Circular No. 13/2018/TT-BYT on the quality of medicinal materials and traditional medicine

CIRCULAR

Regulations on the quality of medicinal materials and traditional medicine

 

 

 

 

Pursuant to the Drug Law No. 105/2016/QH13 dated April 6, 2016;

Based on Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and measures for implementing the Law on Medicines;

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

At the proposal of the Director of the Traditional Medicine Management Department,

The Minister of Health issues this Circular to regulate the quality of medicinal materials and traditional medicine,

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the application of quality standards for medicinal materials and traditional medicine; their origin and place of production; inspection and handling of inspection results concerning the quality of medicinal materials and traditional medicine in production, cultivation, export, import, distribution, wholesale, retail (hereinafter referred to as business establishments), circulation, and use in Vietnam, and the preparation and processing of medicinal materials and traditional medicine according to prescriptions and formulas in medical facilities; procedures for recalling and handling violations of traditional medicine.

Article 2. Applicability

1. This Circular applies to business establishments dealing with medicinal materials and traditional medicine; medical facilities using medicinal materials and traditional medicine, and agencies, organizations, and individuals (hereinafter collectively referred to as units) related to the management of the quality of medicinal materials and traditional medicine in Vietnam.

2. This Circular does not apply to business establishments selling semi-finished medicinal products and herbal medicines; individuals cultivating, harvesting medicinal materials; and individuals extracting natural medicinal materials.

 

Article 3. Explanation of Terms

In this Circular, certain terms are understood as follows:

1. Batch of drug materials A batch of medicinal materials refers to a defined quantity of medicinal materials from the same planting or harvesting location, processed and prepared through the same procedure within a specified period at the same facility.
2. Batch of traditional medicine is a defined quantity of traditional medicines produced through the same process within a specified time frame at the same facility and with consistent quality.
3. Expiry date of medicinal materials is the period or term during which medicinal materials can be used while maintaining their quality as prescribed, expressed in the form of an expiry date in day, month, year format or month, year format (calculated up to the last day of the expiry month).
4. Quality standards for medicinal materials and traditional medicine are documents specifying technical characteristics of medicinal materials and traditional medicine including quality criteria, quality levels, testing methods, and other technical and management requirements related to the quality of medicinal materials and traditional medicine.

Chapter II

APPLICATION OF QUALITY STANDARDS FOR MEDICINAL MATERIALS AND TRADITIONAL MEDICINE

Article 4. Application of quality standards for medicinal materials and traditional medicine

1. Medicinal materials and traditional medicine must comply with quality standards for medicinal materials and traditional medicine as set out in the pharmacopoeia or the enterprise standards of the manufacturing facility (hereinafter referred to as the manufacturing facility).

2. Business establishments dealing with medicinal materials and traditional medicine must conduct an assessment and evaluation of the testing methods recorded in the quality standards for medicinal materials and traditional medicine announced by the manufacturing facility in a laboratory that complies with Good Laboratory Practice (GLP).

3. The Ministry of Health shall organize the review of applications and approve quality standards for medicinal materials and traditional medicine in accordance with regulations on registration of medicinal materials and traditional medicine and regulations on import permits for medicinal materials and traditional medicine without a registration certificate.

Article 5. Application of the Pharmacopoeia

1. Application of the Vietnamese Pharmacopoeia and reference pharmacopoeias:

a) Business entities dealing with medicinal materials and traditional medicines may apply the Vietnamese Pharmacopoeia or one of the following reference pharmacopoeias: China, Hong Kong, Japan, South Korea, India, International, Europe, United Kingdom, United States;

b) The application of standards in the pharmacopoeias specified in point a of this clause must include all provisions regarding quality specifications, quality levels, and testing methods stipulated in the corresponding monographs on medicinal materials and traditional medicines in the applied pharmacopoeia, as well as general quality specifications, quality levels, and general testing methods prescribed in the appendices of the applied pharmacopoeia;

c) In cases where business entities importing medicinal materials and traditional medicines into Vietnam apply the Vietnamese Pharmacopoeia but the quality specifications and quality levels prescribed in the Vietnamese Pharmacopoeia are lower than those in the reference pharmacopoeia, the reference pharmacopoeia shall be applied;

d) In cases where production entities declare the application of the Vietnamese Pharmacopoeia or reference pharmacopoeia as specified in point a of this clause but use testing methods different from those recorded in the specific monographs on medicinal materials and traditional medicines in the applied pharmacopoeia, they must prove the equivalence between their testing method and the method recorded in the pharmacopoeia. Testing results using the method recorded in the pharmacopoeia serve as the basis for concluding the quality of medicinal materials and traditional medicines.

2. Provisions on the application of foreign pharmacopoeias other than those mentioned above:

In cases where business entities dealing with medicinal materials and traditional medicines apply pharmacopoeias other than those specified in point a of Clause 1 of this Article, the minimum quality standards applied must meet the following requirements:

a) They must comply with the quality specifications and quality levels prescribed in the corresponding quality standard monographs of the Vietnamese Pharmacopoeia or reference pharmacopoeia as specified in point a of Clause 1 of this Article;

b) The general testing methods applied must be consistent with the corresponding general testing methods recorded in the Vietnamese Pharmacopoeia or one of the reference pharmacopoeias at point a of Clause 1 of this Article.

Article 6. Application of Basic Standards

1. The basic standards of medicinal materials and traditional medicines established and applied by production entities must comply with the provisions of point b of Clause 2 of Article 102 of the Medicine Law, specifically as follows:

1. They must comply with the quality specifications and quality levels prescribed in the corresponding monographs of the Vietnamese Pharmacopoeia or reference pharmacopoeia and the quality specifications, quality levels, and general testing methods prescribed in the appendices of the Vietnamese Pharmacopoeia or reference pharmacopoeia;
2. In cases where the Vietnamese Pharmacopoeia or reference pharmacopoeia does not have corresponding monographs on medicinal materials and traditional medicines, the entity must establish standards based on scientific research results (including product development results) or according to the provisions of another foreign pharmacopoeia.

