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Appendix E2. Unique Identifier 149018 149498 1503392a. New or Edited 3. Date incident 1. Jurisdiction Name 1a. Email Entry initially reported 4a. Street Address Seattle Public Utilities Nathan.Hart@seattle.gov
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E2B R3 step 5 is a specific section in the EudraVigilance electronic reporting system for reporting certain information related to adverse events.
Marketing authorization holders (MAHs) are required to file E2B R3 step 5 for adverse events related to their medicinal products.
E2B R3 step 5 should be filled out electronically in the EudraVigilance system following the guidelines and instructions provided by the European Medicines Agency (EMA).
The purpose of E2B R3 step 5 is to provide a standardized format for reporting and collecting information on adverse events associated with medicinal products for regulatory and safety monitoring purposes.
Information such as patient demographics, adverse event description, medicinal product information, and treatment details must be reported on E2B R3 step 5.
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