Thông tư 38/2021/TT-BYT chất lượng dược liệu vị thuốc cổ truyền thuốc cổ truyền

CIRCULAR

PRESCRIBING QUALITY OF HERBAL MATERIALS, PREPARED TRADITIONAL MEDICINAL MATERIALS AND TRADITIONAL MEDICINES IN VIETNAM

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;

Pursuant to Decree No. 54/2017/ND-CP dated May 08, 2017 of the Government of Vietnam providing detailed regulations on some Articles and measures for implementation of the Law on Pharmacy;

Pursuant to Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government of Vietnam amending some regulations related to conditions for business investment in terms of state management of the Ministry of Health of Vietnam;

Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government on function, tasks, powers and organizational structures of the Ministry of Health of Vietnam;

At the request of the Director General of Traditional Medicine Administration (TMA),

The Minister of Health promulgates a Circular on quality of herbal materials, prepared traditional medicinal materials and traditional medicines,

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular prescribes the application of quality standards; publication of quality of herbal materials; analysis of quality of herbal materials, prepared traditional medicinal materials and traditional medicines; trace of origin and procedures for recalling herbal materials, prepared traditional medicinal materials and traditional medicines and disposing them.

Article 2. Regulated entities

1. This Circular applies to establishments that cultivate, collect, exploit, produce, export, import, wholesale and retail herbal materials, prepared traditional medicinal materials and traditional medicines (hereinafter referred to as “trading establishments”); health facilities and agencies, organizations and individuals (hereinafter referred to as “units”) relevant to the management of herbal materials, prepared traditional medicinal materials and traditional medicines in Vietnam.

2. This Circular does not apply to establishments trading in semi-finished herbal materials and herbal medicines; individuals cultivating and harvesting and exploiting herbal materials.

Article 3. Definitions

For the purpose of this Circular, the terms below are construed as follows:

1. “batch of herbal materials” means a specific quantity of herbal materials derived from ingredients cultivated or harvested at the same place, prepared by an establishment under the same procedures within a particular period of time.

2. “batch of prepared traditional medicinal materials” means a specific quantity of prepared traditional medicinal materials with the same quality derived from materials prepared or produced by an establishment under the same procedures within a particular period of time.

3. “batch of traditional medicines” means a specific quantity of traditional medicines with the same quality derived from materials processed or produced by an establishment under the same procedures within a particular period of time.

4. “shelf life” of herbal materials, prepared traditional medicinal materials and traditional medicines” means the predetermined length or period of time that the herbal materials, prepared traditional medicinal materials and traditional medicines may be stored for use and after that they are banned from using. The shelf life may be expressed as a period from the date of manufacture to the date of expiration or as the day, month and year of expiration. In case the self life is only expressed as the month and year of expiration, the day of expiration will be understood as the last day of such month.

5. “herbal material/ prepared traditional medicinal material/ traditional medicine quality standards” means technical characteristics of herbal materials, prepared traditional medicinal materials and traditional medicines including quality criteria, quality degrees, testing methods and other technical and managing requirements  related to the quality of such herbal materials, prepared traditional medicinal materials and traditional medicines.

Chapter II

APPLICATION OF QUALITY STANDARDS FOR HERBAL MATERIALS, PREPARED TRADITIONAL MEDICINAL MATERIALS AND TRADITIONAL MEDICINES

Article 4. Application of quality standards for herbal materials, prepared traditional medicinal materials and traditional medicines

1. The quality of herbal materials, prepared traditional medicinal materials and traditional medicines must be governed and guaranteed according to the quality standards specified in the pharmacopoeia or internal applied standards of manufacturers. Herbal material/ prepared traditional medicinal material/ traditional medicine quality standards are presented according to Form 01 of Appendix I issued together with this Circular.

2. Establishments trading in herbal materials, prepared traditional medicinal materials and traditional medicines must carry out the appraisal and assessment of testing methods announced and applied by manufacturers. The appraisal of standards and testing methods must be carried out at testing laboratories meeting Good Laboratory Practice (GLP) or testing service providers that are issued certificates of eligibility for trading in pharmaceuticals.

3. The Ministry of Health (via TMA) organizes appraisal of dossiers and approval of herbal material/ prepared traditional medicinal material/ traditional medicine quality standards according to regulations on registration of prepared traditional medicinal materials and traditional medicines and regulations on issuance of licenses for importing herbal materials, prepared traditional medicinal materials and traditional medicines to which certificates of free sale are not issued and regulations on publication of quality standards of herbal materials.

Article 5. Application of pharmacopoeia

Application of Vietnam’s pharmacopoeia and pharmacopoeias of other countries:

1. Establishments trading in herbal materials, prepared traditional medicinal materials and traditional medicines; health facilities may apply Vietnam's pharmacopoeia or one of pharmacopoeias of other countries but the quality indices and levels prescribed in such pharmacopoeia must be not lower than those specified in Vietnam's pharmacopoeia

2. Establishments which import herbal materials, prepared traditional medicinal materials and traditional medicines into Vietnam must apply pharmacopoeias of countries in which herbal materials, prepared traditional medicinal materials and traditional medicines are exported. Regarding Vietnam’s pharmacopoeia and the pharmacopoeias of exporting countries, pharmacopoeia in which quality indices and levels are higher than those of another one shall be applied.

3. The application of each pharmacopoeia must meet all regulations on quality indices and levels specified in the corresponding treatise on herbal materials, prepared traditional medicinal materials and traditional medicines and the general testing method prescribed in such pharmacopoeia. The testing method in each treatise of medicines, medicinal ingredients and packages directly contacting with medicines which are specified in the pharmacopoeia is voluntarily applied.

4. In case a trading establishment publicizes application of Vietnam's pharmacopoeia or one of the pharmacopoeias of other countries but uses a testing method different from the method specified in the general treatise of herbal materials, prepared traditional medicinal materials and traditional medicines of the applied pharmacopoeia, it must prove the equivalence between these testing methods. Results using the testing method specified in the pharmacopoeia are grounds to conclude the qualities of such herbal materials, prepared traditional medicinal materials and traditional medicines.

Article 6. Application of internal quality standards

Quality standards for herbal materials, prepared traditional medicinal materials and traditional medicines internally developed and applied by manufacturers must fulfill the requirements specified in point b clause 2 Article 102 of the Law on Pharmacy No. 105/2016/QH13 (hereinafter referred to as "Pharmacy Law"). To be specific:

1. They must meet quality indices and levels requirements prescribed in the corresponding treatises of Vietnam’s pharmacopoeia or one of the pharmacopoeias of foreign countries and requirements regarding quality indices, quality levels and common testing methods specified in the Appendices of the same according to regulations specified in Article 5 hereof.

2. In case Vietnam's pharmacopoeia and pharmacopoeia of foreign country does not have a corresponding treatise on herbal materials, prepared traditional medicinal materials and traditional medicines, the manufacturers shall develop their own standards according to scientific research findings, testing, assessment and analysis results or according to regulations of another foreign pharmacopoeia. Approval and publication of herbal material/ prepared traditional medicinal material/ traditional medicine quality standards shall comply with regulations specified in clause 3 Article 4 hereof.

