Circular No. 03/2016/TT-BYT on the operation of herbal medicine trading activities

CIRCULAR

Provisions on the Business of Herbal Medicines

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Pursuant to the Medicine LawNo. 34/2005/QH11 June 14, 2005;

Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law and Decree No.No. 2/2002/NĐ-CP dated October 24, 2002 of the Government detailing the organization and functions of the Ministry of Health;No. 89/2012/NĐ-CP dated October 24, 2002 of the Government supplementing some articles of Decree No. 79/2006/NĐ-CP dated August 9, 2006;1Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government detailing the functions, tasks, powers, and organizational structure of the Ministry of Health;đổamending and supplementing certain articles of the Civil Servants Law and the Civil Servants Law dated November 25, 2019;, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CPm, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CP The Minister of Health issues this Circular providing for the business of herbal medicines.

This Circular provides for the business of herbal medicines including export, import, wholesale, retail, and storage services for herbal medicines.11. This Circular applies to enterprises, cooperatives, households, individuals (hereinafter referred to collectively as establishments) engaged in the business of herbal medicines and management agencies overseeing such activities in Vietnam.

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

a) Establishments engaged in the business of raw herbal medicines; raw herbal medicines not intended for medicinal purposes must be clearly stated on invoices and receipts. đb) Medical facilities that prepare and process medicines (finished medicines, traditional medicine ingredients) for their own use.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of Regulation

Raw herbal medicines (unprocessed herbal medicines)

Article 2. Applicability

are natural materials from plants, animals, minerals that can be used as medicines but have not undergone preliminary processing or manufacturing.

2. This Circular does not apply to:

Herbal medicines

are natural materials from plants, animals, minerals that meet the standards for medicines according to the Vietnamese Pharmacopoeia.

Article 3. Explanation of Terms

In this Circular, the following terms are understood as follows:

1. Toxic herbal medicines used as medicinesNo.are herbal medicines listed in the Catalogue of Toxic Herbal Medicines Used as Medicines in Vietnam as prescribed by the Minister of Health. Traditional medicine ingredients

2. are raw herbal medicines, preliminarily processed herbal medicines, or herbal medicines that have been manufactured and can be used as medicines. Preliminary processing

3. involves inspecting and sorting raw herbal medicines, removing impurities, soaking, fermenting, washing, drying, cleaning, dehydrating, cutting, or grinding into powder.iManufacturingshall is the process of changing the quality and quantity of raw herbal medicines or preliminarily processed herbal medicines into traditional medicine ingredients according to the theories and methods of traditional medicine. EXPORT, IMPORT, WHOLESALE, RETAIL

4. AND STORAGE SERVICES FOR HERBAL MEDICINES Article 4. General Conditions for Establishments Engaged in Export, Import, Wholesale, Retail, and Storage Services for Herbal Medicines

5. 1. Establishments engaged in export, import, wholesale, retail, and storage services for herbal medicines must be issued a certificate of compliance with conditions for operating pharmaceutical businesses with a scope of herbal medicine operations.policies 2. Conditions for issuing a certificate of compliance with conditions for operating pharmaceutical businesses with a scope of herbal medicine operations:

6. a) The professional manager of the establishment must hold a pharmacy practice certificate as stipulated in Article 15 of Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law, except for cases specified in Article 11 of this Circular.policiesFor power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract. At a single business location of an establishment conducting multiple types of pharmaceutical business, only one professional manager meeting the requirements set out herein is required.

Chapter II

b) Must meet corresponding conditions for each type of business as provided for in Articles 5, 6, 7, and 8 of this Circular. Article 5. Export and Import of Herbal Medicines

1. Vietnamese establishments importing herbal medicines must satisfy the following conditions:

a) Have been issued a certificate of compliance with conditions for operating pharmaceutical businesses with a scope of wholesale herbal medicines.

b) Meet the "Good Storage Practices" principles for herbal medicines as stipulated in this Circular and inspected by the Ministry of Health.

c) Establishments engaged in the business of herbal medicines that do not meet the direct import conditions must enter into a consignment import contract with an establishment that meets the import conditions as prescribed and the name of the consignee importer must be reflected on the import order.

