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What is the MHRA FMD guidance?

Visit the MHRA FMD guidance. To sign up to the MHRA’s FMD Safety Features Newsletter, please contact the MHRA.

Does the EMVS and UK MVS cater for multi-market packs labelled and supplied to UKNI and Ireland?

Yes. Multi-market packs can be supplied to the UKNI, Ireland and Malta. The EMVS will know when multi-market packs are uploaded, which systems to send the pack data to, and will also manage the decommissioning activity between them.

What are the mixed-bulk transactions?

The G195 – Mixed Bulk process is used to submit a cache of individual transactions that have buffered while connection to the NMVS has been interrupted.

Why is the ‘mixed bulk transaction’ not available to Wholesalers?

The ‘mixed bulk transaction’ is a bulk of individual transactions, as opposed to a single transaction applied to a bulk of packs. It should only be used to enable cached individual transactions when connectivity has been interrupted.

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.

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.

Is IMT in the scope of baseline testing?

No, whether a pack is IMT or local does not affect the transaction that is submitted to the UKNI MVS nor the response, therefore IMT is not relevant for baseline testing.

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.

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.

Where can I find information about packaging and labelling changes as a result of FMD?

Where stakeholders are unclear on the proposed legislation, for example – packaging and labelling changes, please contact DHSC/MHRA at FMD. safetyfeatures@mhra. gov. uk

Please refer to the Pack Coding Guidelines issued by EMVS

Will the existing endpoints be available for testing purposes following the release of new endpoints?

Yes the existing endpoints will be available for a period, but you should develop your software at the earliest opportunity to the new version. Two versions of endpoints will be available at all times for backwards compatibility

Who will have to decommission homecare supplied drugs?

Where medicines are dispensed for a named patient as a homecare supplied drug, the medicine will be decommissioned by the homecare service provider ‘at the time of supply’ to that patient.

Can Pharmacies and Wholesalers sell data to IMS?

Pharmacies and Wholesalers will be able to sell dispensing data generated by their PMR and Wholesaler systems in the normal way.

Does resetting the password also require a new certificate?

No, the certificate remains valid for the user. Useful Resources:

Technical Bulletin: Certificate and Password Management Issues

 

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

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.

Which professional or sectoral registers are used to verify End User Locations?

SecurMed will provide individual credentials for each Location that is individually registered with the relevant body. This includes, (but is not limited to):

Pharma Services Northern Ireland (PSNI)
Wholesalers (EudraGDMP)
NI Direct
For more information, please visit our End User Registration Guide.  

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