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Enforcement

UK FMD 2021 Changes

With the end of the transition period on 31st December 2020 the UK will leave the EU. Mainland UK then becomes a 3rd country, not part of the EU FMD system. End users such as pharmacists, hospitals and wholesalers and will no longer be able to verify or decommission FMD labelled medicines. Northern Ireland will continue use the European FMD system.

Any end user software including that from Serialogical will be refused connection to the UKNMVS from mainland UK but Northern Ireland users will continue to operate as they do now.

Packers who are supplying prescription products to the UK market will only need to continue to print FMD data on packs that are destined for Northern Ireland. As it is unlikely that the exact destination of a pack will be known when the pack is printed it is probable that FMD labelling will continue for the time being. It is just possible that some of the codes printed from 2021 onwards will not be uploaded to the UKMNVS because the manufacturer is absolutely certain that the related pack will not be dispensed in Northern Ireland.

Parallel importers who take packs from 1 market and re-label them for another will still need to use the FMD system. If a packet is to be re-labelled from a FMD compliant company to the UK the original code will need to be set as ‘exported’. If a UK pack is to be exported to a FMD using country the new label will need to include a FMD code that has been uploaded to the relevant destination country.

Existing codes can still be used for stock control and tracking processes. Serialogical software can be set to run in ‘off-line’ mode. Pack details are then read and stored locally either as plain text on in a database.

The UK government is working on a new bill, Medicines and Medical Devices Bill 2019-21. This will set a new framework for the regulation of UK medicines. This bill could allow the creation of a new system for tracking prescription medicines. In turn that system could be based on the existing FMD barcode solution. This would be a cost effective plan as the technology has already been developed and proven in practice.