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Each healthcare institution, pharmacy and wholesaler will need to purchase the equipment required to enable it to scan the unique identifier and undertake verification and decommissioning.
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.
No. The Delegated Regulation asserts that all parties that are connected to the repositories system, including manufacturers, wholesalers and pharmacies, have sole responsibility, ownership and access to any data that they generate.
The End User Password is valid for 365 days after registration or a reset. In the 30 days prior to the Password expiry date, the UK MVS generates a message to inform the End User Location Contact that the Password must be changed.
Please refer to the European Pack Coding Guidelines at the European Federation of Pharmaceutical Industries and Associations (EFPIA).
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.
Please refer to the Quick Start Guide:
Quick Start Guide
Further information can be found in the Technical Bulletin:
Technical Bulletin: Certificate and Password Management Issues
No. European Marketing Authorisations (EMA) Marketing Authorisations (MAs) are issued by the EMA under the Centralised Procedure (CP) process. Once granted, this enables the MAH to market and distribute medicines within all EU member states without an additional local UK MA.
The UK pack labelling requirements are: – Product code in GTIN format – Batch Number – Expiry Date – Unique serialisation number – 2D matrix.
Guidance has been issued about how to manage alerts on the Community Pharmacy FMDsource website and on the NHS Digital FMD site.
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.
The EU Commission Q&A on FMD can be found on the European Commission site.
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.
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.
Verification is a process that can take place at any time during movement of the medicine through the supply chain.
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