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List of main documents: ​​

  • Instruction for medical use (IMU/PIL);

  • Summary of Product Characteristics (SPС);

  • Tabulated Summary of Adverse Reactions;

  • Addendum to Clinical Overview (AdCO);

  • Risk Management Plan (RMP);

  • Periodic Safety Update Reports (PSURs);

  • Curriculum vitae of Qualified Person Responsible for Pharmacovigilance / Pharmacovigilance (PhV) Contact Person;

  • Curriculum vitae and statement of Clinical Expert;

  • Summary of Applicant’s Pharmacovigilance System.


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