ABPI response to new batch testing guidance

The MHRA has updated their guidance for the batch testing of imported medicines following the end of the Brexit transition period.

In response, Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry, said:

“For many companies, setting up new batch testing operations in two years would be challenging at the best of times. The impact of COVID-19 now makes that impossible.

“This pragmatic guidance means that companies won’t have to set up duplicative batch testing facilities immediately, and can instead focus on making sure medicines and vaccines get to patients in the UK, EU, and around the world.

“We will continue to engage constructively with our members and the government to ensure the outcome of any review supports the continued success of the UK’s life sciences sector.”

What does this mean for companies?

During negotiations for the Trade and Cooperation Agreement, the pharmaceutical industry urged the UK and the EU to sign a Mutual Recognition Agreement (MRA) for inspections, batch release and testing.

Ultimately, both sides agreed to mutually recognise inspections but did not agree to mutually recognise batch testing.

Setting up duplicative and unnecessary batch testing operations is a long, complex, and costly process. To support companies during the pandemic, the UK unilaterally waived batch testing requirements for products coming from the EU for two years, including for COVID-19 vaccines.

Today’s guidance means that instead of companies having to put duplicative batch testing in place for every product by December 2022, the UK government will stick to the current position of recognising batch testing from the EU/EEA for the time being. It now has to give companies two year's notice if it plans to move away from this position.

This notice can only be triggered after a comprehensive review of future batch testing requirements, which must be completed by December 2022. We look forward to fully engaging in this review in due course.  

The pharmaceutical industry continues to call on the UK and the EU to reach a full MRA.