MHRA - Pre-submission Advice & Support

14th August 2024

MHRA

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.

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