2. Production, import, and distribution entities of medicinal materials must publish basic standards for medicinal materials not included in the list of medicinal materials required to be registered for circulation as stipulated in Clause 3.2 Section IV of Circular No. 21/2007/TT-BKHCN dated September 28, 2007, guiding the establishment and application of standards issued by the Ministry of Science and Technology. The published basic standards for medicinal materials must meet technical requirements as specified in Model No. 01B Appendix I attached to this Circular.

         3. Basic standards of traditional medicines produced at medical examination and treatment facilities shall be established, evaluated for suitability, and approved and promulgated by the head of the facility. For medical examination and treatment facilities producing traditional medicines in accordance with Clause 2 of Article 70 of the Medicine Law, they must conduct an assessment of the basic standards and testing methods recorded in the published standards.

         4. The evaluation of the suitability of basic standards and testing methods must be conducted at facilities with laboratories certified under Good Laboratory Practice (GLP) for drug and drug ingredient testing.

Article 7. Updating Quality Standards and Applying Updated Pharmacopoeia

Business entities dealing with medicinal materials and traditional medicines must promptly update the quality standards of medicinal materials and traditional medicines and apply updated pharmacopoeias as follows:

1. For medicinal materials listed in the registration and circulation list and traditional medicines when registering for circulation and renewing registration: At the time of submitting the registration dossier, the quality standards of medicinal materials and traditional medicines in the registration and renewal dossiers must comply with the current version of the pharmacopoeia or previous versions up to two years before the current version becomes effective.

2. For traditional medicines and medicinal materials listed in the registration and circulation list that have been granted permission for circulation: Within two years from the date of issuance of the latest version of the pharmacopoeia, the registration entity and the production entity are responsible for updating the quality standards of medicinal materials and traditional medicines according to the provisions of that version of the pharmacopoeia.

         3. For medicinal materials not listed in the registration and circulation list: Within one year from the date of issuance of the latest version of the pharmacopoeia, the production, import, and distribution entities of medicinal materials are responsible for updating the quality standards of medicinal materials according to the latest version of the pharmacopoeia and re-publishing the quality standards.

         4. During the circulation of medicinal materials and traditional medicines, if the production entity or registration entity discovers factors seriously affecting the quality, safety, and efficacy of medicinal materials and traditional medicines, or upon request of the Ministry of Health (Department of Traditional Medicine Management), the production entity must update the quality standards of medicinal materials and traditional medicines to control such factors and re-publish the quality standards for medicinal materials not listed in the registration and circulation list.

Chapter III

QUALITY MANAGEMENT OF MEDICINAL MATERIALS AND TRADITIONAL MEDICINES

IN THE COURSE OF BUSINESS, CIRCULATION, AND USE

Article 8. Requirements for the Quality Management of Traditional Medicine Materials and Medicines during Business Operations, Circulation, and Usage

1. Apply Good Practice principles and standards throughout the business operations, circulation, and usage in accordance with the scope of business of the entity.

2. Traditional medicine materials, raw materials for producing traditional medicines, and packaging that directly contacts traditional medicines before being put into production must be inspected by the production entity and meet quality standards.

3. Traditional medicines and traditional medicine materials before leaving the factory must be inspected by the production entity and meet quality standards.

4. The head and the person in charge of specialized matters of production, export, import, wholesale, retail entities; and the person in charge of ensuring quality at the production entity shall be responsible for quality management and quality inspection of traditional medicine materials and traditional medicines at the entity.

5. Entities engaged in the business of traditional medicine materials and traditional medicines have the responsibility to organize and implement quality inspection and control of traditional medicine materials, traditional medicines, and raw materials for producing traditional medicines at their premises.

6. Production entities of traditional medicine materials and traditional medicines must organize quality inspection and testing to determine and evaluate the quality of traditional medicine materials, traditional medicines, and raw materials for producing traditional medicines throughout the production process, before leaving the factory, and during circulation and usage.

7. Entities engaged in the business of traditional medicine materials and traditional medicines must retain relevant documents and information related to each purchase, import, factory release, distribution of traditional medicine materials and traditional medicines to track origins, monitor routes, and ensure storage conditions of traditional medicine materials, traditional medicines, and raw materials for producing traditional medicines.

8. Entities have the responsibility to comply with other provisions of the Pharmaceutical Law to ensure and maintain the quality of traditional medicine materials and traditional medicines throughout the business operations, circulation, and usage.

Article 9. Requirements for the Quality Management of Traditional Medicine Materials and Medicines at Medical Examination and Treatment Facilities

1. Traditional medicine materials and traditional medicines used at medical examination and treatment facilities must have a quality inspection certificate issued by the laboratory that meets Good Laboratory Practice standards, except for traditional medicines specified in Clause 2 of this Article.

2. For traditional medicines produced by medical examination and treatment facilities in accordance with Article 70 of the Pharmaceutical Law: Every three months, medical examination and treatment facilities must send the latest batch of traditional medicines to state pharmaceutical testing centers or private pharmaceutical testing service providers that have been granted a business license for pharmaceuticals for testing and quality inspection.

3. Traditional medicine materials and traditional medicines must be inspected and accepted through the hospital's acceptance committee established under Circular No. 22/2011/TT-BYT dated June 10, 2011, issued by the Minister of Health on the organization and operation of the Hospital Pharmacy Department or the acceptance department of other medical examination and treatment facilities. The acceptance department must include at least the following members appointed by the head of the medical examination and treatment facility: the person in charge of the pharmacy department, accountant, warehouse manager, and supply officer. Traditional medicine materials and traditional medicines can only be used within medical examination and treatment facilities if they meet quality requirements.

4. The head of medical examination and treatment facilities has the responsibility to organize regular inspections at least every three months and ad hoc inspections when necessary regarding the quality of traditional medicine materials and traditional medicines within the medical examination and treatment facilities. Inspection results must be recorded in a report.

5. In cases where risk factors affecting the quality of traditional medicine materials and traditional medicines are discovered, medical examination and treatment facilities must send samples to state pharmaceutical testing centers or private pharmaceutical testing service providers that have been granted a business license for pharmaceuticals for testing and quality inspection.

 

 

 

Article 10. Testing of Traditional Herbal Medicines and Traditional Medicines

1. The testing of traditional herbal medicines and traditional medicines must be conducted at a laboratory that complies with Good Laboratory Practice for Pharmaceutical Products and Active Pharmaceutical Ingredients (GLP).

