Where can I find a copy of the Delegated Regulation?

You can find the Delegated Regulation here.

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Which medicines are in scope of FMD?

For details of the scope of the regulation please check: FMD Delegated Regulation 2016_161

Where stakeholders are unclear on the legislation, for example whether types of medicine are in/out of scope, please contact DHSC/MHRA at fmd. safetyfeatures@mhra. gov. uk.

Will anti-tamper devices be allowed on OTCs and other out-of-scope products after February 2019?

The MHRA has confirmed that subject to the outcome of a public consultation anti-tamper devices may continue to be placed on out-of-scope products after 9th February 2019 if the relevant manufacturer considers that it is necessary to do so in the interests of patient safety.

Who can register with SecurMed UKNI MVS?

Registration is a simple and easy process.

What is the FMD?

What is the FMD?

Since 9th February 2019, the Falsified Medicines Directive (FMD) and associated Delegated Regulation (DR) have imposed new regulatory obligations on all organisations that manufacture and/or dispense prescription-only medicines (POMs)*.

I am a Community Pharmacist. Where can I find information on the FMD that is tailored to my sector?

For more information, please visit the NHS Digital FMD Toolkit for Community Pharmacy. FMD Source, the website of the UK FMD Working Group for Community Pharmacy, is also a useful guide. Community Pharmacy Northern Ireland (CPNI) also have some useful information.