GovWire

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.?

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:

• 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 applicants 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)
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