Written Confirmations for export of Active Substances manufactured in the UK Post Brexit

The MHRA have published new guidance today to assist manufacturers in the event that the 'no-deal Brexit'​ scenario happens in October.

18th June 2019

This guidance covers the conditions to be implemented for GMP documentation, for a third country (such as the UK would become) when exporting Active Substances to the EEA.

  • Written Confirmations will be generated for UK Active Substance manufacturers whether they intend to export Active Substances or not, they will automatically become available for download from the MHRA website.

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
  • the manufacturing plant is subject to regular inspections (which may be both announced and unannounced)
  • significant non-compliance events would be communicated to the EEA without delay

For further details please refer to the full MHRA guidance here

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