# Pre-submission Advice & Support

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a02dd76a-831a-4467-b0a2-57ca77ac5d86
Type: Detailed Guide
Published: August 12, 2024
Updated: October 1, 2024

> The Medicines and Healthcare products Regulatory Agency (MHRA) offers a structured pre-submission service to support companies seeking Marketing Authorisations for medicines in the United Kingdom. This guidance outlines the framework for prospective applicants to obtain advice on compiling and submitting their applications. A critical requirement is that companies intending to submit applications for New Active Substances or Biological products must request a pre-submission meeting at least three months prior to their planned application date. This mandatory notification also applies to new indications and line extensions. For applicants using the International Recognition Procedure, Project Orbis, or the Access Consortium, specific notification protocols are required to ensure efficient coordination. The process involves submitting standardized forms to a dedicated MHRA team, which then triages the requests to provide written advice, direct guidance, or formal meetings. By facilitating early engagement, the MHRA aims to clarify evidence requirements and streamline the regulatory pathway for complex medical products. This service is distinct from the agency's scientific advice and is intended to help stakeholders navigate the procedural aspects of the UK’s medicine registration system.

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## Content

Overview The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations. This service aims to provide the best support possible for prospective applicants, whichever application route is chosen. Companies who are intending to submit Marketing Authorisation Applications for New Active Substances and/or Biological products must request a pre-submission meeting with the relevant teams at-least 3 months prior to the intended application date. Pre-submission advice is a service that provides stakeholders with the means to understand how the process of compiling and submitting applications and supporting evidence applies for their product/s. It is distinct from MHRAs Scientific Advice offering. The relevant forms (below) can be downloaded, filled in and returned to presubmission@mhra.gov.uk where one of the team will triage these to the relevant area. The process and template For International recognition Applicants intending to submit via the International Recognition Procedure have the option of requesting pre-submission advice from the MHRA, through the relevant form below and returning to presubmission@mhra.gov.uk . These requests will be assessed and the MHRA will either direct to the relevant guidance, provide written advice or offer a pre-submission meeting. Pre-submission Advice Form - International Recognition Procedure (IRP) ( MS Word Document , 264 KB ) For New Active Substances and/or complex applications Applicants intending to submit Marketing Authorisation Applications for New Active Substances and/or Biological products must notify the MHRA and request a pre-submission meeting from the relevant teams at-least 3 months prior to the intended application date. This can be done by downloading, filling in and returning the relevant form to presubmission@mhra.gov.uk the MHRA will advise on the most appropriate route for delivering the required advice. MHRA are also requesting this form be filled out for new indications and line extensions at least 3 months in advance of submission and sent to the same mailbox. Requests for advice may be requested, however is not mandatory. Pre-submission Advice Form ( MS Word Document , 262 KB ) If there are any questions or queries on the above document/s and process, please direct these to presubmission@mhra.gov.uk . For ACCESS and Orbis procedures Applicants intending to submit Marketing Authorisation Applications for New Active Substances and/or Biological products or applications for new indications through the ACCESS work sharing initiative or the project ORBIS procedure, must also notify the relevant teams as through the pages below: Access Consortium - GOV.UK (www.gov.uk) Project Orbis - GOV.UK (www.gov.uk) If there are any questions or queries on the above document/s and process, please direct these to presubmission@mhra.gov.uk . Further information For queries relating to information on other elements of MHRAs services, please contact the relevant colleagues who will be able to assist: For general MHRA enquiries, including for medical devices, contact info@mhra.gov.uk For medicines regulatory support on all other matters, contact ris.na@mhra.gov.uk For e-cigarettes support, visit E-cigarettes: regulations for consumer products - GOV.UK (www.gov.uk)

## Attachments

- [Pre-submission Advice Form](https://assets.publishing.service.gov.uk/media/66fbecddc71e42688b65ef5c/Pre-submission_Notification_Form.docx)
- [Pre-submission Advice Form - International Recognition Procedure (IRP)](https://assets.publishing.service.gov.uk/media/66ba217149b9c0597fdb0e38/IRP_Pre-submission_Advice_Form.docx)