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.
1. Overview听
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.听 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.听
Find out more about the different바카라 사이트�national and international procedures.听
2. Application process听
All UK marketing authorisation applications should be submitted through the바카라 사이트�MHRA바카라 사이트疭ubmissions Portal. Any questions about the Submissions Portal should be sent by email tosubmissions@mhra.gov.uk.听
The application should be submitted using the바카라 사이트�.听听
罢丑别바카라 사이트�바카라 사이트�(PDF,바카라 사이트�129 KB,바카라 사이트�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.听
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.바카라 사이트�
For more information on the standards visit:听听
- 바카라 사이트�
- 바카라 사이트�
If there are any questions about submitting an application, please contact:听
2.1 PL number听
If applying for a UK or Northern-Ireland, licence, then a PL number must be sought from the바카라 사이트�바카라 사이트� or by emailing바카라 사이트� PLNumberAllocation@mhra.gov.uk 바카라 사이트痓efore you submit the application.听
When requesting a PL number, please note the following prefixes and their definitions:听
- PL:바카라 사이트痑n MA number for an application for a product to be licensed by the바카라 사이트�MHRA바카라 사이트痶hat covers the whole of the UK
- PLNI: 바카라 사이트痑n MA number for an application for a product to be licensed by the바카라 사이트�MHRA바카라 사이트痶hat 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.听 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)听
ASMFs holders must submit dossiers to the바카라 사이트�MHRA. It is the MA applicant바카라 사이트檚 responsibility to make sure that the바카라 사이트�ASMF바카라 사이트痠s submitted either before an application is submitted or at the same time.听 Applications will not be valid without it.听
Submission of a new바카라 사이트�ASMF바카라 사이트痑nd any update to an바카라 사이트�ASMF바카라 사이트痵hould be made by the바카라 사이트�ASMF바카라 사이트痟older using바카라 사이트�MHRA바카라 사이트疭ubmissions. Updated versions of ASMFs should be clearly distinguished from earlier versions with a version number or other code. Questions about the바카라 사이트�MHRA바카라 사이트疭ubmissions portal, should be addressed by email to바카라 사이트�submissions@mhra.gov.uk.听
The MHRA guidance about the바카라 사이트�submission of ASMFs is available at: Handling of Active Substance Master Files and Certificates of Suitability - 바카라 사이트 (www.gov.uk)听
Certificates of Suitability (CEPs) continue to be acceptable in support of UK national authorisations.听
2.3 Summary of product characteristics (SmPC)听
The summary of product characteristics (SmPC) should be submitted to the바카라 사이트�MHRA바카라 사이트痠n the correct format using the바카라 사이트�바카라 사이트�(MS Word Document,바카라 사이트�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.听
2.4 Established medicines听
For established active substance marketing authorisation applications (MAAs).听
2.4.1 Process for review听
To ensure applications are complete on initial assessment, or as soon after submission as possible, read the听 guidance on the .听
Watch the webinar videos:听
- 听
2.4.2 Checklists 바카라 사이트� established active substance MAA听
For established active substances within scope of the relevant checklist, the MHRA encourage applicants to submit the听 following documents with the initial submissions. The main purpose of these checklists is to promote 바카라 사이트榬ight first time바카라 사이트� submissions.听
- 听听
- 听
2.4.3 UK public assessment report (UKPAR) templates听
The lay summary of the UK PAR forms are completed by the applicant of a national abridged applications only听 following the request for further information (RFI) from the MHRA.听
- 바카라 사이트�(MS Word Document,바카라 사이트�123 KB)听
- 바카라 사이트�(MS Word Document,바카라 사이트�114 KB)听
- 바카라 사이트�(MS Word Document,바카라 사이트�110 KB)听
- 바카라 사이트�(MS Word Document,바카라 사이트�97.3 KB)听
- 바카라 사이트�(MS Word Document,바카라 사이트�94.8 KB)听
- 바카라 사이트�(MS Word Document,바카라 사이트�101 KB)听
3. Providing a name for a medicine听
The MHRA바카라 사이트痗onsiders each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly.听
Applicants can find out more in guidance: Naming human medicines - 바카라 사이트听
4. Fast tracking a marketing authorisation听
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).听
To make a request for fast tracking your marketing authorisation you should email a letter of no more than 3 pages to바카라 사이트�RIS.NA@mhra.gov.uk.听
The letter should include:听
- the justification for fast tracking听
- a brief description of the major clinical properties of the product听
- evidence supporting the claimed benefits of the product for the proposed indication(s)听
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 with바카라 사이트�DHSC바카라 사이트痓y emailing 바카라 사이트�DHSCmedicinesupplyteam@dhsc.gov.uk before submitting the request.听
There is no additional fee for fast-tracking applications.听
5. Rejection听
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.听
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.听
Applicants will not be charged if a submission fails technical validation.听
If applicants think a submission has been wrongly rejected, email ris.na@mhra.gov.uk.
6. Fees听
Fees vary depending on the type and route of application. More information about the fees charged can be found in the guidance바카라 사이트� MHRA바카라 사이트痜别别蝉.听
You can find out more about how to pay your fees in our guidance on바카라 사이트�making a payment to바카라 사이트�MHRA.听
6.1 Purchase Orders (POs)听
It is the applicant바카라 사이트檚 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 the바카라 사이트�MHRA바카라 사이트痓efore the invoice is issued.听
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.听
6.2 Payments听
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.听
Penalty fees may be incurred for non-payment. Details of the penalties are explained in our바카라 사이트疐ees Regulations.听
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
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- Added section numbers and document overview바카라 사이트�바카라 사이트� - Updated all sections for clarity and removal of outdated territorial information - Updated links to further guidance documents바카라 사이트�바카라 사이트�
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Added a new webinar video on the established medicines licensing process
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Added details of Lorenz Docubridge validation tool.
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Edited to add Youtube tutorial for Established Medicines licensing process
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Details about new process changes which are being introduced for applications for 听바카라 사이트淓stablished Medicines바카라 사이트�.
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Updated to add further guidance on obtaining a PL number for applications
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Added link to Fees Calculator.
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Added 'Checklist and abstract for bioequivalence studies and/or biowaivers' and 'Checklist for product information', for established active substance MAAs within scope.
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Added links to pages providing further information on some of the procedures.
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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.
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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.
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The DHSC contact for fast-tracking a licence has changed.
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Inserted text - Request for Information (RFI)... Under 'Ways to make your submission'
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Updated email address and naming to Department of Health and Social Care
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Removed link to Excel spreadsheet list of products.
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Added spreadsheet under "types of application" heading
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Added a link to the User Guide for the electronic application form.
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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.
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New fees calculator.
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First published.