Problem with the form generated for PIP Annual Report Submissions

Dear IRIS Team,

I have encountered some discrepancies during the submission of the PIP Annual Report in the IRIS portal. The generated eAF appears to be tailored for an Initial PIP rather than the annual report. Could you please clarify if this is a technical issue, or if it is expected that the eAF for the Annual Report generates sections specific to the initial PIP? 

Specifically, I have noticed the following:

1. Present in Generated Application Form but Not Available to be Filled in IRIS:

   • Procedural Information
   • Completion of Pharmacokinetic Studies in Adults
   • Details on Each Proposed Study/Measure Including Key Elements
   • Waivers
   • Quality Aspects

2. Available Online in IRIS Portal but Not Captured in Downloaded eAF:

   • Annual Report Details
   • Marketing Authorization Information
   • Development Progression

Please find attached screenshots from downloaded eAF for your kind reference.

 

This appears to be a bug. The correct form for annual reports on PIP deferred measures was implemented in IRIS in August this year. A bug ticket has been raised to address this report (Bug 221890). 

Thank you for your prompt response. Could you please provide an estimated timeline for when this bug is expected to be resolved? Understanding the timeframe will help us plan our submissions accordingly.

Unfortunately it is not possible to provide an estimated timeline. The bug is likely to be assigned a medium to low priority, since it does not prevent in any way the correct submission and processing of the annual reports on deferred measures. The Word form is simply a download of the structured data in the database, which are derived from the portal submission. You can therefore submit the annual reports at their normal deadline, whether the bug has been fixed or not.