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 of parallel distributions and manage related activities (e.g., annual reports, 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
Request a Research Product Identifier or change of name and address of an applicant on regulatory entitlements
Increase efficiency on reporting inspections data and create a better overview of scientific/regulatory data by managing your inspections for GMP 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 and submit a transfer or request a withdrawal of an existing PRIME regulatory entitlement.

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