Marine Baixauli

Could you please confirm if the submission of GMP inspection will be created under the MAH organization or the manufacturing site organization ? Should the contact person have access in IRIS to both organizations or is the access to the MAH organization enough?

<span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Could you please confirm whether we will receive:</span></span> <ul> <li><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">an Acknowledgement of Receipt from the Iris system each time we update a marketing status for a CAP e.g. if we add marketing cessation date(s) or marketing date(s) for one or several presentations of a CAP?</span></span></li> <li><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">And if an Acknowledgement of Receipt is sent by the Iris system what kind of information this document&nbsp;will provide: the date of the notification in Iris? And/or the presentation(s) for which the marketing status has been updated? And/or the type of marketing status change (marketing cessation or placing on the market) ?</span></span></li> </ul>

Thank you very much for your response Virginia. We want to share with you that on the basis of the prior responses available in the Forum about the “Marketing status reporting submissions”, we are now using the date of 1.1.1900 for the preparation of the baselines for products authorised before 20 November 2005 and for which the real date of initial placing in the market is unknow because the date "20 November 2005" was used for the submissions of Sunset Clause reporting. Indeed, we understand this situation is an exception allowing the use of the date 1.1.1900.



 

For products authorised before 20 November 2005 (new legislation) and for which the date "20 November 2005" was used for the sunset clause reporting until now (as start date of sunset clause reporting), can we keep this date in Iris for the baseline or do we have to provide the real date of the first placing on the market if it was before 20 November 2005 ?

Additionally, for new products not yet marketed, do we have to delete all the lines with “No data provided” or do we have to keep them?
 

Hello,

Would it be possible to clarify the go-live date for the reporting of marketing status in IRIS ? For now, I can only find "Q1" date with no additional details. 

Thank you very much for your help,
Kind regards,

Marine Baixauli