Безперервний професійний розвиток Вакансії

НАКАЗ МОЗ УКРАЇНИ 27.12.2006 № 898 (із змінами) Про затвердження Порядку здійснення фармаконагляду

06.05.2021 Оновлено 20.09.2021 43011 переглядів

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 КБ · 20.09.2021

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

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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 КБ · 20.09.2021

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

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

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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 КБ · 20.09.2021

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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 КБ · 20.09.2021

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

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

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

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

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

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

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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 КБ · 20.09.2021

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

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

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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 № 996PDF · 99 КБ · 20.09.2021

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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(Annexto Regulations of central and regional group of quick response to AEFI/tuberculin diagnostics)PDF · 404 КБ · 20.09.2021

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