Chương V Thông tư 13/2018/TT-BYT: Thu hồi và xử lý thuốc cổ truyền vi phạm chất lượng

Chapter V

RECALL OF TRADITIONAL DRUGS FAILING TO MEET QUALITY STANDARDS AND HANDLING OF RECALLED DRUGS

Article 16. Procedures for mandatory recall of traditional drugs

1. Receiving information concerning traditional drugs failing to meet quality standards:

The Ministry of Health (the Traditional Medicine Administration of Vietnam) shall receive information concerning traditional drugs failing to meet quality standards from:

a) The evaluation of efficacy and safety of the traditional drug given by the advisory council responsible for giving counsel on registration of traditional drugs;

b) The evaluation of quality of traditional drugs provided by drug-testing facilities;

c) Information concerning traditional drugs failing to meet quality standards discovered by the Traditional Medicine Administration of Vietnam or healthcare/ pharmaceutical inspectorates;

d) Notifications of traditional drugs failing to meet quality standards given by foreign manufacturers, regulatory authorities and quality control authorities;

dd) Information concerning traditional drugs failing to meet quality standards provided by police agencies, customs agencies and market surveillance agencies;

e) Information concerning traditional drugs provided by trading facilities that propose voluntary recalls.

2. Determining the violation degree:

a) Within 24 hours from the receipt of information concerning traditional drugs failing to meet quality standards as prescribed in Points a, c, d, dd and e Clause 1 of this Article, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall determine the degree of violation according to regulations in the Appendix II enclosed herewith and give conclusion about the recall of traditional drugs according their harm to the users' health;

In case where the counsel given by the advisory council responsible for giving counsel on registration of traditional drugs is required according to regulations in Section IV of the Appendix II enclosed herewith, the degree of violation must be determined within 7 days.

b) Handling of information concerning traditional drugs failing to meet quality standards prescribed in Point b Clause 1 of this Article shall follow regulations in Article 18 herein.

3. Issuing a decision on recall of traditional drugs:

a) Within a maximum period of 24 hours after reaching the conclusion about the recall of traditional drugs, the Director of the Traditional Medicine Administration of Vietnam shall issue a decision on recall of traditional drugs failing to meet quality standards in accordance with regulations in Clause 1 or Clause 2 Article 65 of the Law on Pharmacy;

b) A decision on recall of traditional drugs includes the following information: Name of traditional drug to be recalled, registration number or number of the import license, herbal ingredients, quantities, dosage form, batch number, expiry date, name of manufacturer/ importer, the violation degree and the establishment responsible for the recall.

4. Notifying the recall decision:

a) A decision on recall of traditional drugs issued by the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall be notified to the Provincial Department of Health, the manufacturer or importer by letter, fax, email, telephone or other means of mass media;

b) Immediately after a decision on recall of traditional drugs is issued, the Traditional Medicine Administration of Vietnam shall post it on the website of the Ministry of Health, on its website and the national pharmaceutical database of the Ministry of Health; the Provincial Department of Health shall post the decision on recall of traditional drugs on its website immediately when receiving it; the domestic manufacturer or importer shall provide information about the recalled traditional drug for buyers and users;

c) In case the traditional drug is recalled because of the first-degree violation, apart from the compliance with regulation in Point b of this Clause, the Ministry of Health is required to announce the decision on recall of traditional drugs on both Vietnam Television and Voice of Vietnam.

5. Organizing the recall of traditional drugs:

a) Traders and users of traditional drugs must stop selling or using traditional drugs to be recalled; separately store the remaining traditional drugs; make the list of buyers of traditional drugs, contact them and receive returned drugs; transfer all traditional drugs returned by buyers the supplier;

b) The manufacturer (for domestically produced traditional drugs) or importer in cooperation with the import entrustor or establishment in charge of drug distribution service (for imported traditional drugs) shall assume responsibility to recall traditional drugs failing to meet quality standards. The recall of traditional drugs must be properly recorded according to the Form No. 02 in the Appendix I enclosed herewith.

