Pharmacovigilance (WHO, 2002) – is the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
According to the MoH Ukraine Order of 27.12.2006 № 898 pharmacovigilance is the type of activities relating to collection, detection, assessment, investigation and prevention of adverse effects or drug-related problem. This document has been harmonized with international approaches to conducting pharmacovigilance (WHO) and with the European legislation (the Directive of the European Parliament and the Council 2001/83/EEC of 06.11.2001).
Adverse effect/adverse event – is any undesired harmful effect resulting from drug product usage.
The lack of therapeutic drug product effect is also adverse effect.
Patient safety is the highest priority for Ayapharma. In the process of company activities after the drug products output on the Ukrainian market all the employees follow all relevant legal provisions and regulations of the good pharmacovigilance practice. This is also include the providing of the reports about events of the drug product safety, that indicated to ensure safety and quality of the pharmaceutical products. We also adhere to our internal policies and standard operating procedures designed to ensure patient safety and quality assurance.
Control over the drug products safety of the medical use is one of company field of concern.
If you become aware of any information on adverse reactions or lack of efficacy of medicinal products manufactured by our company, please inform us and send it to us by e-mail or phone listed below:
- phone 0 800 210 289 (round-the-clock);
- phone (044) 529 61 21 (9.00 – 17.30);
- e-mail: email@example.com
Also you can inform your doctor about adverse effect, who reports this information to the MoH of Ukraine.