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‘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.

I’ve received my Software (TAN) Code via email but my Username and Password has not arrived by post. How long does this normally take?

Your Username and Password should arrive within five days of the email, addressed to the End User Location Contact at the End User Location provided during registration.

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.

If you have two dispensaries in the same hospital, do they each need a UKNI MVS Certificate?

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

FAQs on Alerts Portal for MAHs

As an MAH I do not have a recent alert ID to submit. Would it be possible to register?You can register using an alert on one of your GTINs / products from the past six weeks. The alert can be any type.

Does the master data (G101 Process) allow the software provider to differentiate between FMD and non-FMD products

The Master Data Download (G101) transaction allows positive confirmation that the product is in the system and is in scope of FMD.

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 PSNI). SecurMed will provide individual credentials for each Location that is individually registered with the relevant body.

Are EMA MAs the same as UK MHRA MAs?

No. European Marketing Authorisations (EMA) Marketing Authorisations (MAs) are issued by the EMA under the Centralised Procedure (CP) process. Once granted, this enables the MAH to market and distribute medicines within all EU member states without an additional local UK MA.

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

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

How do I test my software solution and verify it is ready to connect to the UKNI 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.

How do I register as a software supplier and get access to the Arvato developers toolkit (SDK)?

Software suppliers may register for the SDK on the NMVS Software Supplier Portal.

What happens to medicines that are intended for one market when they are then sold to a new market under an Art.126a/Exceptional MA?

First, the pharmacist scans the medicine to decommission. This sends a message to the relevant NMVS of the new market. As this NMVS will not yet contain pack data, they will then query the number with the EMVO.

Will manufacturers and wholesalers be able to see data on products I have dispensed?

No. The Delegated Regulation asserts that all parties that are connected to the repositories system, including manufacturers, wholesalers and pharmacies, have sole responsibility, ownership and access to any data that they generate.

Can Pharmacists still dispense products without serialisation after 9th February 2019?

Yes – but only until all the stock which was batch released before 9th February 2019 is depleted.

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