Thông tư 13/2018/TT-BYT quy định về chất lượng dược liệu, thuốc cổ truyền

THE MINISTRY OF HEALTH 

Circular No. 13/2018/TT-BYT dated May 15, 2018 of the Ministry of Health on quality of herbal ingredidents and traditional drugs

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

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and organizational structure of Ministry of Health;

At the request of the Director of the Traditional Medicine Administration of Vietnam;

The Minister of Health promulgates a Circular prescribing the quality of herbal ingredients and traditional drugs.

Chapter I

GENERAL PROVISIONS

Article 1. Scopeof adjustment

This Circular provides for the application of quality standards for herbal ingredients and traditional drugs; origins of herbal ingredients and traditional drugs; inspection and handling of inspection results of quality of herbal ingredients and traditional drugs during the manufacture, cultivation, export, import, distribution, wholesaling, retailing, sale and use of herbal ingredients and traditional drugs in Vietnam, and herbal ingredients and traditional drugs prepared and prescribed within health facilities; procedures for recalling traditional drugs and disposal of recalled drugs.

Article 2.Subject of application

1. This Circular applies to establishments trading in herbal ingredients/ traditional drugs; health facilities applying herbal ingredients/ traditional drugs and authorities, organizations and individuals involving in the quality management of herbal ingredients and traditional drugs in Vietnam.

2. This Circular does not apply to establishments trading in semi-finished herbal ingredients and herbal drugs; individuals farming and harvesting herbs and the ones harvesting natural herbs.

Article 3. Interpretation of terms

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

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

2.“batch of traditional drugs”means a specific quantity of traditional drugs of the same quality produced by a manufacturer under the same procedures within a particular period of time.

3.“shelf life”of herbal ingredient means the predetermined length or period of time that the herbal ingredient may be stored for use and after that its quality is no longer guaranteed. The shelf life may be expressed as an expiry date or as the month and year of expiry (including the last day of such month).

4.“herbal ingredient/ traditional drug quality standards”means documents prescribing technical specifications of herbal ingredients/ traditional drugs, including quality indices, quality levels, testing methods and other technical and management requirements related to the quality of herbal ingredients/ traditional drugs.

Chapter II

APPLICATION OF HERBAL INGREDIENT/ TRADITIONAL DRUG QUALITY STANDARDS

Article 4. Application of herbal ingredient/ traditional drug quality standards

1. The quality of herbal ingredients/ traditional drugs must be governed and guaranteed according to the quality standards for herbal ingredients/ traditional drugs specified in the pharmacopoeia or internally applied standards of manufacturers.

2. Facilities trading in herbal ingredients/ traditional drugs must carry out the appraisal of testing methods specified in the quality standards for herbal ingredients/ traditional drugs announced and applied by manufacturers at a testing laboratory meeting Good Laboratory Practice (GLP) requirements.

3. The Ministry of Health shall assess documents and consider giving approval for quality standards for herbal ingredients/ traditional drugs in accordance with regulations on registration of herbal ingredients/ traditional drugs and regulations on licensing to import herbal ingredients/ traditional drugs that are not granted certificate of free sale.

Article 5. Application of pharmacopoeia

1. Application of Vietnam’s pharmacopoeia and reference pharmacopoeias:

a) Facilities trading in herbal ingredients/ traditional drugs are allowed to apply Vietnam s pharmacopoeia or one of the following reference pharmacopoeias: Chinese pharmacopoeia, Hong Kong pharmacopoeia, Japanese pharmacopoeia, Korean pharmacopoeia, Indian pharmacopoeia, international pharmacopoeias, European pharmacopoeia, British pharmacopoeia and U.S. pharmacopoeia;

b) The application of standards of the pharmacopoeias mentioned in Point a hereof must include the application of all regulations on quality indices, quality levels and testing methods laid down in the corresponding treatises for herbal ingredients/ traditional drugs of the applicable pharmacopoeia and common quality indices, quality levels and testing methods laid down in its Annexes;

c) Where an importer of herbal ingredients/ traditional drugs into Vietnam applies Vietnam’s pharmacopoeia in which quality standards are lower than the corresponding standards of a certain reference pharmacopoeia, the quality standards in the reference pharmacopoeia shall apply;

d) If a manufacturer applies Vietnam’s pharmacopoeia or one of the reference pharmacopoeias specified in Point a hereof as announced but employs a testing method other than the one specified in the specific treatise for herbal ingredients/ traditional drugs of the applicable pharmacopoeia, it is required to prove the equivalence of these two testing methods. Testing results obtained by adopting the testing method specified in the pharmacopoeia shall be used as the basis for evaluating quality of herbal ingredients/ traditional drugs.

