Pharmacovigilance, or monitoring of drug safety, is the science and activity aimed at identifying, evaluating and preventing adverse reactions (HP) or any other possible problems associated with drugs. The pharmacovigilance system is one of the components of the quality management system (QMS), which operates in accordance with the international standard ISO 9001-2015.

The holders of registration certificates must create and ensure conditions for the functioning of an effective pharmacovigilance system within the organization in order to increase the organization’s responsibility for the quality and safety of drugs, as well as to take timely, if necessary, adequate measures aimed at improving the safety of drugs.

Tasks of the pharmacovigilance system

Study of the safety of registered drugs in the context of their clinical use on a large population of people;

Dissemination of monitoring data obtained through specialized media;

Identification of adverse drug interactions with chemicals, other drugs and food products;

Detection of falsified and poor-quality drugs, etc .;

Detection of the use of drugs for unexplored and unresolved indications (off label);

Detection of drug abuse;

Identification of medical errors;

Identifying the effect of drugs on quality of life

Basic regulatory documents on pharmacovigilance

Federal Law No. 61-FZ of April 12, 2010, “On the Circulation of Medicinal Products” (as amended on July 03, 2016, as amended and revised, entered into force on January 1, 2017, Article 64)Order of Roszdravnadzor No. 1071 of 02/15/2017 “On approval of the procedure for carrying out pharmacovigilance”

Rules of Good Pharmacovigilance Practices (GVP), approved by the Decision of the Council of the Eurasian Eurasian Economic Commission from 03.11. 2016 №87 (GVP EAEU)

Pharmacovigilance Regulatory Authority

Roszdravnadzor of the Russian Federation (Federal Law of 12.04.2010 N 61-F)

Outsourcing of the pharmacovigilance system of the enterprise (ULF, master file, information solution for working with safety data in accordance with the requirements of the GVP EAEU and Roszdravnadzor):