Article 7. Update of quality standards and application of updated pharmacopoeias

1. Within 02 years from the date on which the current version of the pharmacopoeia takes effect, trading establishments, manufacturers of prepared traditional medicinal materials and traditional medicines and health facilities are responsible for updating quality standards for herbal materials, prepared traditional medicinal materials and traditional medicines as prescribed in the latest version of such pharmacopoeia.

2. For prepared traditional medicinal materials and traditional medicines, upon applying for registration of certificate of free sale: quality standards must fulfill relevant requirements in the current version of the pharmacopoeia or its previous version which has been offered for not more than 02 years by the effective date of such version.

3. In the period of trading and using, in case of trading establishments of herbal materials, manufacturers of prepared traditional medicinal materials and traditional medicines and health facilities detecting factors that affect seriously to the quality, security and effectiveness of herbal materials, prepared traditional medicinal materials and traditional medicines or at the request of TMA of the Ministry of Health, indices must be updated into the quality standards of herbal materials, prepared traditional medicinal materials and traditional medicines according to the new version of pharmacopoeia to control effective factors.

Chapter III

PUBLICATION OF QUALITY STANDARDS FOR HERBAL MATERIALS

Article 8. Regulated entities and requirements for publication of quality standards for herbal materials

1. Herbal materials of which quality standards must be published before they are sold include:

a) Herbal materials for which quality standards are not prescribed in Vietnam’s pharmacopoeia or other foreign pharmacopoeias prescribed in Article 5 hereof;

b) Herbal materials for which quality standards are prescribed in Vietnam’s pharmacopoeia or a foreign pharmacopoeia prescribed in Article 5 hereof but establishments wish to publish quality indices and levels that are higher than those prescribed in the pharmacopoeia.

2. Establishments permitted to publish quality standards include:

a) Trading establishments of herbal materials in Vietnam;

b) Trading establishments of herbal materials in foreign countries which have representative offices located in Vietnam.

Article 9. Dossiers and procedures for publication of herbal materials:

1. A dossier of publishing herbal material quality includes:

a) A written document of publishing herbal material quality under Form 02 Appendix I issued herewith;

b) A testing form for herbal materials meeting quality standards published by institutions testing drugs and medicinal ingredients up to Good Laboratory Practice (GLP) standards;

c) Written proofs of origin of herbal materials as prescribed in Article 13 hereof;

d) Documents contained in the dossier must be written in Vietnamese; must be translated into Vietnamese or English and notarized as prescribed in case of foreign documents. All documents must be still valid in the date of publication. Trading establishments must be responsible for the legality and contents of the dossier.

2. Procedures for publishing quality of herbal materials

a) An organization or individual shall submit one (01) dossier by post, via the website of TMA of the Ministry of Health or in person at TMA of the Ministry of Health;

b) After receiving the dossier of publishing of the organization or individual, within 05 days, the Ministry of Health (via TMA) shall be responsible for consideration of updating the following contents on the website of TMA: name of the organization or individual; name of herbal materials, origin of them; quality standards applied and sent to testing authorities for quality control as prescribed;

c) Immediately after being updated on the website by TMA, the organization or individual shall have the right to sell the above-mentioned herbal materials and take full responsibility for the safety of such herbal materials;

d) In case of a herbal material of which its origin changes, the individual must re-make the procedures for publication of it.

Chapter IV

TESTING QUALITY OF HERBAL MATERIALS, PREPARED TRADITIONAL MEDICINAL MATERIALS AND TRADITIONAL MEDICINES

Article 10. Testing herbal materials, prepared traditional medicinal materials and traditional medicines

1. The testing must be carried out according to herbal material/ prepared traditional medicinal material/ traditional medicine quality standards that have been approved and updated.

a) In case herbal material/ prepared traditional medicinal material/ traditional medicine quality standards are not updated, testing facilities shall apply corresponding pharmacopoeias prescribed in Article 5 hereof for quality testing. The pharmacopoeia shall be applied on the basis of manufacturing dates of herbal materials, prepared traditional medicinal materials and traditional medicines being tested.

b) In case traditional medicinal materials and traditional medicines are processed and manufactured at health facilities, the testing will be carried out according to the quality standards for traditional medicinal materials and traditional medicines developed and issued by manufacturers.

2. Regulations on taking a sample of a herbal material/prepared traditional medicinal material/traditional medicine for testing;

a) The sample of the traditional medicine shall be taken according to regulations specified in Appendix I of Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Ministry of Health on the quality of medicines and medicinal ingredients (hereinafter referred to as “Circular No. 11/2018/TT-BYT);

b) State medicine/medicinal ingredient testing facilities shall take the sample of the herbal material/prepared traditional medicinal material to test its quality according to regulations specified in Appendix 12.1 of Vietnam's pharmacopoeia V;

c) Trading establishment shall take the sample of the herbal material/prepared traditional medicinal material according to regulations specified in Section I, clause 9, diagram r of Appendix I of Circular No. 11/2018/TT-BYT;

d) Record of taking the sample of the herbal material/prepared traditional medicinal material/traditional medicine shall be made according to regulations specified in Form 03 of Appendix I issued herewith.

3. Response to results from analysis and testing of herbal materials/prepared traditional medicinal materials/traditional medicines must be made according to regulations of clause 3 Article 7 of Circular No. 11/2018/TT-BYT. Testing forms and analysis forms are made under regulations specified in Form 04 and Form 05 of Appendix I issued herewith.

4. Complaints and handling of complaints about testing results:

In case a trading establishment opposes its testing result, the trading establishment has the right to send a request to the Ministry of Health (via TMA) for appointment of another testing facilities to take an additional sample for analysis and testing to re-determine the testing result within 05 days from the date on which the testing result is notified. The retesting of the result that is complained must comply with regulations specified in clause 2 Article 105 of the Pharmacy Law.

5. Storage of samples:

a) Herbal materials/prepared traditional medicinal materials/traditional medicines must be stored after completing quality testing and providing conclusions.  The stored samples must be sealed and preserved in suitable conditions specified in their labels;

b) Duration of storing samples:

Each sample of traditional medicine shall be stored until the expiry date of the medicine or 06 months from the day on which the testing sample is taken.

Each sample of herbal material or prepared traditional medicinal material shall be stored until the expiry date of such material or 12 months from the day on which the testing sample is taken.

6. Storage of dossiers and documents:

a) Dossiers and documents related to the quality testing of herbal materials, prepared traditional medicinal materials and traditional medicines must be stored according to regulations specified in the Law on Archives, Decree guiding the Law on Archives and Circular No. 53/2017/TT-BYT dated December 29, 2017 of the Ministry of Health on deadlines for preservation of professional health dossiers or documents;

b) Dossiers and documents shall be handled according to the current regulations after ending the duration of storage.

Article 11. Update and withdrawal of name from the List of trading establishments having herbal materials, prepared traditional medicinal materials and traditional medicines failing to meet quality standards

1. Update of the List of trading establishments having herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quality standards:

a) TMA shall update the List of trading establishments having herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quality standards on the website of TMA (ydct.moh.gov.vn) within 72 hours from the time at which the decisions on recalling herbal materials, prepared traditional medicinal materials or traditional medicines are made;

b) TMA shall not update the List of trading establishments committing offences against quality standards for herbal materials, prepared traditional medicinal materials or traditional medicines on the website of TMA for trading establishments having recalled herbal materials, prepared traditional medicinal materials or traditional medicines which are recalled may be fixed and reused according to regulations of clause 2 Article 20 and clause 3 Article 21 hereof.

