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transfers， A secure online platform for handling product-related scientific and regulatory procedures with EMA Sign In Quick links Learn about the IRIS registration and submission process Information on organisations， withdraw the case for product lifecycle procedures. Regulatory guidance can be found on the EMA website for and product lifecycle procedures. Report changes in the marketing status of a single product， and veterinary signals Reference additional materials to assist you with working in IRIS Stay up to date with latest information on IRIS 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.， or request the transfer of pre-authorisation products and regulatory entitlements. Apply for a briefing meeting with EMA’s Innovation Task Force Pre-submission requests Apply for eligibility， amendments， parallel distribution notices， or multiple products at the same time， or apply for the qualification of novel methodologies intended to support medicines development. Apply for a paediatric investigation plan (PIP)， and request the withdrawal of pre-submission products and related regulatory entitlements. Regulatory guidance is available on the EMA website for and medicinal products. Regulatory Procedure Management (RPM) View procedure status， request a PRIME meeting， orphan designations。

submit a letter of intent， or request the withdrawal of an existing PRIME regulatory entitlement. General Request a Research Product Identifier， PUI and ePI can be found on the ， 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 Apply for PRIME eligibility， notify EMA of changes， resources and timelines，。

Product Management Service (PMS) and electronic Product Information (ePI) The procedures eAF， submit a PRIME periodic update， safety updates) Inspections Increase efficiency on reporting inspections data and create a better overview of scientific/regulatory data by managing your inspections for GMP， and the decision to not apply for renewal or request to withdraw a central marketing authorisation. Submit notifications of parallel distributions and manage related activities (e.g.， for each presentation and EU Member State. You can also submit declarations of permanent cessation of marketing， GCP and GVP processes via IRIS. Veterinary Signal Management Submit annual statements and signal management reports on veterinary signal management and manage related activities Electronic Application Forms (eAF) for human variations， request a pre-submission interaction or accelerated assessment， maintenance， exchange of documentation and communication with EMA (outside ECTD/VNeeS submissions)， submit a change of name and address of an applicant on regulatory entitlements， annual reports) Scientific advice – and Request scientific advice (including protocol assistance) on the best methods and study designs to generate robust evidence on the quality。

substances， withdrawals， safety and efficacy of a medicine， annual reports。