2. Application of other foreign pharmacopoeias:

If an establishment trading in herbal ingredients/ traditional drugs applies a pharmacopoeia other than the ones specified in Point a Clause 1 of this Article, the applied quality standards must:

a) meet quality index and level requirements prescribed in the corresponding quality standard treatises of Vietnam’s pharmacopoeia or one of the reference pharmacopoeias mentioned in Point a Clause 1 of this Article; and

b) common testing methods applied must be conformable with corresponding common testing methods specified in Vietnam’s pharmacopoeia or one of the reference pharmacopoeias mentioned in Point a Clause 1 of this Article.

Article 6. Application of internal quality standards

1. Quality standards for herbal ingredients/ traditional drugs internally developed and applied by manufacturers must fulfill the requirements in Point b Clause 2 Article 102 of the Law on Pharmacy. To be specific:

a) They must meet quality index and level requirements prescribed in the corresponding treatises of Vietnam’s pharmacopoeia or one of the reference pharmacopoeias and requirements regarding quality indices, quality levels and common testing methods specified in the Annexes of the same;

b) Where Vietnam’s pharmacopoeia or reference pharmacopoeia does not have a corresponding treatise of herbal ingredients/ traditional drugs, the manufacturers shall develop their own standards according to scientific research findings (including R&D findings) or a foreign pharmacopoeia.

2. Manufacturers, importers and distributors of herbal ingredients must announce their internal quality standards applicable to herbal ingredients which are not in the list of herbal ingredients to be registered as prescribed in Clause 3.2 Section IV of the Circular No. 21/2007/TT-BKHCN dated September 28, 2007 by the Ministry of Science and Technology. The announced quality standards must meet technical requirements specified in the Form No. 01B of the Appendix 1 enclosed herewith.

3. Health facilities shall develop and appraise the conformity of quality standards internally applied to their prepared traditional drugs under the approval and promulgation of heads of health facilities. With respect to traditional drugs prepared by health facilities in accordance with regulations in Clause 2 Article 70 of the Law on Pharmacy, their quality standards internally applied and testing methods specified in such standards must be duly appraised.

4. The conformity of internal quality standards and testing methods must be assessed by testing laboratories that meet GLP requirements.

Article 7. Updating quality standards and application of updated pharmacopoeia

Establishments trading in herbal ingredients/ traditional drugs must updated quality standards applicable to herbal ingredients/ traditional drugs and apply updated pharmacopoeia in a timely manner as follows:

1. With regard to herbal ingredients in the list of herbal ingredients to be registered and traditional drugs: When submitting application for registration or renewal of certificate of free sale of herbal ingredients/ traditional drugs, quality standards including in such applications 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 the current version.

2. With regard to herbal ingredients in the list of herbal ingredients to be registered and traditional drugs granted certificate of free sale: Within a period of 02 years from the release of the latest version of the pharmacopoeia, manufacturers or applicants for registration of herbal ingredients/ traditional drugs shall update quality standards for herbal ingredients/ traditional drugs specified in such pharmacopoeia’s latest version.

3. With regard to herbal ingredients which are not in the list of herbal ingredients to be registered: Within a period of 01 year from the release of the latest version of the pharmacopoeia, manufacturers, importers and distributors of herbal ingredients shall update quality standards for herbal ingredients specified in such pharmacopoeia’s latest version and re-make declaration of applicable quality standards.

4. When manufacturers or applicants find out any elements causing adverse effects on the quality, safety and efficiency of their herbal ingredients/ traditional drugs or at the request of the Ministry of Health (via the Traditional Medicine Administration of Vietnam), manufacturers must update quality standards for monitoring such elements and re-make declaration of applicable quality standards in case a herbal ingredient is not in the list of herbal ingredients to be registered.

Chapter III

MANAGEMENT OF QUALITY OF HERBAL INGREDIENTS AND TRADITIONAL DRUGS DURING TRADING AND USE THEREOF

Article 8. Requirements for management of quality of herbal ingredients and traditional drugs during trading and use thereof

1. Trading facilities must apply Good Practice standards during the process of trading and using herbal ingredients/ traditional drugs in conformity with their scope of business.

