Chương VI Thông tư 38/2021/TT-BYT: Thu hồi và xử lý dược liệu, vị thuốc cổ truyền, thuốc cổ truyền vi phạm chất lượng

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.

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