UK Changes Guidance on Testing Imports After End of Brexit Transition Period

In guidance published on September 1, 2020, the UK MHRA stated that the re-testing of medicines on importation into the UK would not be necessary if the medicine was manufactured and tested in the EU, EEA or MRA countries.

In a revision issued on September 25, this guidance was changed to time limit the exemption for re-testing of product from the EU/EEA to just 2 years after the end of the transition period; i.e. until January 1, 2023. See https://www.gov.uk/government/publications/list-of-approved-countries-for-authorised-human-medicines-from-1-january-2021--2/list-of-approved-countries-from-1-january-2021. The change is in the last paragraph of part 1.

This change has shocked and appalled the UK pharmaceutical industry. The BIA CEO is quoted as saying that this "small but significant change of guidance" was "unnecessary, ill considered, [and] goes against positions industry agreed with health ministers."