2. Sample retention:

a) After quality inspection and conclusion of quality, traditional herbal medicines and traditional medicines must be retained as samples. The retained samples must be sealed and stored under conditions suitable as indicated on the label;

b) Sample storage period:

- For production, export, and import establishments of traditional herbal medicines and traditional medicines: the retention period for traditional medicine formulations is at least 12 months after the expiration date of the medicine; the retention period for traditional herbal medicines and traditional medicinal ingredients is until the expiration date of the herbal medicines and medicinal ingredients;

- For testing establishments: the retention period for traditional herbal medicines and traditional medicinal ingredients is at least six months from the date of sampling or twelve months from the date of sampling for samples taken to check quality; the retention period for traditional medicines is at least twelve months after the expiration date of the medicine or twenty-four months from the date of sampling for samples taken to check quality.

3. In case the traditional herbal medicine or traditional medicine sample does not meet quality standards, within 24 hours from the issuance of the analysis report or test report, the testing establishment must publish this information on its electronic information website and send a formal letter notifying the non-compliant traditional herbal medicine or traditional medicine sample along with the test report or analysis report to the Department of Traditional Medicine Management - Ministry of Health via administrative documents and electronic documents (scanned copies) on the Ministry of Health's electronic document management system (Voffice) or call the phone number of the Department of Traditional Medicine Management from the official address and phone number of the testing establishment and the Provincial Health Department (hereinafter referred to as the Provincial Health Department) where the traditional herbal medicine or traditional medicine sample was taken.

4. Other provisions regarding the testing of traditional herbal medicines and traditional medicines shall be applied according to the regulations of the Ministry of Health concerning the testing of chemical drugs, herbal medicines, and active pharmaceutical ingredients.

Article 11. Testing of Traditional Herbal Medicines and Traditional Medicines Listed in the List of Production and Import Establishments Violating Quality Standards and Removal from the List of Production and Import Establishments Violating Quality Standards

1. From the date of the first batch of traditional medicines produced or imported after the Ministry of Health (Department of Traditional Medicine Management) publishes the List of Production and Import Establishments Violating Quality Standards, the establishment must conduct testing on all batches of traditional medicines violating quality standards within the prescribed time limit as follows:

a) Six months for a production establishment with one batch of traditional medicines violating level 3;

b) Twelve months for a production establishment with one batch of traditional medicines violating level 2 or two batches of traditional medicines violating level 3 or higher;

c) Twenty-four months for a production establishment with one batch of traditional medicines violating level 1 or two batches of traditional medicines violating level 2 or higher;

d) If the production establishment continues to have batches of traditional medicines violating quality standards, the testing period will be extended cumulatively.

2. From the date of the first batch of herbal medicines produced or imported after the Ministry of Health (Department of Traditional Medicine Management) publishes the List of Production and Import Establishments Violating Quality Standards, the establishment must conduct testing on all batches of herbal medicines violating quality standards within the prescribed time limit as follows:

a) Six months for a production establishment with one batch of herbal medicines violating quality standards that is allowed to be corrected and reused;

b) Twelve months for a production establishment with one batch of herbal medicines violating quality standards that must be destroyed or two batches of herbal medicines violating quality standards that are allowed to be corrected and reused;

c) Eighteen months for a production establishment with two batches of herbal medicines violating quality standards that must be destroyed;

d) If the production establishment continues to have batches of herbal medicines violating quality standards, the testing period will be extended cumulatively.

3. A production or import establishment may be removed from the List of Production and Import Establishments Violating Quality Standards when it meets the following requirements:

a) The production or import establishment fully conducts testing of traditional herbal medicines and traditional medicines before releasing them for circulation within the time limits specified in Clause 1 or Clause 2 of this Article;

b) The production establishment or the registration establishment of traditional herbal medicines and traditional medicines reports on the sampling and quality testing of traditional herbal medicines and traditional medicines in accordance with Form No. 05 of Appendix I issued together with this Circular, accompanied by evidence of testing all batches of traditional herbal medicines and traditional medicines imported into Vietnam within the time limits specified in Clause 1 or Clause 2 of this Article;

c) The production or import establishment has no violations of quality standards for traditional herbal medicines and traditional medicines (including voluntary recalls due to quality reasons) during the implementation period specified in Points a, b, and c of Clause 1 or Clause 2 of this Article.

4. Monthly, based on the reports of participating testing establishments and the results of reviewing the reports of production and registration establishments, the Ministry of Health (Department of Traditional Medicine Management) will update and publish the List of Production and Import Establishments Violating Quality Standards, removing production and import establishments that meet the requirements of Clause 3 of this Article from the List of Production and Import Establishments Violating Quality Standards.

Article 12. State inspection on the quality of traditional herbal medicines

1. Quality inspection agencies for traditional herbal medicines:

a) The central agency responsible for inspecting the quality of traditional herbal medicines is the Traditional Medicine Management Agency under the Ministry of Health;

b) The local agency responsible for inspecting the quality of traditional herbal medicines is the Provincial Department of Health.

2. Content of quality inspection for traditional herbal medicines during production includes:

a) Control of raw material and packaging quality before production;

b) Production conditions, testing procedures, implementation of production technology processes, testing procedures, factory hygiene, and machinery maintenance, including:

- Control of semi-finished and finished product quality;

- Product quality control before warehousing and dispatch;

- Inspection of batch records;

- Inspection of traceability records for herbal materials and raw materials.

3. Content of quality inspection for exported, imported, and circulating traditional herbal medicines includes:

a) Inspection of compliance with regulations on quality and origin control of traditional herbal medicines during warehousing, storage, transportation, and dispatch;

b) Inspection of registration certificates for traditional herbal medicines (if applicable) or import permits for traditional herbal medicines, and compliance with labeling and usage instructions for traditional herbal medicines;

c) Inspection of compliance with recall notifications issued by quality inspection agencies and producers, importers, entrusted importers, and wholesalers;

d) Sampling for analysis and testing to determine the quality of traditional herbal medicines according to the quality standards in the registration dossier, declaration dossier, or import dossier of traditional herbal medicines without a registration certificate accepted by the Ministry of Health.