2. Herbal ingredients and primary packages of traditional drugs must be tested by the traditional drug manufacturer and meet quality standards before their manufacture is commenced.

3. Finished traditional drugs/ herbal ingredients must be tested by their manufacturers and meet quality standards before being released.

4. The head and the chief pharmacist of the manufacturer, exporter, importer, wholesaler or retailer; the person in charge of quality assurance of the manufacturer shall be responsible for the management and inspection of quality of its herbal ingredients/ traditional drugs.

5. Establishments trading in herbal ingredients/ traditional drugs shall inspect and control the quality of their herbal ingredients, traditional drugs and ingredients of traditional drugs.

6. Manufacturers shall test and assess the quality of their herbal ingredients, traditional drugs and ingredients of traditional drugs during the process of manufacture, release and sale.

7. Establishments trading in herbal ingredients/ traditional drugs must keep all documents concerning every trading, import, release or distribution of herbal ingredients/ traditional drugs for the purposes of monitoring origins, transport and storage conditions of such herbal ingredients/ traditional drugs and ingredients of traditional drugs.

8. Manufacturers and trading facilities shall also comply with other regulations of the Law on pharmacy so as to ensure the quality of herbal ingredients/ traditional drugs during trading and use thereof.

Article 9. Requirements for management of quality of herbal ingredients/ traditional drugs in health facilities

1. Herbal ingredients/ traditional drugs used by a health facility must be tested by a testing laboratory that meets GLP requirements, except traditional drugs specified in Clause 2 of this Article.

2. With regard to traditional drugs prepared by a health facility in accordance with regulations of Article 70 of the Law on Pharmacy: The health facility must, on the basis of every 03 months, send a batch of new traditional drugs to the State-owned drug-testing facility, or a provider of drug-testing services granted Certificate of eligibility, for testing the quality of its prepared traditional drugs.

3. Herbal ingredients/ traditional drugs must be inspected by the hospital’s medicine warehousing inspection board in accordance with regulations of the Circular No. 22/2011/TT-BYT dated June 10, 2011 by Minister of Health, or the medicine warehousing inspection department of another health facility. The medicine warehousing inspection department shall be established according to the decision given by the head of health facility and comprised of: the person in charge of pharmaceutical department, accountant, warehouse-keeper and supply staff. Herbal ingredients/ traditional drugs shall be used by a health facility when they meet quality standards.

4. The head of a health facility shall conduct inspection of quality of herbal ingredients/ traditional drugs applied in the health facility on the basis of every 03 months or where necessary. Inspection results must be properly recorded.

5. If the health facility discovers any elements that may cause adverse effects on the quality of herbal ingredients/ traditional drugs, it must herbal ingredient/ traditional drug samples to the State-owned drug-testing facility, or a provider of drug-testing services granted Certificate of eligibility, for testing the quality of the suspected herbal ingredients/ traditional drugs.

Article 10. Testing herbal ingredients and traditional drugs

1. Herbal ingredients/ traditional drugs must be tested by a testing laboratory that meets GLP requirements.

2. Sample storage:

a) Samples of herbal ingredients/ traditional drugs which have been properly tested and granted conclusion about their quality must be retained. Retained samples must be sealed and stored under suitable conditions as specified in their labels;

b) Storage period:

- Manufacturers, exporters and importers of herbal ingredients/ traditional drugs must store samples of traditional drug preparations for at least 12 months after the expiry date and samples of herbal ingredients/ traditional ingredients until the end of their shelf life;

- Drug-testing facilities must store samples of herbal ingredients/ traditional ingredients for at least 06 months from the sampling date, or 12 months from the sampling date if such samples of herbal ingredients/ traditional ingredients are taken for testing their quality; store samples of traditional drugs for at least 12 months after the expiry date, or 24 months from the sampling date if samples of traditional drugs are taken for testing their quality.

3. In case a herbal ingredient/ traditional drug sample fails to meet quality standards, within a maximum period of 24 hours from the release of the analytical report or testing report, the testing facility is required to post a notification of herbal ingredient/ traditional drug sample failing to meet quality standards on its website and send a notification thereof, accompanied by the analytical report or testing report, to the Traditional Medicine Administration of Vietnam affiliated to the Ministry of Health in the form of administrative documents and by sending scanned copies thereof to the Voffice of the Ministry of Health, or calling to the Traditional Medicine Administration of Vietnam from the official telephone number and address of the testing facility, and also send the same to the Department of Health of province or central-affiliated city where such herbal ingredient/ traditional drug sample is taken.