2. In addition to the conditions stipulated in Clause 1 of this Article, when registering customs declarations, establishments importing herbal medicines must present the original and submit copies stamped by the enterprise to the customs authority for the following documents to complete customs clearance procedures:

a) Herbal medicine import permit issued by the Traditional Medicine Management Department under the Ministry of Health in accordance with this Circular.

b) Certificate of Origin (C/O) of herbal medicines issued by the authorized organization of the exporting country. If international agreements to which Vietnam is a party provide for the submission of electronic certificates of origin for imported goods, customs authorities will accept these documents.

c) From July 1, 2016, imported herbal medicines listed in the Catalogue must have a batch test report (with an English or Vietnamese translation) from the manufacturer if it meets the "Good Manufacturing Practice" (GMP) standard; for manufacturers that do not meet the GMP standard, a batch test report from the authorized agency or organization of the exporting country must be provided. Annually, the Ministry of Health publishes a list of herbal medicines that require a batch test report from the authorized agency or organization of the exporting country.

3. Vietnamese establishments exporting herbal medicines must satisfy the following conditions:

a) The conditions stipulated in Point a Clause 1 of this Article.

c) A business entity that does not have the conditions to directly import medicinal materials must conclude a consignment import contract with an entity that has the required import conditions as stipulated and the name of the consignment importer must be reflected on the import order.

2. In addition to the conditions specified in Clause 1 of this Article, when registering the customs declaration for importing medicinal materials, the importing entity must present the original and submit a copy stamped by the enterprise to the customs authority for the following documents to complete the clearance procedures for goods:

a) The Import Permit for medicinal materials issued by the Traditional Medicine Management Department under the Ministry of Health according to the provisions of this Circular.

b) The Certificate of Origin (C/O) of medicinal materials issued by the authorized organization of the exporting country. In cases where international treaties to which Vietnam is a party provide for the submission of an electronic Certificate of Origin for imported goods, the customs authority will accept such documents.

c) From July 1, 2016, imported medicinal materials listed in the Catalogue must have a Test Report for each batch of medicinal materials (accompanied by an English or Vietnamese translation) from the manufacturing entity if it meets the "Good Manufacturing Practice" (GMP) standard; for manufacturing entities that do not meet the GMP standard, a Test Report issued by the authorized agency or organization of the exporting country is required. Annually, the Ministry of Health publishes the list of medicinal materials that require a Test Report issued by the authorized agency or organization of the exporting country.

3. Vietnamese entities exporting medicinal materials must meet the following conditions:

a) The conditions specified in Point a of Clause 1 of this Article.

b) The conditions stipulated by the importing country for pharmaceutical herbs (if any).

Article 6. Conditions for wholesale drug ingredient establishments

1. Comply with the "Good Storage Practices" principles for drug ingredients as stipulated in Article 9 and the "Good Distribution Practices" principles for drug ingredients as stipulated in Article 10 of this Circular.

2. A wholesale drug ingredient establishment that has been granted a Certificate of Compliance for Drug Business Operations within the scope of wholesale drug ingredients may operate drug ingredient storage services without having to go through additional business scope procedures.

Article 7. Conditions for retail drug ingredient establishments

1. Regarding physical facilities:

a) Have a fixed location with an area suitable for the scale of business, at least 25 square meters, separate; located in a dry, well-ventilated, safe place, far from pollution sources, ensuring fire prevention and explosion protection; must have display areas and drug ingredient storage areas.²b) Equip sufficient facilities to store drugs to avoid adverse effects from light, heat, humidity, contamination, insect intrusion, including:

- Solid, smooth, easy-to-clean shelves, counters, and racks that facilitate drug display and storage.

