06.01.2017 Набув чинності Порядок здійснення фармаконагляду, затверджений наказом Міністерства охорони здоров’я України від 27 грудня 2006 року № 898, зареєстрований в Міністерстві юстиції України 19 грудня 2016 року за № 1649/29779 (у редакції наказу Міністерства охорони здоров’я України від 26 вересня 2016 року № 996).

Pharmacovigilance Procedure approved by Order of the Ministry of Health of Ukraine of 27.12.2006 № 898 (in wording of the MoH Ukraine Order of 26.09.2016 № 996), registered at the Ministry of Justice of Ukraine on 19.12.2016 under № 1649/29779

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• Annex 1. Classification of adverse events following immunization (AEFI)/tuberculin diagnostics
• Annex 2. REPORT FORM on adverse reaction to medicinal product, vaccine, tuberculin and/or lack of efficacy of medicinal product (MP) and/or adverse event following immunization (AEFI)/tuberculin diagnostics to be submitted by patient and/or his/her representative
• Annex 3. LIST of clinical manifestations of adverse reactions after use of vaccine, tuberculin
• Annex 4. TIME INTERVALS between use of vaccine, tuberculin and clinical manifestations of adverse reactions by codes
• Annex 5. REPORT on cases of adverse reactions to medicinal products, vaccines, tuberculin and/or lack of efficacy of medicinal products and/or adverse events following immunization/tuberculin diagnostics
• Annex 6. REPORT FORM on adverse reaction to medicinal product, vaccine, tuberculin and/or lack of efficacy of medicinal product and/or adverse event following immunization/tuberculin diagnostics (AEFI)
• Annex 7. GENERAL REPORT about registered cases of infectious disease controlled by specific immunoprophylaxis in vaccinated persons according to epidemiologic investigation form
• Annex 8. EPIDEMIOLOGIC INVESTIGATION FORM about cases of infectious diseases controlled by specific immunoprophylaxis in vaccinated persons
• Annex 9. REPORT about quantitative distribution of vaccines by administrative territorial units
• Annex 10.FREQUENCY OF SUBMITTING periodic safety update reports for medicinal products, vaccines, tuberculin by INN of API or combination of API
• Annex 11. STRUCTURE of applicant’s pharmacovigilance system master file
• Annex 12. STRUCTURE of periodic safety update report
• Annex 13. FORM for cumulative safety data related to medical use of medicinal product/vaccine/tuberculin in Ukraine during the validity period of the most recent registration certificate to be submitted by applicant (or his representative)
• Annex 14. STRUCTURE of risk management plan
• Annex 15. STRUCTURE of protocol, final report and summary of post-registration safety study

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Regulations of central and regional group of quick response to AEFI/tuberculin diagnostics approved by the Order of the Ministry of Health of Ukraine as of 26 September 2016 № 996

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PROTOCOL of investigation and establishment of a causal association between serious and/or cluster of AEFI/tuberculin diagnostics and use of vaccine, tuberculin (Annex to Regulations of central and regional group of quick response to AEFI/tuberculin diagnostics)

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НАКАЗ МОЗ України від 27.12.2006 № 898 «Про затвердження Порядку здійснення нагляду за побічними реакціями лікарських засобів, дозволених до медичного застосування» зареєстрований в Міністерстві юстиції України 19 грудня 2016 року за № 1649/29779 (у редакції наказу МОЗ України від 26.09.2016 № 996)

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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

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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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