4. Other contents concerning the testing of herbal ingredients/ traditional drugs shall be performed in accordance with the Ministry of Health s regulations on testing of modern drugs, herbal drugs and ingredients thereof.

Article 11. Testing herbal ingredients/ traditional drugs of a manufacturer or importer in the List of manufacturers and importers committing violations of quality standards and delisting a manufacturer or importer

1. From the manufacture/import of the first batch of traditional drugs, the manufacturer/ importer whose name appears in the List of manufacturers and importers committing violations of quality standards as announced by the Ministry of Health (via the Traditional Medicine Administration of Vietnam) must conduct the testing of all batches of manufactured/ imported traditional drugs failing to meet quality standards within the following periods of time:

a) 06 months if the manufacturer produces 01 batch that constitutes the third-degree violation;

b) 12 months if the manufacturer produces 01 batch that constitutes the second-degree violation or produces 02 or more batches that constitute the third-degree violation;

c) 24 months if the manufacturer produces 01 batch that constitutes the first-degree violation or produces 02 or more batches that constitute the second-degree violation;

d) If a manufacturer keeps producing traditional drugs failing to meet quality standards, the testing period shall be extended according to the accumulation method.

2. From the manufacture/import of the first batch of herbal ingredients, the manufacturer/ importer whose name appears in the list of manufacturers and importers committing violations of quality standards as announced by the Ministry of Health (via the Traditional Medicine Administration of Vietnam) must conduct the testing of all batches of manufactured/ imported herbal ingredients failing to meet quality standards within the following periods of time:

a) 06 months if the manufacturer produces 01 batch that fails to meet quality standards, is recalled and recycled;

b) 12 months if the manufacturer produces 01 batch that fails to meet quality standards, is recalled and destroyed or produces 02 or more batches that fail to meet quality standards, are recalled and recycled;

c) 18 months if the manufacturer produces 02 or more batches that fail to meet quality standards, are recalled and destroyed;

d) If a manufacturer keeps producing herbal ingredients failing to meet quality standards, the testing period shall be extended according to the accumulation method.

3. A manufacturer or importer is delisted from the List of manufacturers and importers committing violations of quality standards if it meets all of the following requirements:

a) The manufacturer or importer properly tests its herbal ingredients/ traditional drugs before putting them on the market within the periods of time specified in Clause 1 or Clause 2 of this Article;

b) The manufacturer or applicant for registration of herbal ingredients/ traditional drugs has submitted reports on sampling of herbal ingredients/ traditional drugs made according to the Form No. 05 stated in the Appendix I enclosed herewith, accompanied by evidences of its testing of all batches of herbal ingredients/ traditional drugs imported into Vietnam within the periods of time specified in Clause 1 or Clause 2 of this Article;

c) The manufacturer or importer does not commit any violations against regulations on quality of herbal ingredients/ traditional drugs (including the voluntary recall of herbal ingredients/ traditional drugs because of quality reasons) within the period of time for performing the contents specified in Points a, b and c Clause 1 of Clause 2 of this Article.

4. Every month, the Ministry of Health (the Traditional Medicine Administration of Vietnam) shall publicly announce the updated List of manufacturers and importers committing violations of quality standards and delist manufacturers and importers that meet the requirements in Clause 3 of this Article on the basis of reports submitted by testing facilities and the review of reports submitted by manufacturers and applicants for registration of herbal ingredients/ traditional drugs.

Article 12. State inspection of quality of herbal ingredients/ traditional drugs

1. The agency in charge of inspecting the quality of herbal ingredients/ traditional drugs:

a) Central-level agency in charge of inspecting the quality of herbal ingredients/ traditional drugs is the Traditional Medicine Administration of Vietnam affiliated to the Ministry of Health.

b) Local agencies in charge of inspecting the quality of herbal ingredients/ traditional drugs are provincial Departments of Health.

2. An inspection of quality of herbal ingredients/ traditional drugs during the manufacture includes:

a) The control of quality and origins of ingredients, materials and packages before the manufacture is commenced;

b) Inspection of manufacturing and testing conditions, and adoption of manufacturing and testing procedures, factory and machinery hygiene, consisting of:

- The control of quality of semi-finished and finished products;

- The control of quality of products before they are warehoused or released;

- The inspection of documentation of batch of products;

- The inspection of documents concerning origins of herbal ingredients/ traditional drug ingredients.

