Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland

On 7 February 2022 the MHRA updated guidance on how to implement the ‘Written Confirmation’ process for 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
  • 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

A template for the Written Confirmation can be found on the European Commission website. The requirement for the Written Confirmation is stated in Article 46b(2)(b) of Directive 2001/83/EC.

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