2. Trading establishments are permitted to withdraw their names from the List of trading establishments having herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quality standards when they meet the following regulations:

a) The quality testing must be fully carried out according to the duration prescribed in clause 1 Article 12 hereof;

b) Trading establishments must have reports on taking testing samples according to regulations specified in Form 06 Appendix I issued together with this Circular and written proofs of the testing for all batches of herbal materials, prepared traditional medicinal materials or traditional medicines in the same types with the herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quality standards when they are manufactured and imported into Vietnam as prescribed in clause 1 Article 12 hereof;

c) In the period of implementation of regulations specified in clause 1 Article 12 hereof, trading establishments shall not commit offences against quality standards for herbal materials, prepared traditional medicinal materials or traditional medicines in the same types with the violating herbal materials, prepared traditional medicinal materials or traditional medicines and voluntarily recall them to ensure the quality.

3. Based on reporting results of trading establishments, the Ministry of Health (via TMA) shall review monthly to withdraw names of trading establishments meeting regulations specified in clause 2 of this Article from the List of trading establishments having herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quality standards.

Article 12. Deadlines for testing herbal materials, prepared traditional medicinal materials or traditional medicines of trading establishments named in the List of trading establishments having herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quality standards.

1. Deadline for testing herbal materials, prepared traditional medicinal materials or traditional medicines in the same types with herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quality standards shall be calculated from the date on  which the first batch of  herbal materials, prepared traditional medicinal materials or traditional medicines is imported and manufactured after the date on which the Ministry of Health (via TMA) publishes the List of trading establishments having violating herbal materials, prepared traditional medicinal materials or traditional medicines as follows:

a) For herbal materials of an establishment named in the List of trading establishments having herbal materials failing to meet quality standards:

- 06 months, if the establishment has 01 batch of herbal materials involving second-degree violations;

- 12 months, if the establishment has 01 batch of herbal materials involving first-degree violations or at least 02 batches of herbal materials involving second-degree violations or higher.

b) For prepared traditional medicinal materials of an establishment named in the List of trading establishments have violating prepared traditional medicinal materials:

- 06 months, if the establishment has 01 batch of prepared traditional medicinal materials involving third-degree violations;

- 12 months, if the establishment has 01 batch of prepared traditional medicinal materials involving second-degree violations or has at least 02 batches of prepared traditional medicinal materials involving third-degree violations;

- 18 months, if the establishment has 01 batch of prepared traditional medicinal materials involving first-degree violations or has at least 02 batches of prepared traditional medicinal materials involving second-degree violations or higher or has 03 batches of prepared traditional medicinal materials involving third-degree violations.

c) For traditional medicines of an establishment named in the List of trading establishments have traditional medicines failing to meet quality standards:

- 06 months, if the establishment has 01 batch of traditional medicines involving third-degree violations;

- 12 months, if the manufacturer has 01 batch traditional medicines involving second-degree violations or has at least 02 batches of traditional medicines involving third-degree violations or higher;

- 24 months, if the manufacturer has 01 batch traditional medicines involving first-degree violations or has at least 02 batches of traditional medicines involving second-degree violations or higher;

2. In case the establishment fails to withdraw its name from the List of trading establishments having violating herbal materials, prepared traditional medicinal materials or traditional medicines but the establishment still have herbal materials, prepared traditional medicinal materials or traditional medicines in the same types with herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quality standards, the establishment must prolong testing for such herbal materials, prepared traditional medicinal materials or traditional medicines according to the accumulation method.

3. The testing of herbals, prepared traditional medicinal materials or traditional medicines must be taken at state testing facilities achieving GLP according to regulations specified in clause 1 of this Article.

Chapter V

ORIGIN TRACING OF HERBAL MATERIALS, PREPARED TRADITIONAL MEDICINAL MATERIALS AND TRADITIONAL MEDICINES

Article 13. Written proofs of origin of herbal materials, prepared traditional medicinal materials and traditional medicines

1. A written proof of origin of herbal materials imported is a certificate of origin (C/O) of each batch of herbal materials issued by a state competent authority of the exporting country.

2. A written proof of origin of herbal materials cultivated, harvested or naturally extracted by a domestic establishment meeting the Good Agricultural and Collection Practices (GACP) requirements is a GACP-compliance certificate of such herbal materials.

3. A written proof of origin of herbal materials acquired by a trading establishment from domestic individuals cultivating, harvesting such herbal materials is a commitment to sites where such herbal materials are cultivated and harvested according to Form 07 in the Appendix I enclosed herewith.

4. A written proof of origin of a prepared traditional medicinal material includes:

a) Written proofs of origin of herbal materials used to process the traditional medicinal material;

b) A certificate of free sale for the prepared traditional medicinal material. 

5. A written proof of origin of a traditional medicine includes:

a) Written proofs of origin of herbal materials used to process the traditional medicine;

b) A certificate of free sale for the traditional medicine. 

Article 14. Archives of documents related to origin of herbal materials, prepared traditional medicinal materials and traditional medicines

1. A trading establishment must fully archive physical copies or soft copies of documents concerning each time of import and export of herbal materials, prepared traditional medicinal materials or traditional medicines with full accurate information as below:

a) Information on sellers and buyers of herbal materials, prepared traditional medicinal materials or traditional medicines: name, address, phone number and email (if any);

b) Information on herbal materials: common name, binomial name, used parts, origin and quality standards;

c) Information on prepared traditional medicinal materials: common name, processing method, binomial name, quality standards, batch number, date of manufacture, expiry date;

d) Information on traditional medicines: name, dosage form, content, batch number, date of manufacture, expiry date;

dd) Quantity of herbal materials, prepared traditional medicinal materials or traditional medicines imported and sold;

e) Date of importing herbal materials, prepared traditional medicinal materials or traditional medicines; date of selling herbal materials, prepared traditional medicinal materials or traditional medicines.

2. Each trading establishment of herbal materials must have a software of tracing origin of herbal materials.

3. Each manufacturer or importer that provide the distribution service or each wholesaler in charge of distribution must cooperate with other wholesalers or retailers in establishing a distribution system and adopting measures for monitoring and ensuring the origin traceability as well as monitoring the story and storage conditions of herbal materials, prepared traditional medicinal materials or traditional medicines.

4. Each trading establishment must archive dossiers and documents according to regulations specified in the Law on Archives, Decree guiding the Law on Archives and Circular No. 53/2017/TT-BYT dated December 29, 2017 of the Ministry of Health of Vietnam on deadlines for preservation of professional health dossiers or documents.

Chapter VI

RECALL OF HERBAL MATERIALS, PREPARED TRADITIONAL MEDICINAL MATERIALS AND TRADITIONAL MEDICINES FAILING TO MEET QUALITY STANDARDS AND HANDLING THEREOF

Article 15. Form and scope of recall

1. Form of recall:

a) Herbal materials shall be recalled according to the form of recall prescribed in clause 1 Article 101 of Decree No. 54/2017/ND-CP dated May 07, 2017 of the Government of Vietnam elaborating providing detailed regulations on some Articles and measures for implementation of the Law on Pharmacy (hereinafter referred to as “Decree No. 54/2017/ND-CP);

b) Prepared traditional medicinal materials and traditional medicines shall be recalled according to regulations specified in clause 1 Article 63 of the Law on Pharmacy.

