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Regulation on licensing of traditional herbal medicinal products.

País/Territorio
Türkiye
Tipo de documento
Reglamento
Fecha
2023
Fuente
FAO, FAOLEX
Fuente original
Official Gazette No. 32093, 3 February 2023.
Materia
Cultivos
Palabra clave
Acceso-a-la-información Negocios/industria/corporaciones Certificación Envasado/etiquetado Cuestiones de procedimiento Salud pública
Área geográphica
Asia, Mar Negro, Europa, Europa y Central Asia, Mediterráneo, Medio Oriente, Asia Occidental
Entry into force notes
This Regulation enters into force on the day it is published in the Official Gazette.
Resumen

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.

Texto completo
Turco
Página web
www.resmigazete.gov.tr

Referencias - Legislación

Implementa

Law No. 3359 on health services.

Legislación | Türkiye | 1987 (2022)

Palabra clave: Legislación básica, Educación, Equidad, Institución, Gobierno local, Salud pública, Agua potable, Protección de los animales, Investigación

Fuente: FAO, FAOLEX