MAHs need first to consider whether the marketing authorisation (MA) for the concerned medicine(s) covers the marketing of the medicine(s) in Northern Ireland, and then to add the safety features to the respective packs and load the data to the EU Hub accordingly. If the MA does not apply to Northern Ireland, then no pack data load is required. Regarding decommissioning, please refer to Q14 for the latest relevant guidelines from the EU Commission.
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Written by Tracy Slosse
Updated over 2 years ago