Changes to safety update notification procedure for parallel distribution

As of 1^st July 2024 notifications of safety update for products distributed in parallel will not be required and will be removed from the list of submission types in IRIS.
The obligation to implement safety-related changes in the product information within three months of publication of the updated annexes to the marketing authorisation, and within six months for non-safety-related changes, will continue to rest with parallel distributors.
Parallel distributors are advised to sign up for automated notifications (RSS feed) by clicking on “RSS” icon in the right corner of the product banner next to the authorisation status icon on European public assessment report (EPAR) page, in order to be timely notified about the published changes of the product information.

For more details, please refer to the revised procedural guidance documents:
Frequently asked questions about parallel distribution | European Medicines Agency (europa.eu)
Parallel distribution: Regulatory and procedural guidance | European Medicines Agency (europa.eu)
 

Could you please help us how the RSS feed works? When we click on the RSS feed button for example Advagraf, another page opens with the computer language, but we don't get any confirmation that we successfully signed up. Is EMA still working on the RSS feed?