EMA's updated Implementation Plan for the Introduction of Safety Features

Recommendation

18 June 2024
Barcelona, Spain

QP pre-course Session: Interpersonal and Soft Skills for the QP

From February 9th, 2019 onwards, the only prescription medicines allowed to be marketed will be those that - when necessary - bear safety features on their outer packaging.

The EMA has published a revised plan for the implementation of safety features on the packaging of centrally authorized products for human use on June 29th, 2017.

Several aspects of the implementation of the Falsified Medicines Directive and the Delegated Regulation for the safety features can influence product information as well as details in the authorisation dossier, especially where the safety features - the 2-D barcode and anti-tampering device - are to be placed for authentication and identification.

The marketing authorisation holder has to inform the authorities that the safety features are going to be used from February 9th, 2019.

The EMA's plan for implementation distinguishes between four starting positions:

• New marketing authorisation applications for products which have to bear the safety features.
• Ongoing authorisation applications for products which have already been submitted.
• Existing marketing authorisations granted via the centralised procedure before the publication of the Delegated Regulation and the revised QRD template.
• Cases in which the medicinal product no longer has to bear the safety features.

If a marketing authorisation already exists, safety features may be implemented before the official approval by the authority.

Please also see the complete plan for implementation of the safety features.