CEO Update | 20 December 2021

Best wishes of the season from everyone at BIA. It has been fantastic working with you in 2021 and we would like to take this opportunity to thank you for your support throughout the year. Wishing you a happy, healthy and prosperous 2022!

For those following the implications of the Northern Ireland Protocol discussions with regard to medicines there was significant development on Friday. I’m delighted the practical voice of industry, a coalition we’ve been active in for years, has been listened to. We are working up a full brief on the implications but practically speaking this will mean for companies that:

  • On Falsified Medicines Directive, there will be an extension to the existing derogation on all medicines for three years from 1 January 2021.
  • Regulatory importation requirements will be removed for all medicines moving between Great Britain and Northern Ireland from 1 January 2021. This is not time limited.
  • Companies can continue to choose whether to license generic medicines (MR/DCP) either through the EU’s process or using the UK national process.
  • Companies will also be able to use regulatory functions such as an MAH or QP based in GB for EU MR/DCP applications for Northern Ireland.
  • For new novel medicines (CAPs), companies will, in the future, be able to make use of a new bridging mechanism to ensure their product is licensed for the whole of the UK if the MHRA licences a product before the EMA.

The UK’s statement can be found here

The EU’s statement can be found here.

Lord Frost has now resigned from the UK government and Liz Truss takes up the UK negotiator role.

The UK Department of Health will be hosting an industry wide webinar on Tuesday 21 December at 3pm with colleagues from the Department and MHRA. Register for the webinar

Steve Bates OBE
CEO, BioIndustry Association

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