OREANDA-NEWS. May 24, 2013. The Federal Antimonopoly Service (FAS Russia) found that the Health Care Department of the Kemerovo region violated Part 3 Article 15 of the Federal Law “On Protection of Competition”. The Department assigned the functions and rights of a regulatory state control body to an economic entity by approving the Statutes of the “Centre for Quality Control and Certification of Medicines” State Budgetary Health Institution.

According to the Statutes, the Centre exercised acceptance control of medicines brought by wholesalers in the Kemerovo region and inspected pharmacies and wholesalers upon petitions of legal entities and individual entrepreneurs on a fee-paid basis.

At the same time, the Government of the Russian Federation assign to Roszdravnadzor [the Federal Service for Supervision over Public Health and Social Development] the functions for exercising quality control of medicines and inspecting health care organizations, pharmacies, drug wholesalers, and other organizations and individual entrepreneurs involved in the field of health care.

Thus, the Health Care Department of the Kemerovo region assigned the functions of a federal executive body to the “Centre for Quality Control and Certification of Medicines” State Budgetary Health Institution.

In the course of the investigation, FAS received documents confirming that the Centre had voluntary eliminated the antimonopoly violations, and the case was terminated.

“The FAS decision restored the unity of the legal and economic space of the Russian Federation”, said Deputy Head of FAS Andrey Kashevarov.

Reference:

Under Article 5 of the Federal Law “On Circulation of Medicines” state control (regulation) over medicines circulation is exercised by federal executive bodies.

Part 3 Article 15 of No.135-FZ Federal Law “On Protection of Competition” (2006) prohibits assigning the functions and rights of regulatory bodies to economic entities.