Translation of an adverse drug reaction reporting form is required for submission to foreign regulators, safety assessment of medicinal products and accurate inclusion of data in international pharmacovigilance and reporting systems.
| Source | Target |
| This adverse reaction reporting form shall be completed for any suspected undesirable effect associated with the use of the medicinal product. The report must include patient identifiers, dosage information, description of the reaction, onset date, outcome and any corrective treatment applied. All data shall be submitted to the competent authority in accordance with pharmacovigilance reporting requirements and timelines. | Данная форма регистрации побочных реакций заполняется при любом подозреваемом нежелательном эффекте, связанном с применением лекарственного средства. Отчёт должен содержать данные пациента, сведения о дозировке, описание реакции, дату начала, исход и принятые меры лечения. |
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