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End User Registration Guidance

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)*.

Will Community/Hospital Pharmacies be able to return stock to their Wholesaler or a DTP manufacturer’s distributor?

This depends upon the terms and conditions of both the Wholesaler and the manufacturer. However, in general, we expect the current returns process will remain valid as long as the stock has not been decommissioned and the anti-tamper device is still intact.

Should we contact SecurMed to infiliate to GS1?

No. Please contact GS1 directly.

Who is going to pay for software and hardware changes in healthcare institutions, pharmacy and wholesaler systems - and how much will it cost?

Each healthcare institution, pharmacy and wholesaler will need to purchase the equipment required to enable it to scan the unique identifier and undertake verification and decommissioning.

I am having a problem logging onto my FMD software. What should I do?

If you have successfully logged onto the UK MVS but are having a problem logging onto your FMD software, please contact your Software Supplier.

One hospital has several ‘goods in’ addresses. Is this a Single or Bulk Registration?

Each Location must be identifiable within the UK MVS. Bulk Registrations can contain one or more Locations from one or more legal entities.

Is Gibraltar in scope of the FMD implementation and what about British Crown Dependencies and British Overseas Territories?

MHRA have confirmed with the UK Foreign Office that the Crown Dependencies of Jersey and Guernsey (including the other Channel Islands) and the Isle of Man are included within the FMD implementation. Gibraltar and all other British Overseas Territories e. g.

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.

Password Renewal

The End User Password is valid for 365 days after registration or a reset. In the 30 days prior to the Password expiry date, the UK MVS generates a message to inform the End User Location Contact that the Password must be changed.

Brexit and FMD

The UK Government has passed the EU Withdrawal Agreement Bill and the UK left the EU on 31st January 2020. The UK has thus entered an Implementation Period which, under the Withdrawal Agreement, will end on 31st December 2020.

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.

How should serialisation be implemented for ‘titration’ packs, only to outer box or it should also be applied to the inner boxes too?

Serialisation should be applied to the pack which is the unit of sale and to which the labelling provisions in Article 54 of Council Directive 2001/83/EC apply.

How does my company apply for the ‘micro MAH’ Fee Waiver?

Fill out an MAH Registration Form and return to SecurMed.  
Complete a SecurMed MAH Agreement and return to SecurMed.

Is the End User Registration process capable of registering up to 9,000 GP Practices across the UK, many with multiple Locations?

Yes, SecurMed have the capacity to process this workload. Please help us by emailing the SecurMed Service Desk ahead of time if you are planning a significant Bulk Registration. Please note, your Bulk Registration may be processed in several batches, issued weekly.  

 

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