2. Scope of recall

a) Scope of recall of herbal materials is prescribed in clause 2 Article 101 of Decree No. 54/2017/ND-CP;

b) Scope and duration of recall of prepared traditional medicinal materials and traditional medicines are prescribed in clause 3 Article 63 of the Law on Pharmacy.

Article 16. Procedures for mandatory recall of herbal materials, prepared traditional medicinal materials or traditional medicines

1. Receiving information on herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quantity standards:

The Ministry of Health (via TMA) shall receive information on herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quantity standards from:

a) The evaluation of efficacy and safety of herbal materials, prepared traditional medicinal materials or traditional medicines given by the advisory council responsible for issuing certificates of free sale of medicines and medicinal ingredients;

b) Information on the quality of herbal materials, prepared traditional medicinal materials or traditional medicines provided by medicine and medicinal ingredient testing facilities archiving GLP;

c) Information on herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quality standards reported by the Departments of Health of provinces or cities to TMA or discovered by TMA or healthcare/ pharmaceutical inspectorates;

d) Notification of herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quality standards given by foreign regulatory authorities or quality control authorities;

dd) Information on herbal materials, prepared traditional medicinal materials or traditional medicines failing to meet quality standards provided by police agencies, customs agencies or market surveillance agencies;

e) Information on herbal materials, prepared traditional medicinal materials or traditional medicines provided voluntarily by trading establishments that proposed to recall them;

g) The evaluation of efficacy and safety of herbal materials, prepared traditional medicinal materials or traditional medicines given by the National Centre of Drug Information and Adverse Drug Reactions Monitoring (National DI & ADR Centre).

2. Determining violation degrees:

a) Determining violation degrees of traditional medicines:

- Within 24 hours from the time of receipt of information concerning traditional medicines failing to meet quality standards as prescribed in points a, c, d, dd, e and g clause 1 of this Article, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall determine violation degrees of the traditional medicines according to regulations in the Appendix II enclosed herewith and give conclusion about the recall of the traditional medicines failing to meet quality standards on the basis of their harm to the users' health.

- In case where the counsel given by the advisory council responsible for giving counsel on registration of traditional medicines and medicinal ingredients is required, the violation degrees must be determined within 7 days.

b) Determining violation degrees of herbal materials and prepared traditional medicinal materials:

Within 72 hours from the time of receipt of information concerning herbal materials failing to meet quality standards as prescribed in points c, d, dd, e and g clause 1 of this Article, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall determine violation degrees of the herbal materials and prepared traditional medicinal materials according to regulations in the Appendix III and Appendix IV enclosed herewith and give conclusion about the recall of the herbal materials and prepared traditional medicinal materials failing to meet quality standards on the basis of their harm to the users' health.

In case where the counsel given by the professional council is required, the violation degrees of herbal materials and prepared traditional medicinal materials must be determined within 15 days.

c) For information on herbal materials, prepared traditional medicinal materials and traditional medicines failing to meet quality standards prescribed in point b clause 1 of this Article, violation degrees shall be determined according to regulations specified in Articles 18 and 19 hereof. The Ministry of Health (via TMA) shall only determine violation degrees when the quality testing is taken by state testing facilities achieving GLP.

3. Issuing decisions on recall of herbal materials, prepared traditional medicinal materials or traditional medicines:

a) Within 48 hours from the time at which a conclusion of the recall of herbal materials is made, the Ministry of Health shall authorize the Director General of TMA to make a decision on recall of herbal materials failing to meet quality standards as prescribed in regulations of clause 1 or clause 2 Article 102 of Decree No. 54/2017/ND-CP;

The decision on recall of herbal materials must include: names herbal materials, import license number or the quality standard number, volume, batch number, expiry date, manufacturer or importer, violation degrees, establishment responsible for recall;

b) Within 14 hours from the time at which a conclusion of the recall of prepared traditional medicinal materials and traditional medicines is issued, the Ministry of Health shall authorize the Director General of TMA to make a decision on recall of prepared traditional medicinal materials and traditional medicines failing to meet quality standards as prescribed in regulations of clause 1 or clause 2 Article 65 of the Law on Pharmacy;

The decision on recall of prepared traditional medicinal materials must include: names of prepared traditional medicinal materials, number of certificate of free sale or import license, processing method, volume of recalled materials, batch number, expiry date, manufacturer or importer, violation degrees, establishment responsible for recall.

The decision on recall of traditional medicines must include: names of prepared traditional medicines, number of certificate of free sale or import license, names of herbal ingredients, volume of recalled medicines, dosage forms, batch number, expiry date, manufacturer or importer, violation degrees, establishment responsible for recall.

4. Information of the decisions on recall:

a) The decisions on recall of herbal materials, prepared traditional medicinal materials and traditional medicines of the Ministry of Health of Vietnam (via TMA) shall be informed to Departments of Health, trading establishments through mail, fax, email, telephone or mass media;

b) For herbal materials, prepared traditional medicinal materials and traditional medicines failing to meet quality standards at level 2 or level 3, the Ministry of Health (via TMA) shall, immediately after having decisions on recall, publish the decisions on recall on the website of TMA.

The Departments of Health shall publish information on the decisions on recall on the website of the Departments immediately after receiving the decisions on recall.

The trading establishment must send a notification of information on herbal materials, prepared traditional medicinal materials and traditional medicines recalled to establishments which have been trading and using such materials or medicines; the recall shall be carried out in the areas specified in the decisions on recall of the Ministry of Health;

c) For herbal materials, prepared traditional medicinal materials and traditional medicines failing to meet quality standards at level 1, apart from carrying out according to regulations in point b of this clause, the decisions on recall must be informed on Vietnam Television and Voice of Vietnam by the Ministry of Health of Vietnam.

5. Organizing the recall of herbal materials, prepared traditional medicinal materials and traditional medicines

a) Traders and users of herbal materials, prepared traditional medicinal materials and traditional medicines must refrain from supply and use thereof; separately store the remaining materials and medicines; make the list of buyers, contact them and receive returned materials and medicines; transfer all such materials and medicines returned by buyers to the supplier;

b) Manufacturers and importers shall cooperate with import entrustors or establishments in charge of material/medicine distribution service in being responsible for organizing the recall of herbal materials, prepared traditional medicinal materials and traditional medicines failing to meet quality standards. The recall of herbal materials, prepared traditional medicinal materials and traditional medicines must be properly recorded according to the Form 08 in the Appendix I enclosed herewith.

In case traders do not organize the recall or receive materials/medicines returned, buyers and users shall send reports to the Departments of Health in their areas for handling as prescribed;

c) The recall of prepared traditional medicinal materials and traditional medicines must be completed in the time limit prescribed in clause 3 Article 63 of the Law on Pharmacy.

d) The recall of herbal materials must be completed within 30 days from the day on which the decision on recall is issued.

