Posted Tue, 09 Apr 2024 10:19:04 GMT by Karishma Varsani
Posted Tue, 09 Apr 2024 17:01:23 GMT by Paolo Tomasi EMA
GCP Inspections are run on an Authorization Medicinal product, not on an RPI, so the status and the ownership of the RPI is irrelevant and may be different from that of the Authorization product. As such, it cannot be the cause of your problem. Please note, however, that you can only add managers or contributors among IRIS Industry Portal Users who are affiliated (also) to the company which is the applicant/MAH for the Authorization Product, for reasons of confidentiality. 

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