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RE: RPI for an academic
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). -
RE: Product specific waiver
The question is not completely clear, but it does not seem to be related to IRIS. Product-specific waivers (and Paediatric Investigation plans) are granted for specific conditions, they do not cover all possible indications and conditions for a given product. Please also consult available information in Paediatric investigation plans | European Medicines Agency (EMA). For more specific issues, please submit your question with as much detail as possible, toAsk EMA. -
RE: Combination product with separate RPIs
Dear Daniel Sargon, what you describe is a "combination pack". In such case, a single RPI is sufficient. However, please be aware that combination packs are only exceptionally acceptable in the centralised procedures and are subjected to special rules. Please see section 1.11 of European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. If the Request for Acceptability is not approved, this may have consequences on the RPI, which could be split, and for any related Regulatory Entitlement. -
RE: Transfer of Scientific Advice
It is not necessary to upload any document for a transfer of Scientific Advice (or a PIP or waiver regulatory entitlement). These procedures are entirely automated, and even if a document is uploaded, it will not affect the outcome. However, you need to click on the specific tab and then confirm that "all" necessary documents have been uploaded, i.e. none in these cases. -
RE: Acknowledgment of Day+25 PI submission
When you upload a document in an IRIS submission via the IRIS portal, the document remains visible indefinitely in the tab "Documents from applicant". You can check the document there at any time, and if necessary, download it. IRIS does not send an acknowledgement for every document uploaded by applicants into the system. -
RE: Procedure Number vs Submission Number
Yes, your understanding is correct. -
RE: update substance name
Please consult the "IRIS guide to Registration, Substances and RPIs", available in the IRIS Portal (pages 19 to 25). -
RE: PIP Annual Report
In answer to the questions:- There is no need to provide additional documents in an annual report on PIP deferred measures. The information in the portal forms is sufficient. If the applicant desires, it is possible to provide additional documents with the submission, but this is optional.
- There can be two possible situations:
- The study has already started: please put the actual start date of the study (for clinical trials, this is usually first patient first visit)
- The study has not started yet: please put the currently planned date of start, regardless of what was agreed in the PIP (if anything).
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RE: Paediatric submissions in IRIS: one condition per submission
Current legislation does not explicitly prevent a single EMA decision from covering multiple conditions with a paediatric investigation plan and/or product-specific waiver(s), even if this may not be in the applicant's best interest. As such, if an applicant desires to modify an existing PIP regulatory entitlement covering multiple conditions, this is still possible; it is sufficient to submit the application on the basis of the existing Regulatory Entitlement. Alternatively, the applicant may decide to "split" the PIP decision beforehand. For further information on the likely consequences of each course of actions, please see the following documents available on the EMA website: -
RE: IRIS Roles from Multiple Organizations
IRIS works on a system of affiliation to organisations, which is not linked to any contractual relationship of IRIS users with any particular organisation. Affiliation is under the control of the organisations, each of which has to nominate an initial "Admin User", in charge of allowing future affiliations. In this particular case, you can be added to the submission as a contributor or manager for that submission if you are also affiliated to the CRO in question, with an IRIS role, in addition to the company where you already have an IRIS affiliation and role.
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