6. Reporting the recall and its results

Within 01 day if materials/medicines are recalled due to the first-degree violations, or 03 days if materials/medicines are recalled due to the second or third-degree violations, from the date on which the recall is completed, the establishment responsible for the recall must report the recall result in writing to the Ministry of Health (via TMA) and relevant provincial Departments of Health, including the following documents:

- The report on recall according to the Form No. 09 in the Appendix I enclosed herewith;

- The list of direct and indirect buyers accompanied by their addresses, telephone number, email (if any), quantity of materials/medicines supplied and quantity of materials/medicines returned;

- The record of receipt of returned materials/medicines, invoice of returned materials/medicines or other evidences of the recall;

- The written self-assessment of the recall;

- The result of investigation and evaluation of reasons for violations and risks to other batches of herbal materials, prepared traditional medicines and traditional medicines failing to meet quality standards and/or other prepared traditional medicinal materials, traditional medicines that are produced by the same production line.

7. Evaluating results of the recall

The Ministry of Health (via TMA) shall consider report on recall result of the establishment responsible for the recall to self-evaluate or designate the Provincial Department of Health to evaluate the recall result. If the recall result is not satisfactory and materials and medicines are still sold, used and threaten to cause serious harm to users’ health, the Traditional Medicine Administration of Vietnam shall cooperate with the Provincial Department of Health and relevant competent authorities to enforce the recall.

Article 17. Procedures for voluntary recall of herbal materials, prepared traditional medicinal materials and traditional medicines

1. Each establishment trading in herbal materials, prepared traditional medicinal materials and traditional medicines shall self-determine the level of its violation against regulations on quality standards of materials and medicines and send a written report thereof to the Ministry of Health (via TMA) and is accompanied by relevant documents. The report includes the information about the herbal materials, prepared traditional medicinal materials and traditional medicines failing to meet quality standards, the level of violation, reasons for the recall and proposal of measures for disposal of recalled materials and medicines as prescribed in Articles 20 and 21 hereof.

2. Within 03 days from the receipt of the report sent by the drug trading establishment, the Ministry of Health (via TMA) shall consider and determine the level of violation according to provisions in the Appendix II, III and IV enclosed herewith.

a) The Ministry of Health (via TMA) shall give a written approval for the voluntary recall to the trading establishment if its proposal that herbal materials, prepared traditional medicinal materials and traditional medicines constitute the third-degree violation is accepted.

b) The Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall carry out procedures for recall of herbal materials, prepared traditional medicinal materials and traditional medicines as prescribed in Clauses 3, 4, 5 and 6 Article 16 herein if it determines that such materials and medicines constitute the first or second-degree violations;

c) If the report is not satisfactory, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall send a written request to the trading establishment for provision of supplemented documents and explanations. Within a maximum period of 05 days from the receipt of the written request from the Ministry of Health (via the Traditional Medicine Administration of Vietnam), the trading establishment must supplement all requested documents and explanations.

Article 18. Determining the level of violation against regulations on quality standards of herbal materials and prepared traditional medicinal materials informed by state testing facilities achieving GLP standard

1. Within 48 hours from the receipt of testing report or analytical report given by the testing facility, the Provincial Department of Health shall seal herbal materials and prepared traditional medicinal materials failing to meet quality standards at the establishment where such samples are taken;

2. Within 72 hours from the receipt of testing report or analytical report given by the testing facility, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall determine the level of violation against the quality standards of herbal materials and prepared traditional medicinal materials as prescribed in Appendices III and IV issued herewith and have a conclusion of the recall of such materials and medicines on the basis of evaluating risks for users' health.

In case it is requested to have opinions of a pharmacopoeia council, the level of violation against quality standards of traditional medicines must be completely determined within 15 days.

3. Where necessary, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall request the testing facility of province or city to take 01 (one) additional sample of the batch of herbal materials/ prepared traditional medicinal materials failing to meet quality standards at the manufacturer or importer and 01 (one) additional sample of the batch of herbal ingredients/ traditional ingredients failing to meet quality standards at the wholesaler or health facility in another province and send samples taken to the Central testing facility for testing of unsatisfactory quality.

a) In case 01 (one) additional sample of herbal materials/ prepared traditional medicinal materials taken fails to meet quality standards, the Ministry of Health (via TMA) shall:

- Determine its level of violation according to regulations in Appendices III and IV issued herewith;

- Promulgate a Decision on recall and notification of the recall according to regulations in clauses 3 and 4 Article 16 hereof;

- Update a list of establishments trading herbal materials/ prepared traditional medicinal materials/traditional medicines failing to meet quality standards according to Article 11 hereof.

b) If all the additional samples of herbal materials/ prepared traditional medicinal materials meet quality standards, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall only determine the violation degree and carry out procedures for recall of materials whose samples have been taken for the first time, and do not update information thereof on the list of establishments trading herbal materials/ prepared traditional medicinal materials failing to meet quality standards in this case.

4. With regard to samples of herbal materials/ prepared traditional medicinal materials taken by a testing facility from manufacturers, importers or storage service providers, or samples of herbal materials/ prepared traditional medicinal materials found to meet quality standards during the manufacture, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall determine the violation degree according to regulations in the Appendix III and Appendix IV enclosed herewith. Promulgate a Decision on recall and notification of the recall of traditional medicines according to regulations in clauses 3 and 4 Article 16 hereof.

Article 19. Determining the degree of violation against quality standards of traditional medicines informed by state testing facilities achieving GLP standard

1. With regard to samples of traditional medicines taken by a testing facility from a retailer or Class III or Class IV health facility:

a) Within 24 hours from the receipt of testing report or analytical report given by the testing facility, the Department of Health shall seal the batch of traditional medicines failing to meet quality standards at the establishment where such samples are taken;

Within 48 hours from the receipt of testing report or analytical report given by the testing facility, the Ministry of Health (via TMA) shall request the applicant for registration, the manufacturer or importer for the responsibility in writing to:

- Submit a report on distribution of the batch of medicines failing to meet quality standards (the quantity of medicines manufactured, imported, and distributed; names and addresses of the buyers, quantity of purchased medicines and quantity of medicines in stock of each establishment) to the Ministry of Health (via the Traditional Medicine Administration of Vietnam) and the Department of Health within 07 days from the day on which the Ministry of Health (via the Traditional Medicine Administration of Vietnam) promulgates the written request;

- Request the testing facility of province or city to take additional samples of the batch of traditional medicines failing to meet quality standards at the domestic or foreign traditional medicine manufacturer and at least 02 wholesalers. The additional samples are requested to be taken within 15 days from the day on which the Ministry of Health (via TMA) promulgates the written request;

- Submit the samples taken to the Central testing facility for testing of unsatisfactory quality.

c) On the basis of the testing result of traditional medicine samples additionally taken, The TMA shall handle as prescribed in clause 6 hereof.

2. In case samples taken by a testing facility from a wholesaler, class II health facility or higher:

a) Within 24 hours from the receipt of testing report or analytical report given by the testing facility, the Department of Health shall seal the batch of traditional medicines failing to meet quality standards at the establishment where such samples are taken;

b) Within 48 hours from the receipt of testing report or analytical report given by the testing facility, the Ministry of Health (via TMA) shall determine the violation degree according to regulations in Appendix II issued herewith.

