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Counterfeit medicines

UK should remain temporarily connected to EU FMD database in a no-deal Brexit, SecurMed says

SecurMed, the not-for-profit organisation that manages the Falsified Medicines Directive in the UK, wants to remain temporarily connected to the European Medicines Verification System if the UK system is shut down in a no-deal Brexit

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Removing a country from the European Medicines Verification System could lead to each pack triggering an alert if medicines are decommissioned on import to the UK and then later shipped back to an EU country

The UK should remain temporarily connected to the EU-wide database that houses the Falsified Medicines Directive (FMD) in case of a no-deal Brexit, SecurMed — which manages FMD in the UK — has said.

SecurMed has proposed that it should remain connected to the European Medicines Verification System (EMVS) “in the short term”, as preparations are made for the eventual shutdown of the UK system. 

In June 2019, Martin Sawer, executive director of the Healthcare Distribution Association, told MPs that a no-deal Brexit could result in the UK being “unplugged” from FMD “because we’d have no access to the EU database that is based throughout the 28 countries”.

Then, on 14 October 2019, a statement from Rick Greville, chair of the SecurMed UK board, said the European Commission had confirmed that medicines must be decommissioned on the FMD system if they are exported to the UK from the EU.

The statement added that an amendment to EU exit regulations meant that a no-deal Brexit “removes the obligations on the UK supply chain to affix the safety features, upload unique identifier data, fund the repositories system or to scan packs of medicines”.

According to Greville, these rules impact SecurMed’s future — but may also impact the “functionality and integrity” of the EMVS as a whole.

The statement added that the European Medicines Verification Organisation (EMVO), which operates FMD across the EU, said that removing a national medicines verification system from the EMVS is “complex and significant”.

For example, errors could appear if multi-market packs — designed to be sold in more than one country — are decommissioned on import to the UK from the EU and then later reshipped back to an EU country. If the packs are not re-commissioned when they leave the UK, each pack will trigger an alert at the point where the pack is dispensed.

To avoid such errors and alerts, SecurMed said it “may be appropriate to retain a level of UK connectivity to the EMVS”.

As part of its proposal to retain short-term connectivity to the EMVS, SecurMed said that contracts with the EMVO and Arvato Systems, which implements the UK’s IT infrastructure for FMD, would be retained until the end of December 2019.

Greville told The Pharmaceutical Journal that retaining connection to the EMVS in the short term was unlikely to affect the UK supply chain and reiterated that all regulatory obligations on UK stakeholders would be removed in a no-deal scenario.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20207197

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