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

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

Information for marketing authorisation holders

In February 2016, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, established by the Heads of Medicines Agencies, prepared the Implementation plan for the introduction of the safety features on the packaging of medicinal products . It contains detailed information for marketing authorisation holders (and applicants) regarding the procedure for the introduction of these safety features. The plan also explains the timelines for implementation.

See contents of the aforementioned plan here (PDF).

As the State Agency of Medicines (SAM) informed before, the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on the safety features to appear on medicinal product packaging (Commission Delegated Regulation (EU) 2016/161) that came into force on 29 February 2017 lay down detailed regulations regarding safety features on packaging of medicinal products for human use, including the placing of two safety features, a unique identifier (UI) carried by a 2-D barcode and an anti- tampering device (ATD), on the packaging of the majority of medicinal products for human use. Marketing authorisation holders shall implement the required safety features for the relevant medicinal products by 9 February 2019. Read more