4. State inspections on the quality of traditional herbal medicines shall be carried out in accordance with laws on product and commodity quality.

Chapter IV

ORIGIN AND PLACE OF PRODUCTION OF TRADITIONAL HERBAL MEDICINES

Article 13. Origin control of traditional herbal medicines

1. Businesses dealing in traditional herbal medicines and healthcare facilities using such medicines must establish a traceability system to ensure the ability to identify and track products at each stage of cultivation, harvesting, trading, and use of traditional herbal medicines.

2. Traceability must ensure that information about the supplier and producer of traditional herbal medicines can be determined throughout the business and use process of the entity.

Article 14. Documentation proving the origin of traditional herbal medicines

1. Documentation proving the origin for imported traditional herbal medicines not included in the list requiring circulation registration includes:
   1. Certificate of origin and export of each batch of traditional herbal medicines issued by the competent authority of the exporting country (Certificate of Origin/Certificate of Export);
   2. Certificate of conformity with the quality standard of the producing country or international standards (Certificate of Quality) (accompanied by a Vietnamese translation) for each batch of traditional herbal medicines and Test Report (accompanied by a Vietnamese translation) for each batch of traditional herbal medicines.

2. Documentation proving the origin for domestically cultivated, harvested, or naturally sourced traditional herbal medicines meeting Good Agricultural and Collection Practices (GACP) includes: Documentation proving the entity's compliance with Good Agricultural and Collection Practices (GACP).
3. Documentation proving the origin for traditional herbal medicines purchased from domestic individuals cultivating, harvesting, or collecting traditional herbal medicines includes: A commitment statement regarding the location of cultivation and harvesting of traditional herbal medicines in the locality according to Model No. 06 of Appendix I issued together with this Circular.
4. Documentation proving the origin for traditional herbal medicines listed in the mandatory circulation registration list is the Registration Certificate for Circulation of Traditional Herbal Medicines.

          5. Documentation proving the origin for traditional medicines includes:

          a) Documentation proving the origin of raw materials for producing traditional medicines;

          b) Registration Certificate for Circulation of Traditional Medicines.

Article 15. Provisions on the storage of documentation related to the origin and place of production of traditional herbal medicines, of traditional medicines

1. Pharmaceutical businesses must retain relevant documentation in paper form or through management software for each receipt and supply of traditional herbal medicines, medicinal raw materials ensuring complete and accurate information including:

a) Name of the manufacturing entity, name of the importing entity for drugs and medicinal raw materials;

b) Information about drug and medicinal raw material products (product name, dosage form, concentration or content, batch number, date of manufacture, expiration date...);

c) Quantity received or supplied;

d) Date of receipt, date of supply;

đ) Name, address, phone number, email (if available) of the supplying entity/person for each receipt, receiving entity/person for each supply.

2. Manufacturing entities, importers conducting distribution activities, wholesale entities acting as distribution hubs must cooperate with retail entities, establish a distribution chain, and implement measures to monitor and ensure traceability, control the route and storage conditions of traditional herbal medicines, medicinal raw materials.

3. Retention period for documentation related to origin and place of production

a) Documentation related to the origin of traditional herbal medicines and traditional medicine ingredients must be retained for at least six months after the expiration date of the traditional herbal medicines and traditional medicine ingredients;

b) Documentation related to the origin of traditional medicines must be retained for at least twelve months after the expiration date of the traditional medicines.

Chapter V

RECALL AND HANDLING OF TRADITIONAL MEDICINES VIOLATING QUALITY STANDARDS

Article 16. Procedure for Compulsory Recall of Traditional Medicines

1. Receiving Information on Violating Traditional Medicines:

The Ministry of Health (Traditional Medicine Management Department) receives information on violating traditional medicines from:

1. Evaluation information on the effectiveness and safety of traditional medicines provided by the Advisory Council for Traditional Medicine Registration;
2. Quality information on traditional medicines from testing facilities;
3. Information on violating traditional medicines discovered by the Traditional Medicine Management Department, Health Inspection Authority, and Pharmaceutical Inspection Authority;

d) Reports on violating traditional medicines from production establishments, management agencies, and state quality control agencies of foreign countries;

đ) Information on violating traditional medicines discovered by police, customs, and market management authorities;

e) Information on traditional medicines voluntarily offered for recall by pharmaceutical business establishments.

2. Determining the Level of Violation:

a) Within twenty-four hours from the time of receiving information on violating traditional medicines as stipulated in points a, c, d, đ, and e of Clause 1 of this Article, the Ministry of Health (Traditional Medicine Management Department) shall determine the level of violation of traditional medicines as specified in Appendix II issued together with this Circular and conclude on the recall of violating traditional medicines based on the assessment of health risks posed by the violating medicines.

In cases where opinions of the Advisory Council for Issuing Registration Certificates for Traditional Medicines as stipulated in Section IV of Appendix II issued together with this Circular need to be sought, the determination of the level of violation of traditional medicines must be completed within a maximum period of seven days.

b) For information on violating traditional medicines as stipulated in point b of Clause 1 of this Article, the handling process shall be carried out according to the provisions of Article 18 of this Circular.

3. Issuing Recall Decisions for Traditional Medicines:

a) Within no more than twenty-four hours from the conclusion on the recall of traditional medicines, the Director of the Traditional Medicine Management Department shall issue a decision to recall violating traditional medicines in accordance with Clause 1 or Clause 2 of Article 65 of the Drug Law;

b) The recall decision must include the following information: name of medicine, registration certificate number or import permit number, herbal ingredient name, quantity, dosage form, batch number, expiration date, manufacturing establishment, importing establishment, level of recall, responsible entity for recall.

4. Announcing Decisions on Recall:

a) The recall decision of the Ministry of Health (Traditional Medicine Management Department) shall be notified to provincial Health Departments, manufacturing establishments, or importing establishments through postal mail, fax, email, telephone, or mass media;

b) Immediately upon issuance of the recall decision, the Traditional Medicine Management Department shall publish the recall decision for traditional medicines on the Ministry of Health's electronic portal, the Traditional Medicine Management Department's website under the Ministry of Health, and the national pharmaceutical database of the Ministry of Health; the provincial Health Department shall publish information about the recall decision on its website immediately after receiving the recall decision; domestic traditional medicine manufacturing establishments and importers must notify information about recalled medicines to businesses and users who have purchased the medicines;

c) In cases of recalling traditional medicines at Level 1, in addition to implementing the provisions of point b of this clause, the recall decision for traditional medicines must be announced by the Ministry of Health on Vietnam Television and Voice of Vietnam Radio.

