Guidance

Baseline guidance for medicine licence submissions

Definitions of baseline submissions for medicine licences and when they should be used.

From:
Medicines and Healthcare products Regulatory Agency
Published
1 December 2015

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Documents

MHRA baseline guidance

PDF, 61.1 KB, 4 pages

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Details

This guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) includes scenarios that need baseline submissions and reminders and tips.

Published 1 December 2015