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

Pays/Territoire
Éthiopie
Type du document
Règlement
Date
2022
Source
FAO, FAOLEX
Sujet
Plantes cultivées, Général
Mot clé
Santé publique Protection du consommateur Équipement Fraude Autorisation/permis Certification Emballage/étiquetage Enregistrement Transport/dépôt Savoir traditionnel/savoir autochtones Inspection Monitorage Collecte de données/déclarations
Aire géographique
Afrique, Afrique Orientale, Nations en développement sans littoral, Pays les moins avances, Sahel
Résumé

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

Texte intégral
Amharique/Anglais
Site web
www.ilo.org