Marketing Status Notifications: Query on options for ‘Reason for Shortage’

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)

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