Law “On medicines and medical devices”.
Country
Type of law
Legislation
Abstract
This Law is a comprehensive legal framework governing the regulation, registration, and control of pharmaceuticals, medical devices, and health-related products, with a focus on ensuring safety, quality, and accessibility. Its primary objectives include establishing a unified policy for the production, import, export, distribution, and sale of these products, aligning with the national broader health and legal policies. The framework emphasizes principles such as state oversight, transparency, and international cooperation, aiming to safeguard public health while fostering domestic industry development. Key measures outlined involve the issuance of special permits for manufacturing, importing, and selling medical products, with detailed requirements for compliance, registration procedures, and standards adherence. The document specifies the roles of various authorities, including the Ministry of Health, regional health agencies, and specialized committees, in licensing, monitoring, and enforcement activities. It also delineates procedures for product registration, quality control, and post-market surveillance, including mandatory reporting, testing, and certification processes, with explicit timelines and institutional responsibilities. Additionally, it addresses the regulation of advertising, promotion, and informational activities related to medical products, emphasizing transparency and ethical standards. Implementation mechanisms include the establishment of national registries, licensing commissions, and expert panels, with specified procedures for issuing, renewing, suspending, or revoking permits. The framework prescribes timelines for transition to new standards, stipulates penalties for violations, and underscores stakeholder participation, including industry representatives and professional associations. Overall, the document provides a detailed, procedural blueprint for the regulation of health products, emphasizing compliance, safety, and effective oversight within a structured institutional and legal context. This Law promotes herbal medicine based on the use of medicinal plants and traditional knowledge.
Attached files
Web site
Date of text
Entry into force notes
This Law enters into force on 1 October 2024.
Repealed
No
Source language
English
Legislation Amendment
No
Original title
МОНГОЛ УЛСЫН ХУУЛЬ ЭМ, ЭМНЭЛГИЙН ХЭРЭГСЛИЙН ТУХАЙ.
Implements