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Brexit response: Irish drugs regulator loosens packaging rules

UK pharmaceutical companies will have up to six months to change the packaging of their medicines if they decide to transfer marketing authorisations to Ireland as a result of Brexit, an Irish regulator has said.19 Dec 2018

EU law will prevent UK-based pharmaceutical companies from relying on their UK licence and certifications to supply goods into the EU market post-Brexit, unless an agreement is reached otherwise between the UK and remaining 27 EU countries. To continue supplying goods to the EU market, UK drugs manufacturers will need to transfer marketing authorisations to businesses based within the EU or wider European Economic Area (EEA), such as in Ireland.

Generally, when marketing authorisation licenses are transferred, drugs companies are obliged to update the information on their packaging to reflect the change. However, the Health Products Regulatory Authority (HPRA) said it will waive this requirement for up to six months for UK drugs manufacturers that transfer marketing authorisations to an Irish entity because of Brexit.

In its Brexit guidance, the HPRA said: "HPRA transfer procedures have recently been changed to allow MAHs up to six months to implement packaging changes following issue of the transferred authorisation, for Brexit related transfers. In addition the HPRA no longer requires stock to be recalled from wholesaler level six months following the issue of the transferred authorisation/ licence/registration."

A report by the Irish Times contained a further explanation, from an HPRA spokeswoman, for the loosening of the rules.

"Normally, where the licence holder changes, all packaging must be updated to reflect this prior to any further batch of that medicine being certified for the Irish market; this can take some time," the HPRA spokeswoman said, according to the report. "However, for licence transfers directly related to Brexit, and to facilitate continuity of supply, the HPRA has agreed that stock bearing the details of the UK-based licence holder can continue to be batch-certified for six months post transfer of the licence."

Karen Gallagher, a Dublin-based life sciences expert at Pinsent Masons, the law firm behind Out-Law.com, said the HPRA has sent "a clear message" to UK-based pharmaceutical companies "that Ireland is open for business".

"The HPRA has said it will be will be happy to receive requests to act as reference member state for all product types and that it will not impose a fee for switching from the UK to Ireland," Gallagher said. "The recent changes to the transfer procedures reflect the general policy of the HPRA of encouraging marketing authorisation holders to relocate to Ireland."

"Both the Irish and UK pharmaceutical industries have recently ramped up preparations for a 'no deal' scenario, and the HPRA is doing the same. The new packaging rules seek to make it easier for UK marketing authorisation holders to choose Ireland as reference member state as well as putting practical measures in place to ensure that supplies of medicines to the Irish market from the UK will not be interrupted post 29 March 2019," she said.