It promulgates a Decision on recall and notification of the recall of the batch of traditional medicines in the province or central-affiliated city where the samples are taken according to regulations in clauses 3 and 4 Article 16 hereof;

It sends the request to the applicant for registration, manufacturer or importer in writing to:

- Submit a report on distribution of the batch of traditional medicines failing to meet quality standards to the wholesaler or health facility (the quantity of medicines manufactured, imported, and distributed; names and addresses of the buyers, quantity of purchased medicines and quantity of medicines in stock of each establishment) to the Ministry of Health (via the Traditional Medicine Administration of Vietnam) and the Department of Health within 07 days from the day on which the Ministry of Health (via the Traditional Medicine Administration of Vietnam) promulgates the written request;

- Request the testing facility of province or city to take at least 02 additional medicine samples of the batch of medicines failing to meet quality standards at another wholesaler. The additional samples are requested to be taken within 15 days from the day on which the Ministry of Health (via TMA) promulgates the written request;

- Submit the samples taken to the Central testing facility for testing of unsatisfactory quality.

c) On the basis of the testing result of traditional medicine samples additionally taken, The TMA shall handle as prescribed in clause 6 hereof.

3. With regard to samples of traditional medicines taken by the testing facility from manufacturers, importers or storage service providers, or samples of traditional medicines found to meet quality standards during the manufacture, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall determine the violation degree according to regulations in the Appendix II enclosed herewith. It promulgates a Decision on recall and notification of the recall of traditional medicines according to regulations in clauses 3 and 4 Article 16 hereof.

4. In case prepared traditional medicinal materials/ traditional medicines failing to meet quality standards are manufactured by a health facility according to clauses 1 and 2 Article 70 of the Law on Pharmacy, the Ministry of Health (via TMA) shall determine the violation degree and promulgate a decision on recall of traditional medicines as prescribed in clauses 2 and 3 Article 16 hereof. The decision on recall shall be sent to the health facility that manufactured the prepared traditional medicinal materials/ traditional medicines failing to meet quality standards and the Department of Health of province or city where the health facility operates for recall. Report on the recall result shall be sent to the Ministry of Health (via TMA) and the Department of Health of the same provinces as that of the manufacturing facility.

5. Requests for additionally sampling for testing of quality as prescribed in clauses 1 and 2 of this Article:

The quality control agency shall determine the sampling plan according to the report on the distribution of the manufacturer or importer; the sampling is preferred as follows:

a) The sampling carried out at wholesalers in different provinces or cities; including the wholesaler which has provided traditional medicines for establishment whose samples have been taken;

b) The sampling carried out at wholesalers in different provinces or cities;

c) The sampling carried out at wholesalers in the same province or city;

d) The sampling carried out at wholesalers and retailers;

dd) The sampling carried out at retailers;

e) The sampling according to point dd only carried out when manufacturers and importers proving that their medicines are no longer preserved or stored at wholesalers. The additional sampling shall not be carried out for medicines that have been recalled.

6. Handling testing results of samples of traditional medicines

a) If all the additional samples of traditional medicines meet quality standards, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall promulgate a document on determination of the violation degree and establishment responsible for the violation; direct the Department of Health to carry out procedures for handling traditional medicines of retailers which have taken initial samples whose samples have been taken for the first time, and do not update information thereof on the list of establishments trading herbal materials/ prepared traditional medicinal materials failing to meet quality standards in this case. Scope and duration of recall are prescribed in clause 3 Article 63 of the Law on Pharmacy;

b) If there is at least 01 additional sample of traditional medicines taken at a retailer failing to meet the quality standards, except for the cases prescribed in point a of this clause, the Ministry of Health (via TMA) shall assess risks and promulgate documents of determining the violation degree, establishments responsible for the violation; direct the Department of Health to handle such violating traditional medicines and issue warnings about requirements for medicine preservation and medicine quality.

c) In case there is at least 01 (one) additional sample of traditional medicines taken at a wholesaler or all additional samples taken at a retailer as prescribed in point dd clause 5 of this Article failing to meet the quality standards, the Ministry of Health (via TMA) shall determine violation degrees as per regulation in Appendix II issued herewith; And promulgate a decision and a notification of recall of such traditional medicines as prescribed in clause 3 and clause 4 Article 16 hereof.

Article 20. Handling herbal materials recalled

1. Batches of herbal materials recalled must be destroyed in the following cases:

a) Herbal materials are recalled as prescribed in points c, dd, e and g clause 1 Article 104 of Decree No. 54/2017/ND-CP.

b) Herbal materials are recalled due to the first or second-degree violation;

c) Herbal materials are recalled due to the third-degree violation and are unable to be reprocessed upon the consideration of the Ministry of Health (via TMA) according to regulations specified in clause 3 of this Article;

d) Herbal materials are recalled due to the third-degree violation and can be reprocessed or re-exported but it is unable to carry out the reprocessing or re-exporting.

2. Batches of herbal materials recalled shall be permitted to be reprocessed and re-used in the following cases:

a) Herbal materials are recalled as prescribed in clause 2 Article 104 of Decree No. 54/2017/ND-CP;

b) Herbal materials are recalled due to the third-degree violation and are not stated in point c clause 1 of this Article.

3. The reprocessing, recycling, re-exporting and transfer of purposes for using herbal materials shall be carried out according to regulations in clause 4 Article 104 of Decree No. 54/2017/ND-CP.

For establishments which have recalled herbal materials wish to change use purposes, reprocess, recycle or re-export, they must send a written request attached to the use purposes or reprocessing measures or recycling process to the Ministry of Health (via TMA);

4. Procedures for destruction of batches of herbal materials are prescribed in clause 5 Article 104 of Decree No. 54/2017/ND-CP. Establishments carrying out the destruction of herbal materials must submit a report, accompanied by a written record of destruction of such traditional drugs, to the Department of Health of province/city as prescribed in Form No. 10 Appendix I issued herewith.

Article 21. Handling recalled herbal materials and prepared traditional medicinal materials

1. Batches of recalled prepared traditional medicinal materials and traditional medicines must be destroyed in the following cases:

a) Prepared traditional medicinal materials and traditional medicines are recalled due to the first-degree or second-degree violation;

b) Prepared traditional medicinal materials and traditional medicines are recalled due to the third-degree violation and they are unable to be reprocessed upon the consideration of the Ministry of Health (via TMA) according to regulations specified in clause 3 of this Article;

c) Prepared traditional medicinal materials and traditional medicines are recalled due to the third-degree violation and can be reprocessed or re-exported but it is unable to carry out the reprocessing or re-exporting.

2. Batches of recalled prepared traditional medicinal materials and traditional medicines must be destroyed in the following cases:

a) The head of the establishment whose traditional medicines or traditional medicines have to be destroyed shall establish a medicine destruction council. The council consists of at least 03 persons, including the chief pharmacist of the establishment;

b) The destruction of traditional drugs must ensure safety of human and animals and avoid causing environmental pollution in accordance with regulations of law on environmental protection;

c) Establishments carrying out the destruction of prepared traditional medicinal materials and traditional medicines must submit a report, accompanied by a written record of destruction of such traditional medicines, to the Department of Health of province/city as prescribed in Form No. 10 Appendix I issued herewith.

d) The establishment having the recalled prepared traditional medicinal materials and traditional medicines shall pay for their destruction;

3. Batches of recalled prepared traditional medicinal materials and traditional medicines may be reprocessed or re-exported in case their violations are constituted in the third degree and are not prescribed in point b clause 1 of this Article.