5. Implementation of Recall of Traditional Medicines

a) Businesses and users of traditional medicines must stop supplying and using; store remaining medicines at their premises; compile a list of businesses, users, and individuals (if any) who have purchased the medicines, contact and accept returned medicines; return the medicines to the supplier;

b) Manufacturing establishments (for domestically produced medicines) and importers (for imported medicines) must cooperate with entrusted importers or primary distributors to take responsibility for recalling violating traditional medicines. The recall record shall be conducted in accordance with Model No. 02 of Appendix I issued together with this Circular.

In cases where businesses and suppliers of traditional medicines fail to implement the recall or accept returned medicines, the businesses and individuals purchasing and using traditional medicines must report to the provincial Health Department for handling in accordance with regulations.

c) The recall of traditional medicines must be completed within the time limit prescribed in Clause 3 of Article 63 of the Drug Law.

6. Reporting Recall Results, Evaluating Recall Effectiveness, and Additional Handling:

a) Within one day for Level 1 recalls, and three days for Level 2 and Level 3 recalls from the completion of the recall, the entity responsible for the recall must submit a written report on the recall results to the Ministry of Health (Traditional Medicine Management Department) and the provincial Health Department of the traditional medicine business establishment responsible for the recall, including the following documents:

- Report on the recall of traditional medicines as specified in Model No. 03 of Appendix I issued together with this Circular;

- List of businesses and users of traditional medicines supplied directly, along with address, phone number, email (if available), quantity supplied, and quantity of traditional medicines recalled;

- List of businesses and users of traditional medicines supplied through distributors, along with address, phone number, email (if available), quantity supplied, and quantity of traditional medicines recalled;

- Delivery and receipt records, return invoices, or other evidence demonstrating the recall of traditional medicines;

- Self-assessment results on the effectiveness of the recall of traditional medicines;

- Investigation and evaluation results on the causes, risk assessment of other batches of violating medicines, and/or other traditional medicines produced on the same production line.

b) The Ministry of Health (Traditional Medicine Management Department) shall review the report on recall results and evaluate the effectiveness of the recall, or assign the provincial Health Department to conduct the evaluation. If the recall effectiveness is assessed as not thorough enough, and there is a possibility that the product may continue to circulate and be used, posing a risk to user health, the Traditional Medicine Management Department shall coordinate with the provincial Health Department and relevant authorities to enforce the compulsory recall.

Article 17. Procedure for Voluntary Recall of Traditional Medicines

          1. The entity shall self-assess the level of violation of traditional medicines, prepare a report to the Ministry of Health (Traditional Medicine Management Department) along with relevant documents, clearly stating information about the violating traditional medicine, the level of violation, reasons for recall, proposed measures for handling the medicine after recall, and attach relevant documents.

          In case of requesting remediation, the entity must submit the remediation process, risk assessment regarding the quality and stability of the medicine, monitoring and supervision procedures for the quality, safety, and efficacy of the medicine during circulation.

2. Within three days from the date of receipt of the report from the pharmaceutical business entity, the Ministry of Health (Traditional Medicine Management Department) shall review the report of the pharmaceutical business entity and determine the level of violation of traditional medicines according to Appendix II issued together with this Circular.

          a) In case of agreement with the pharmaceutical business entity's proposal on level 3 violation of traditional medicines, the Ministry of Health (Traditional Medicine Management Department) shall issue a document agreeing to the voluntary recall by the entity;

b) In case of determining level 1 or 2 violation of traditional medicines, the Ministry of Health (Traditional Medicine Management Department) shall implement the recall procedures for traditional medicines as stipulated in Clauses 3, 5, and 6 of Article 16 of this Circular;

          c) In case additional or clarifying information is needed in the report of the pharmaceutical business entity, the Ministry of Health (Traditional Medicine Management Department) shall issue a document requesting the entity to provide supplementary information and explanations. Within five days from the date of receipt of the document from the Ministry of Health (Traditional Medicine Management Department), the entity must submit a supplementary document and explanation.

          3. Notification of Recall Decision:

          a) In case of level 1 or level 2 violation, the Ministry of Health shall implement the notification procedure as stipulated in Clause 4 of Article 16 of this Circular;

          b) In case of level 3 violation, the entity shall notify the Provincial Health Department, the production facility, or the importing entity through mail, fax, email, telephone, or mass media;

          4. Implementation of Recall and Reporting of Recall Results, Evaluation of Recall Effectiveness, and Additional Handling Shall Be Conducted According to the Provisions of Clauses 5 and 6 of Article 16 of This Circular.

Article 18. Handling of Traditional Medicines Not Meeting Quality Standards

1. In case the sample of traditional medicine violating quality standards is taken from retail pharmacies, medical examination and treatment facilities of Class III or IV by the quality control agency:

a) Within twenty-four hours from the time of receiving the test report or analysis sheet sent by the testing facility, the Provincial Health Department shall seal the non-compliant traditional medicine at the sampling location;

b) Within forty-eight hours from the time of receiving the test report or analysis sheet sent by the testing facility, the Ministry of Health (Traditional Medicine Management Department) shall issue a document requiring the registration entity, production facility, or importing entity to take responsibility for:

- Reporting the distribution of traditional medicines to the Ministry of Health (Traditional Medicine Management Department);

- Requesting the quality control agency to take additional samples from domestic traditional medicine production facilities or foreign traditional medicine importers and wholesale facilities;

- Sending the collected samples to central-level testing facilities for quality control on non-conforming criteria.

c) In case at least one additional sample of traditional medicine does not meet quality standards, the Ministry of Health (Traditional Medicine Management Department) shall determine the level of violation and conclude on the recall of the violating traditional medicine according to Appendix II issued together with this Circular, and issue a decision to recall the violating traditional medicine as stipulated in Clause 3 of Article 16 of this Circular;

d) In case all additional samples of traditional medicine meet quality standards, the Ministry of Health (Traditional Medicine Management Department) shall only determine the level of violation, conclude on the recall of the violating traditional medicine, and issue a decision to recall the medicine from the initial sampling entity.