If a trader or supplier of traditional drugs to be recalled fails to organize the recall or refuses to receive traditional drugs returned, buyers and users of traditional drugs shall report to the Provincial Department of Health for consideration.

c) The recall of traditional drugs failing to meet quality standards must be finished within the time limit prescribed in Clause 3 Article 63 of the Law on Pharmacy.

6. Reporting the recall and its result, and other actions:

a) Within 01 day if traditional drugs are recalled due to the first-degree violations, or 03 days if traditional drugs are recalled due to the second or third-degree violations, from the date on which the recall is finished, the establishment responsible for the recall must report the recall result in writing to the Ministry of Health (via the Traditional Medicine Administration of Vietnam) and the relevant Provincial Department of Health, including the following documents:

- The report on recall of traditional drugs according to the Form No. 03 in the Appendix I enclosed herewith;

- The list of direct buyers of traditional drugs, accompanied by their addresses, telephone number, email (if any), the quantity of drugs supplied and the quantity of drugs returned;

- The list of traders and users of traditional drugs provided by distributors, accompanied by their addresses, telephone number, email (if any), the quantity of drugs supplied and the quantity of drugs returned;

- The record of receipt of returned drugs, invoice of returned drugs or other evidences of the recall of traditional drugs;

- The written self-assessment of the recall of traditional drugs;

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

b) The Ministry of Health (the Traditional Medicine Administration of Vietnam) considers the report on recall result or designates the Provincial Department of Health to evaluate the recall result. If the recall result is not satisfactory and traditional drugs 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 of traditional drugs.

Article 17. Procedures for voluntary recall of traditional drugs

1. Each establishment trading in traditional drugs shall self-determine the degree of its violation against regulations on quality of traditional drugs and send a written report thereof to the Ministry of Health (via the Traditional Medicine Administration of Vietnam). The report includes the information about the traditional drugs failing to meet quality standards, the degree of violation, reasons for recall and proposal of measures for disposal of recalled drugs, and is accompanied by relevant documents.

In case of proposal of remedy, the drug trading establishment is required to enclose the report with remedial procedures, evaluation of risks to quality and stability of traditional drugs, procedures for control of quality, safety and efficacy of traditional drugs while they are sold on the market.

2. Within 03 days from the receipt of the report sent by the drug trading establishment, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall consider the report and determine the degree of violation according to provisions in the Appendix II enclosed herewith.

a) The Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall give a written approval for the voluntary recall to the drug trading establishment if its proposal that traditional drugs 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 traditional drugs as prescribed in Clause 3, Clause 5 and Clause 6 Article 16 herein if it determines that traditional drugs 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 request the drug trading establishment in writing to provide 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 drug trading establishment must supplement all requested documents and explanations.

3. Notification of a recall decision:

a) If traditional drugs constitute the first or second-degree violations, the Ministry of Health shall carry out procedures for notification of recall decision in accordance with regulations in Clause 4 Article 16 herein;

b) If traditional drugs constitute the third-degree violations, the drug trading establishment shall notify the Provincial Department of Health, the manufacturer or importer of the recall decision by letter, fax, email, telephone or other means of mass media.

4. Organizing the recall and reporting recall result, efficiency and other actions shall be performed in accordance with regulations in Clause 5 and Clause 6 Article 16 herein.

