Construction of a Prefabricated Modular Building for a Thermal Disinfection and Decontamination Station for Pathogenicity Groups III–IV Effluents

On October 5, 2020, the Ministry of Justice of the Russian Federation officially registered Order No. 60229 from the Federal Service for Surveillance in Healthcare (Roszdravnadzor). This order approves the new Administrative Regulation for the execution of federal state supervision within the sphere of medicinal circulation.

This document serves as the primary legal framework for how Roszdravnadzor and its territorial branches conduct inspections and quality control across the entire pharmaceutical lifecycle.

Scope of State Supervision: The new regulation defines the specific areas subject to federal oversight, ensuring that all entities involved in drug circulation adhere to unified safety and quality standards. Key areas of focus include:

• Life Cycle Compliance: Inspections regarding the organization of pre-clinical and clinical trials, as well as the storage, transportation, dispensing, and sale of medicinal products.

• Pharmacopoeial Standards: Verifying that drugs currently in circulation meet the precise requirements of the relevant pharmacopoeial monograph (or the applicable normative documentation if a monograph is unavailable).

• Remote Retail Control: Specific oversight of pharmacy organizations involved in the online/distance retail of medicinal products for medical use.

• Waste Management: Monitoring the legal and safe destruction of pharmaceutical products.

Impact on Market Participants: For manufacturers, distributors, and retailers, this regulation clarifies the procedural steps taken during audits. It emphasizes the government's commitment to eliminating counterfeit products and ensuring that the logistical chain—from the laboratory to the patient—remains transparent and compliant with current standards.

[Image: Digital database icon representing the official Russian legal portal for regulatory documentation]