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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.

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.

I have forgotten my Password. How do I reset it?

Your UK MVS Certificate must be installed locally to be able to reset your Password. You can only reset your Password using the UK MVS GUI.

Error 403 forbidden - what does it mean?

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

Solution

UK MVS Certificate has expired (two years)

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

Do dental pharmaceuticals companies, dental wholesalers or dentists need to comply with the FMD regulatory requirements?

Pharmaceutical companies manufacturing or supplying prescription only dental pharmaceuticals will need to comply with the FMD regulatory requirements. Dental pharmaceutical wholesalers will need to comply with the FMD regulation where they also supply human medicines as those medicines may be returned from dental practitioners.

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 does a company affiliate to GS1?

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

How many manufacturers are now supplying codes to SecurMed UK?

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

Is aggregation data available in the NMVS/EMS?

Aggregation data is not available in the NMVS/EMVS. Off-system solutions may be available dependent on the particular supply chain system. Further guidance is expected from the UK NCAs (DHSC/MHRA) who can be contacted at fmd. safetyfeatures@mhra. gov. uk.

Is aggregation permitted, in particular for use of downstream wholesalers?

The Delegated Regulation allows for aggregation but does not stipulate the need for pack aggregation and the EMVS / NMVS system does not support aggregation. It is for manufacturers and MAHs to decide unilaterally whether their IT functionality extends to aggregation of pack data.

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

The UK 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.

What are the UK pack labelling requirements?

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

What happens in the result of a negative response to a pack scan?

Guidance has been issued about how to manage alerts on the Community Pharmacy FMDsource website and on the NHS Digital FMD site.      

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.

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