Posted Thu, 07 Nov 2024 12:03:54 GMT by Koen Peeters Manager, Global Regulatory Affairs
Once added, the enabling technologies can't be removed anymore. Please advise on how to correct this.
Posted Thu, 07 Nov 2024 20:18:37 GMT by Paolo Tomasi EMA
Thank you for this question, which offers us the chance to clarify that the behaviour described is in fact by design: applicants can only add new technologies, or therapeutic areas, to RPIs (research products), but not remove them. These attributes apply to the development product in general, and not to a specific application for a given condition. If an applicant has added an enabling technology or therapeutic area by mistake, it is necessary to send a request to remove the attribute, with a declaration that the specific item has not applied and will not apply, in the intention of the applicant, to the global development of the product.

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