3. An inspection of quality of herbal ingredients/ traditional drugs during the export, import and sales includes:

a) The inspection of adoption of procedures for monitoring origins and quality of herbal ingredients/ traditional drugs during the process of warehousing, preservation, transport and release.

b) The inspection of the certificate of registration of herbal ingredients (if any) or traditional drugs or the license to import herbal ingredients/ traditional drugs and the compliance with regulations on labeling and package insert of herbal ingredients/ traditional drugs;

c) The inspection of the compliance with notifications of recall of herbal ingredients/ traditional drugs by quality inspection agencies and manufacturers, importers, import entrustors and wholesalers;

d) Samples of herbal ingredients/ traditional drugs shall be taken and tested to determine their quality according to quality standards thereof specified in the application for registration/ announcement/ import of herbal ingredients/ traditional drugs that are not granted certificate of free sale approved by the Ministry of Health.

4. State inspection of quality of herbal ingredients/ traditional drugs shall be carried out in accordance with regulations of the Law on quality of goods and products.

Chapter IV

ORIGINS OF HERBAL INGREDIENTS AND TRADITIONAL DRUGS

Article 13. Checking origins of herbal ingredients and traditional drugs

1. Establishments trading in herbal ingredients/ traditional drugs and health facilities applying herbal ingredients/ traditional drugs are required to establish the origin tracing system so as to identify and trace the entire origins of herbal ingredients/ traditional drugs to their cultivation, harvesting, trading and use.

2. The information concerning suppliers and manufacturers of herbal ingredients/ traditional drugs must be traceable during the trading and use thereof by trading facilities and health facilities.

Article 14. Documents attesting origins of herbal ingredients and traditional drugs

1. Documents attesting the origin of imported herbal ingredients which are not in the list of herbal ingredients to be registered include:

a) Certificate of origin (C/O) issued by a competent authority of the exporting country to each batch of herbal ingredients;

b) Certificate of quality (C/Q) and Testing report (enclosed with Vietnamese translations thereof) issued to each batch of herbal ingredients.

2. Documents attesting the origin of herbal ingredients cultivated, harvested or naturally extracted by a domestic establishment meeting the Good Agricultural and Collection Practices (GACP) requirements include: Documents proving the fulfillment of the Good Agricultural and Collection Practices (GACP) requirements by that domestic establishment.

3. Documents attesting the origin of herbal ingredients acquired by a trading facility from domestic individuals cultivating, harvesting or naturally extracting herbal ingredients include: The commitment to sites where herbal ingredients are cultivated and harvested according to the Form No. 06 in the Appendix I enclosed herewith.

4. The document attesting the origin of herbal ingredients in the list of herbal ingredients to be registered is the Certificate of free sale.

5. Documents attesting the origin of traditional drugs include:

a) Documents proving the origins of ingredients of traditional drugs;

b) Certificate of free sale.

Article 15. Retention of documents concerning origins of herbal ingredients and traditional drugs

1. An establishment trading in herbal ingredients/ traditional drugs must fully keep hard copies or soft copies of documents concerning each receipt or supply of herbal ingredients, traditional drugs and traditional drug ingredients with the accurate information about:

a) Name of manufacturer or importer of herbal ingredients/ traditional drugs;

b) Information concerning herbal ingredients/ traditional drugs (name, dosage form, concentration or content, batch number, manufacturing date and expiry date, etc.);

c) Quantity of herbal ingredients/ traditional drugs received or supplied;

d) Date of receipt or supply;

dd) Name, address, telephone and email (if any) of the person/ facility supplying or receiving herbal ingredients/ traditional drugs.

2. Manufacturers, importers providing distribution service and wholesalers in charge of distribution service must cooperate with other wholesalers and 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 ingredients, traditional drugs and ingredients thereof.

3. Retention period of origin-related documents:

a) Documents concerning the origin of a herbal ingredient or traditional ingredient must be kept for at least 06 months after its expiry date;

b) Documents concerning the origin of a traditional drug must be kept for at least 12 months after its expiry date.

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.

