BREXIT? NI EXIT? WHAT’S NEXT?
With the ‘Brexit’ effect causing ongoing supply issues with food items such as gluten-free bread and baby foods - and some specials’ suppliers pulling out of NI, PiF shows you how to ‘keep it legal’…
M
ost pharmacies are – gradually - getting to grips with the effects of Brexit, and the Trader Support Service
(TSS) and Department of Health (DoH) assistance have been invaluable.
While there are some issues – pharmacists are being told, for example, that they need an importer declaration, but are not being told who the supplier is. Also, the fact that NI’s community pharmacy is also tied to the English drug tariff means that a number of items will cease generating surplus, possibly even creating losses.
To avoid confusion, PiF asked the DoH for advice as to what pharmacists should be doing.
Current situation ‘Medicines for the NI market,’ a DOH spokesman told us, ‘must follow EU acquis as a requisite of the NI Protocol. This means supplies of medicines from GB require batch testing, Qualified Person checks and must follow FMD requirements after the end of the grace period, from 1st January 2022.
‘Import declarations on goods coming from GB to NI is another requisite of the NI Protocol. There
COMMENT Dr Turlough Hamill, Managing Director, Purepharm
As the dust begins to settle after Brexit, the challenges being placed upon Marketing Authorisation Holders to continue supply to Northern Ireland and the EU at the end of the derogation period are becoming more apparent. The unique position in which Northern Ireland finds itself clearly has resulted in challenges, but also opportunities to maintain access to historic EU markets as we remain under EU ‘acquis’ for pharmaceuticals.
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Huge work has been undertaken by DOH, MHRA and the pharmaceutical industry to mitigate the issues which have arisen as a result of Brexit.
Whilst significant uncertainty remains around many aspects of the post-derogation period environment, it’s clear that manufacturers will legally be able to continue supply NI. The great question is - will they continue to do so?
Cost and complexity is being added to a supply chain that already works on low margins in the generic sphere especially. We must remember that NI is similar to Kent in population so makes up around three per cent of the UK market and the margins available from low-price generics may simply not render them viable. Whilst we remain tethered to the English tariff, the commercial viability of many such lines remains questionable - to say the least.
are currently exemptions on these requirements for parcels with goods under £135 to businesses in NI and goods sent to residents in NI using express carriers until 31 March 2021.
‘DoH is working with the pharmaceutical industry and wider supply chain, such as wholesalers, to ensure the continued supply of medicines into NI and helping to identify possible solutions to meet the regulatory requirements from 1st January 2022. Ultimately these decisions need to be made by individual companies based on their portfolios to meet these requirements.’
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