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MoH ORDER OF UKRAINE 27.12.2006 No. 898 (as amended) On Approval of the Procedure for Pharmacovigilance

06.05.2021 Updated 20.09.2021 43041 views

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 № 1649/29779PDF · 401 KB · 20.09.2021

Annex 1 Classification of adverse events following immunization (AEFI)/tuberculin diagnosticsPDF · 86 KB · 20.09.2021

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 representativePDF · 169 KB · 20.09.2021

Annex 3 List of clinical manifestations of adverse reactions after use of vaccine, tuberculinPDF · 158 KB · 20.09.2021

Annex 4 TIME INTERVALS between use of vaccine, tuberculin and clinical manifestations of adverse reactions by codesPDF · 194 KB · 20.09.2021

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 diagnosticsPDF · 197 KB · 20.09.2021

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)PDF · 236 KB · 20.09.2021

Annex 7 GENERAL REPORT about registered cases of infectious disease controlled by specific immunoprophylaxis in vaccinated persons according to epidemiologic investigation formPDF · 172 KB · 20.09.2021

Annex 8 EPIDEMIOLOGIC INVESTIGATION FORM about cases of infectious diseases controlled by specific immunoprophylaxis in vaccinated personsPDF · 168 KB · 20.09.2021

Annex 9 REPORT about quantitative distribution of vaccines by administrative territorial unitsPDF · 94 KB · 20.09.2021

Annex 10 FREQUENCY OF SUBMITTING periodic safety update reports for medicinal products, vaccines, tuberculin by INN of API or combination of APIPDF · 2.6 MB · 20.09.2021

Annex 11 STRUCTURE of applicant’s pharmacovigilance system master filePDF · 249 KB · 20.09.2021

Annex 12 STRUCTURE of periodic safety update reportPDF · 227 KB · 20.09.2021

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)PDF · 81 KB · 20.09.2021

Annex 14 STRUCTURE of risk management planPDF · 673 KB · 20.09.2021

Annex 15 Structure of protocol, final report and summary of post-registration safety studyPDF · 116 KB · 20.09.2021

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 № 996PDF · 99 KB · 20.09.2021

PROTOCOL of investigation and establishment of a causal association between serious and/or cluster of AEFI/tuberculin diagnostics and use of vaccine, tuberculin(Annexto Regulations of central and regional group of quick response to AEFI/tuberculin diagnostics)PDF · 404 KB · 20.09.2021