The new IT platform launched by the European Medicines Agency is based on the Iris Regulatory & Scientific Information Management Platform, to directly and safely manage notifications of medicinal products intended for parallel distribution.
The new notification methods
The use of the new platform has become mandatory starting from February 11th; a single point becomes available for the management of all information and documentation relating to the parallel distribution of medicines. The Iris platform allows the control from multiple devices of the status of the notifications, and sends automatic updates to the distributors as soon as there are news about their practices.
Tools on EMA’s Webside
EMA share a manual explaining the use of the Iris platform for notification procedures together with the guide for registration to the system.
The platform, initially created in June 2018 for the management of procedures related to orphan drugs, will be gradually extended to a greater number of regulatory procedures.
The manual touches this point:
- How to create an initial notification for parallel distribution
- How to create a safety update
- How to create an Update Parallel Distribution Notice Status
- How to add contributors to a draft PD notification
- How to delete a draft application
- How to display and sort submissions
- How to search for submissions
- How to respond to a notification email from EMA requesting VSI
Ema also announced that the filing of annual updates of the parallel distribution is suspended from 1 February to 30 April 2019, to allow an easier transfer of the Agency to the new Amsterdam office.