- Thermometers, hygrometers, dehumidifiers to control temperature and humidity at retail drug ingredient establishments, lighting systems, and exhaust fans.

- Storage equipment appropriate to the storage requirements indicated on the label. Room temperature storage conditions must be maintained below 30°C, with humidity not exceeding 75%.

a) Have sufficient staff with qualifications appropriate to their assigned tasks, including at least one person with a level of qualification from a pharmacy assistant or higher.

2. Regarding personnel:

b) All staff must regularly undergo specialized training and updates on new state regulations regarding drug ingredient storage and management.

3. Retail establishments may only sell drug ingredients purchased from establishments with the necessary business qualifications; these must have clear origins and packaging labels as prescribed in Clause 1, Section B, Part II of Circular No. 04/2008/TT-BYT dated May 12, 2008 issued by the Minister of Health on labeling guidelines for drugs; they shall not sell unprocessed toxic drug ingredients as prescribed in Circular No. 33/2012/TT-BYT dated December 28, 2012 issued by the Minister of Health on the list of toxic drug ingredients used as medicine in Vietnam.

Article 8. Conditions for drug ingredient storage service establishments

Drug ingredient storage service establishments must comply with the "Good Storage Practices" principles for drug ingredients as stipulated in Article 9 of this Circular.in Article 9. "Good Storage Practices" principles for drug ingredients

1. Staff conditions for storage warehouses:

a) The warehouse manager must have a degree from a pharmacy college or higher.n lb) There must be sufficient staff with qualifications appropriate to their assigned tasks, including at least one person with a level of qualification from a pharmacy assistant or higher.

c) All staff in the warehouse must regularly undergo specialized training and updates on new state regulations regarding drug ingredient storage and management.

2. Warehouse location:

a) Must be built in a dry, safe place with drainage systems to ensure drug ingredients are protected from underground water, heavy rain, and floods.

b) Must have a specific address in a convenient location for transportation of drug ingredients.

3. Design and construction of storage warehouses:

a) The storage area for drug ingredients must be spacious enough to accommodate different types of products orderly, with a minimum total area of 300 square meters and a minimum volume of 1,000 cubic meters, until January 1, 2017, the minimum total area must be 500 square meters and a minimum volume of 1,500 cubic meters (if already inspected and confirmed to meet the "Good Storage Practices" principles, it only needs to be applied when re-inspected), including areas: receiving area; raw drug ingredient storage area; processed drug ingredient storage area; pending inspection area; pending processing area; toxic drug ingredient storage area.

b) The pending inspection area and raw drug ingredient storage area must be separated from other areas to prevent cross-contamination and dust.

c) The storage area must prevent insect, rodent, and other animal intrusions, inhibit mold and pest growth, and prevent cross-contamination.

d) The ceiling, walls, and roof of the warehouse must be designed and constructed solidly and ventilated to withstand weather impacts such as sun, rain, typhoons, and floods.²đ) The warehouse floor must be high enough, flat, smooth, strong, and properly treated to prevent underground water impact, ensuring easy movement of mechanical transport vehicles; there must be no cracks or crevices where dust accumulates or pests hide.³4. Equipment and hygiene conditions must comply with the provisions in Section 2.3; Section 3, Part 2 of the Appendix issued along with Decision No. 2701/2001/QĐ-BYT dated June 29, 2001 issued by the Minister of Health on implementing the "Good Storage Practices" principles.²5. Storage procedures and documentation:³ General storage procedures and documentation guidelines must be implemented according to the instructions in Section 4, Section 7, Part II of the "Good Storage Practices" principles issued along with Decision No. 2701/2001/QĐ-BYT dated June 29, 2001 issued by the Minister of Health on implementing the "Good Storage Practices" principles.

6. Authority to inspect the "Good Storage Practices" principles for drug ingredients:

a) The Ministry of Health will organize inspections of the "Good Storage Practices" principles for drug ingredients for warehouses of establishments engaged in import activities and those providing drug ingredient storage services.

b) Provincial Health Departments will organize inspections of the "Good Storage Practices" principles for drug ingredients for warehouses of other drug ingredient business establishments, except in cases specified in Point a of this Clause.