Article 18. Handling traditional drugs failing to meet quality standards

1. With regard to samples of traditional drugs taken by a quality inspection agency at 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 Provincial Department of Health shall seal traditional drugs 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 the Traditional Medicine Administration of Vietnam) shall request the applicant for registration, the manufacturer or importer in writing to:

- Send report on distribution of traditional drugs to the Ministry of Health (via the Traditional Medicine Administration of Vietnam);

- Request the quality inspection agency to take additional samples of traditional drugs at the domestic manufacturer or importer and wholesaler;

- Send samples taken to a central-level testing facility for testing unsatisfactory quality indices.

c) When there is an additional sample of traditional drugs fails to meet quality standards, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall determine the violation degree and reach a conclusion about recall of traditional drugs according to regulations in the Appendix II enclosed herewith, and issue a decision on recall of traditional drugs according to regulations in Clause 3 Article 16 herein;

d) If the testing result shows that additional samples of traditional drugs meet quality standards, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall only determine the violation degree, reach a conclusion and issue decision on recall of traditional drugs of the establishment where initial samples are taken.

2. With regard to samples of traditional drugs taken by a quality inspection agency at a wholesaler or a health facility of Class II or higher class:

a) Within 24 hours from the receipt of testing report or analytical report given by the testing facility, the Provincial Department of Health shall seal traditional drugs 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 the Traditional Medicine Administration of Vietnam) shall issue a decision on recall of traditional drugs sold in the province or central-affiliated city where samples are taken according to regulations in Clause 3 Article 16 herein and request the applicant for registration, the manufacturer or importer in writing to:

- Send report on distribution of traditional drugs to the Ministry of Health (via the Traditional Medicine Administration of Vietnam);

- Request the quality inspection agency to additionally take at least 02 samples of traditional drugs of other wholesalers;

- Send samples taken to a central-level testing facility for testing unsatisfactory quality indices.

c) When there is an additional sample of traditional drugs fails to meet quality standards, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall determine the violation degree and reach a conclusion about recall of traditional drugs according to regulations in the Appendix II enclosed herewith, and issue a decision on nationwide recall of traditional drugs according to regulations in Clause 3 Article 16 herein;

d) If the testing result shows that additional samples of traditional drugs meet quality standards, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall only determine the violation degree, reach a conclusion and issue decision on recall of traditional drugs sold in the province or central-affiliated city where samples are taken to the establishment where initial samples are taken.

3. With regard to samples of traditional drugs taken by a quality inspection agency from manufacturers, importers or storage service providers, or samples of traditional drugs are found not to meet quality standards during the manufacture, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall determine the violation degree and reach a conclusion about recall of traditional drugs according to regulations in the Appendix II enclosed herewith and issue a decision on recall of traditional drugs according to regulations in Clause 3 Article 16 herein.

4. If traditional drugs prepared by a health facility as prescribed in Clause 1, Clause 2 Article 70 of the Law on Pharmacy fails to meet quality standards, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall determine the violation degree and issue a decision on recall of traditional drugs according to regulations in Clause 2 and Clause 3 Article 16 herein. The recall decision shall be sent to the health facility where traditional drugs failing to meet quality standards are prepared and the Department of Health of province where such health facility is located.

Article 19. Handling of recalled traditional drugs

1. Traditional drugs that constitute the third-degree violations and are not prescribed in Point b Clause 2 of this Article may be remedied or re-exported.

2. Recalled traditional drugs must be destroyed in the following cases:

a) Traditional drugs are recalled because of the first or second-degree violations;

b) Traditional drugs are recalled because of the third-degree violation and cannot be reprocessed upon the consideration by the Ministry of Health (via the Traditional Medicine Administration of Vietnam) according to regulations in Clause 3 of this Article;

c) Traditional drugs are recalled because of the third-degree violation and may be reprocessed or re-exported but it is unable to carry out the reprocessing or re-exporting.

