Virginia Rojo Guerra

If the cessation actually led to a shortage at that point, you can answer yes. This field is for information only, as an early warning to authorities, so if it happened in the past, this is not that relevant anymore. In the event of a potential future shortage, this still needs to be communicated through the appropriate channels separately.

There is no need to report the launch of a new strain each year. The first time that the product is launched needs to be reported (when the initial MAA was first launched), but the cessation only needs to be reported if the company decides to take it out of the market at some point, or not to apply for a new strain in a given year. It is understood that this is a seasonal product. 

The system is designed to report one authorized product at time. It is a bulk upload since it allows to report different marketing status for different presentations in different MS. It cannot be added as a new feature because of the way the system works. This should be a one off exercise only during the reporting of the baseline.

The fields Date of Marketing status change, Reason for cessation and Does cessation leads to shortages are mandatory fields and cannot be left blank. 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 presentations that have never been marketed, just remove the rows from the Excel. Otherwise you'll be receiving validation errors. We expect the new feature to be in production within a couple of weeks. If there are any rows showing No data provided, please remove those too and only report the Marketed ones.

On the validation error EU Number should be associated with Authorised Product, it seems to be a recurrent issue we are investigating. Please raise a ticket with EMA Service Desk so the IT team can check what the problem is. Please indicate the case number and provide the excel you are trying to upload.

More info on reporting in the thread: Questions and answers on Marketing Status reporting submissions
 

The first time you upload a product, the first reported status should be Marketed with the date of initial placing in the market. Is not a dummy submission, but reflecting the current status. Afterwards, you could report the future cessation. This will only happen now during the baseline submission and is explained in the regulatory guidance Notifying a change of marketing status | European Medicines Agency (europa.eu). Moving forward, all new products are uploaded in IRIS with the status Not Marketed, so the first report will always be the first placing in the market.

Only 8 reasons are applicable to Marketing status, which are the ones included in the IRIS guide for applicants. Other reasons may be applicable to other procedures within IRIS. We are working to ensure that only the applicable ones are visible in the system when reporting a Marketing status.

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.

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.

The current Marketing status is always visible. When reporting future dates, both the current status and the future one are visible. When a date in the future is reached, it becomes the current status and the future dates are emptied. This is to allow for visibility on current and future marketing status. The report allows to search for the situation in the market at a future timepoint, so National Competent Authorities can have visibility of planned changes.

As an example, if I have reported that presentation 001 is marketed in Austria and then I report a cessation by 10th Dec, I will be able to see both until the 10th of Dec. On that day, the status will change to Not marketed and the columns showing future cessations will be empty.

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)