đ) The warehouse floor must be sufficiently high, flat, smooth, solid, and properly treated to avoid the influence of underground water, ensuring easy movement of mechanical transportation equipment; there should be no cracks or fissures that can accumulate dust or serve as hiding places for pests and insects.

4. Equipment and hygiene conditions must comply with the provisions set out in Section 2.3; Section 3, Part 2 of the Appendix issued together with Decision No. 2701/2001/QĐ-BYT dated June 29, 2001 of the Minister of Health on implementing the principle of "Good Storage Practices for Drugs".

5. Storage procedures and documentation records:

General storage procedures and documentation guidance must be carried out in accordance with the guidelines provided in Section 4, Section 7, Part II of the principle of "Good Storage Practices for Drugs" issued together with Decision No. 2701/2001/QĐ-BYT dated June 29, 2001 of the Minister of Health on implementing the principle of "Good Storage Practices for Drugs".

6. Authority to inspect the principle of "Good Storage Practices for Drugs" for medicinal materials:

a) The Ministry of Health shall organize inspections of the principle of "Good Storage Practices for Drugs" for medicinal materials for warehouses storing medicinal materials of entities engaged in import activities and entities providing medicinal material storage services.

b) The People's Committee of Health shall organize inspections of the principle of "Good Storage Practices for Drugs" for medicinal materials for warehouses storing medicinal materials of other medicinal material trading entities, except in the case specified in Point a of this Clause.

Article 10. Good Distribution Practice Principles for Medicinal Materials

The Good Distribution Practice principles for medicinal materials shall be applied according to the Good Distribution Practice principles stipulated in Circular No. 48/2011/TT-BYT dated December 21, 2011, issued by the Minister of Health on Good Distribution Practice; however, the provisions regarding the storage of medicinal materials shall be implemented in accordance with the provisions set forth in Clauses 2, 3, and 4 of Article 9 of this Circular.

Article 11. Trading in Medicinal Materials in Village Crafts, Traditional Villages, and Traditional Medicine Streets

1. The forms of export, import, wholesale trade, and service of medicinal material preservation in village crafts, traditional villages, and traditional medicine streets must comply with the relevant trading regulations stipulated in Articles 4, 5, 6, and 8 of this Circular.

2. The form of retail trade in medicinal materials in village crafts, traditional villages, and traditional medicine streets must comply with the provisions set forth in Article 7 of this Circular; specifically, the person responsible for professional matters or the owner of the retail establishment in village crafts, traditional villages, and traditional medicine streets must hold a degree as prescribed in Point c Clause 3 Article 15 of Decree No. 79/2006/NĐ-CP or a certificate or training certificate in pharmacy or traditional medicine issued by an institution authorized to provide such training.

Chapter III

CONDITIONS FOR PROCESSING MEDICINAL MATERIALS

Article 12. Conditions for Processing Medicinal Materials

1. Enterprises that have the necessary conditions to operate pharmaceuticals within the scope of medicinal materials and engage in processing medicinal materials must meet the conditions stipulated in this Chapter.

At least thirty days before commencing operations in the business of processing medicinal materials, enterprises that have the necessary conditions to operate pharmaceuticals within the scope of medicinal materials and engage in processing medicinal materials must submit a notification document regarding their qualification to process medicinal materials in the format prescribed in Appendix No. 07 attached to this Circular to the Department of Traditional Medicine Management under the Ministry of Health for inspection in accordance with the regulations.

2. The Ministry of Health shall organize inspections of enterprises qualified to process medicinal materials every three years and conduct spot checks when necessary.

Article 13. Human Resources Conditions

1. The professional manager of medicinal material processing must have a bachelor's degree in pharmacy or higher and a valid pharmacy practice certificate as prescribed by law.

