Dear all,
Yesterday, we have received below message on the baseline submissions of Marketing Status in IRIS. To our understanding, this is only applicable to human health, as for veterinary companies like ours, the same has to be done in the Union Product Database.
Can you please confirm this?
Thank you very much in advance,
Bernd
Dear MAHs,
We appreciate your feedback and cooperation on the submission of Marketing Status notifications via IRIS. Your continuous feedback via Service Desk is extremely valuable and is being analysed and prioritised with the objective to resolve the reported issue in the shortest possible timeframe.
To that effect, we would like to update you on some consequential changes implemented to address reported industry stakeholders’ issues on the bulk and single submissions for Marketing Status.
Most of the reported challenges are system and data related, mainly wrong format of the data in the uploaded Excel file or new products/product presentations not being visible in IRIS. These are being addressed by having implemented a set of improved validation rules on the content of the Excel file which MAHs are asked to upload in the section ‘Uploaded proposed marketing status’.
In relation to the reported issue of new products/product presentations, a new routine for data integration is expected to be deployed within the next couple of weeks.
You will find below additional information on actions taken by EMA and to be taken by MAHs to enable baseline Marketing Status submissions by the set deadline of 30 April 2022.
You are also advised to read the updated IRIS user guide and updated Q&A available on the IRIS Forum for more information on validation stage issues: Questions and answers on Marketing Status reporting submissions · IRIS (europa.eu) .
We continue working towards further improving the submission processes to facilitate the reporting by MAHs and would appreciate receiving your feedback. For any technical query related to a specific IRIS Marketing Status submission, please do not hesitate to contact the Agency through the EMA ServiceDesk Portal.
For more information follow the links below:
Please do not reply to this email, replies will not be monitored.
With best regards,
European Medicines Agency
Actions taken by EMA
Please find below a summary of steps recently taken by IRIS Marketing Status team:
- A release of a major fix which is aimed to address most of the validation issues in the key columns of the file (Country, Marketing Status, Date of Marketing Status Change, Reason for Cessation, Estimated Date of Reintroduction, Does Cessation lead to Shortage?).
- Validation error email is sent when the data in the key columns of the file could not be validated.
- The required corrections are listed in ‘Upload proposed marketing status’ section of the submission form.
- Date format is automatically set to the local date and time.
- Updated Q&A in Forums in IRIS with more practical information.
Actions to be taken by MAHs
Below we have listed the actions which are expected to facilitate the submission process and avoid validation errors.
- Follow the IRIS user guide (Section 6), and, in particular refer to Figure 17 which outlines the acceptable format and values for the fields on which the validation runs.
- All dates must stay in the local format which Excel applies automatically to the current marketing status file you have downloaded. Do not change it.
- Country code must meet ISO standards and consist of two letters, see the above guide.
- Comply with the set of conditions laid for the four marketing statuses when populating the Excel file:
- ‘Marketed’ - ‘Date of Marketing Status Change’ is mandatory.
- ‘Temporarily unavailable’ - ‘Date of Marketing Status Change’, ’Reason of cessation’, ‘Estimated date of Reintroduction’, Does cessation lead to Shortage’ are mandatory.
- ‘Not marketed’ - ‘Date of Marketing Status Change’, ’Reason of cessation’, Does cessation lead to Shortage’ are mandatory.
- ‘Never marketed’ – column ‘Date of Marketing Status Change’ must be blank, no other columns need to be populated.
The default marketing status ‘No data provided’ – should preferably be replaced with actual marketing status, otherwise the row should be deleted, since validation rule will run on that row too. If ‘No data provided’ is kept in the file, column ‘Date of Marketing Status Change’ must be blank.
See the updated Q&A available from the IRIS Forum for more information on validation stage issues: Questions and answers on Marketing Status reporting submissions · IRIS (europa.eu)
Unsuccessful validation
- When a submission cannot be validated, a validation error email is sent. Visit the submission form in ‘My draft submissions’ in IRIS and check for validation errors in section ‘Upload proposed marketing status’.
- Errors in columns F, G, H, I, J or K – IRIS form will refer you to the row with a mistake and an explanation of what needs to be corrected. Correct the data and make a new submission.
- Errors in other columns - there will be no explanation in IRIS. Please review the data using IRIS user guide. If you are not able to find the mistake, please log a Service Desk ticket, attach the Excel file and a print screen of the error.
- "EU Number should be associated with Authorised Product" error in the form – please check the EU number in the Excel file. If you cannot find a mistake, log a Service Desk ticket with a print screen of the error.
If the submission passes validation, the case is closed within 10-15 minutes. If the case remains open beyond this time (in Ongoing submissions), it means there are errors in the form. Please follow the above points in that case.
