Authorisations and Procedures Required for Importing Investigational Medicinal Products to Great Britain from Approved Countries

On 7 July 2021 the UK MHRA updated the guidance on authorisation and procedure requirements for importing IMPs to the UK.

Investigational Medicinal Products (IMPs) imported into Great Britain from a country on the ‘approved country for import’ list that have been QP certified in a country on the list will not require recertification in Great Britain.

From 1 January 2022 a UK Manufacturing and Import Authorisation (MIA(IMP)) will be required to verify that these IMPs have been certified by a Qualified Person (QP) in a listed country (the ‘oversight process’). This guidance describes what existing authorisation holders and new applicants should do to put procedures in place for the oversight process. It also describes how to apply for the required authorisation.

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