RPI for an academic

Nourredine Ait Rahmoune
Posted Fri, 28 Mar 2025 13:43:06 GMT by Nourredine Ait Rahmoune
Dear all
We are an academic sponsor and we would like to request a scientific advice  through the IRIS platform.
This concerns a clinical trial protocol in oncology. We use 3 products in this protocol. In IRIS we are asked for the 3 RPI, these are not our molecules and we do not have access to them. How can we fill in the submission form with the 2 RPI?
Thank you for your help.
 
Answer
Paolo Tomasi
Posted Fri, 28 Mar 2025 21:31:00 GMT by Paolo Tomasi EMA
Please note that substances in SMS are public and can be included in an RPI requested by any company. If you are planning to request SA for a co-administration protocol where one medicinal product of your company will be used, together with 2 other products of other companies, you only need an RPI for your product. You can then request the SA for that RPI and discuss the co-administration of the other two in the scientific document. If none of the 3 products is yours, please contact directly the Scientific Advice office (see page 23 of the IRIS guide to registration and RPIs v2.16). 

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