EMA update | Notification of marketing status for marketed CAPS

As of end of July 2021, EMA requests MAHs of CAPs to submit their marketing status notifications via the IRIS Platform.

As of end of July 2021, EMA requests MAHs of CAPs to submit their marketing status notifications via the IRIS Platform.
December 20, 2021

As of end of July 2021, EMA requests MAHs of CAPs to submit their marketing status notifications via the IRIS Platform. As follow-up of the last EMA/Industry Platform meeting on the centralised procedure, an extension of the timelines in the implementation plan for IRIS Marketing status reporting from 6 to 9 months has been communicated.

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 (previous 31.01.2022).

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 marketed in the EU/EEA MS.

From the agency, MAHs are encouraged 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.

 

 

 

Search News & Events

  • Filter by category

Share

Related news and events

EVENT | EMA PMS Info Day

EMA is holding a new public event with the purpose to provide a comprehensive understanding of Product Management Service (PMS) and its implications on other EMA digital services with the objective to introduce the core concepts of PMS, ensuring that all attendees have the chance to understand its implementation.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting