Letter of Announcement: Clarifying the uploading requirements for packs intended for supply in Northern Ireland into the EMVS

The European Commission with its Notice C (2020) 9264, confirmed that the placing of safety features foreseen in the Falsified Medicines Directive will be required for medicinal products placed in Northern Ireland, but not for products placed in any other part of the United Kingdom. MAHs need 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.

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