EMA Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use

New legislative requirements from the European Medicines Agency and the European Commission, specifically the new Commission Delegated Regulation (EU) 2016/161) will implement regulatory changes to Marketing Authorisation Holders (MAHs) safety feature standards.  Sections 17 and 18 of Annex IIIA of the Delegated Regulation require MAHs notification of implementation within three years of publication of the revised QRD template, 9th February 2019. The recent changes will require the addition of a unique identifier (UI) and an anti-tampering device (ATD) to prescription medication and specified non-prescription medicines packaging.

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