Attention, applicants!

The audit of applicants' pharmacovigilance systems is conducted by the State Expert Center of the MoH in accordance with the provisions of Chapter 2 of Section VII of the Pharmacovigilance Procedure approved by order of the Ministry of Health of Ukraine of 27 December 2006 No. 898 (as amended by order of the Ministry of Health of Ukraine of 26 September 2016 No. 996) (hereinafter – the Pharmacovigilance Procedure). It also publishes their results in accordance with the requirements of the Pharmacovigilance Procedure.

In the structure of the State Expert Center of the Ministry of Health, the function of auditing pharmacovigilance systems is assigned to the Department for Auditing Applicants' Pharmacovigilance Systems.

The purpose of auditing the applicants' pharmacovigilance system is to clarify issues regarding its existence and functioning, and its compliance with the requirements of the current legislation of Ukraine on pharmacovigilance.

The applicant must establish, ensure and guarantee the operation of a pharmacovigilance system in Ukraine, which is a mandatory condition for the circulation of medicinal products, vaccines and tuberculin in the territory of Ukraine, in accordance with the requirements of the Procedure for Pharmacovigilance.

The description of the applicant's pharmacovigilance system must be contained in the pharmacovigilance system master file (hereinafter – PSMF), which is used by the applicant in relation to one or more medicinal products. The PSMF is drawn up in accordance with the structure given in Annex 11 to the Procedure for Pharmacovigilance

In accordance with the requirements of the Procedure for Pharmacovigilance, the applicant's pharmacovigilance system consists of elements that make it possible to monitor the safety of medicinal products and to determine any changes in the benefit/risk balance.

Also, when carrying out pharmacovigilance, the applicant/its representative may use the recommendations of the standard “Guideline. Medicinal Products. Good Pharmacovigilance Practice. ST-N MOZU 42-8.7:2015,” approved by order of the Ministry of Health of Ukraine of May 21, 2015 No. 299 (as amended by order of the Ministry of Health of Ukraine of April 05, 2018 No. 620). The requirements for the PSMF are set out in Part II of the Guideline

A pharmacovigilance system audit is an important event for the applicant and its contractual partners, requiring careful preparation and resolution of the identified problems.

In accordance with the Procedure for Pharmacovigilance, an audit of the pharmacovigilance system may be scheduled or targeted.

When drawing up the schedule of planned audits of applicants’ pharmacovigilance systems, factors based on a systemic and risk-based approach are taken into account.

Information on planned audits of applicants’ pharmacovigilance systems will be published on the website of the State Expert Center of the Ministry of Health of Ukraine at the following link:

“Information on planned audits of applicants’ pharmacovigilance systems”

A targeted audit may be conducted:

– for reasons unrelated to the safety of medicinal products, vaccines or tuberculin, or for reasons of non-compliance with established requirements (changes in the organizational and legal form of enterprises, a significant change in one's own pharmacovigilance system, etc.);

- for reasons related to the safety of the medicinal product, vaccine or tuberculin, or for reasons of non-compliance with established requirements (late submission of reports on cases of adverse reactions to the medicinal product, vaccine or tuberculin and/or lack of efficacy of the medicinal product, incomplete submission of reports, submission of addenda to the clinical overview of inadequate quality, submission of periodic safety update reports of inadequate quality, submission of risk management plans of inadequate quality, discrepancy between the data stated in reports and data from other sources of information; changes in the benefit/risk ratio, results of previous audits, publication of pharmacovigilance information that is biased or misleads the public, etc.).

Based on the results of the audit of the applicant's pharmacovigilance system, a report will be drawn up confirming that the audit was conducted and specifying comments on the applicant's pharmacovigilance system, identified violations/deficiencies, and non-conformities (critical, major, minor), if any.

The ultimate goal is to bring the applicant’s pharmacovigilance system into compliance with regulatory requirements, using the most appropriate method (or combination of methods) available in the auditor’s toolkit.

If critical and/or major non-conformities and violations (deficiencies) are identified, the applicant must send to the Department for Audit of Applicant Pharmacovigilance Systems of the State Expert Center of the MoH, for approval, information on the timelines of corrective and preventive actions to eliminate them. This information must be provided in the form of a corrective and preventive action plan aimed at eliminating the identified non-conformities.

Guide for the applicant on responding to the results of the audit of pharmacovigilance systems and an example of correct and incorrect completion by the applicant of the table based on the results of the audit of pharmacovigilance systems.

The audit is an opportunity for:

• raising the issue of the importance of pharmacovigilance activities in the business process and obtaining greater support from management;
• improving pharmacovigilance processes;
• training and professional development of employees.

If the applicant fails to eliminate the critical non-conformities identified during the audit of the applicant's pharmacovigilance system within the specified period, the State Expert Center of the MoH will submit to the Ministry of Health of Ukraine proposals for a temporary ban on the use of the medicinal product(s) by suspending the registration certificate of such applicant due to the applicant's lack of a pharmacovigilance system or its components in accordance with subparagraph 9 of paragraph 1 of Section II of the Procedure for Suspension of a Registration Certificate for a Medicinal Product, approved by order of the Ministry of Health of Ukraine of 05 August 2020 No. 1801

The Applicants' Pharmacovigilance System Audit Division conducts information sessions/training seminars on the organization of the applicants' pharmacovigilance system and the conduct of applicants' pharmacovigilance audits.

Frequently asked questions on the audit of the applicant's pharmacovigilance system

If you have questions regarding the audit of the pharmacovigilance system, you can contact the Department for Audit of Applicants’ Pharmacovigilance Systems by sending your question to the e-mail address: gpvp-audit@dec.gov.ua or by using the Online consultation option. The answer to your question, provided within the authority of the Center, will be sent to your address.