TBT BSN | Notification

Notification Detail :: G/TBT/N/THA/743

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Draft Notification of the Herbal Product Committee Re: The Quality Control Methods and Specifications of Herbal Product and the Criteria, Procedures and Conditions for the Issuance of Certificate of Analysis of Herbal Products3rd edition) B.E….

Objective

Protection of human health or safety (TBT); Quality requirements (TBT)

Product Covered

Herbal products

Document Notification

Link to ePing

HSCODE

ICSCODE

Keywords

Human health

Specific Regions

Description

Amendments to the Notification of the Herbal Product Committee Re: The quality control methods and specifications of herbal product and the criteria, procedures and conditions for the issuance of certificate of analysis of herbal products B.E. 2564 (2021) are made to revise as follows;Clause 2 This notification shall come into force as from the day following the date of its publication in the Government Gazette. Clause 3 The text stated in Clause 4 of the Notification of the Herbal Product Committee Re: The quality control methods and specifications of herbal product and the criteria, procedures and conditions for the issuance of certificate of analysis of herbal products B.E. 2564 (2021) shall be repealed and replaced with the following text: “Clause 4 The quality control methods and specifications of herbal products shall comply with the following criteria: (1) The testing parameters for each dosage form shall be in accordance with Annex 1 to this Notification. (2) The test method for each type of testing parameters according to (1) shall be in accordance with Annex 2 to this Notification.(3) The acceptance criteria for each testing parameter according to (1), shall be in accordance with Annex 2 and 3 to this Notification. A Certificate of analysis of herbal product according to Clause 3 shall be issued in consequence ofthe testing reports conducted and issued by laboratories or organizations as specified in Clause 5 or Clause 6 of this Notification”Clause 4 The text stated in Clause 5 of the Notification of the Herbal Product Committee Re: the quality control methods and specifications of herbal product and the criteria, procedures and conditions for the issuance of certificate of analysis of herbal products B.E. 2564 (2021) shall be repealed and replaced with the following text: “Clause5 Testing reports of the testing parameters on microbial contamination, heavy metals, assay and others shall be conducted and issued by one of the following laboratories or organizations:(1)Department of Medical Sciences or Regional Medical Sciences Center  (2) Department of Science Service (DSS)(3) ISO/IEC 17025 Accredited Laboratory (4) A Laboratoryin a licensed manufacturing facility according to the Herbal Product Act B.E. 2562 (2019).(5)A laboratoryin a licensed manufacturing facility according to the Drug Act B.E. 2510 (1967) and its amended version. (6) Other laboratories granted by the Thai Food and Drug Administration. In case of necessity, the testing reports from (3) to (6) may include the submission of additional descriptions of methods and method validation reports.Clause 5 The text stated in Clause 6 ofthe Notification of the Herbal Product Committee Re: The qualitycontrol methods and specifications of herbal product and the criteria, procedures and conditions for the issuance of certificate of analysis of herbal products B.E. 2564 (2021)shall be repealed.Clause 6 The text stated in the second paragraph of Clause 7 of the Notification of the Herbal Product Committee Re: the quality control methods and specifications of herbal product and the criteria, procedures and conditions for the issuance of certificate of analysis of herbal products B.E. 2564 (2021) shall be repealed and replaced with the following text: “A Certificate of analysis of herbal productaccording to paragraph one shall be issued in consequence of the testing reports conducted and issued by the laboratories or organizations as specified in Clause 5 of this Notification” Clause 7 Annex 1 of the Notification of the Herbal Product Committee regarding the quality control methods and specifications of herbal products, and the criteria, procedures, and conditions for the issuance of a certificate of analysis of herbal products B.E. 2564 (2021), shall be repealed and replaced with Annex 1 of this Notification. Clause 8 Annex 2 of the Notification of the Herbal Product Committee Re: the quality control methods and specifications of herbal product and the criteria, procedures and conditions for the issuance of certificate of analysis of herbal products B.E. 2564 (2021) shall be repealed and replaced with Annex 2 of this Notification.

Notified Document

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Link to Notification

EN:File here

FR:File here

ES:File here

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Notification Detail :: G/TBT/N/THA/743

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