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RE: Paediatric Regulatory entitlements in IRIS (Decisions on PIPs and product-specific waivers)
No, regulatory entitlement numbers will not change once assigned after the agreement of the initial Paediatric Investigation Plan. -
RE: PIP - Full waiver: Completion of Scientific information section in IRIS
The fields you mention should not be visible in a request for a product-specific waiver. Please check that the submission type selected for the draft submission is the correct one (Product-specific waiver) - from a check of IRIS it seems that the only draft submission in your name is an Initial Paediatric Investigation Plan, not a waiver. Please note that you cannot change the submission type after creation of a submission, you need to delete the existing one and create a new submission of the correct type if the initial submission type is incorrect. If there are further issues, please raise an incident in Report an issue with IRIS, mentioning the submission number. -
RE: Clarification on Articles 33 and 35 for Paediatric Indication Marketing Obligations
These questions pertain to legal aspects of the Paediatric Regulation and are not relevant to the operation of IRIS. As such, please submit them via the appropriate channel, namely Ask EMA. In relation to the second question, you should clarify the name of the product and whether it is authorised centrally or non-centrally.
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RE: Change in the name of Active substance in OD
The name of the substance changes automatically if the preferred term changes in SMS. To provide an update to substance name(s) in SMS, please follow the procedure described in the IRIS guide to registration and RPIs v2.16. -
RE: Forum searchability
The search function in the IRIS Forums has not been activated yet. If you would like to have it, please request it with a ServiceDesk ticket, using the link at the bottom of this page (Report an issue with IRIS).
Meanwhile, please note that the Forum pages are public and are therefore crawled by all major search engines, such as Bing and Google. It should be possible to conduct specific searches by using the appropriate keywords and also "IRIS stakeholder forums" in the search. -
RE: Where can I find orphan maintenance reports
Completed submissions can be seen by the Industry IRIS users that were associated to those procedures, either because they created them or because they were added as IRIS Industry Manager specifically for a procedure. In addition, all completed, ongoing or draft procedures for an applicant can be seen by IRIS Users that have the IRIS affiliation as "IRIS Industry Coordinator". See chapter 5 in the IRIS guide to registration and RPIs v2.16 for further details on the various roles and permissions available in IRIS. -
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.
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