Guidance

Submitting changes to labelling and patient information leaflets

Guidance on how to submit changes to labelling and patient information leaflets to MHRA.

Document

Submitting changes to labelling and patient information leaflets to MHRA

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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