Are we sleep-walking into a Healthcare Crisis in Northern Ireland?

by | Feb 25, 2021 | Blog, Brexit

There is much discussion at all levels at the moment about the Withdrawal Agreement and Post Brexit trading in relation to Northern Ireland. One area that keeps cropping up in discussions I am having is to do with licensed Medicinal Products for the province. Under the Withdrawal Agreement, Prescription product supplied in Northern Ireland must continue to be serialised and batch data uploaded into the EMVS.

In the short-term manufacturers can serialise all UK stock and upload batch data, with stock used in GB dropping off the database at expiry and Northern Irish stock being de-commissioned at the point of supply, as before. If, and when, stock used in GB must be decommissioned or not commissioned in the first place, manufacturers will effectively have to hold two inventories of the same product. Whilst that doesn’t sound too complicated, the operational cost and complexity of this can be considerable compared with the value of the product. Struggling to make the sums add up I am already aware of discussions about simply discontinuing supply into Northern Ireland. If we are not careful unilateral decisions made at a company level could seriously impact the integrity of supplies within Northern Ireland.

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Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it see… Read more
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