Chapter VI

IMPLEMENTATIONORGANIZATION

Article 21.Effect

1. This Circular takes effect on June 30, 2018.

2. The following documents shall be abrogated from the date of entry into force of this Circular:

a) Regulations on quality of herbal ingredients and traditional drugs of the Circular No. 09/2010/TT-BYT dated April 28, 2010 by Minister of Health providing guidelines for management of drug quality;

b) The Circular No. 05/2014/TT-BYT dated February 14, 2014 by Minister of Health on application of herbal ingredients and traditional ingredients in health facilities.

Article 22. Referenceterms

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

Article 23. Implementation organization

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:

- Formulating the plan for sampling of herbal ingredients and traditional drugs 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 ingredients and traditional drugs for testing their quality and updating the drug quality information system of the Ministry of Health with information concerning samples taken (including name of traditional drug, name of herbal ingredient, concentration/ content, dosage form, batch number, expiry date, registration number or import license number, manufacturer, importer or establishment where samples are taken) and quality testing results;

c) Provide the National Institute of Drug Quality Control and the Institute of Drug Quality Control of Ho Chi Minh city with specimens of labels and standards for quality of herbal ingredients/ traditional drugs granted certificate of free sale or import license, and adjusted ones, if any.

d) Conduct inspection of quality of herbal ingredients and traditional drugs manufactured, prepared and sold nationwide; instruct and supervise testing facilities taking charge of testing herbal ingredients and traditional drugs nationwide; reach conclusions about quality of herbal ingredients and traditional drugs based on testing reports given by state-owned testing facilities and relevant documents; organize recall of herbal ingredients failing to meet quality standards in accordance with regulations in Article 102 of the Government s Decree No. 54/2017/ND-CP dated May 08, 2017;

dd) Take charge or cooperate in performing state inspection and handling violations against regulations on quality of herbal ingredients and traditional drugs intra vires;

e) Consolidate reports on use of herbal ingredients and traditional drugs nationwide by December 30 of every year;

g) Update its website with the list of establishments making commitments to sites where herbal ingredients are cultivated and harvested.

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

a) Conduct inspection of quality of herbal ingredients and traditional drugs in the province and take actions against violations according to law regulations;

b) Formulate the plan for sampling of herbal ingredients and traditional drugs for testing their quality, submitting the plan to the Provincial People’s Committee for considering giving approval, and allocating budget for implementing the plan intra vires;

c) Update the drug quality information system of the Ministry of Health with information concerning samples of herbal ingredients and traditional drugs taken (including name of traditional drug, name of herbal ingredient, concentration/ content, dosage form, batch number, expiry date, registration number or import license number, manufacturer, importer or establishment where samples are taken) and quality testing results.

d) Collect information and update its website with the list of locations and establishments growing, harvesting and extracting herbs in the province.

3. Responsibility of herbal ingredient and traditional drug testing facilities:

a) Central-level testing facilities (including 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 ingredients and traditional drugs manufactured, sold and used; send testing reports to the Ministry of Health (via the Traditional Medicine Administration of Vietnam) and the Department of Health of province where samples are taken if samples of herbal ingredients and traditional drugs fail to meet quality standards under the provisions of Article 10 herein;

- Do research, establish and publish on their websites and the website of the Traditional Medicine Administration of Vietnam the list of reference standards, reference substances and impurity reference substances used for analysis and testing of samples of herbal ingredients and traditional drugs manufactured, imported, sold and used in the territory of Vietnam;

- Provide testing centers of provinces and central-affiliated cities as assigned with the copies or electronic files of quality standards of herbal ingredients and traditional drugs.

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

- Conduct analysis and testing of samples so as to determine the quality of herbal ingredients and traditional drugs manufactured, sold and used;

- Send testing reports to the Provincial Department of Health and the Ministry of Health (via the Traditional Medicine Administration of Vietnam) if samples of herbal ingredients and traditional drugs fail to meet quality standards under the provisions of Article 10 herein.

4. Establishments trading in herbal ingredients and traditional drugs shall:

a) Comply with regulations on quality of herbal ingredients and traditional drugs herein;

b) Ensure quality of their herbal ingredients and traditional drugs; manage quality of herbal ingredients and traditional drugs according to the licensed scope of business and in compliance with law regulations;

c) Preserve imported herbal ingredients and traditional drugs at warehouses meeting Good Storage Practice requirements after being granted customs clearance;

d) Regularly report and provide documents proving the origins of herbal ingredients to the Traditional Medicine Administration of Vietnam for publishing on its website;

dd) Separately store counterfeit herbal ingredients/ traditional drugs when discovering, trace back to their origins and inform competent quality inspection agencies and other traders.

