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
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
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
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
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)
