All medicinal products in LTD “Pro-Pharma Ukraine” are subject to a strict testing and assessment of their quality, efficacy and safety before being authorised. Once placed on the market they continue to be monitored so to assure that any aspect which could impact the safety profile of a medicine is detected and assessed and that necessary measures are taken. Pharmacovigilance service of LTD “Pro-Pharma Ukraine” is responsible for monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines.
Functioning of Pharmacovigilance service in LTD “Pro-Pharma Ukraine” is strictly regulated by Standart Operation Procedures (SOPs). The procedures describe in detail all objectives and mechanisms of safety control according to the local legislation.
Regular supervision and periodic analysis of drug safety is performed on ongoing basis.
Pharmacovigilance personal is available for consultations 24 hours a day/7 days a week. If we become aware about changes in safety profile of the company’s drugs we report about as soon as possible to the State Expert Center of MoH of Ukraine and the other partners following the contractual pharmacovigilance obligations.
Each employee of LTD “Pro-Pharma Ukraine” has a personal responsibility for information gathering about adverse events during taking the company’s drugs and transfer this information during 24 hours to pharmacovigilance department.