• RE: Marketing status - Cancel submission

    Processing of marketing status submissions is automatic, and therefore it is not possible to withdraw a submission, once this is completed, submitted and validated by the system. Of course, it is possible to create a new submission to reflect the new situation; this will overwrite the data stored for the individual presentations in each member state. 
  • RE: PIP Initial Submission and use of IRIS from 04 June 2024

    A final decision has still to be made on this issue, however it is likely that for submissions sent before 4 Jun the current (non-IRIS) process will apply, for validation and the initial assessment. Special arrangements may prove indicated for applications for initial Paediatric Investigation Plans, if a Request for Modifications is issued. Please check the What's New in IRIS forum regularly, closer to the go-live of IRIS for Paediatrics, for updated information. 
  • RE: GCP inspection

    For documents to be uploaded to IRIS submissions, XML-based file formats are preferred, e.g. .docx, .xlsx, .pptx.
    As described in the IRIS guide to applicants (creation of submissions), while there is no maximum number of files or global size, there is a size limit of 50 Mb per individual file. Please upload individual files for each document, rather than a single Zip file (or similar) for the set of all documents; it is possible to upload multiple files in a single operation.
    If appropriate, for example for literature references, you can merge several PDF files into a single one, using specific software, before uploading. A Zip file is recommended only as the container for the literature references, as an alternative to a single PDF; all other documents should be uploaded individually.
  • RE: GCP Inspection Managers

    GCP Inspections are run on an Authorization Medicinal product, not on an RPI, so the status and the ownership of the RPI is irrelevant and may be different from that of the Authorization product. As such, it cannot be the cause of your problem. Please note, however, that you can only add managers or contributors among IRIS Industry Portal Users who are affiliated (also) to the company which is the applicant/MAH for the Authorization Product, for reasons of confidentiality. 
  • RE: Substance registration - orphan designation

    It is indeed possible to apply for orphan designation without a rINN, but the preferred term of the substance involved must be sufficiently descriptive, and as such a company code is not sufficient. Please follow the recommendations of the EMA Substance names best practice document, and proceed to request a modification of the substance name in SMS. This will automatically update the name of your RPI in IRIS, which will allow validation of the submission for orphan designation.
  • RE: First placing on the market

  • RE: Uploading of newly authorised products

    Please consult the specific EMA page, Notifying a change of marketing status | European Medicines Agency (europa.eu), which reports the obligations of the Marketing Authorization holders and the procedure to fulfil them. 
  • RE: Unable to see Authorized Products

    In addition, please note the following:
    • When creating a new submission on behalf of an organisation, IRIS will show you a pop-up box that contains the list of all the (parent) organizations to which you are affiliated, with an IRIS Industry Manager role, which also shows the ORG-ID.
    • Once you select a location, IRIS will show you the authorisation products that are associated to that location, in accordance with the marketing authorization data. It is recommended that all Authorization Products are associated to a single location, which should be the one corresponding to the legal seat of the organization. If necessary, this requires an external procedure that is not currently managed in IRIS.  
  • RE: Unable to see Authorized Products

    For technical issues with IRIS, please Report an issue with IRIS in the EMA ServiceNow system. Please provide as much information as possible, including the procedure type, submission number, and relevant screenshots. 
  • RE: Follow-up scientific advice

    When creating a new submission in IRIS, on behalf of a specific Location of a parent Organization, the system will show RPIs and Regulatory entitlements belonging to that location. For follow-up Scientific Advice, this is described in page 22 of the IRIS Guidance for Applicants. For this reason, it is recommended that all RPIs and all REs belonging to an Organization are transferred to a single location, which should be the one matching the legal seat of the organisation. This simplifies the creation of new submissions in IRIS.