I am designing my software solution connection to the NMVS. Are Concentrator/Aggregator type architectures acceptable in the UK?

Following consultation with UK national competent authorities we can provide some clarification on connection methodologies:

Software solutions for the wholesaler and dispensing communities must provide for transparency of end-user locations (i.e. physical location, place of business, registered premises) and therefore direct connection to the NMVS where the certificate is stored on the terminal, is the preferred methodology.

Where thin-client/aggregator/concentrator type architecture is used, alignment between certificate and location may be maintained via a centralised certificate-management application.

Compliant operation of this type of system will rely on accurate association of credentials (User-ID, Password and Certificate) with a single Location.

For clarity, ‘Hiding’ of locations behind a single connection to a central system (User ID obscured to the NMVS) will not be compliant.

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EU Exit and UK MVS

The United Kingdom formally departed from the European Union on 31st January 2020, entering into a Transition Period lasting until 31st December 2020.

First Login to UK MVS - Quick Start Guide - Step 1

Ready to log in to the UK MVS?  Please follow the links to instructions below.

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.

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.