Frequently asked questions about auditing the applicant's pharmacovigilance system

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

How much time does the applicant have to prepare for the pharmacovigilance system audit?

17.12.2019 1990

In accordance with the requirements of the organization's quality management system, the "Guideline. Medicinal Products. Good Pharmacovigilance Practices" approved by MoH order of 05.04.2018…

What tools can an applicant use when establishing a pharmacovigilance system in Ukraine?

17.12.2019 2347

To comply with the provisions of the Procedure for Pharmacovigilance1, the applicant must establish and operate a pharmacovigilance system (systems). The applicant’s pharmacovigilance system must make it possible to…

Does the applicant have the right to submit a request to postpone the audit date?

17.12.2019 2366

In Ukraine, the legislation does not provide for the submission, consideration and approval of a request to postpone the date of an audit of an applicant’s pharmacovigilance system. In accordance with…

How much time does the applicant have to prepare for the pharmacovigilance system audit?

What tools can an applicant use when establishing a pharmacovigilance system in Ukraine?

Does the applicant have the right to submit a request to postpone the audit date?

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