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Drugs: Counterfeit Manufacturing

Question for Department of Health and Social Care

UIN HL9032, tabled on 27 June 2018

To ask Her Majesty's Government whether they intend to bring into force all aspects of the Falsified Medicines Dirctive (EU2016/161); and if so, when.

Answered on

10 July 2018

The United Kingdom will still be a Member State of the European Union 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 19 March 2018, the Secretary of State for Exiting the European Union 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.