Last updated: 1 October 2024
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The UK MHRA offers 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.
- 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.
For International recognition
- Applicants intending to submit via the International Recognition Procedure have the option of requesting pre-submission advice from the MHRA, by downloading the Pre-submission Advice Form – International Recognition Procedure (IRP , completing and returning it 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
- Companies 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.
- This can be done by downloading the Pre-submission Advice Form completing and and returning it to presubmission@mhra.gov.uk.
- 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 via 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.
Source: MHRA