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RE: Questions on access to IRIS for Product Contacts (for Inspections procedures)
We have received this email in connection with an marketing authorization application. The person handling the correspodence with the EMA regarding this submission is an external regulatory service provider, would be possible to restrict access to IRIS (and the view of all other current and past submission) for such an external provider only to the submission regarding the marketing authorization?
Will only the person handling the correspondences with the EMA notified by email of a planned inspection or also the contact at the sponsor?