A no-deal Brexit threatens to derail plans to help remove over a million units of counterfeit medicines per year from the Irish market.
The upcoming Falsified Medicines Directive (FMD) will introduce a range of measures to ensure that every pharmaceutical product reaching the consumer is fit for consumption.
From February 9, all medicines must be scanned and authenticated by pharmacists before being dispensed, making it illegal to sell any products not registered by manufacturers on the European Medicines Verification System.
However, UK access to the EU database will be revoked in the case of a hard Brexit, according to industry expert John Cahill of PharmaLex.
In 2017, more than one million dosage units of counterfeit or substandard medicines destined for the Irish market were detained by authorities, including steroids, sedatives, erectile dysfunction pills and cancer medication.
"Without access to this data hub, UK pharmaceutical manufacturers and distributors will be unable to work within the FMD's authentication system and their legal obligation to adhere to the new regulations would be removed," he said.
The Irish Government has abandoned its policy of keeping out of Theresa May's way by staying out of the Brexit debate in the UK. In November a directive was issued to TDs, senators, MEPs and ministers to steer clear of British media in a bid to take the heat out of the negotiations.