the following alternatives could be considered in respect of the medicinal product: the need to suspend the clinical trial, the need of early termination of the clinical trial or introduction of changes into the clinical trial protocol. 62. Information on decisions of the Ministry of Health of the Russian Federation adopted following the review of information from Roszdravnadzor defined in hereof shall be placed by Roszdravnadzor on its official website. Appendix No. 1 to the Pharmacovigilance Procedure approved by order of the Federal Service for Surveillance in Healthcare, No. 1071 dated 15 February 2017 Recommended form NOTIFICATION OF ADVERSE REACTION OR LACK OF THERAPEUTIC EFFECT OF MEDICINAL PRODUCT Initial Follow-up to report No. _________ dated _____________________ Patient Initials (patient ID) ________ Sex M F Weight __ kg Age __________ Pregnancy , term ___ weeks Allergy None Yes, __________________________________ Treatment outpatient inpatient self-treatment Suspect medicinal product Name Batch Dose, Start Date Stop date Indication (trade) <*> number route 1 2 3 Adverse reaction Date of AR onset _____ Description of reaction <*> (provide all details, including the AR seriousness criteria: laboratory findings) Death
the following alternatives could be considered in respect of the medicinal product: the need to suspend the clinical trial, the need of early termination of the clinical trial or introduction of changes into the clinical trial protocol. 62. Information on decisions of the Ministry of Health of the Russian Federation adopted following the review of information from Roszdravnadzor defined in hereof shall be placed by Roszdravnadzor on its official website. Appendix No. 1 to the Pharmacovigilance Procedure approved by order of the Federal Service for Surveillance in Healthcare, No. 1071 dated 15 February 2017 Recommended form NOTIFICATION OF ADVERSE REACTION OR LACK OF THERAPEUTIC EFFECT OF MEDICINAL PRODUCT Initial Follow-up to report No. _________ dated _____________________ Patient Initials (patient ID) ________ Sex M F Weight __ kg Age __________ Pregnancy , term ___ weeks Allergy None Yes, __________________________________ Treatment outpatient inpatient self-treatment Suspect medicinal product Name (trade) <*> Batch number Dose, route Start Date Stop date Indication 1 2 3 Adverse reaction Date of AR onset _____ Description of reaction <*> (provide all details, including the laboratory findings) AR seriousness criteria: Death
order_1071_eng.docx