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Implementation of Safety Changes in the Artworks

MHRA

Once you have received approval from the MHRA, you must introduce the changes within 3 to 6 months, unless you have been told to introduce the new information early because of safety reasons.

You can submit changes to labels, leaflets and packaging for the same product at the same time using a notification or for a full assessment.

A separate application must be submitted for each product name. The submission must also include all affected MAs, particularly when a leaflet may be shared across several MAs.

A number of changes to labels and PILs can be made with each submission or notification using the same notification form or application form. You can also group changes that would have been a notification on their own with changes that need to be submitted for full assessment.

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