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EMA coordinated CHMP/CVMP requested GVP Inspections available on the IRIS Portal from 12/09/22
EMA is pleased to announce the launch of the GVP Inspections feature in the IRIS platform. With the implementation of this new feature, Marketing Authorisation Applicants/Holders as well as EU/EEA inspectorates will be able to interact with EMA via a single portal for the exchange of documents and information on GVP Inspections procedures.
This is expected to streamline the Inspection co-ordination process, ensure more secure information exchanges, and increase data quality through integration with other EMA master data systems (e.g. SPOR).
For more information please check the updated IRIS guide for applicants and the Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections co-ordinated by EMA.
Kindly note a recording from the training session on GVP for Industry users will be made available from the IRIS portal section “Additional guidance & training videos”.
If you have general questions with regard to the IRIS feature on GVP Inspections, please post a new thread in the IRIS Forum “General Discussion and Self-Help”. If you have technical questions or issues please raise a ticket via the new EMA ServiceNow system.
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RE: Updated IRIS guide for applicants - Registering an i-SPOC
Yes, a person with "Industry manager" role can nominate himself/herself for MAH i-SPOC (only consideration is that the user should be affiliated in IAM).
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RE: The webhook call failed because the http request received non-success
For this kind of technical issue, you should submit your request to the EMA Service Desk by using the EMA Service Desk Portal.
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