Darnytsia Successfully Passed a Large-Scale Pharmacovigilance System Audit

Darnytsia’s pharmacovigilance system went through a rigorous inspection by the State Expert Center of the Ministry of Health of Ukraine. This was a special step for our team: an opportunity to gain outside perspective and become even better. It is also an important milestone for the entire pharmaceutical industry.

Pharmacovigilance is a system of continuous and professional monitoring of the safety of medicines. Thanks to pharmacovigilance, we promptly track and analyze all adverse events, side effects, and patient feedback after taking our products. The effective operation of the pharmacovigilance system allows us to update recommendations for doctors, enhance the safety of medicines, and, if necessary, adjust instructions. 

This ensures that every patient receives a modern, high-quality, and safe medicine, and doctors have full and up-to-date information about its use.

In 2021, Darnytsia underwent an external, independent pharmacovigilance audit by a German auditing firm — all recommendations were successfully implemented in the challenging year of 2022. The current inspection by the State Expert Center was even more extensive: inspectors trained in the EU emphasized compliance with European standards and meticulously analyzed absolutely all documents and processes — from staff competencies and adverse event reports to the validation of software and contracts with partners.

Darnytsia successfully confirmed the highest level of compliance: not a single critical remark was found during the inspection. The pharmacovigilance team continues to improve the system.

"This audit proved that Darnytsia is a company that operates at the highest level, meets global standards, and provides patients with safe and effective medicines. We are ready for any challenges and proud of our transparency and professionalism," said Vyacheslav Turok, Head of the Pharmacovigilance Department at Darnytsia Pharmaceutical Company.