Testing herbal ingredients, traditional medicinal herbs and traditional medicines in Vietnam

What are regulations on testing herbal ingredients, traditional medicinal herbs and traditional medicines in Vietnam?

Pursuant to Article 10 of the Circular 38/2021/TT-BYT (takes effect from 15/02/2022) stipulating regulations on testing herbal ingredients, traditional medicinal herbs and traditional medicines in Vietnam as follows:

- The testing must be carried out according to the approved and updated quality standards of herbal ingredients, traditional medicines and traditional medicines.

+ In case the quality standards of herbal ingredients, traditional herbs and traditional drugs have not been updated, the testing establishment shall apply the corresponding pharmacopoeias specified in Article 5 of this Circular for quality testing. The application of the pharmacopoeia is calculated according to the date of production of the tested batch of herbal ingredients, traditional herbs and traditional drugs;

+ In case the traditional medicine or traditional medicine is processed and produced at the medical examination and treatment establishment, the testing shall be carried out according to the quality standards of the traditional medicine and traditional medicine promugated by the establishment.

- Regulations on taking samples of herbal ingredients, traditional herbs and traditional drugs for testing:

+ The collection of traditional drug samples for testing shall comply with the provisions in Appendix I of the Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Minister of Health providing for the quality of drugs and raw materials (hereinafter referred to as Circular No. 11/2018/TT-BYT);

+ State-owned drug and medicinal ingredient testing establishments that take samples of herbal ingredients and traditional herbs for quality testing shall comply with the provisions of Appendix 12.1 of the Vietnam Pharmacopoeia V;

+ Business establishments that take samples of herbal ingredients and traditional herbs for testing shall comply with the provisions of Section I, Clause 9, Diagram r of Appendix I of Circular No. 11/2018/TT-BYT;

+ Minutes of taking samples of herbal ingredients, traditional herbs and traditional drugs as prescribed in Form No. 03, Appendix I issued with this Circular.

- Responding to the results of analysis and testing of herbal ingredients, traditional herbs and traditional medicines according to the provisions of Clause 3, Article 7 of Circular No. 11/2018/TT-BYT. Samples of test sheets and analysis sheets as prescribed in Form No. 04 and Form No. 05, Appendix I promulgated together with this Circular.

- Complaints and settlement of complaints about test results:

In case of disagreement with the test results, within 05 days from the date of receipt of the notice of testing results, the pharmacy business establishment has the right to request the Ministry of Health (the Administration of Traditional Medicine and Pharmacy). appoint another testing facility to take additional samples for analysis, testing and re-determination of test results. The re-examination of the complained quality criteria shall comply with the provisions of Clause 2, Article 105 of the Law on Pharmacy.

- Save template:

+ The herbal ingredients, traditional herbs, and traditional drugs after quality inspection and quality conclusions have been concluded must be stored as samples. Stored samples must be sealed and stored under the appropriate conditions indicated on the label;

Sample retention time:

Time to keep samples of traditional medicinal preparations until the expiry date of the drug or 06 months from the date of sampling for quality inspection.

Time to keep samples of herbal ingredients or traditional medicines until the expiry date of herbal ingredients or traditional medicines or 12 months from the date of taking samples for quality inspection.

- Save files and documents:

+ Records and documents related to quality control of herbal ingredients, traditional medicines and traditional medicines must be kept according to the provisions of the Law on Archives, the Decree guiding the Law on Archives and Circular No. 53 /2017/TT-BYT dated December 29, 2017 of the Minister of Health providing for the preservation period of professional documents and documents in the health sector;

+ Dossiers and documents when the storage time expires shall be handled according to current regulations.

What is the time limit for testing herbal ingredients, traditional medicinal herbs and traditional medicines of establishments named in the List of business establishments having herbal ingredients, traditional medicinal herbs or traditional medicines in violation of quality in Vietnam?

Pursuant to Article 12 of the Circular 38/2021/TT-BYT (takes effect from 15/02/2022) stipulating the time limit for testing herbal ingredients, traditional medicinal herbs and traditional medicines of establishments named in the List of business establishments having herbal ingredients, traditional medicinal herbs or traditional medicines in violation of quality in Vietnam as follows:

- The time limit for testing herbal ingredients, traditional medicinal herbs, traditional drugs of the same type as those in violation of quality from the time the batch of herbal ingredients, traditional medicines, the first traditional medicine to be imported or produced after the Ministry of Health (the Department of Traditional Medicine and Medicine) publishes the list of business establishments that have herbal ingredients, traditional medicinal herbs or traditional medicines in violation of the quality as follows:

+ For herbal ingredients of establishments whose names are on the list of business establishments with medicinal ingredients that violate quality:

++ 06 months for establishments having 01 batch of herbal ingredients with level 2 violations;

++ 12 months for establishments having 01 batch of herbal ingredients in violation of level 1 or having 02 batches of herbal ingredients in violation of level 2 or more.

+ For the traditional medicine of the establishment whose name is on the list of business establishments that have the traditional medicine that violates the quality:

++ 06 months, for establishments having 01 batch of traditional medicinal herbs, violating level 3;

++ 12 months for establishments that have 01 batch of traditional medicines with level 2 violations or have 02 or more batches of traditional medicines with level 3 violations;

++ 18 months for establishments that have 01 batch of traditional medicines in violation of level 1 or have 02 batches of traditional medicines with level 2 violations or more or have 03 batches of traditional drugs with level 3 violations .

+ For traditional drugs of establishments whose names are on the list of business establishments that have traditional drugs in violation of quality:

++ 06 months for establishments having 01 batch of traditional drugs with level 3 violations;

++ 12 months for a manufacturer having 01 batch of traditional drugs with level 2 violations or 02 batches of traditional drugs with level 3 violations or more;

++ 24 months for a manufacturing establishment that has 01 batch of traditional drugs in violation of level 1 or has 02 batches of traditional drugs with level 2 violations or more.

- In case the establishment has not yet withdrawn its name from the List of business establishments that have herbal ingredients, traditional medicines or traditional medicines that violate the quality, but the establishment continues to have herbal ingredients, traditional medicines or traditional medicines together with If the type of herbal ingredient, traditional medicinal ingredient or traditional medicine has been violated, prolonged testing of such herbal ingredient, traditional medicinal ingredient or traditional medicine must be carried out by the cumulative method.

- The testing of herbal ingredients, traditional herbs and traditional drugs as prescribed in Clause 1 of this Article must be carried out at a GLP-certified state testing facility.

Best regards!