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Details
Marketing authorisation holders must inform the relevant competent authority of all changes to labels and patient information leaflets which are not connected with changes to the summary of product characteristics (SPC).
This guidance sets out how to submit a change to labelling and patient information leaflets to MHRA, either for full assessment or through the notification scheme.
Published 29 December 2014 Last updated 22 December 2023 +show all updates
- Removed out of date paragraph on submitting notifications- Updated Notification of Changes to Labels and Patient Information Leaflets for Self-Certification Form.
Published a HTML version, updated to reflect the end of the transition period.