3. Procedures for remedy of recalled traditional drugs:

a) The establishment whose traditional drugs are recalled shall send a written request for permission to remedy recalled traditional drugs to the Ministry of Health (via the Traditional Medicine Administration of Vietnam), accompanied by remedial procedures, evaluation of risks to quality and stability of traditional drugs, and the plan for control of quality, safety and efficacy of traditional drugs while they are sold on the market;

b) The Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall respond in writing within 60 days from the day on which such written request is received. If a request is refused, reasons for refusal shall be given in writing;

c) If a written request is not satisfactory, within 30 days from the date on which such written request is received, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall request the requesting establishment to provide additional documents and explanations;

The requesting establishment must supplement all requested documents and explanations within 30 days from the receipt of the written request from the Ministry of Health (via the Traditional Medicine Administration of Vietnam). Over this time limit, the written request shall be invalid if the requesting establishment fails to supplement documents and explanations as requested.

4. Procedures for re-exporting of recalled traditional drugs:

a) The establishment whose traditional drugs are recalled shall send a written request for permission to re-export recalled traditional drugs to the Ministry of Health (via the Traditional Medicine Administration of Vietnam), accompanied by the re-export plan which specifies re-exporting time and importing country;

b) The Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall respond in writing within 15 days from the day on which such written request is received. If a request is refused, reasons for refusal shall be given in writing.

5. Recalled traditional drugs shall be reprocessed or re-exported after obtaining a written permission from the Ministry of Health (via the Traditional Medicine Administration of Vietnam).

6. Procedures for destroying recalled traditional drugs:

a) The head of the establishment whose traditional drugs have to be destroyed shall establish a drug 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) The establishment destroying traditional drugs must send a report, accompanied by the written record of destruction of traditional drugs, to the Provincial Department of Health according to the Form No. 04 in the Appendix I enclosed herewith;

d) The establishment having the recalled traditional drugs shall pay for their destruction;

7. Handling of recalled traditional drugs must be finished within 12 months from the completion of recall as prescribed in Points a, b and c Clause 3 Article 63 of the Law on Pharmacy.

Article 20. Responsibility to recall traditional drugs

1. Manufacturers, traders, health facilities and users have the responsibility to:

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

b) Regularly check and update information concerning recall of traditional drugs available on the websites of the Ministry of Health, the Traditional Medicine Administration of Vietnam and the Provincial Department of Health.

2. The Traditional Medicine Administration of Vietnam shall:

a) Receive information, determine degrees of violations against regulations on quality of traditional drugs and issue recall decisions;

b) Notify recall decisions as prescribed in Point a Clause 4 Article 16 herein, publish information concerning traditional drugs to be recalled on the website of the Ministry of Health and its website after the recall decision comes into force. Cooperate with the Vietnam Television and the Voice of Vietnam in publishing information concerning traditional drugs to be recalled because of the first-degree violations;

c) Consider reports and respond to received requests for voluntary recall, requests for permission to remedy or re-export recalled traditional drugs;

d) Cooperate with relevant agencies (including the Ministry Inspectorate, Provincial Departments of Health and health agencies of relevant Ministries) to supervise the recall of traditional drugs; take actions against violators in accordance with law regulations;

dd) Give written guidance on procedures for recalling and handling traditional drugs, and evaluate the recall results.

3. Each the Provincial Department of Health shall:

a) Publish every decision on recall of traditional drugs on its website;

b) Disseminate information concerning recall of traditional drugs to manufacturers, traders and health facilities in the province;

c) Directly take or request the qualified testing center in cooperation with the establishment whose traditional drugs fail to meet quality standards to take additional samples of traditional drugs as prescribed in Point b Clause 1 or Point b Clause 2 Article 18 herein;

d) Supervise the recall of traditional drugs failing to meet quality standards in the province; take actions against establishments that commit violations against recall of traditional drugs intra vires;

dd) Participate in or take charge of evaluating results of recall of traditional drugs by local establishments as assigned by the Ministry of Health (via the Traditional Medicine Administration of Vietnam). Submit reports on manufacturers, importers or wholesalers in charge of distribution services that fail to or improperly organize recall of traditional drugs to the Ministry of Health (via the Traditional Medicine Administration of Vietnam);

e) Enforce or participate in the enforcement of recall of traditional drugs failing to meet quality standards.