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How to use the EMA IRIS portal to ensure timely submissions

Submitting your scientific advice (SA), orphan drug designation (ODD) or Innovation Task Force (ITF) consultation to the EMA? Avoid delays with our submission recommendations.

In the EU, 90% of interactions with European Medicines Agency (EMA) must be done through various online platforms, like IRIS, the portal for submitting scientific advice (SA), orphan drug designations (ODD), and Innovation Task Force (ITF) consultations. These submissions must be done at specific times designated by EMA, and any unexpected challenges using the IRIS platform can delay your timeline by a month or more.  

EMA SA, ODD, and ITF are critical regulatory tools offered by EMA to guide companies in their drug development. Alira Health has extensive experience engaging with regulators and supporting companies as they prepare their interactions with EMA, developing scientific advice briefing packs, ITF consultations, and ODD dossiers.  

Articles
Published on:
July 14, 2022
Written by:
Oriane Courbier, Marie-Aude Ohresser
These five recommendations can help you ensure a timely submission. Timeliness alone is not a guarantee for a successful submission—the content of your dossier is essential.
Marie-Aude Ohresser, Pharm.D Vice President, Regulatory Affairs

Preparation is key for these interactions, as well as understanding the submission process.  Once you’ve created your EMA account, here are our recommendations for successful submissions: 

  1. Plan ahead: Register your organization in the Organization Management Service (OMS) portal. If your company is not registered in the OMS portal, you will need to “request a new organization” which can take up to 10 business days.  
  1. Be sure to choose the correct roles in IRIS. Multiple roles can be requested in IRIS. The first person needs to be the IRIS Industry User Admin. This first role is reviewed and approved by the EMA, which can take up to two business days. Other roles can then be requested and approved by your Industry User Admin, including IRIS Industry/Parallel Distribution Manager/Contributor. 
  1. Confirm product substances are registered in the EMA public list of all substances. If you cannot find the appropriate substance(s) in the EMA list of substances, you will need to complete a form and raise a request to include the substance in the Substance Management Service (SMS) database. Any substance(s) in the product must be registered in the EMA SMS database before submission to IRIS. This can take up to 10 business days.
  1. Ensure you have a Research Product Identifier (RPI). An RPI identifies a potential new or previously authorized medicinal product developed for one or more conditions by a single company, or by multiple companies in parallel and under an agreement. If your RPI is not for a single medicinal product, you will need to seek assistance from the ITF or scientific advice office, which takes approximately four business days. 
  1. Get a valid EMA customer account number from the EMA account team. Your EMA account number is a required, unique reference number provided by the EMA for financial matters. If you’re using the IRIS portal for the first time, you’ll need to contact the EMA account team first to get your account number. 
Regulatory Expertise

The five recommendations we shared above can help you ensure a timely submission. Timeliness alone is not a guarantee for a successful submission—the content of your dossier is essential. We at Alira Health can help you define the right time and content for successful interactions with regulators. Our regulatory team’s extensive track record includes over 30 SA, 20 ODD, and 15 ITF and EU Innovation National Offices briefing meetings. 

Abbreviations 
  • EMA: European Medicines Agency 
  • ITF: Innovation Task Force  
  • ODD: Orphan drug designation 
  • OMS: Organization Management Service 
  • RPI: Research Product Identifier 
  • SA: Scientific advice 
  • SMS: Substance Management Service 
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