Starting from November 2023 Variations*, Article 61.3 notifications** and Marketing Authorisation Transfers procedures will be possible to manage from a secure online portal IRIS.
The first trial products were selected using the following criteria:
- Valid, standard Marketing Authorization;
- Unlimited MA products with no history of periodic safety update reports (PSURs), Single Assessment Procedures (PSUSAs), Extensions of applications, WS/IG and referrals;
- No ongoing/upcoming Post-Authorisation Measures (PAMs).
All the selected products are low regulatory complexity centrally authorized medicinal products.
EMA’s goals for managing regulatory procedures on IRIS are process simplification and standardization for MAHs.
EMA will organize an open webinar targeted at pharmaceutical industry firms, particularly individuals possessing regulatory affairs expertise. This webinar aims to provide insights into the Regulatory Procedures concerning the integration of medicinal products onto the IRIS platform.
Marked on the calendar for September 15, 2023, the event is to occur between 10:00 and 11:30 Central European Summer Time (CEST). The registration form can be accessed through this link.
Throughout the duration of the webinar, attendees will be granted the chance to engage with the EMA product team, pose inquiries, and receive updates pertaining to the ongoing efforts linked with regulatory procedures.
* Variations for veterinary use products not requiring assessment (VNRA) will be submitted and managed via UPD
** For human medicinal products