2. In case the sample is taken from wholesale facilities, medical examination and treatment facilities of Class II or higher by the quality control agency:

a) Within twenty-four hours from the time of receiving the test report or analysis sheet sent by the testing facility, the Provincial Health Department shall seal the non-compliant traditional medicine at the sampling location;

b) Within forty-eight hours from the time of receiving the test report or analysis sheet sent by the testing facility, the Ministry of Health (Traditional Medicine Management Department) shall issue a decision to recall traditional medicines within the province or centrally administered city where the sample was taken as stipulated in Clause 3 of Article 16 of this Circular, and issue a document requiring the registration entity, production facility, or importing entity to take responsibility for:

- Reporting the distribution of medicines to the Ministry of Health (Traditional Medicine Management Department);

- Requesting the quality control agency to take at least two additional samples of traditional medicine from other wholesale facilities;

- Sending the collected samples to central-level testing facilities for quality control on non-conforming criteria.

c) In case at least one additional sample of traditional medicine does not meet quality standards, the Ministry of Health (Traditional Medicine Management Department) shall determine the level of violation and conclude on the recall of the violating traditional medicine according to Appendix II issued together with this Circular, and issue a decision to recall the violating traditional medicine nationwide as stipulated in Clause 3 of Article 16 of this Circular;

d) In case all additional samples of traditional medicine meet quality standards, the Ministry of Health (Traditional Medicine Management Department) shall only determine the level of violation, conclude on the recall of the violating traditional medicine, and issue a decision to recall the traditional medicine from the initial sampling entity within the province or centrally administered city where the sample was taken.

3. In case the traditional medicine sample is taken from the production facility, import facility, service preservation facility, or the traditional medicine is determined to violate quality due to reasons during the production process, the Ministry of Health (Traditional Medicine Management Department) shall determine the level of violation and conclude on the recall of the violating traditional medicine according to the provisions set out in Appendix II issued together with this Circular, and issue a decision to recall the violating traditional medicine according to the provisions of Clause 3, Article 16 of this Circular.

4. In case the violating traditional medicine is produced by a medical examination and treatment facility in accordance with Clauses 1 and 2, Article 70 of the Drug Law, the Ministry of Health (Traditional Medicine Management Department) shall assess and determine the level of violation and issue a decision to recall the traditional medicine according to the provisions of Clauses 2 and 3, Article 16 of this Circular. The recall decision shall be sent to the hospital and the Provincial Health Department where the medical examination and treatment facility operates for the purpose of recalling the traditional medicine.

Article 19. Handling of recalled traditional medicines

1. Recalled traditional medicines may be allowed to be rectified or re-exported in cases of violation at Level 3 and not falling under the circumstances stipulated in Point b, Clause 2 of this Article.

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

a) Recalled traditional medicines due to violations at Level 1 or Level 2;

b) Recalled traditional medicines due to violations at Level 3 that cannot be rectified after the Ministry of Health (Traditional Medicine Management Department) reviews according to the provisions of Clause 3 of this Article;

c) Recalled traditional medicines due to violations at Level 3 that are permitted to be rectified or re-exported but fail to implement such rectification or re-exportation.

3. Procedures for requesting rectification of recalled traditional medicines:

a) The facility with recalled traditional medicines must submit a written document to the Ministry of Health (Traditional Medicine Management Department) along with the rectification procedure, risk assessment concerning the quality and stability of the medicine, and a monitoring program for the quality, safety, and efficacy of the medicine during circulation;

b) Within a maximum period of 60 days from the date of receipt of the request document from the facility, the Ministry of Health (Traditional Medicine Management Department) shall provide a written response agreeing or disagreeing with the rectification. If disagreement occurs, the reasons must be clearly stated;

c) In case additional information related to rectification is required, within a maximum period of 30 days from the date of receipt of the request document from the facility, the Ministry of Health (Traditional Medicine Management Department) shall issue a document requesting the facility to provide supplementary information or explanations;

Within 30 days from the date of receipt of the document from the Ministry of Health (Traditional Medicine Management Department) requesting supplementary information or explanations, the facility must submit the supplementary documents or explanations. After this period, if the facility does not submit the supplementary documents or explanations, the rectification request will lose its validity.

4. Procedures for requesting re-exportation of recalled traditional medicines:

a) The facility with recalled traditional medicines must submit a written document to the Ministry of Health (Traditional Medicine Management Department) along with a re-export plan specifying the time and country of re-exportation;

b) Within 15 days from the date of receipt of the request document from the facility, the Ministry of Health (Traditional Medicine Management Department) shall provide a written response; if disagreement occurs, the reasons must be clearly stated.

5. Rectification and re-exportation of recalled traditional medicines can only be carried out after receiving a written agreement from the Ministry of Health (Traditional Medicine Management Department).

6. Destruction of traditional medicines:

a) The head of the facility with traditional medicines to be destroyed shall issue a decision to establish a Committee for Medicine Destruction. The Committee must consist of at least three members, including one representative responsible for the technical aspect;

b) The destruction of traditional medicines must ensure safety for people and animals and prevent environmental pollution in accordance with the relevant laws on environmental protection;

c) The facility destroying traditional medicines must report along with the minutes of the medicine destruction to the Provincial Health Department in accordance with Model No. 04 in Appendix I issued together with this Circular;

d) A pharmaceutical business facility with violating traditional medicines must bear responsibility for the costs of destruction;

7. The handling period for recalled traditional medicines shall not exceed 12 months from the completion date of the recall as specified in Points a, b, and c, Clause 3, Article 63 of the Drug Law.

 

Article 20. Responsibility for recalling traditional medicine

1. Responsibilities of production facilities, business entities, medical examination and treatment establishments, and users:

a) Implement the provisions set forth in Clauses 1, 2, and 3 of Article 64 of the Drug Law;

b) Regularly check and update information on the recall of traditional medicine on the Ministry of Health's electronic portal, the Traditional Medicine Management Department's website, and the Provincial Health Department’s website.

