MoH ORDER "On Approval of the Procedure for Pharmacovigilance" No. 898 of 27.12.2006, registered with the Ministry of Justice of Ukraine on 19 December 2016 under No. 1649/29779

MoH ORDER "On Approval of the Procedure for Pharmacovigilance" No. 898 of 27.12.2006, registered with the Ministry of Justice of Ukraine on 19 December 2016 under No. 1649/29779

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PROCEDURE FOR CONDUCTING PHARMACOVIGILANCE, approved by order of the Ministry of Health of Ukraine of 27 December 2006 No. 898, registered with the Ministry of Justice of Ukraine on 19 December 2016 under No. 1649/29779 (as amended by order of the Ministry of Health of Ukraine of 26 September 2016 No. 996).

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APPENDICES

• Appendix 1. Classification of adverse events following immunization with tuberculin diagnostics
• Annex 2. Notification card for submission by a patient and/or their representative of information on an adverse reaction
• Annex 3. List of adverse reactions after administration of vaccines and tuberculin
• Appendix 4. Timelines of AR development following use of vaccines, tuberculin, by codes
• Annex 5. Report on cases of AR, LoE and/or NPPI (provided by healthcare facilities)
• Appendix 6. Report card on ADR/LOE and/or AEFI (submitted by healthcare professionals)
• Annex 7. General report on epidemiological investigation cards
• Appendix 8. Epidemiological investigation card
• Annex 9_Report on the quantitative distribution of vaccines by administrative-territorial units
• Appendix 10. Frequency of PSUR submission
• Annex 11. Structure of the applicant's pharmacovigilance system master file
• Appendix 12. Structure of the PSUR
• Appendix 13. Form for submission of summary data by the applicant (or its representative)
• Annex 14. RMP structure
• Annex 15. Structure of the protocol, final report and summary of the post-authorization safety study

Regulations on the central and regional rapid response teams for adverse events following immunization/tuberculin testing.

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PROTOCOL for investigating and establishing a causal relationship between serious and/or clustered adverse events following immunization/tuberculin testing and the use of a vaccine or tuberculin.

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