Welcome to IRIS



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

Quick links

Access & submission

Learn about the IRIS registration and submission process

Public registers & lists

Information on organisations, substances, orphan designations, parallel distribution notices, and veterinary signals

Guidance & support

Reference additional materials to assist you with working in IRIS

News

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

Procedures you can carry out on the platform
Orphan designation
Apply for orphan designation for a medicine and manage related pre- and post- orphan designation activities (e.g., maintenance, transfers, amendments, withdrawals, annual reports)
Parallel distribution
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
Innovation Task Force's consultation
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.
Marketing status
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
PRIority MEdicines (PRIME)
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.
Variations type IA, IA_IN, IG, IB, II, WS - human domain
Variations requiring assessment (reduced, standard, extended, I-changes), WS - veterinary domain
Transfer of marketing authorisation – human and veterinary domain
Article 61(3) notifications human domain
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.
Paediatric procedures
Apply for a paediatric investigation plan (PIP), a product-specific waiver or a modification on an agreed PIP; request a compliance check; submit an annual report on paediatric deferred measures; ask for confirmation of applicability of a class waiver, or of inclusion of an indication within a condition; submit a notification of discontinuation
Electronic Application Forms (eAF) for human variations, Product Management Service (PMS) and electronic Product Information (ePI)
The procedures eAF, PUI and ePI can be found on the PLM portal








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