2. Responsibilities of the Traditional Medicine Management Department:

a) Receive information, determine the level of violation of traditional medicine, and issue a decision to recall traditional medicine;

b) Announce the decision to recall traditional medicine according to point a, Clause 4, Article 16 of this Circular, publish information about recalled traditional medicine on the Ministry of Health's electronic portal and the Traditional Medicine Management Department's website after issuing the decision to recall traditional medicine. Coordinate with Vietnam Television and Voice of Vietnam to announce information about the recall of traditional medicine at level 1 violations;

c) Examine reports on evaluations and responses regarding voluntary recalls, proposals for corrective actions, and re-exportation of recalled traditional medicine from production and business entities;

d) Coordinate with related units (Ministry Inspectorate, Provincial Health Department, Health Departments of various sectors) to inspect and supervise the organization and implementation of the recall of traditional medicine; handle violative entities according to the law;

đ) Issue detailed guidance documents on the procedures for handling and recalling traditional medicine, evaluating the effectiveness of recall notifications issued by production and business entities;

3. Responsibilities of the Provincial Health Department:

a) Publish information on decisions to recall traditional medicine on the Provincial Health Department’s website;

b) Organize announcements and dissemination of information about the recall of traditional medicine to production and business entities, medical examination and treatment establishments within their jurisdiction;

c) Conduct or direct testing centers to cooperate with entities whose traditional medicine has quality issues to take additional samples of traditional medicine according to point b, Clause 1 or point b, Clause 2 of Article 18 of this Circular;

d) Supervise the recall of traditional medicine within their jurisdiction; handle and impose penalties on violative entities according to their authority;

đ) Participate or conduct evaluations of the effectiveness of the recall of traditional medicine by entities within their jurisdiction as directed by the Ministry of Health (Traditional Medicine Management Department). Report to the Ministry of Health (Traditional Medicine Management Department) on cases where production entities, import entities, and wholesale entities that are primary distributors of traditional medicine fail to implement or inadequately implement the recall of traditional medicine;

e) Organize or participate in forced recalls of traditional medicine.

Chapter VI

IMPLEMENTING PROVISIONS

  Article 21. Effective Date

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

2. The following documents and regulations are abolished from the date this Circular takes effect:

a) Provisions on the quality of medicinal materials and traditional medicine in Circular No. 09/2010/TT-BYT dated April 28, 2010, issued by the Minister of Health on guiding the management of drug quality;

b) Circular No. 05/2014/TT-BYT dated February 14, 2014, issued by the Minister of Health on the use of medicinal materials and traditional medicines in medical examination and treatment establishments.

Article 22. Reference Provisions

In cases where the referenced documents in this Circular are replaced or amended, they shall be applied according to the replacement or amended documents.

Article 23. Implementation Organization

1. The Traditional Medicine Management Department shall be responsible for:

a) Taking the lead and coordinating with relevant units to organize publicity, dissemination, and implementation of this Circular;

b) Taking the lead and coordinating with the Central Institute of Pharmaceutical Inspection, Ho Chi Minh City Institute of Pharmaceutical Inspection:

- Developing plans to collect samples of medicinal materials and traditional medicine for quality testing, submitting them to the Ministry of Health for review and approval, and arranging the budget to implement the plan according to its authority;

- Implementing the collection of samples of medicinal materials and traditional medicine for quality testing and updating the Ministry of Health's quality testing drug information system with information on collected samples (including information such as name of traditional medicine, name of medicinal material, concentration/content, dosage form, batch number, expiration date, registration certificate number or import permit number, manufacturing entity, importing entity, sampling entity) and the results of quality testing for medicinal material and traditional medicine samples;

c) Provide the Central Institute of Pharmaceutical Inspection, Ho Chi Minh City Institute of Pharmaceutical Inspection with sample labels and quality standards of medicinal materials and traditional medicine that have been granted registration certificates or import permits, and updates if there are changes;

d) Organize quality inspections of medicinal materials and traditional medicine produced, processed, circulated, and used nationwide; Direct and supervise the national pharmaceutical inspection system regarding the inspection of medicinal materials and traditional medicine; Conclude on the quality of medicinal materials and traditional medicine based on the results of quality inspections conducted by state inspection facilities and relevant files; Carry out the recall of non-compliant medicinal materials according to Article 102 of Decree No. 54/2017/NĐ-CP dated May 8, 2017, of the Government detailing certain provisions and measures to enforce the Drug Law;

đ) Take the lead or coordinate in performing state inspection functions, inspections, and handling violations of laws concerning the quality of medicinal materials and traditional medicine according to their authority;

e) Compile and report on the use of medicinal materials and traditional medicine nationwide before December 30 each year;

g) Update and post on the Traditional Medicine Management Department's website lists of entities that have signed commitments regarding cultivation and harvesting sites for medicinal materials in localities;

2. Provincial Health Departments shall be responsible for:

a) Organizing the implementation of quality inspections of medicinal materials and traditional medicine within their jurisdiction and handling violations according to the law;

b) Develop plans to collect samples of medicinal materials and traditional medicine for quality testing, submit them to the People's Committee of the province or centrally governed city for review and approval, and arrange the budget to implement the plan according to their authority;

c) Update the Ministry of Health's quality testing medicinal material and traditional medicine information system with information on collected samples (including information such as name of traditional medicine, name of medicinal material, concentration/content, dosage form, batch number, expiration date, registration certificate number or import permit number, manufacturing entity, importing entity, sampling entity) and the results of quality testing for medicinal material and traditional medicine samples.

d) Organize the collection of information and update the publication on the Department of Health's provincial electronic information website of the list of locations, breeding, harvesting, and extraction sites for medicinal materials in the locality.

