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RE: Marketing Status reporting implementation plan and baseline requirements
User Acceptance Testing of the Marketing Status component of IRIS is currently ongoing, and there is a tentative go-live date of end of May. -
NEW VERSION OF THE IRIS GUIDE TO REGISTRATION (AND RPI) PUBLISHED
A revised version of the "IRIS Guide to Registration" (including information on RPI principles and transfers) has been published on the IRIS Guidance and Support page.
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RE: Variations
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RE: Product name associated to RPI
Your understanding is correct: an RPI is intended for a single medicinal product/development, including fixed-dose combination products (FDCs). It is thus possible in IRIS to select more than one SMS substance when requesting a new RPI.
However, for separate products to be co-administered, or for so-called combination packs, separate RPIs should be requested.
There is no need for the requester to provide a "product name" to relate to the requested RPI: the name of the RPI is simply the name of the active substance, or the concatenation of the active substances in alphabetical order (if more than one).
Finally, there are currently no plans to make the list of EMA RPIs public. -
RE: RPI request - substances to select keep loading - no progress possible
The issue may be caused by a local setup problem - you may wish to check whether using a different computer and/or browser and/or network solves the issue. There have been cases where using Chrome instead of Safari has sorted the problem.
Otherwise, the way to proceed is indeed to report the issue via a Servicedesk ticket. -
RE: Reporting of marketing status - go-live date ?
We are hoping to put the system online by the end of April. -
RE: RMS Lists used in IRIS procedures
These are RMS lists used currently in IRIS, or which will be added shortly. In IRIS, all RMS lists are imported in a single data table, so additonal lists may be added with new releases of the tool (which normally occur every two weeks). Please note that the lists with the shorter number (9 digits only) are IRIS-only and not present in RMS.
Name List Id Age Range 100000000001 Anatomical Therapeutic Chemical classification system - Human 100000093533 Anatomical Therapeutic Chemical classification system - Veterinary 100000116677 Clinical Trial Design Elements 200000014686 Clinical Trial Inspection Outcome 100000075860 Clinical Trial Inspection Scope 100000075861 Clinical Trial Inspection Status 100000075862 Clinical Trial Methodology Elements 200000014631 Comparator Type 100000075863 Domain 100000000004 Dosage Form Term Type 100000073350 Eligibility for Centralised Procedure 100000116083 Enabling technologies 200000003244 Marketing Authorisation Application Legal Basis 100000116045 Medical Dictionary For Regulatory Activities 100000000006 Medicine Profile 200000003186 Nature of the Active Substance 200000003243 Non-Clinical Development Areas 200000014632 Organisation Role Type 220000000031 Pharmaceutical Dose Form 200000000004 Post-Authorisation Safety Study (PASS) category 123456789 Qualification Procedure - Context Biomarker 223456789 Qualification Procedure - Purpose Biomarker 223456788 Qualification Procedure - Questions Biomarker 223456787 Qualification Procedure - Type Biomarker 223456786 Quality Development Scientific Advice Topics 200000014608 Routes and Methods of Administration 100000073345 Scientific Advice - Consent to exchange documents 1000001555521 Scientific Advice Source 100000075871 Scope 100000072055 Scopes of Advice - Clinical 123456786 Scopes of Advice - Non-Clinical 123456787 Scopes of Advice - Quality 123456788 Submission Mode 100000155553 Substance Type 100000075826 Target Species 100000108853 Trial Categorisation 100000116653 Trial Design 100000075934 Trial Phase 100000075935 Trial Scope 100000075936 Trial Subjects Group 100000075937 Variation Classification 100000152091 Veterinary Dictionary For Drug Regulatory Activities 100000111593 -
RE: Q&As on IRIS registration, login and RPI requests
New Q&A on RPIs added:- An RPI has been assigned for one active substance to a company ("Company A"). This organisation does now reassign this RPI to another company ("Company B"). What is the consequence of this reassignment for Company A? I assume that both companies can use this RPI in parallel. Is this correct?
No, only company B can now use the RPI.
- Or does this mean that this RPI can be thereafter only be used by Company B and no longer by Company A?
Indeed, but company B can reassign back to company A at any time (including during a submission done by company B using the RPI, after it has been chosen and associated to the submission)
- In consequence, that this "reassignment" is essentially a transfer.
Indeed, that's why the process is called "transfer of RPI".
- Would is be possible that for an "old" and well-known active substance two companies assign RPI individually, i.e. that different RPI exist thereafter for the same active?
Yes, this is in fact the rule for off-patent products: separate RPIs for generic products. An RPI tracks a development programme, essentially, rather than a specific substance or fixed-dose combination. As a consequence, if the same (off-patent) substance is developed independently, this is reflected in different RPIs. At the same time, the same development programme for a (normally patented) product would maintain the same RPI, regardless of transfers of the product to a different developer, mergers, use of consultants, etc.
- An RPI has been assigned for one active substance to a company ("Company A"). This organisation does now reassign this RPI to another company ("Company B"). What is the consequence of this reassignment for Company A? I assume that both companies can use this RPI in parallel. Is this correct?
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Communication from EMA for IRIS submissions is directed to the "Portal contact" only
The communication model for IRIS is that while there can be any number of Industry managers and Industry contributors associated to a single submission, only one of them is the "submission contact", also called the "portal contact" i.e. the primary contact person to whom all communication is sent (by default) for a given submission. The default "submission contact" is the Industry manager who submits the application.
The "submission contact" role can be reassigned at any moment, and repeatedly, by any of the Industry managers associated to a draft or ongoing submission (but not for completed submissions). EMA users of the IRIS system will send communications only to the "submission contact", by default. This is for efficiency and security reasons.
Applicants can nominate additional Industry managers, and reassign the "submission contact" role as required, for example before a period of leave of the "submission contact". This can be done in IRIS, for draft or ongoing submissions, by clicking on the V to the right of the submission, and selecting "Manage submission contact".
In addition, applicants may also wish to set up appropriate auto-forwarding rules in the email system of the "submission contact".
IRIS is being built to allow applicants to self-manage their "submission contact" role for each draft or ongoing submission. In future, EMA plans to extend this concept to self-management of the contact person and contact data for interested parties assigned to Regulatory Entitlement, and potentially also for Authorisation Products. Changes will be made by sponsor/marketing authorisation holders directly in the IRIS Industry portal.
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RE: IRIS Industry Contributor
To do what you intend, the consultant would need first to get an affiliation to your organization as an IRIS Industry contributor. If you grant this role, the consultant will indeed be able to see all your RPIs. However, the consultant will not be able to create a new submission, nor withdraw an existing one.