Written Confirmations for Export to EEA and Northern Ireland of Active Substances Manufactured in Great Britain

A Written confirmation confirms that, for a third country exporting Active Substances to the EEA, the standards of Good Manufacturing Practice (GMP) are equivalent to those in the EU/EEA. From 1 January 2021, Great Britain will be recognised as a third country for the export of Active Substances for human use to the EEA. A Written confirmation will then be required for each shipment of Active Substance manufactured in Great Britain that is exported to the EEA and Northern Ireland.

Written confirmations will be generated for Active Substance manufacturers in Great Britain whether they intend to export Active Substances or not. No written confirmation will be issued, as this is already confirmed by the MHRA GMP certificate. A Written confirmation will not be required for the supply of Active Substance manufactured in Northern Ireland to Great Britain.

Written confirmations will not be generated for distributors of Active Substances that you did not manufacture. A Written Confirmation is valid for the same period as the corresponding GMP certificate. Where required the MHRA will offer an assessment to reissue GMP certificates of Active Substance manufacturing sites in Great Britain.

The Written confirmation will be sent to the contact named on your Active Substance registration. UK law requires a GMP certificate to be issued after an inspection and EU regulations require a Written confirmation for any import of Active Substances into the EEA by a third country.

Source: MHRA guideline on . Written Confirmations for export to EEA and Northern Ireland of Active Substances manufactured in Great Britain


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