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