Despite the prospect of Brexit, the UK remains a part of the EU and all rights and obligations of EU Membership remain in force until we leave. That means the FMD and Delegated Regulation will come into force on 9th Feb 2019 and all obliged stakeholders need to prepare for this regulation. The Department of Health & Social Care and MHRA have consistently re-iterated this view.
The United Kingdom (UK) will still be a Member State of the European Union (EU) until 29 March 2019 and, in line with our existing obligations, will therefore be required to implement the Falsified Medicines Directive (FMD) Delegated Regulation before 9 February 2019.
When the UK exits the EU, the Withdrawal Bill will convert existing EU law into UK law and preserve the laws we have made in the UK to implement our EU obligations. This means that the duties of the regulations under the FMD would continue to apply, unless specifically revoked.
Furthermore, on 19th March 2018, David Davis confirmed that the UK and EU have agreed a fixed implementation period of 21 months, lasting until December 2020. During this time, access to each other’s markets will continue on current terms, including all aspects of FMD, providing certainty for businesses and citizens across the EU and UK, and time to prepare for the future.
However, in preparation for a no-deal Brexit the Government has released a Statutory Instruments (SI) The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 draft legislation outlining the changes to be made to regulations around the use of medicines in the UK, in the event of a No-Deal EU Exit.
Its related Explanatory Memorandum (Article 7.14) makes clear that the requirements placed on all actors in the UK supply chain from 9 February 2019 by virtue of the Human Medicines (Amendment) Regulations 2019/62, regarding the safety features aspects of the Falsified Medicines Directive, will be removed by this instrument, because UK stakeholders would no longer be able to comply with the requirement to verify and authenticate all relevant medicines. For example, the unique identifier in a 2D data matrix code for products coming from the EU will have been decommissioned (made inactive) on export from the EU and before entry to the UK as a third country. Furthermore, this instrument ensures that there will be no obligations on the UK supply chain to affix the safety features or to scan packs of medicines. Packs already affixed with FMD safety features will continue to be accepted in the UK, provided that they are in line with other UK packaging requirements. In the interests of public safety, the Government will evaluate the options for a future UK falsified medicines framework, taking into account the investment already made by stakeholders.