Posted Wed, 01 Dec 2021 14:53:20 GMT by Sampada Tupe
What is expected information to be submitted to EMA when we receive validation query as "invalid reason for cessation"?
Posted Wed, 01 Dec 2021 16:40:57 GMT by Virginia Rojo Guerra
The reasons for cessation are listed in the IRIS guide for applicants (how to submit) v1.8 (europa.eu). They should be entered in the same format as included in the guide, as below:
01. Safety - Medicinal product is harmful (Articles 116 and 117)
02. Efficacy - Medicinal product lacks therapeutic efficacy (Articles 116 and 117)
03. Benefit/risk - risk-benefit balance is not favourable (Articles 116 and 117)
04. Quality - Quantitative and qualitative composition of the medicinal product is not as declared (Articles 116 and 117)
05. 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)
06. 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)
07. Any conditions referred to in Articles 21a, 22 or 22a have not been fulfilled (PAES, PASS, PV obligations, obligations under exceptional circumstances) (Article 116)
08. Commercial reasons (excluding any ground of art 116 or 117)

 
Posted Wed, 01 Dec 2021 16:55:15 GMT by Sampada Tupe
Thank you Virginia. The product has not undergone cessation in any of the markets, therefore, the “Reason for Cessation” field is not applicable. When I mentioned "Not Applicable", I received a validation error.
Posted Thu, 02 Dec 2021 07:49:36 GMT by Paolo Tomasi EMA
For technical issues, including assistance on a specific submission, please create a Servicedesk incident. Please attach screenshots of the submission data in the Industry Portal, to help Servicedesk staff identify the problem and find a solution. 
Posted Wed, 08 Dec 2021 13:11:43 GMT by Virginia Rojo Guerra
A new feature is being implemented to allow the reporting of products that have never been on the market. The list of reasons for cessation will be updated to add a new one 'Never marketed' and in this case, the date of marketing status change won't be mandatory. Until this feature is implemented, please do not report these presentations, leave them as No data provided. Otherwise you'll be receiving validation errors. We expect the new feature to be in production within a couple of weeks.
Posted Thu, 09 Dec 2021 10:04:00 GMT by Stephen Mackenzie
I am confused by the guidance, as there are actually 11 reasons for cessation available when creating a draft IRIS submission.
Posted Fri, 10 Dec 2021 10:17:18 GMT by Paolo Tomasi EMA
Please see the other thread 11 reasons for cessation vs 8 in the guidance · IRIS (europa.eu)

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