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EMA coordinated CHMP/CVMP requested GVP Inspections available on the IRIS Portal from 12-09-22
EMA coordinated CHMP/CVMP requested GVP Inspections available on the IRIS Portal from 12-09-22
Posted
Mon, 12 Sep 2022 08:10:54 GMT
by
Caterina Scarpati
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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