**Please be aware that IRIS Industry & Network Portals will be unavailable from Friday, 12 April 2024 (18:00 CEST) to Monday, 15 April 2024 (7:00 CEST) due to human medicines data load to EMA's Product Management Service (PMS).**
Welcome to IRIS
A secure online platform for handling product-related scientific and regulatory procedures with EMA
Apply for orphan designation for a medicine and manage related pre- and post- orphan designation activities (e.g., maintenance, transfers, amendments, withdrawals, annual reports)
Request scientific advice (including protocol assistance) on the best methods and study designs to generate robust data on how well a medicine works and how safe it is
Apply for a briefing meeting with EMA’s Innovation Task Force
General
Request a Research Product Identifier or change of name and address of an applicant on regulatory entitlements
Inspections
Increase efficiency on reporting inspections data and create a better overview of scientific/regulatory data by managing your inspections for GMP, GCP and GVP processes via IRIS.
Report changes in the marketing status of a single product, or multiple products at the same time, for each presentation and EU Member State. You can also submit declarations of permanent cessation of marketing, and the decision to not apply for renewal or request to withdraw a central marketing authorisation.
Veterinary Signal Management
Submit annual statements and signal management reports on veterinary signal management and manage related activities
Apply for PRIME eligibility procedure, PRIME meeting request, PRIME periodic update and submit a transfer or request a withdrawal of an existing PRIME regulatory entitlement.
View procedure status, resources and timelines, exchange of documentation and communication with EMA (outside ECTD/VNeeS submissions), withdraw the procedure for a subset of human (67) and veterinary (44) medicinal products with low regulatory complexity.
Origin of the name
The Iris, or “Blue Flag”, is a plant used in healing and medicine since ancient times. In Greek mythology, Iris was a messenger to the Gods who carried the “Caduceus”, or staff, now found at the centre of the international symbol for medicine. The IRIS platform facilitates the exchange of regulatory and scientific information between EMA and organisations developing medicinal research products for potential use in the European Union