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IRIS Marketing Status - Updated version of the Regulatory guidance published
This update is to communicate a new version of the Regulatory guidance has been published at the following link: Notifying a change of marketing status | European Medicines Agency (europa.eu)
Main updates include:
- A new feature has been implemented in IRIS to allow reporting of products/presentations that have never been in the market. A new Marketing Status option 'Never marketed' has been included. When choosing this option, the rest of the fields (Date of marketing status change, Reason for cessation and Does the cessation leads to shortages) are not mandatory and can be left blank. This can be used in both single and bulk notifications. Newly authorised products will be displayed in IRIS as Never marketed by default.
- Clarification on the reporting of shortages
- Clarification on the reporting of ROW withdrawals
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Veterinary Signal Management & PhV Inspection Outcomes are available on IRIS portal from 28 Jan
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IRIS Marketing Status - New deadline for submission of Mkt status reports for marketed CAPs
As follow up of the last EMA/Industry Platform meeting on the centralised procedure on 01.12.2021, this update is to communicate an extension of the timelines in the implementation plan for IRIS Marketing status from 6 to 9 months.
The Agency is analysing the feedback provided by industry and fixing some technical issues in the ´bulk submission´ to ensure the correct upload of all data for marketed CAPs. This submission type is the most widely used by MAHs to report the current marketing status of medicinal products currently markted in the EU/EEA MS.
The new deadline for the submission of the Marketing status data for all presentations of each CAP in the EU/EEA MS is 30.04.2022 (prev. 31.01.2022).
We encourage MAHs to continue gathering the data to be reported and to submit as soon as possible.
The regulatory guidance will be updated in January to reflect the change in the deadline.
For any technical query related to a specific IRIS marketing status submission, please do not hesitate to contact the Agency through EMA ServiceDesk Portal.
For more information follow the links below: