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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.

Where can I find the EU Commission Q&A on FMD?

The EU Commission Q&A on FMD can be found on the European Commission site.

Can the initial certificate download be done via the web service?

Yes, this service is available. Useful resources:

Technical Bulletin: Certificate and Password Management Issues

How can I prevent my UKNI MVS account being locked?

Your UKNI MVS account will be automatically locked if you try to access the system using an incorrect Password three times.

When using Bulk Registration for onboarding Locations, can our organisation/company or Software Supplier provide authorisation on behalf of all Locations in a single notification?

Authorisation is required from each legal entity, for all its Locations. If you submit a Bulk Registration for multiple legal entities, the EULA can only be accepted once for each entity, so please ensure you have permission from each of them before submission.

Bulk Registrations: Will each Location have unique credentials?

Bulk Registrations are suitable for multiple organisations/companies within the same legal entity at the same time. Each organisation/company will be an individual End User Location and will therefore have its own Username and UKNI MVS Certificate.

Does the WDA holder need to connect to the EMVS?

No. Unless the WDA holder is also an MAH or a Parallel Distributor, there is no need to connect to the EMVS.

What are the UKNI pack labelling requirements?

The Northern Ireland pack labelling requirements are: – Product code in GTIN format – Batch Number – Expiry Date – Unique serialisation number – 2D matrix.

Are medical devices in the scope of serialisation?

If the medicine associated with a device has an MA and is included in the list or products within scope (virtually all POMs) then under the FMD, it should be labelled with safety features.

What is the EMVO and how can I contact them?

The European Medicines Verfication Organsiation (EMVO) is a Belgian non-profit organisation representing stakeholders united in securing the legal supply chain from falsified medicines. For more details go to their website.

How does a company affiliate to GS1?

Contact the GS1 organisation in your respective country or at www. gs1. org/contact

What do I do when the NMVS returns an Alert?

Refer to your SOP and/or guidance on FMD Source or RPS. To progress the investigation of an Alert with SecurMed UK please click here.

Do we need to implement bulk transactions in our Wholesaler software?

We expect Wholesaler solutions to include bulk transactions and the baseline testing process includes single and bulk transactions. If you feel that your use case does not warrant bulk transactions contact tech@securmed. org. uk to confirm.

Has the password expiry changed from 90 days to 365?

Yes. SecurMed UK has configured UKNI MVS passwords to expire 365 days after a change.

A manufacturer has a WDA as does its 3rd Party Logistics (3PL) provider. Can the manufacturer decommission the medicines?

The MHRA does not allow direct decommissioning by manufacturers in the NMVS or EMVS for Article 23 customers.

How many manufacturers are now supplying codes to SecurMed UK?

Product, Batch and Pack data started being transmitted to the UKNI MVS when SecurMed UK was connected to the European Hub (EMVS) on 31st October 2018. Data for millions of packs is already downloaded.

What is Peppol?

Pan-European Public Procurement OnLine (PEPPOL) enables government organisations such as the NHS, and private companies, to exchange electronic trading documents over an interoperable, European-wide network. It offers a standardised network connection for electronic ordering, invoicing and shipping. For more information, please visit NHS Scan4Safety.

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