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Regulation on licensing of traditional herbal medicinal products.

Country/Territory
Türkiye
Document type
Regulation
Date
2023
Source
FAO, FAOLEX
Original source
Official Gazette No. 32093, 3 February 2023.
Subject
Cultivated plants
Keyword
Access-to-information Business/industry/corporations Certification Packaging/labelling Procedural matters Public health
Geographical area
Asia, Black Sea, Europe, Europe and Central Asia, Mediterranean, Middle East, Western Asia
Entry into force notes
This Regulation enters into force on the day it is published in the Official Gazette.
Abstract

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.

Full text
Turkish
Website
www.resmigazete.gov.tr

References - Legislation

Implements

Law No. 3359 on health services.

Legislation | Türkiye | 1987 (2022)

Keyword: Basic legislation, Education, Equity, Institution, Local government, Public health, Potable water, Animal welfare, Research

Source: FAO, FAOLEX