Welcome to IRIS



A secure online platform for handling product-related scientific and regulatory procedures with EMA

Quick links


Learn about the IRIS registration and submission process


Access information on parallel distribution notices, organisations and substances


Reference additional materials to assist you with working in IRIS


Stay up to date with latest information on IRIS and participate in the online Forums

Procedures you can carry out on the platform
Apply for orphan designation for a medicine and manage related pre- and post- orphan designation activities (e.g., maintenance, transfers, amendments, withdrawals, annual reports)
Submit notifications for parallel distribution and manage related activities (e.g., annual updates, safety updates)
Scientific advice – human and veterinary
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








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