# Apply for a licence to market a medicine in the UK

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/75c3eee0-7c34-41c4-a70f-c21b585abd32
Type: Detailed Guide
Published: December 18, 2014
Updated: April 1, 2026

> The Medicines and Healthcare products Regulatory Agency (MHRA) provides comprehensive guidance for pharmaceutical companies seeking Marketing Authorisations (MA) in the United Kingdom. Effective from March 1, 2024, for established medicines, this framework mandates the use of the MHRA Submissions Portal and the electronic Common Technical Document (eCTD) format, adhering to international ICH standards. Applicants must obtain a Product License (PL) number prior to submission, noting that PLGB prefixes will be replaced by UK-wide licensing starting January 1, 2025. Key requirements include the timely submission of Active Substance Master Files (ASMF) and the strict use of the MHRA’s specific Summary of Product Characteristics (SmPC) template. For established medicines, specific checklists for bioequivalence and product information are required to ensure submissions are complete upon initial assessment. Common issues leading to application rejection include incomplete documentation, failure to use mandated templates, or non-compliance with the Human Medicines Regulations 2012. While fast-tracking is available for public health emergencies or critical supply shortages, it requires formal justification and prior coordination with the Department of Health and Social Care. Compliance also extends to financial obligations; failure to provide purchase orders or settle invoices promptly may result in license suspension or legal action. To avoid delays, the MHRA recommends using technical validation tools before submission to ensure all regional requirements are met.

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## Content

1. Overview This information is common to all routes of application. 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 MA applications should be submitted through the MHRA Submissions Portal. Accessing and using the MHRA submissions portal Any questions about the Submissions Portal should be sent by email to submissions@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 checks 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) eSubmissions updates and questions and answers 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 MA , 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: PL : an MA number for an application for a product to be licensed by the MHRA that covers the whole of the UK PLNI: an MA number for an application for a product to be licensed by the MHRA that covers Northern Ireland (NI) only as the territorial application. PLGB: MA numbers with a PLGB prefix will not be issued from or after 1 January 2025. MA numbers already issued with a PLGB prefix can continue to be used but authorisation, if granted, will cover the whole of the UK from 1 January 2025. 2.2 Active substance master files (ASMFs) In the case of applications supported by an ASMF , the ASMF holder must submit their master file to the MHRA . It is the MA applicant’s responsibility to ensure that the ASMF is submitted either before an application is submitted or at the same time. Applications will not be validated 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 . See the MHRA guidance on the submission of ASMFs 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 . 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 is 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 As part of the assessment of each application, the MHRA considers the proposed product name to ensure that it 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 MA 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 explain 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.

## Attachments

- [Public Assessment Report (PAR) template - Full Dossier Reg 50 (8.3)](https://assets.publishing.service.gov.uk/media/65e06d4fcf7eb16adff57fec/2021_PAR_TEMPLATE_FULL_DOSSIER_Reg_50__8.3_.docx)
- [guidance on submitting an ASMF](https://assets.publishing.service.gov.uk/media/5a8071eded915d74e33fa777/Submit_an_Active_Substance_Master_File.pdf)
- [this spreadsheet](https://assets.publishing.service.gov.uk/media/5a85ab77ed915d74e3404831/Reference_products_list_for_website_final.xlsx)
- [Checklist and abstract for bioequivalence studies and/or biowaivers](https://assets.publishing.service.gov.uk/media/653108700b5392000da9299e/Bioequivalance_Biowaiver_Checklist_Abstract.docx)
- [Checklist for product information](https://assets.publishing.service.gov.uk/media/6531088126b9b1000daf1b94/Product_Information_Checklist.docx)
- [Public Assessment Report (PAR) template - Bibliographic  Reg 54 (10a)](https://assets.publishing.service.gov.uk/media/65e06d4fb8da630f42c86303/2021_PAR_TEMPLATE_BIBLIOGRAPHIC_Reg_54__10a_.docx)
- [Public Assessment Report (PAR) template - Fixed Combination Reg 55 (10b)](https://assets.publishing.service.gov.uk/media/65e06d4fb8da63b345c8628e/2021_PAR_TEMPLATE_Fixed_Combination_Reg_55__10b_.docx)
- [Public Assessment Report (PAR) template - Generic Reg 51 (10.1)](https://assets.publishing.service.gov.uk/media/65e06d4fb8da630f42c86304/2021_PAR_TEMPLATE_GENERIC_Reg_51__10.1_.docx)
- [Public Assessment Report (PAR) template - Hybrid Reg 52 (10.3)](https://assets.publishing.service.gov.uk/media/65e06d4fb8da630f42c86305/2021_PAR_TEMPLATE_HYBRID_Reg_52__10.3_.docx)
- [Public Assessment Report (PAR) template - Informed Consent Reg 56 (10c)](https://assets.publishing.service.gov.uk/media/65e06d4fcf7eb1b0e5f57f41/2021_PAR_TEMPLATE_INFORMED_CONSENT_Reg_56__10c_.docx)
- [informed consent checklist ](https://assets.publishing.service.gov.uk/media/5a7ee31740f0b6230268c2ad/Informed_consent_checklist.doc)
- [BROMI checklist](https://assets.publishing.service.gov.uk/media/5a7efabce5274a2e87db3177/BROMI_checklist.doc)
- [naming of medicines guidance](https://assets.publishing.service.gov.uk/media/5a7d4fc640f0b60aaa293abe/naming_of_medicines_guidance.pdf)
- [guidance on common reasons for invalidation](https://assets.publishing.service.gov.uk/media/5a7dfdb8ed915d74e33ef56d/Most_frequent_invalidation_issues.pdf)
- [pre-submission checklist](https://assets.publishing.service.gov.uk/media/5a7eefdfed915d74e33f35c5/Pre-submission_checklist.pdf)
- [SPC template](https://assets.publishing.service.gov.uk/media/5a7e28e240f0b62305b812e7/SPC_template.doc)
- [Fees calculator](https://assets.publishing.service.gov.uk/media/5a74c2fee5274a3cb2866f97/Fees_Calculator_April_2016.zip)
- [Electronic Common Technical Document (eCTD) submissions update](https://assets.publishing.service.gov.uk/media/68512eb029fb1002010c4f02/25-0612_eCTD_submissions_update_FINAL_2-RC.docx)