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Traditional medicinal products Manufacturing Certificate of Competence and Market Authorization Directive No. 957/2022.

Country/Territory
Ethiopia
Document type
Regulation
Date
2022
Source
FAO, FAOLEX
Subject
Cultivated plants, General
Keyword
Public health Consumer protection Equipment Fraud Authorization/permit Certification Packaging/labelling Registration Transport/storage Traditional knowledge/indigenous knowledge Inspection Monitoring Data collection/reporting
Geographical area
Africa, Eastern Africa, Landlocked Developing Nations, Least Developed Countries, Sahel
Abstract

This Directive is applicable to traditional medicinal products produced in the country at semi-industrial or industrial level according to good manufacturing practice, which have gone through pre-clinical research and clinical trial procedures. "Traditional medicinal product" means any finished, labeled traditional medicinal product, containing active ingredients from natural sources (plant, animal or mineral) applicable for the human health use. "Good production practice (GMP)" means a practice that is a part of the quality assurance system and ensures that the traditional medicinal product is manufactured in a consistent manner in accordance with the required quality standards and market licensing and product quality standards for the intended purpose

Full text
English/Amharic
Website
www.ilo.org