My company has not yet submitted to the MHRA White List of products exempt from FMD charges. Can products still be added to the White List?

Yes. Article 46 of the Delegated Regulation (DR) notifies the commission of additional medicinal products that are at risk or not at risk of falsification.

All submissions must be made by the MHRA. Please contact the MHRA for information on how to submit.

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Software Development queries (Registered Software Suppliers only)

Please login to the Jira Service Desk and select ‘Service Request’ if your query relates to any of the following:

Software developer toolkit
Sandbox environment
Technical queries to support your software solution development activities
Software Supplier baseline testing
Alternatively, please contact the NMVS Helpdesk.

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.

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.

Is the Product Code (PC) taken from the Agency or can it be taken from MAH internal database assigned by GS1?

Please refer to the European Pack Coding Guidelines at the European Federation of Pharmaceutical Industries and Associations (EFPIA).

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.

Is aggregation data available in the NMVS/EMVS?

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.