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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.

Will the Certificate renewal email be sent to the Requestor or the Location?

The renewal email is sent automatically by the UKNI MVS to the End User Location Contact email address provided at the time of registration, unless this has since been changed.

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

I am a Manufacturer – where can I find more information?

More information is available from the British Generic Manufacturers Association (BGMA).

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.

Is there any order that the text has to appear in the 2D Matrix or as ‘human readable’ on the pack?

Northern Ireland does not require the text to appear in any particular order in the 2D matrix or on the pack. Changes to packs need to be submitted to the MHRA in the usual manner for approval.

Error 403 forbidden - what does it mean?

This error code occurs because the UKNI MVS cannot find the TAN Certificate. Problem

Solution

UKNI MVS Certificate has expired (two years)

Contact the SecurMed Service Desk to request a new Software (TAN) Code.

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.

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.

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.

Does the UK GTIN product code require 13 or 14 characters?

GTIN product codes require 14 characters. For more information, please refer to the EMVS Pack Coding Guidelines.

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.

What is the difference between decommissioning and verification?

Verification is a process that can take place at any time during movement of the medicine through the supply chain.

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.

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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