How can we help?

Are you looking for some specific information? Please use the search options below. Either type key words into the 'How can we help you?' box, then choose a category and your user type, or simply use the Category / User type selections. Then press the search icon and a series of articles will be generated for you.

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.

End User Registration Guidance

Registration is a simple and easy process.

‘Product Not Found’ alert

‘Product Not Found’ alerts amount to more than 30% of the total alerts generated when scanning medicines under FMD. Often, this is due to packs which are not part of FMD or are from batches generated prior to FMD coming into effect.

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)*.

If you have independent subsidiaries across one hospital trust, does each subsidiary need to be registered separately to the hospital in which it is located?

Please check which Location(s) are registered with the relevant professional or sectoral body (such as GPhC, CQC, NIS). SecurMed will provide individual credentials for each Location that is individually registered with the relevant body.

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.

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.

Should we contact SecurMed to infiliate to GS1?

No. Please contact GS1 directly.

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.

How long is my UK MVS Certificate available to download?

The UK MVS Certificate is only available for download for 60 days. Please store a local copy with your Password.

How do I test my software solution and verify it is ready to connect to the UK MVS?

SecurMed UK’s Blueprint System provider, Arvato Systems, employ a Baseline Testing process where software suppliers must test and verify their own solutions. A package of supporting documentation is available on the NMVS Software Supplier Portal.

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.

How will credentials be sent for Bulk Registrations?

Bulk Registration is for one or more Locations from one or more legal entities.

I am a Hospital Pharmacist. Where can I find more information on FMD tailored to my sector?

For more information, please visit the NHS Digital FMD Toolkit for Secondary Care. The NHS Special Pharmacy Service website is also a useful resource for Hospital Pharmacists.

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