Pre-submission Advice & Support
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
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.
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.
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)
Updates to this page
Published 13 August 2024Last updated 1 October 2024 + show all updates
-
Information on the webpage has been updated, along with the latest version of the Pre-submission Notification Form.
-
First published.