Pharmacovigilance is a scientific field and practical activity related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
Timely identification of adverse reactions allows for the evaluation of the benefit-risk balance of medicinal products and the development and implementation of measures aimed at improving their safety.
To ensure the monitoring of the safety and effectiveness of medicinal products, the applicant establishes, maintains, and guarantees the functioning of a pharmacovigilance system within their company. This is a mandatory requirement for the circulation of medicinal products in Ukraine and is carried out in accordance with international pharmacovigilance standards and the current regulatory documents of Ukraine (in particular, the Procedure for Pharmacovigilance, approved by Order of the Ministry of Health of Ukraine No. 898 dated 26.12.2006, as amended by Order No. 996 dated 26.09.2016).
What should be reported:
adverse reactions during medical use of a medicinal product;
lack of effectiveness;
off-label use of a medicinal product;
overdose;
interaction with other medicinal products;
misuse and/or abuse;
use during pregnancy and/or breastfeeding;
unexpected therapeutic effect;
prescription and/or administration errors;
undesirable effects during professional activity;
transmission of an infectious agent through a medicinal product.
If you experience an adverse reaction, other undesirable effects, or lack of effectiveness while using products by VORWARTS PHARMA, please report this to us in any convenient way:
Fill out the appropriate reporting form below.
Contact us by phone or email:
24/7 Phone: +38 (067) 386 05 83
Email: pharmacovigilance@pbsvd.com
You may also report all suspected adverse reactions and/or lack of effectiveness of any medicinal products to the State Expert Center of the Ministry of Health of Ukraine through the automated pharmacovigilance information system at: https://aisf.dec.gov.ua
The information you provide is strictly confidential and will not be disclosed except as required by law.