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RE: Non-EU based consultants
Yes and yes. This is from a technical point of view, but keep in mind the legal requirements and procedural rules for each submission category, such as orphan designations and scientific advice. -
RE: IRIS Release Information - Week of 14 September 2020
The inclusion of the "Entitlement Status" column and its filter have been added to the IRIS backlog. -
RE: Technical specification
I have asked out IT colleagues to look into your request. Bear in mind, however, that for example the picklist values are dynamic, as they reflect RMS lists from SPOR; every time the RMS list changes, the picklist is automatically updated. -
RE: Technical specification
Please specify more in detail what you intend by this, and what you need to know. Are you referring to the requirements to use the IRIS online platform, to create and submit applications? -
RE: Scientific Advice follow up submission
Submissions are evaluated according to the SAWP timeline, which you can find in the two documents with the 2020 and 2021 deadlines and timelines in this page. -
RE: draft briefing document
The feature appears within the draft submission. You need to create a draft submission, and then select the appropriate option. -
Online training on submitting scientific advice applications (human medicines) published
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RE: Scientific Advice go-live update including training schedule
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RE: Scientific Advice follow up submission
You can submit an application through IRIS at any time -
RE: SA Process, Dates of SAWP meetings and IRIS
Your understanding is correct.- An application for Scientific Advice (or any other procedure) can be submitted at any time, the deadline only determines at which SAWP (COMP) meeting the submission will be discussed the first time.
- After submission, the application is indeed locked and cannot be edited unless reopened by EMA (for example to make changes needed for validation). If the submission is unlocked by EMA before validation, all data can be changed, and documents can be overwritten or added (they cannot be removed after submission). If the submission is unlocked after validation and start date, the data cannot be edited but documents can still be overwritten or added (but not deleted). A document can be deleted from a submission only if the submission is in "draft" state (i.e. before being submitted to EMA for the first time).