The industry has this week welcomed new guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA), which confirms that recognition by the UK of EU/EEA batch testing of imported medicines will not be ending on 1 January 2023 as previously agreed.
The guidance further confirms the introduction of a two-year notice period for potential changes to the current position, and an upcoming comprehensive review (to be held before 31 December 2022) to decide on a longer-term strategy.
Despite the industry's calls for a mutual recognition agreement during Brexit negotiations, the UK and the EU did not agree to mutually recognise batch testing. Given that setting up duplicative batch testing operations is a time-consuming, complex, and expensive process, the UK unilaterally waived batch testing requirements for products coming from the EU for two years, including for COVID-19 vaccines, to support companies during the pandemic.
The new guidance confirms that the UK will continue with its current position of recognising batch testing from the EU/EEA, and will give companies two years' notice if it plans to move away from this approach. Businesses will therefore not need to establish duplicative batch testing facilities immediately, and can instead remain focused on ensuring access to medicines and vaccines for patients in the UK, EU, and around the world.
Such continued recognition arrangements, along with the upcoming review and new notice period for changes, will provide the life sciences sector with much-needed certainty on the issue of batch testing in the short-term, although the industry continues to call on the UK and the EU to reach a full mutual recognition agreement to avoid unnecessary regulatory duplication in the long-term.
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