If you use assistive technology (such as a screen reader) and need a
version of this document in a more accessible format, please email email@example.com.
Please tell us what format you need. It will help us if you say what assistive technology you use.
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.