Ministry of Health of Ukraine The State Expert Center
Pharmacovigilance system in Ukraine: history, results, objectives
ORDER of the Ministry of Health of Ukraine of 27.12.2006 № 898 About Approval of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical UseAnnex 1 to item 5.1 of the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — REPORT FORM ON ADVERSE REACTION OR LACK OF EFFICACY OF MEDICINAL PRODUCT AT MEDICAL USE (to be filled by physician) Annex 2 to Item 5.2 of the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — REQUIREMENTS TO COMPLETION OF REPORT FORM ON ADVERSE REACTION OR LACK OF EFFICACY OF MEDICINAL PRODUCT AT MEDICAL USE (to be completed by doctor) Annex 3 to item 6.1 of the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — REPORT ON ADVERSE REACTIONS AT MEDICAL USE OF MEDICINAL PRODUCTS AT HEALTH CARE SETTINGS during 20_ Annex 4 to Item 6.2 of the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — REQUIREMENTS FOR DRAWING UP A REPORT ON ADVERSE REACTIONS AT MEDICAL USE OF MEDICINAL PRODUCTS IN HEALTH CARE SETTINGS Annex 5 to sub-item 7.1.1. of item 7.1. of the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — CASE REPORT ON ADVERSE REACTION OR LACK OF EFFICACY OF MEDICIANL PRODUCT AT MEDICAL USE (to be filled by manufacturer/ applicant (or his representative) Annex 6 to sub-item 7.1.1 of Item 7.1 of the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — REQUIREMENTS FOR DRAWING UP A CASE REPORT ON ADVERSE REACTION OR LACK OF EFFICACY OF MEDICINAL PRODUCTS AT MEDICAL USE (to be completed by manufacturer/applicant (or his representative) Annex 7 to item 7.2. of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — STRUCTURE OF PERIODIC SAFETY UPDATED REPORT OF MEDICINAL PRODUCT PERMITTED FOR MEDICLA USE Annex 8 to item 7.5. of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — FORM FOR SUBMITTING BY MANUFACTURER/APPLICANT (OR HIS REPRESENTATIVE) OF SUMMARY DATA ABOUT SAFETY OF MEDICINAL PRODUCT IN UKRAINE DURING THE VALIDITY PERIOD OF THE MOST RECENT REGISTRATION CERTIFICATE Annex 9 to sub-item 8.3.1. of item 8.3. of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — STRUCTURE OF THE PROTOCOL OF SAFETY STUDY OF MEDICIANL PRODUCT PERMITTED FOR MEDICAL USE Annex 10 to sub-item 8.3.3. of item 8.3. of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — NOTIFICATION ABOUT STARTING SAFETY STUDY OF MEDICINAL PRODUCT PERMITTED FOR MEDICAL USE Annex 11 to sub-item 8.3.6. of item 8.3. of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — NOTIFICATION ABOUT THE END OR SUSPENSION OF SAFETY STUDY OF MEDICIANL PRODUCT PERMITTED FOR MEDICAL USE Annex 12 to sub-item 8.3.8. of item 8.3. of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — STRUCTURE OF REPORT ON SAFETY STUDY OF MEDICIANL PRODUCT PERMITTED FOR MEDICAL USE
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