Posted Fri, 21 Oct 2022 15:55:08 GMT by Carly Anderson
In the IRIS Marketing Status Notification section, the following options are available to select for ‘Reason for Shortage’ none of which apply to the scenario we wish to report. In a shortage situation there are reasons that are not listed below. Can it be confirmed that the list is correct and complete.
  • Safety - Medicinal product is harmful (Articles 116 and 117)
  • Efficacy - Medicinal product lacks therapeutic efficacy (Articles 116 and 117)
  • Benefit/risk - risk-benefit balance is not favourable (Articles 116 and 117)
  • Quality - Quantitative and qualitative composition of the medicinal product is not as declared (Articles 116 and 117)
  • Quality - Controls of the medicinal product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or some other requirement or obligation related to the grant of the marketing authorisation have not been fulfilled (Article 117)
  • Particulars supporting the application as provided for in Articles 8, 10, 10a, 10b, 10c or 11 are incorrect or have not been amended in accordance with Article 23 (obligation to keep dossier up to date) (Article 116)
  • Any conditions referred to in Articles 21a, 22 or 22a have not been fulfilled (PAES, PASS, PV obligations, obligations under exceptional circumstances) (Article 116)
  • Commercial reasons (excluding any ground of art 116 or 117)
Posted Tue, 25 Oct 2022 07:45:46 GMT by Paolo Tomasi EMA
The list of reasons is indeed complete in IRIS, and it is the same list as in RMS list "Reason for Marketing Unavailability" (8 terms) which is based on current legislation. You should therefore choose the term that best approaches your situation.
Note: if you would like to suggest an addition to the terms in the RMS list, this can be done via the established procedure in SPOR (please consult document G in the RMS Documents). 
Posted Wed, 05 Feb 2025 09:52:04 GMT by Ailbhe Henderson Manager Specialist, Regulatory Affairs
Thank you for this post, albeit 2 years old, it has assisted me with part of my query.

Now the the ESMP platform is fully operational. it is clear from the current guidance that the marketing status of a product is obtained via the IRIS database. 
My question is when reporting a shortage via ESMP, it is also required to update IRIS to change the marketing status from "marketed" to "temporarily unavailable" as a result of this shortage?  If the duration of the shortage is less than 4 weeks, should the marketing status be updated, I refer to the point in the attached Q & A "excluding an out of stock situation less than 12 months" (refer to:  Q&A - Actual marketing & cessation ext).  Any clarification would be most welcome.

You must be signed in to post in this forum.