4. Procedures for reprocessing recalled prepared traditional medicinal materials and traditional medicines:

a) An establishment whose prepared traditional medicinal materials or traditional medicines are recalled shall send a written request to the Ministry of Health (via TMA), accompanied by reprocessing process, risk assessment in terms of medicine quality and stability, efficiency - safety - quality control program for medicines on the market;

b) Within 30 days from the day on which such written request is received, the Ministry of Health (via TMA) must consider and issue a written rely on reasons for approval for or refusal to reprocessing. In case the request is refused, reasons for refusal shall be given in writing.

c) In case additional information or explanation about the reprocessing is required, within 30 days from the day on which the written rely of the Ministry of Health (via TMA), the establishment must submit additional documents or explanation. After the above time limit, if the establishment does not submit its additional documents or explanation, its written request shall be invalid.

5. Procedures for re-exporting recalled prepared traditional medicinal materials and traditional medicines:

a) An establishment whose prepared traditional medicinal materials or traditional medicines are recalled shall send a written request to the Ministry of Health (via TMA), accompanied by plans for re-exporting with specific time for re-exporting and importing country;

b) Within 15 days from the day on which such written request from the establishment is received, the Ministry of Health (via TMA) must issue a written rely on approval for or refusal to the re-exporting; if the request is refused, reasons for refusal must be clarified.

6. The reprocessing and re-exporting of batches of recalled prepared traditional medicinal materials and traditional medicines shall only be carried out after receiving the written rely for approval of the Ministry of Health (via TMA).

7. Time limit for handling recalled prepared traditional medicinal materials and traditional medicines shall not exceed 12 months from the date on which the recall ends as prescribed in points a, b and c clause 3 Article 63 of the Law on Pharmacy.

Article 22. Responsibilities for recall of herbal materials, prepared traditional medicinal materials and traditional medicines

1. Responsibilities of trading establishments, health facilities and users:

a) Comply with regulations in clauses 1, 2 and 3 Article 64 of the Law on Pharmacy;

Regularly inspect and update information on the recall of herbal materials, prepared traditional medicinal materials and traditional medicines on the e-portal of the Ministry of Health and website of TMA and Provincial Department of Health

2. Responsibilities of TMA:

a) Receive information and determine violation degrees of herbal materials, prepared traditional medicinal materials and traditional medicines failing to meet quality standards as prescribed in Articles 17 hereof;

b) Consider reports on assessment of and response to proposals for  voluntary recall, reprocessing and re-exporting of recalled herbal materials, prepared traditional medicinal materials or traditional medicines of trading establishments;

c) Cooperate with relevant units (Ministerial inspectorate, Department of province/city, health divisions/departments) in inspecting the organization and compliance of recall of herbal materials, prepared traditional medicinal materials and traditional medicines; handle violating establishments as prescribed by laws;

d) Promulgate detailed guidelines on the process for handling and recall of herbal materials, prepared traditional medicinal materials and traditional medicines, assess effectiveness of giving notification of recalling medicines of pharmaceutical manufacturers and traders.

3. Responsibilities of the Provincial Department of Health:

a) Publish information on the recall of herbal materials, prepared traditional medicinal materials and traditional medicines on the website of the Provincial Department of Health;

b) Notify pharmaceutical traders, health facilities in the province of information on the recall thereof in the province;

c) Direct testing centers to cooperate with establishments having herbal materials, prepared traditional medicinal materials and traditional medicines failing to meet quality standards in taking additional samples as prescribed in Article 18 and Article 19 hereof; 

d) Organize supervision of the recall of herbal materials, prepared traditional medicinal materials and traditional medicines in the province; handle and penalize pharmaceutical traders committing violations under its competence;

dd) Participate or assess effectiveness of the recall of herbal materials, prepared traditional medicinal materials and traditional medicines of trading establishments in the province at the request of the Ministry of Health (via TMA).  If trading establishments do not recall or do not recall adequate herbal materials, prepared traditional medicinal materials and traditional medicines failing to meet quality standards, report these violations to the Ministry of Health (via TMA);

e) Organize and participate in compelling the recall of herbal materials, prepared traditional medicinal materials and traditional medicines.

Chapter VII

IMPLEMENTATION CLAUSES

Article 23. Effect

1. This Circular comes into force from February 15, 2022.

2. Circular No. 13/2018/TT-BYT dated May 15, 2018 of the Ministry of Health of Vietnam on quality of herbal materials and traditional medicines is no longer valid from the date on which this Circular takes effect.

Article 24. Terms of reference

If legislative documents referred to herein are superseded or amended, the new ones shall be applied.

Article 25. Transitional provisions

Before May 15, 2022, establishments trading in herbal materials must publish the quality standards as prescribed in this Circular.

Article 26. Responsibilities for organizing implementation

1. The Traditional Medicine Administration of Vietnam has the responsibility to:

a) Take charge and cooperate with relevant agencies to disseminate and organize the implementation of this Circular;

b) Take charge and cooperate with the National Institute of Drug Quality Control and the Institute of Drug Quality Control of Ho Chi Minh City in:

Annually formulating the plan for sampling of herbal materials, prepared traditional medicinal materials and traditional medicines for testing their quality, submitting the plan to the Ministry of Health for considering giving approval, and allocating budget for implementing the plan intra vires;

Organizing sampling of herbal materials, prepared traditional medicinal materials and traditional medicines for testing their quality;

c) Provide the National Institute of Drug Quality Control and the Institute of Drug Quality Control of Ho Chi Minh city with samples of labels and standards for quality of herbal materials, prepared traditional medicinal materials and traditional medicines published or granted certificate of free sale;

d) Conduct inspection of quality of herbal materials, prepared traditional medicinal materials and traditional medicines imported, farmed, harvested, manufactured, prepared and sold nationwide; instruct and supervise testing facilities taking charge of testing herbal materials, prepared traditional medicinal materials and traditional medicines nationwide; reach conclusions about quality of  herbal materials, prepared traditional medicinal materials and traditional medicines based on testing reports given by state-owned testing facilities and relevant documents;

dd) Take charge or cooperate in performing state inspection and handling violations against regulations on quality of herbal materials,  prepared traditional medicinal materials and traditional medicines intra vires;

e) Update its website with the list of establishments making commitments to sites where herbal materials are cultivated and harvested within 30 days after receiving the commitments to sites where herbal materials are cultivated and harvested of such establishments;

g) Consolidate quantity of types and volumes of herbal materials imported annually;

h) Consolidate reports on use of herbal materials, prepared traditional materials and traditional medicines nationwide by December 31 of every year;

i) Formulate systems of tracing origins of herbal materials, prepared traditional medicinal materials and traditional medicines.