5. While herbal ingredient/ traditional drug quality controllers are not assigned at all levels, the Ministry of Health shall:

a) Assign the National Institute of Drug Quality Control and the Institute of Drug Quality Control of Ho Chi Minh city, within the ambit of assigned functions, duties and scope of operation, to:

- Formulate the plan for sampling of herbal ingredients and traditional drugs for testing quality; estimate and receive annual budget allocated for cover testing expenses;

- Take samples of herbal ingredients and traditional drugs according to the approved plan;

- Establish and develop the herbal ingredient and traditional drug quality information system of the Ministry of Health. Update their websites with information concerning samples of herbal ingredients and traditional drugs taken for quality testing and testing results;

- Send testing reports to the Ministry of Health (via the Traditional Medicine Administration of Vietnam) and the Department of Health of province where samples are taken if samples of herbal ingredients and traditional drugs fail to meet quality standards under the provisions of Article 10 herein.

b) Assign testing centers of provinces and central-affiliated cities to:

- Formulate the plan for sampling of herbal ingredients and traditional drugs for testing quality; estimate and receive annual budget allocated for cover testing expenses;

- Take samples of herbal ingredients and traditional drugs for testing their quality according to the approved plan;

- Update their websites with information concerning samples of herbal ingredients and traditional drugs taken for quality testing and testing results;

- Send testing reports to the Ministry of Health (via the Traditional Medicine Administration of Vietnam) and Provincial Departments of Health if samples of herbal ingredients and traditional drugs fail to meet quality standards under the provisions of Article 10 herein.

6. Health facilities have the responsibility to:

a) Use and apply herbal ingredients and traditional drugs that have clear origins as prescribed in Article 14 herein and are supplied by establishments granted certificate of eligibility to trade herbal ingredients and traditional drugs;

b) Carry out periodic inspection or unexpected inspection of quality of herbal ingredients and traditional drugs used in health facilities according to quality standards applicable to selected herbal ingredients and traditional drugs. Separately store herbal ingredients and traditional drugs when finding that they fail to meet quality standards, and immediately trace to their origins.

7. Drug quality inspections agencies shall assume the responsibility to prevent and control counterfeit herbal ingredients and traditional drugs. To be specific:

a) Receive information and proposals given by relevant organizations and individuals, and publicly announce contact information (including telephone number, email and fax, etc.);

b) Disseminate adverse effects of counterfeit herbal ingredients and traditional drugs, signs for indentifying and measures for avoiding buying counterfeit herbal ingredients and traditional drugs, and ways to report regulatory authorities on suspected herbal ingredients and traditional drugs;

c) Publish on their websites and other appropriate means of mass media information concerning counterfeit herbal ingredients and traditional drugs discovered and handling results;

d) Directly carry out or cooperate with relevant agencies to carry out market surveillance so as to discover and handle counterfeit herbal ingredients and traditional drugs sold on the market in a timely manner;

dd) Cooperate and assist relevant authorities to investigate and trace back to the origins of counterfeit herbal ingredients and traditional drugs;

e) Take actions against the manufacture and trading in herbal ingredients and traditional drugs which are counterfeit, illegally imported or have unknown origins;

g) The Traditional Medicine Administration of Vietnam shall take charge of cooperating, communicating and exchanging information concerning counterfeit herbal ingredients and traditional drugs with relevant international organizations (such as WHO) and foreign pharmaceutical agencies.

8. Social security agencies shall:

a) Regularly update information concerning the origins of herbal ingredients published on the website of the Traditional Medicine Administration of Vietnam so as to manage the payment of costs covered by health insurance fund;

b) Suspend payment for covered services in case the origins of herbal ingredients/ traditional drugs are unidentified.

Article 24. Implementationresponsibilities

The Director of Traditional Medicine Administration of Vietnam, Chief of the Ministry’s Office, the Ministry’s Chief Inspector, heads of departments and affiliates of the Ministry of Health, the Provincial Departments of Health, establishments trading in herbal ingredients and traditional drugs, and other relevant authorities, organizations and individuals shall implement this Circular.

Any difficulties arising in the course of the implementation of this Circular should be promptly reported to the Traditional Medicine Administration of Vietnam affiliated to the Ministry of Health for consideration./.

For the Minister

The Deputy Minister

Nguyen Viet Tien