New guidance on authorisations and procedures required for importing Investigational Medicinal Products to Great Britain from approved countries

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 QP in a listed country (the ‘oversight process’). The new guidance describes what existing authorisation holders and new applicants should do to put procedures in place for the oversight process and how to apply for the required authorisation.
_{July 13, 2021}