Guidance

Make a licence submission to MHRA on CD or DVD

How to submit a medicines licence application to the Medicines and Healthcare Products Regulatory Agency (MHRA) on CD or DVD.

This publication was withdrawn on

MHRA no longer accepts submissions on CD/DVD.

Document

Making a submission to the Medicines and Healthcare products Regulatory Agency (MHRA) on CD or DVD

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Details

Please note that MHRA will no longer accept submissions on physical media from 1 February 2016.

MHRA will not accept medicines licence submissions sent on disk that do not comply with the standards and conventions in this document.

Companies are encouraged to send submissions via the MHRA Portal or for larger submissions (more than 100mb zipped) via CESP. If this is not possible, MHRA will accept submissions on disk.

This documents sets out the standards, conventions and formats needed for a submission to MHRA on CD/DVD.

Published 18 December 2014