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In July 2018 the Government launched a public consultation on the steps proposed to make sure the UK meets its obligations to transpose the provisions of the Falsified Medicines Directive (FMD) requiring ‘safety features’ to appear on the packaging of certain medicinal products.
The consultation closed in September, and this document provides the Agency’s official response to the more than 50 replies received from a wide range of stakeholders.
As with all EU regulations, the Delegated Regulation on ‘safety features’ will apply automatically in all EU Member States and therefore, as of 9 February 2019, these new requirements will be directly applicable as part of UK law.
Our consultation focused on the national flexibilities in the Delegated Regulation, and the level of sanctions applied to a breach of each new requirement, for which we are obliged to take additional legal steps, culminating in the laying of a Statutory Instrument in Parliament.
Overall, the responses broadly supported the Government’s proposed positions regarding the level of sanctions imposed and on each national flexibility, where the UK has legal scope to make changes. Therefore, the Government intends to implement as per the positions proposed in our consultation, with the exception of Article 26(3), which exempts those within a healthcare institution from decommissioning under certain conditions. The Government did not originally see any benefit of applying this flexibility, but now understands it could be beneficial for certain healthcare institutions, in line with the criteria fixed in the Delegated Regulation.
Any questions about the consultation process, or regarding FMD and the safety features more broadly can be directed to firstname.lastname@example.org.
Further information and a wide range of guidance related to FMD and the safety features is available.
The EU Falsified Medicines Directive (2011/62/EU) (FMD) was adopted in 2011 and introduced new harmonised measures to ensure that medicines in the European Union (EU) are safe and that trade in medicines is properly controlled. Member States have until 9 February 2019 to implement the final part of the Directive, the ‘safety features’ Delegated Regulation. This consultation invites views on the proposed steps that the Government intends to take to make sure the United Kingdom (UK) meets its obligations to transpose the provisions of the Falsified Medicines Directive (FMD) requiring ‘safety features’ to appear on the packaging of certain medicinal products.
The detailed rules for the ‘safety features’ are set out in Commission Delegated Regulation (EU) 2016/161, but are essentially:
a unique identifier (a 2D data matrix code and human readable information) that must be scanned at fixed points along the supply chain
an anti-tampering device allowing verification of whether the packaging of a medicinal product has been tampered with