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Regulation on licensing of traditional herbal medicinal products.

Pays/Territoire
Türkiye
Type du document
Règlement
Date
2023
Source
FAO, FAOLEX
Source d'origine
Official Gazette No. 32093, 3 February 2023.
Sujet
Plantes cultivées
Mot clé
Accès-à-l'information Commerce/industrie/sociétés Certification Emballage/étiquetage Questions de procédures Santé publique
Aire géographique
Asie, Mer Noire, Europe, Europe et Asie Centrale, Méditerranée, Moyen-Orient, Asie Occidentale
Entry into force notes
This Regulation enters into force on the day it is published in the Official Gazette.
Résumé

This Regulation sets out the procedures and principles to be applied in licensing procedures in order to ensure the quality, safety and efficacy of traditional herbal medicinal products. The provisions of this Regulation shall apply to herbal medicinal products which are prepared industrially or produced by a method involving an industrial process. This Regulation lays down provisions on the evaluation, grant, refusal, duration and cancellation of licenses; obligations of the licensee; summary of product characteristics; and requirements of packaging. This Regulation has been drafted in line with the Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.

Texte intégral
Turc
Site web
www.resmigazete.gov.tr

Références - Législation

Implemente

Law No. 3359 on health services.

Législation | Türkiye | 1987 (2022)

Mot clé: Législation de base, Éducation, Équité, Institution, Collectivité locale, Santé publique, Eau potable, Protection des animaux, Recherche

Source: FAO, FAOLEX