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
fmd.safetyfeatures@mhra.gov.uk.
Further information and a wide range of guidance related to
FMD and the safety features is available.
