Registering New Packaging Information for Medicines from 1 January 2021

You will have no later than 24 months after the end of the transition period to establish and register a Great Britain presence for your MA. You will have a further 12 months (36 months in total from 1 January 2021) to ensure all stock released to market is in compliant packaging. You may need to amend the labelling and/or the patient information leaflet (PIL) to take account of new information as a result of a variation application submitted between the grant of the new MA and 24 months from 1 January 2021.

MHRA will continue to allow multi-country packs. Changes to packaging components, which previously may have been suitable for submission, will now be considered under the national rules.

Source: MHRA guideline on Registering new packaging information for medicines from 1 January 2021


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