My company has not yet submitted to the MHRA White List of products exempt from FMD charges. Can products still be added to the White List?

Yes. Article 46 of the Delegated Regulation (DR) notifies the commission of additional medicinal products that are at risk or not at risk of falsification.

All submissions must be made by the MHRA. Please contact the MHRA for information on how to submit.

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Should we contact SecurMed to infiliate to GS1?

No. Please contact GS1 directly.

Does Article 37(d) require that a National Medicine Verification Organisation (NMVO) directly alerts the relevant national competent authorities, the EMA and the Commission about a falsification? Is there is a time limit for such alerting?

The use of the term “provide for” in Article 37(d) of Commission Delegated Regulation (EU) 2016/161 means that an NMVO has to ensure that the National Competent Authorities (NCA), the EMA and the Commission are informed.

Where can I find a copy of the Delegated Regulation?

You can find the Delegated Regulation here.

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.

List of IT Software Suppliers

For those organisations who do not have an IT software provider, or who seek to find companies providing solutions, SecurMed has published the following list of providers.

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)*.

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