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

EMA NEWS

Certain aspects of the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on the safety features (Commission Delegated Regulation (EU) 2016/161 - "the Delegated Regulation") may impact on the product information and the marketing authorisation dossier; in particular the placing of safety features, a unique identifier (UI) carried by a 2-D barcode and an anti-tampering device (ATD), on the packaging of prescription medicines and certain nonprescription medicines for the purposes of authentication and identification. 

The European Medicines Agency and the European Commission have prepared this implementation plan to guide applicants and Marketing Authorisation Holders (MAHs) through the regulatory changes necessary to accommodate the new legislative requirements. 

The European Medicines Agency and the Quality Review of Documents (QRD) Group have revised the Human Product Information templates. The updated QRD Template will facilitate the implementation of the relevant standard statements on the UI and its carrier under sections 17 and 18 of Annex IIIA, in order for the MAHs to implement the safety features by the 9th of February 2019 as required by the Delegated Regulation. 

The inclusion of the safety features standard statements under sections 17 and 18 of Annex IIIA does not indicate that the safety features have been actually implemented on the packaging placed on the market, but rather that the product information has been updated to confirm that the safety features will be implemented on the marketed packaging in line with the provisions of the Delegated Regulation (i.e. by the 9th of February 2019).

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