2. Each Provincial Department of Health has the responsibility to:

a) Organize implementation of quality control of herbal materials, prepared traditional medicinal materials and traditional medicines in the province and handle violation as prescribed by law;

b) Direct the qualified testing center of province to develop plans on taking samples of herbal materials, prepared traditional medicinal materials and traditional medicines for annual quality inspection and  cost estimates and send them to the Department of Health for consideration and allocation of budgets;

c) Update information about samples of herbal materials, prepared traditional medicinal materials and traditional medicines taken (including names of herbal materials, prepared traditional medicinal materials and traditional medicines; origins; active elements; dosage forms; quality standards; numbers of sales registration forms; numbers of licenses for import; numbers of batches; expiry dates; names, addresses of importers, manufacturers and establishments taking samples);  

d) Organize collection of information and update lists of establishments and locations of farming and cultivating herbal materials in the province on the website of the Provincial Department of Health.

3. Responsibilities of medicine testing facilities:

a) Central testing facilities (the National Institute of Drug Quality Control and the Institute of Drug Quality Control of Ho Chi Minh City) shall:

- Carry out analysis and testing of samples so as to determine the quality of herbal materials, prepared traditional medicinal materials and traditional medicines imported; farmed, cultivated; manufactured, processed; sold and used. Send testing reports to the Ministry of Health (via TMA) and the Department of Health of province where samples are taken;

- Do research, establish and publish on their websites and the website the list of reference standards, reference substances and impurity reference substances used for analysis and testing of samples of herbal materials, prepared traditional medicinal materials and traditional medicines imported; farmed and cultivated; manufactured and processed; sold and used in the territory of Vietnam;

- Provide qualified testing centers of provinces and central-affiliated cities as assigned with the copies or electronic files of quality standards of herbal materials, prepared traditional medicinal materials and traditional medicines.

b) Testing centers of provinces or central-affiliated cities shall:

- Carry out analysis and testing of samples so as to determine the quality of herbal materials, prepared traditional medicinal materials and traditional medicines imported; farmed, cultivated; manufactured, processed; sold and used.

- Notify the Ministry of Health (via TMA) and the National Institute of Drug Quality Control of the list of qualified testing criteria and issuance of Certificates as prescribed.

- Report the testing results of samples of herbal materials, prepared traditional medicinal materials and traditional medicines to the Departments of Health of the province where the samples are taken and the Ministry of Health (via TMA).

4. Establishments trading in herbal materials, prepared traditional medicinal materials and traditional medicines shall:

a) Comply with regulations on quality control of herbal materials, prepared traditional medicinal materials and traditional medicines herein;

b) Ensure quality of their herbal materials, prepared traditional medicinal materials and traditional medicines during their operation (farming, cultivating; exporting, importing; processing, manufacturing; preserving; transporting; distributing) and manage quality thereof according to the licensed scope of business and in compliance with law regulations;

c) Periodically report the situation of farming and cultivating herbal materials; situation of domestically trading in herbal materials, prepared traditional medicinal materials according to Form 11 of Appendix I issued together with this Circular;

d) Participate in the origin tracing system for updating written proofs of origins of herbal materials, prepared traditional medicinal materials and traditional medicines;

dd) Immediately trace origins and notify state regulatory authorities and other traders when discovering counterfeit or substandard herbal materials, prepared traditional medicinal materials and traditional medicines;

e) Store documents and information related to the import, sales, export and distribution of herbal materials, prepared traditional medicinal materials and traditional medicines in a manner that origins thereof are able to be traced, and quality thereof during the period of farming, cultivating; exporting, importing; processing, manufacturing; preserving; transporting; distributing is able to inspect and control;

g) Pay for testing and providing reference standards and reference substances for testing facilities in case the testing facilities do not have any reference standard or reference substance or do not find out reference standards and reference substances for the samples of herbal materials, prepared traditional medicinal materials and traditional medicines whose testing results are sent by trading establishments;

h) Comply with regulations of law on pharmacy to maintain quality of herbal materials, prepared traditional medicinal materials and traditional medicines during their business, sales and use.

5. Health facilities shall:

a) Use and apply herbal materials, prepared traditional medicinal materials and traditional medicines that have clear origins as prescribed in Article 13 herein and are supplied by trading establishments granted certificate of eligibility for pharmaceutical trading;

b) Periodically or ad hoc inspect quality of herbal materials, prepared traditional medicinal materials and traditional medicines that they use. Separately store and trace origins to carry out the next steps as per regulation when discovering counterfeit or substandard herbal materials, prepared traditional medicinal materials and traditional medicines. Herbal materials, prepared traditional medicinal materials and traditional medicines used in these facilities must be inspected via Board of import inspection of hospitals as prescribed in Circular No. 22/2011/TT-BYT dated June 10, 2011 of the Ministry of Health on organization and operation of the Faculty of Pharmacy of hospitals or the registration department of other health facilities;

c) With regard to traditional medicines produced by health facilities as prescribed in Article 70 of the Law on Pharmacy and prepared traditional medicinal materials processed by other health facilities as prescribed in Clause 2, Article 70 of the Law on Pharmacy, health facilities must carry out the quality control at state testing facilities achieving GLP or testing service providers that have been granted certificates of eligibility for pharmaceutical business. In case health facilities have laboratories achieving GLP certificate, the quality testing of herbal materials, prepared traditional medicinal materials and traditional medicines shall be done at laboratories of such health facilities;

d) In case prepared traditional medicinal materials are processed at a health facility and only used at such facility, the facility must inspect the quality processing, manufacture and control process;

dd) Heads of health facilities shall be responsible for organizing periodic inspection for at least once every 03 month or ad hoc inspection if necessary of the process for processing, manufacturing and controlling herbal materials, prepared traditional medicinal materials and traditional medicines at such health facilities. Results of the inspection must be recorded in writing and stored as prescribed;

e) If there is a risk affecting the quality of herbal materials, prepared traditional medicinal materials and traditional medicines, health facilities must send a sample to state testing facilities achieving GLP certificate or testing service providers which have been granted certificates of eligibility for pharmaceutical business.

6. Responsibilities of management agencies in control and prevention of unknown, counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines:

a)  Receive feedbacks from organizations and individuals;

b) Disseminate signs to prevent unknown, counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines for pharmaceutical trading establishments; methods for notifying state management agencies of suspicious cases of unknown, counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines;

c) Inform publicly on websites or e-portals of such agencies and mass media about cases of unknown, counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines detected on the market and results of handling such cases;

d) Carry out or cooperate with relative functional agencies in inspecting, monitoring and promptly detecting unknown, counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines sold on the market;

dd) Offer cooperation with and support to functional agencies in tracing origins of counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines;

e) Handle as prescribed violation cases of trading in unknown and unapproved herbal materials, prepared traditional medicinal materials and traditional medicines;

g) TMA is the focal agency to cooperate, contact and exchange information about unknown, counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines with relative international organizations and pharmaceutical management agencies of other countries.

Article 27. Responsibility for implementation

Chief of the Ministry Office, Chief Inspector of the Ministry, Director General of TMA, heads of units affiliated to the Ministry of Health, Departments of Health of provinces and central-affiliated cities, pharmaceutical trading establishments, relevant agencies, organizations and individuals are responsible for the implementation of this Circular.

Agencies, organizations and individuals should report difficulties that arise during the period of implementation of this Circular to the TMA of the Ministry of Health for consideration and settlement./.

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