Apply for orphan designation for a medicine and manage related pre- and post- orphan designation activities (e.g., maintenance, transfers, amendments, withdrawals, annual reports)
Scientific advice – human and veterinary
Request scientific advice (including protocol assistance) on the best methods and study designs to generate robust evidence on the quality, safety and efficacy of a medicine, or apply for the qualification of novel methodologies intended to support medicines development.
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
Apply for PRIME eligibility, request a PRIME meeting, submit a PRIME periodic update, or request the withdrawal of an existing PRIME regulatory entitlement.
General
Request a Research Product Identifier, submit a change of name and address of an applicant on regulatory entitlements, or request the transfer of pre-authorisation products and regulatory entitlements.
Apply for a briefing meeting with EMA’s Innovation Task Force
Submit notifications of parallel distributions and manage related activities (e.g., annual reports, safety updates)
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.
Veterinary Signal Management
Submit annual statements and signal management reports on veterinary signal management and manage related activities
