Regulatory Focus™ > News Articles > 8 > No-Deal Brexit Scenario: UK Gov Calls to Stockpile Medicines

No-Deal Brexit Scenario: UK Gov Calls to Stockpile Medicines

Posted 23 August 2018 | By Zachary Brennan 

No-Deal Brexit Scenario: UK Gov Calls to Stockpile Medicines

UK Health and Social Care Secretary Matt Hancock on Thursday sent letters to the pharmaceutical and medical device industries to warn about what’s to come in what it says is “the unlikely event of a no-deal Brexit.”

The letter to pharmaceutical companies calls for an increase in medicine stockpiles by at least six weeks on top of their usual stocks by 29 March 2019 and to ensure plans are in place to air freight products with a short shelf life that cannot be stockpiled to avoid any border delays that may arise.

“In the unlikely event we leave the EU without a deal in March 2019, based on the current cross Government planning scenario we will ensure the UK has an additional six weeks supply of medicines in case imports from the EU through certain routes are affected,” the letter says.

Also, if there is a no-deal Brexit scenario as of March 2019, the UK will continue to accept products that have been batch tested and released in accordance with EU rules, the letter adds. “This means there will be no requirement for any further manufacturer led batch testing and release of medicines in the UK,” Hancock writes.

Companies are requested to respond to the letter by 10 September via an email they will receive in the next 24 hours.

The UK-based BioIndustry Association said in a statement Thursday: "A ‘no deal’ Brexit would mean the biggest disintegration of the complex regulated medicines market in Europe in terms of regulation, cross border movement of goods, comparative pricing and intellectual property. On behalf of patients we encourage all participants to be as prepared as possible for a scenario industry really does not want, but we should be under no illusions that this will be easy or smooth.”

As far as medical devices, Hancock writes that separate contingency plans are being developed and stock holding at a national level will be increased. More information will be provided to industry in September, the letter says.

The letter follows the UK’s Medicines & Healthcare products Regulatory Agency explanation from earlier this month on what pharmaceutical and medical device companies can expect during the period that the Brexit agreement is implemented. The European Medicines Agency has also issued its own guidance for pharmaceutical companies.

DHSC publishes Brexit guidance for pharmaceutical industry and suppliers of medical devices

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe