P.A.Pharmaceutical organizations have warned that Northern Ireland could face shortages of some medicines unless implementation of the Windsor Framework is delayed.
The framework is a post-Brexit agreement between the EU and the UK that governs trade between the UK and Northern Ireland.
The new requirements for drug labeling will come into effect from January 1, 2025.
However, the British Generic Manufacturers Association (BGMA) said not all suppliers would be ready.
“Serving the patient’s best interests, not bureaucracy”
It is understood that the UK government is confident that transitional measures will avoid disruption and has no plans to ask the EU for an extension.
BGMA’s concerns were first reported by the Financial Times.
BGMA CEO Mark Samuels said the industry was “fully supportive” of the framework and the intentions behind the labeling changes.
However, he added that the changes were more complex and time-consuming than expected.
“We are in an absurd situation where patients in Northern Ireland are unable to access millions of packs of medicines due to technical and artificial deadlines, when shortages are already at record levels. “We need to serve the best interests of patients, not bureaucracy,” he said.
The supply of medicines from GB to NI is one of the most complex post-Brexit issues, and the original agreement reached in 2019 has been amended several times.
The Windsor Framework included an agreement that would allow manufacturers to produce a single pack of medicines for the whole of the UK, including Northern Ireland.
This means that the relevant medicines must be labeled as ‘UK only’.
It may sound relatively trivial, but manufacturers have warned that previous plans to require Northern Ireland-specific labeling were commercially unviable and would lead to the withdrawal of some products. was.
BGMA said operational work at the factory to prepare the new “UK only” packaging was “nearly complete on 1 January, but there will be an unavoidable impact in the first half of 2025”.
Mr Samuel said he was calling on the government and the European Commission not to implement the new rules from January 1 “because of the potentially serious consequences for patients”.
Other aspects of the Windsor Framework include: already late.
