Regulatory framework for pharmacovigilance

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

06.05.2021 43584

MoH order No. 898 of 27.12.2006 (as amended) approves the Procedure for Pharmacovigilance. The document contains reporting forms, the classification of adverse events following immunization, requirements for safety reports and the structure of the applicant’s pharmacovigilance system. compiled automatically

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

18.09.2019 11401

Наказ МОЗ України від 26.09.2016 № 996 про внесення змін до наказів МОЗ, яким викладено у новій редакції Порядок здійснення фармаконагляду та затверджено форми звітності й додатки щодо несприятливих подій після імунізації. Документ призначено для заявників, закладів охорони здоров’я та фахівців, які подають і опрацьовують повідомлення про побічні реакції. складено автоматично

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

18.09.2019 33968

Наказ МОЗ України від 27.12.2006 № 898 затверджує Порядок здійснення фармаконагляду (у редакції наказу № 996 від 26.09.2016) та містить 15 додатків — форми звітів, карт-повідомлень, протоколів розслідування несприятливих подій після імунізації. Документ призначений для закладів охорони здоров'я, медичних працівників і заявників лікарських засобів. складено автоматично

ORDER of the MoH of Ukraine “On approval of the standard ‘Guideline. Medicinal products. Good Pharmacovigilance Practices’” No. 299 dated 21.05.15

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MoH of Ukraine ORDER “On approval of the standard ‘Guideline. Medicinal products. Good pharmacovigilance practices’” No. 299 of 21.05.15 Download View on…

Law of Ukraine "Fundamentals of Ukrainian Legislation on Health Care"

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No. 2801-XII dated 19.11.1992 Open

Law of Ukraine “On Medicinal Products”

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No. 123/96-VR dated 04.04.1996 Open

Resolution of the Cabinet of Ministers of Ukraine, “On Approval of the Procedure for State Registration (Re-registration) of Medicinal Products and the Amounts of the Fee for Their State Registration (Re-registration)”

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No. 376 of 26.05.2005 Open

MoH of Ukraine order "On Designating the Lead Organization in the Field of Developing Medical Technological Documents on Standardization of Medical Care, Draft Regulatory Acts on Medical, Including Pharmaceutical, Services, and Pharmacovigilance"

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No. 786 of 08.10.2012 Open

MoH of Ukraine order “On Approval of the Procedure for Conducting Expert Evaluation of Registration Materials for Medicinal Products Submitted for State Registration (Re-Registration), and Expert Evaluation of Materials on Amendments to Registration Materials during the Validity of the Registration Certificate”

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No. 426 of 26.08.2005 Registered: Ministry of Justice of Ukraine on 19.09.2005 No. 1069/11349 Open

MoH Order “On measures to implement monitoring of the safety and efficacy of medicinal products in inpatient healthcare facilities”

18.09.2019 1898

No. 736 of 31.08.2010 Download

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

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

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

ORDER of the MoH of Ukraine “On approval of the standard ‘Guideline. Medicinal products. Good Pharmacovigilance Practices’” No. 299 dated 21.05.15

Law of Ukraine "Fundamentals of Ukrainian Legislation on Health Care"

Law of Ukraine “On Medicinal Products”

Resolution of the Cabinet of Ministers of Ukraine, “On Approval of the Procedure for State Registration (Re-registration) of Medicinal Products and the Amounts of the Fee for Their State Registration (Re-registration)”

MoH of Ukraine order "On Designating the Lead Organization in the Field of Developing Medical Technological Documents on Standardization of Medical Care, Draft Regulatory Acts on Medical, Including Pharmaceutical, Services, and Pharmacovigilance"

MoH Order “On measures to implement monitoring of the safety and efficacy of medicinal products in inpatient healthcare facilities”

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