. First published.

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