Posted Wed, 06 Oct 2021 09:11:04 GMT by Patrizia Oelker Ms
Dear EMA colleague, as there have been no news from EMA via email distribution list after the IRIS webinar from Sept 10, I connected to IRIS looking for information. A post mentions IRIS is live for Inspections since Sept. 21st, but I do not find any guidance on how to navigate in IRIS to come to the right page. The user registration guidance available online is dated April 2021, so assumed not covering the Inspections module. Thanks in advance for clarifying the status.
Posted Thu, 07 Oct 2021 11:46:04 GMT by Paolo Tomasi EMA
There is no specific Inspections module. Once EMA starts an Inspection process, submissions will be created for applicants / holders of Marketing Authorisation, which are involved in the Inspection. These submissions will appear in the (existing) submission tab of the IRIS Industry Portal. The industry contact person for the product will be notified automatically via email. It is therefore recommended that the product contact person is kept up to date, using the existing procedures (Notifying EMA of changes to contact persons). The Industry contact person for the product needs to have an IRIS Industry Manager role, to access the submission. 

You must be signed in to post in this forum.