Traditional medicines must declare quality standards before circulation.

Traditional medicines must declare quality standards before being circulated - Photo 1.

Traditional medicines and medicinal herbs must declare quality standards before being circulated.

Subjects and requirements for publishing quality standards of traditional medicines

The Circular clearly stipulates the subjects and requirements for announcing quality standards of traditional medicines and medicinal herbs. Accordingly, traditional medicines and medicinal herbs must announce quality standards before being circulated in one of the following cases:

a- Traditional medicines and medicinal herbs that do not have quality standards specified in the Vietnamese pharmacopoeia or the reference pharmacopoeia specified in Article 4 of this Circular.

b- Traditional medicines and medicinal herbs have quality standards specified in the Vietnamese pharmacopoeia or reference pharmacopoeia, but the facility wants to announce quality indicators and quality levels higher than those specified in the pharmacopoeia.

Traditional medicine is a medicinal herb processed according to the theory and methods of traditional medicine used to produce traditional medicine or to prevent and treat diseases.

In case traditional medicines and medicinal herbs have a monograph on quality standards in the Vietnamese pharmacopoeia or reference pharmacopoeia and the pharmaceutical business establishment declares that it applies quality standards according to the Vietnamese pharmacopoeia or reference pharmacopoeia, it is entitled to do business immediately after self-declaration without having to submit documents and procedures for declaring the quality of traditional medicines and medicinal herbs.

Establishments that announce quality standards for traditional medicines and medicinal herbs include: Establishments trading in traditional medicines and medicinal herbs in Vietnam; medical examination and treatment establishments that process and prepare traditional medicines and medicinal herbs; establishments trading in traditional medicines and medicinal herbs of foreign countries with representative offices in Vietnam.

Procedures for recalling traditional medicines and medicinal herbs

According to the Circular, cases of voluntary recall include:

Business establishments self-detect and conclude that traditional medicines, traditional medicinal ingredients, and medicinal herbs violate or show signs of violating, not ensuring quality, safety, and effectiveness.

Business establishments withdraw for commercial reasons.

Business establishments shall self-collect samples, test the quality or send samples and have a written document voluntarily recalling traditional medicines, traditional medicinal ingredients, and medicinal herbs and report in writing to the Department of Traditional Medicine and Pharmacy Management before the time the samples of traditional medicines, traditional medicinal ingredients, and medicinal herbs are collected for quality testing by competent authorities.

Cases not considered as voluntary withdrawal :

Traditional medicines, traditional medicinal herbs, and medicinal herbs have been sampled by the management and quality control agency to test for quality, and it is concluded that traditional medicines, traditional medicinal herbs, and medicinal herbs violate quality.

Traditional medicines have serious side effects or have a chain of adverse reactions according to the report of the National Center for Drug Information and Adverse Drug Reaction Monitoring.

Traditional medicines, traditional medicines, and medicinal herbs do not guarantee safety and treatment effectiveness according to the Council's conclusion.

Voluntary recall procedures

After discovering that traditional medicines, traditional medicinal ingredients, or medicinal herbs violate quality standards or show signs of quality violations, business establishments must self-assess and determine the level of violation according to regulations.

Issue a recall document to the distribution and usage facility: The recall document must clearly state the scope of the recall in one or several provinces or cities or nationwide according to the assessment of risk and cause of violation.

Organize the recall and receipt of recalled traditional medicines, traditional medicinal ingredients, and medicinal herbs. Report to the Department of Traditional Medicine and Pharmacy Management, the specialized health agency under the Provincial People's Committee for traditional medicines, traditional medicinal ingredients, and medicinal herbs in violation, including information related to the violation, results of self-assessment of the level of violation, level and scope of recall.

Report on the results of recall and handling of recalled traditional medicines, traditional medicinal ingredients, and medicinal herbs; results of investigation and assessment to determine the causes and measures to overcome and prevent the quality of traditional medicines, traditional medicinal ingredients, and medicinal herbs produced and imported.

9 cases of recalled traditional medicine must be destroyed

The Circular stipulates that recalled traditional medicines must be destroyed in the following cases:

1- Expired traditional medicine.

2- Traditional medicine is damaged during production, storage and transportation.

3- Traditional medicine is a sample that has expired the prescribed sample storage period.

4- Traditional medicine is recalled due to level 1 or level 2 violations.

5- Traditional medicine is recalled due to irremediable level 3 violations.

6- Traditional medicines recalled due to level 3 violations are allowed to be remedied or re-exported, but remediation and re-export cannot be carried out.

7- Fake traditional medicine, smuggled traditional medicine, traditional medicine of unknown origin, traditional medicine containing banned substances.

8- Traditional medicines must be destroyed according to the provisions of Decree No. 117/2020/ND-CP dated September 28, 2020 on administrative sanctions in the health sector.

9- Traditional medicines produced from raw materials that do not meet quality standards, except in cases where the unsatisfactory criteria are handled during the production process and do not affect the production process and quality of the medicine.

Minh Hien

Source: https://baochinhphu.vn/vi-thuoc-co-truyen-phai-cong-bo-tieu-chuan-chat-luong-truoc-khi-luu-hanh-102250710151745329.htm