3. The system for testing medicinal materials and traditional medicine shall be responsible for:

a) Central-level drug testing facilities (Central Institute for Drug Testing, Ho Chi Minh City Institute for Drug Testing):

- Conducting analysis and testing samples to determine the quality of medicinal materials and traditional medicine produced, circulated, and used; reporting the test results to the Ministry of Health (Traditional Medicine Management Department) and the provincial Department of Health where the sample was taken for medicinal materials and traditional medicine that do not meet the quality standards as stipulated in Article 10 of this Circular;

- Researching, establishing, and publishing on the electronic information websites of Institutes and the Traditional Medicine Management Department the list of reference substances, comparison substances, and standard impurities serving the analysis and testing of medicinal material and traditional medicine samples produced, imported, circulated, and used within the territory of Vietnam;

- Being responsible for providing copies or electronic documents of the quality standards of medicinal materials and traditional medicine to the provincial drug testing centers under the central cities assigned to their respective areas;

b) Provincial and municipal drug testing centers under the central government:

- Conducting analysis and testing samples to determine the quality of medicinal materials and traditional medicine produced, circulated, and used;

- Reporting the test results to the provincial Department of Health and the Ministry of Health (Traditional Medicine Management Department) for medicinal materials and traditional medicine samples that do not meet the quality standards as stipulated in Article 10 of this Circular;

4. Business entities shall be responsible for:

a) Organizing research and implementation of legal regulations on the management of the quality of medicinal materials and traditional medicine issued in this Circular;

b) Ensuring the quality of medicinal materials and traditional medicine throughout the operation of the facility; implementing quality management activities for medicinal materials and traditional medicine within the scope permitted based on compliance with legal provisions;

c) Must store imported medicinal materials and traditional medicine in warehouses that comply with Good Storage Practices for Drugs and Drug Raw Materials after customs clearance;

d) Regularly reporting and updating documents proving the origin and source of medicinal materials to the Traditional Medicine Management Department for publication on the Traditional Medicine Management Department's electronic information website;

đ) When detecting counterfeit medicinal materials or traditional medicine, immediately separate them and conduct an immediate traceability investigation of the origin of the medicinal materials and traditional medicine and promptly notify relevant supervisory and quality control agencies and other medicinal material and traditional medicine business establishments;

5. During the period when quality control officers for medicinal materials and traditional medicine at various levels have not been appointed, the Ministry of Health assigns:

a) The Central Institute of Pharmaceutical Inspection, the Ho Chi Minh City Institute of Pharmaceutical Inspection, according to their functions, tasks, and operational scope assigned:

- Developing plans for sampling medicinal materials and traditional medicine for quality monitoring; budgeting and accepting annual funding for sampling and testing medicinal materials and traditional medicine;

- Implementing sampling of medicinal materials and traditional medicine according to approved plans at facilities engaged in the sale and use of medicinal materials and traditional medicine;

- Establishing a database of information for the quality inspection of medicinal materials and traditional medicine of the Ministry of Health. Updating information about sampled medicinal materials and traditional medicine for quality testing and test results on the Institute's electronic information website;

- Reporting test results to the Ministry of Health (Traditional Medicine Management Department) and the provincial Department of Health where the sample was taken for medicinal materials and traditional medicine that do not meet the quality standards as stipulated in Article 10 of this Circular;

b) Provincial drug testing centers under the central cities are responsible for:

- Developing plans for sampling for quality monitoring of medicinal materials and traditional medicine; budgeting and accepting annual funding for sampling and testing medicinal materials and traditional medicine;

- Implementing sampling of medicinal materials and traditional medicine for quality testing according to approved plans at facilities engaged in the sale and use of medicinal materials and traditional medicine;

- Updating information about sampled medicinal materials and traditional medicine for quality testing and test results on the Center's electronic information website;

- Reporting test results to the Ministry of Health (Traditional Medicine Management Department) and the provincial Department of Health for medicinal materials and traditional medicine samples that do not meet the quality standards as stipulated in Article 10 of this Circular;

6. Medical examination and treatment facilities shall be responsible for:

a) Only using medicinal materials and traditional medicine with clear origins and sources as stipulated in Article 14 of this Circular and provided by medicinal material and traditional medicine business establishments that have certificates of eligibility for pharmaceutical business operations;

b) Periodically or randomly checking the quality of medicinal materials and traditional medicine in the facility according to the quality standards of the medicinal materials and traditional medicine awarded contracts. In case counterfeit medicinal materials or traditional medicine are discovered, they must be separated immediately and an immediate traceability investigation of the origin of the medicinal materials must be conducted;

7. Responsibilities of management agencies, inspection, and quality control departments in the work of preventing counterfeit medicinal materials and traditional medicine:

a) Receiving information from related organizations and individuals, announcing necessary contact addresses (direct phone numbers, emails, faxes...);

b) Communicating and disseminating to the public and businesses about the dangers of counterfeit medicinal materials and traditional medicine, signs of identification, preventive measures against purchasing counterfeit medicinal materials and traditional medicine, and methods of reporting suspected cases of counterfeit medicinal materials and traditional medicine to state management agencies;

c) Announcing publicly on the portal/electronic information website and appropriate mass media about counterfeit medicinal materials and traditional medicine detected in the market, and the results of handling such cases;

d) Conducting inspections and supervision of the market or coordinating with relevant functional agencies to promptly detect counterfeit medicinal materials and traditional medicine circulating in the market.

đ) Cooperate and support competent authorities in investigating and tracing the origin of fake traditional herbal medicines and fake traditional drugs;

e) Handle cases of violation related to the production and sale of fake traditional herbal medicines and fake traditional drugs of unknown origin, and smuggled goods according to regulations;

g) The Traditional Medicine Management Agency shall be the focal point for coordination, communication, and information exchange on fake traditional herbal medicines and fake traditional drugs with relevant international organizations (such as WHO) and drug regulatory agencies of other countries.

8. Social insurance agencies shall be responsible for:

a) Regularly updating information about the origin and source of traditional herbal medicines published on the website of the Traditional Medicine Management Agency to monitor health insurance payments;

b) Temporarily suspending health insurance payments in cases where the origin and source of traditional herbal medicines and traditional drugs cannot be verified.

  Article 24. Responsibility for Implementation

The Director of the Traditional Medicine Management Agency, the Head of the Ministry's Office, the Inspector General of the Ministry, the Heads of units under and directly affiliated with the Ministry of Health, provincial and municipal health departments under the central government, pharmaceutical business establishments, and other relevant agencies, organizations, and individuals shall be responsible for implementing this Circular.

During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are advised to promptly reflect them to the Traditional Medicine Management Department, Ministry of Health for consideration and resolution./.