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 the MHRA has published the following document which provides their 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.
The 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 the Government is 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 their 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.
Their additional guidance on Article 23 providers, Healthcare Institutions and Article 26 exemption is available here: