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Law on medicine and drugs.

Pays/Territoire
Mongolie
Type du document
Législation
Date
2010 (2015)
Source
FAO, FAOLEX
Sujet
Bétail
Mot clé
Législation de base Santé des animaux Médicaments Biotechnologie Savoir traditionnel/savoir autochtones Enregistrement Autorisation/permis Certification Commerce intérieur Commerce international
Aire géographique
Asie, Asie et Pacifique, Asie Orientale, Nations en développement sans littoral
Entry into force notes
This Law enters into force on 1 July 2011.
Résumé

This Law shall be applicable to medicine and veterinary, including traditional medicines and drugs, medical equipment and bioactive products, regulating manufacturing, import, export, storage, trade, distribution and control thereof. The National Drug Policy shall be directed to provide medical organizations, veterinary hospitals and population with guaranteed registered high quality drugs. It establishes plenary powers of the Council on Animal Husbandry in the field of animal health and veterinary drugs. Manufacturing, import, export, distribution and control of drugs shall be subject to mandatory licensing. Drugs shall be subject to mandatory certification. Veterinarians shall provide services to owners of livestock using exclusively medical equipment and veterinary drugs supplied by registered licensed drug supplying organizations. Veterinary drugs shall be packaged and labelled in accordance with the established modalities. New veterinary drugs must pass mandatory pre-clinical and clinical testing and registration. Information on drugs shall be aimed at proper and correct application thereof. This Law consists of IX Chapters divided into 30 Articles. Chapter I lays down general provisions. Chapter II regards regulation of drugs, registration thereof and healthcare activity. Chapter III regards protection of health and manufacturing of drugs and medical equipment. Chapter IV regards import and export of drugs and medical equipment. Chapter V regards risk management. Chapter VI regards new pharmaceutical products. Chapter VII regards manufacturing and trade of medicinal products and bioactive products. Chapter VIII regards information and advertisement of drugs. Chapter IX contains additional provisions.

Texte intégral
Mongol
Site web
www.legalinfo.mn