Good Pharmacovigilance Practice Guideline Updated

16/ 04/ 2018

In accordance with Order of the Ministry of Health of Ukraine of No. 620 as of April 5th, 2018, a new edition of the standard Guideline. Medicines. Good Pharmacovigilance Practices (hereinafter referred to as the Guideline) has been issued. The Guideline has been adopted based on the relevant guideline of the European Union “Guideline on Good Pharmacovigilance Practices” (hereinafter – GVP), which contains technical approaches to planning and carrying due pharmacovigilance practice. It has been developed based on the following modules: Module І — Pharmacovigilance and its quality system; Module ІІ — Pharmacovigilance master file; Module ІІІ — Audit of the pharmacovigilance system of the applicant (registration certificate owner) which is carried by an authorized specialized expert institution in the area of pharmacovigilance; Module ІV — Pharmacovigilance audit; Module V — Risk management systems; Module VI — Management and reporting of side effects of medicines; Module VII —Regularly updated security report; Module VIІІ — Post-registration security research; Module IX — Signal management; Module X — Additional monitoring; Module XV — Security communication process; Module XVI —Risk minimization measures: selection of tools and effectiveness indicators. Part XIIІ – Special issues on drugs or population II: biological medicines. Moreover, additional structural elements such as “Preface”, “National Introduction”, “Scope”, “Normative Links”, “Terms and Definitions”, “Markings and Abbreviations”, and “Bibliography” are also included in the Guideline. Please pay attention that the Guideline, same as GVP of the European Union, has a status of a technical document to provide recommendations to applicants and owners of registration certificates, competent authorized bodies and other persons concerned with respect to the best and the most acceptable way of performing the legislation of Ukraine governing the pharmaceutical sphere. It is planned to review the Guideline regularly in line with the changes and amendments made to GVP of the European Union. Contact the author: Natalia Spivak, associate at Legal Alliance Company, [email protected]

In accordance with Order of the Ministry of Health of Ukraine of No. 620 as of April 5^th, 2018, a new edition of the standard “Guideline. Medicines. Good Pharmacovigilance Practices “(hereinafter referred to as the “Guideline”) has been issued.

The Guideline has been adopted based on the relevant guideline of the European Union “Guideline on Good Pharmacovigilance Practices” (hereinafter – GVP), which contains technical approaches to planning and carrying due pharmacovigilance practice. It has been developed based on the following modules:

Module І — Pharmacovigilance and its quality system;
Module ІІ — Pharmacovigilance master file;
Module ІІІ — Audit of the pharmacovigilance system of the applicant (registration certificate owner) which is carried by an authorized specialized expert institution in the area of pharmacovigilance;
Module ІV — Pharmacovigilance audit;
Module V — Risk management systems;
Module VI — Management and reporting of side effects of medicines;
Module VII —Regularly updated security report;
Module VIІІ — Post-registration security research;
Module IX — Signal management;
Module X — Additional monitoring;
Module XV — Security communication process;
Module XVI —Risk minimization measures: selection of tools and effectiveness indicators.

Part XIIІ – Special issues on drugs or population II: biological medicines.

Moreover, additional structural elements such as “Preface”, “National Introduction”, “Scope”, “Normative Links”, “Terms and Definitions”, “Markings and Abbreviations”, and “Bibliography” are also included in the Guideline.

Please pay attention that the Guideline, same as GVP of the European Union, has a status of a technical document to provide recommendations to applicants and owners of registration certificates, competent authorized bodies and other persons concerned with respect to the best and the most acceptable way of performing the legislation of Ukraine governing the pharmaceutical sphere.

It is planned to review the Guideline regularly in line with the changes and amendments made to GVP of the European Union.

Contact the author: Natalia Spivak, associate at Legal Alliance Company, [email protected]