In Great Britain, pre-notification of studies is not currently required. However, it is a requirement for applications in Northern Ireland and the EU. Notification under Article 32b of the GFL is still necessary for stability studies and studies demonstrating the absence of viable cells and recombinant DNA from a production microorganism.
This applies even when data is submitted as certificates of analysis or as part of batch-to-batch variability analyses (EFSA FAQs practical arrangements). Applications will be deemed invalid if they do not include all pre-notified studies, unless a valid justification is provided for any omissions.