List of main documents: ​​

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• 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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