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