The main barriers to the organization and proper functioning of the pharmacovigilance system at the enterprise are the lack of methodological guidelines, recommendations, experience and practical skills, the imperfection of the regulatory framework, and the lack of trained personnel in this area. The result of the study showed that 5% of respondents could turn to the help of outsourcing (consulting) companies in the field of pharmacovigilance. [1].

  That is, pharmacovigilance services are delegated to an outsourcing company.

  The outsourcing (consulting) model of organizing individual services in drug manufacturing companies is a recognized way to improve the efficiency of business activities in combination with a low level of costs. Due to this, the scale of outsourcing in the pharmaceutical industry is constantly increasing, naturally leading to a targeted reduction in operating and infrastructure costs by companies or to a way out of the situation in the absence or high cost of the necessary internal resources [1].

  Thus, the cost of costs is significantly reduced in comparison with the situation when it is necessary to have specialists with the necessary knowledge and skills in the field of pharmacovigilance on the staff of the company.

  Outsourcing of pharmacovigilance does not contradict the current legislation, provided that a number of requirements for the quality system are met when the manufacturer delegates this responsibility: requirements for the organization of the pharmacovigilance system to the contractor, the mandatory inclusion of a description of the delegated activities in the master file of the pharmacovigilance system, recommended systems for auditing contractors by the holders of registration certificates. In addition, the flexibility of outsourcing systems allows you to quickly adapt to the business structure and tasks of the company, reduces the total cost of operations, and increases the efficiency of the process.

The role of outsourcing services for the pharmacovigilance system of pharmaceutical companies around the world is increasing due to the superior economic the effectiveness of external administration, as well as legitimacy, in accordance from clause 2.18 of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union [1].