2. Personnel directly involved in the processing of medicinal materials must have a level of education from a pharmacy assistant or higher and must regularly undergo training and updates on specialized knowledge related to medicinal material processing.

Article 14. Infrastructure Conditions

1. Factories and equipment must be designed, constructed, repaired, and maintained in accordance with the production processes and scale of the enterprise, specifically as follows:

a) The area for storing incoming medicinal materials must meet the conditions stipulated in Clauses 2 and 3 of Article 9 of this Circular.

b) Production and processing areas:

Depending on the production scale, the production areas for medicinal materials must be arranged to facilitate the movement of raw materials during production, including two areas: preliminary processing area and complex processing area.

The preliminary processing area for medicinal materials includes several sections: removing impurities; washing, cutting, drying; with an area of ≥ 9 m² and volume of ≥ 27 m³.² and capacity ≥ 27 m³.

The complex area for processing medicinal materials, including areas for roasting, soaking, and fermenting, must have an area ≥ 9 m² and capacity ≥ 27 m³.

The complex processing area for medicinal materials includes several sections: stir-frying, soaking, fermenting; with an area of ≥ 9 m².

c) Quality Control Area:

The production area must be spacious, well-ventilated, easy to clean, ensuring safe production and convenient operation, equipped with a clean water supply system for medicinal material production.

2. Auxiliary systems:

5. Auxiliary Systems:

The facility must install separate air handling or air conditioning systems for each area.

The establishment must install separate air handling or air conditioning systems for each area.

Depending on the requirements of different processing methods for medicinal materials, the water used for production purposes must at least meet national technical standards for potable water.

Depending on the requirements of different processing methods for medicinal materials, the water used for processing purposes must at least meet national technical standards for potable water.

The facility must have appropriate measures to treat wastewater, exhaust gases, and solid waste generated during processing, ensuring safety and hygiene.

The establishment must have appropriate measures to treat wastewater, exhaust gas, and solid waste generated during processing, ensuring safety and hygiene.

d) Fire Prevention and Extinguishing System:

Article 15. Equipment Requirements

1. The facility must have sufficient equipment necessary for processing medicinal materials. These devices must ensure safety during operation, be easy to clean and maintain, prevent cross-contamination, dust accumulation, and dirt, and avoid adverse effects that may impact product quality. The facility must establish and comply with all operational and cleaning guidelines for equipment.

2. The quality control area must be equipped with appropriate machines, devices, and tools for sampling, analysis, calibration, and data processing. Analytical equipment must be suitable for testing methods and meet the quality control requirements of the unit.

Article 16. Quality During Processing tại các) Medicinal materials used in the processing must be inspected and meet quality standards as specified in Circular No. 09/2010/TT-BYT dated April 28, 2010, issued by the Minister of Health on guiding the management of drug quality. The facility must establish records to monitor the quality status of medicinal materials upon receipt, dispatch, and inventory.

Article 17. Processing Steps

1. Weighing and Distribution:

Before conducting weighing and distribution of medicinal materials, the facility must inspect environmental conditions regarding hygiene, temperature, humidity in the weighing and distribution areas, and ensure accurate weighing and distribution. Staff performing these tasks must wear work attire as prescribed by laws on labor safety and hygiene.

2. Processing:

a) The facility must arrange an appropriate number of staff wearing suitable attire for processing tasks and implement appropriate measures to supervise processing activities.

b) All equipment must be inspected before use. Scales and measuring devices must be calibrated and have accuracy appropriate for the materials being weighed and measured.

c) There must be processing procedures and diagrams for each type of medicinal material at the facility according to the processing methods stipulated by the Ministry of Health in Decision No. 3759/QĐ-BYT dated October 8, 2010, on issuing processing methods to ensure the quality of 85 traditional Chinese medicine formulas, and Decision No. 3635/QĐ-BYT dated September 16, 2014, on issuing processing methods to ensure the quality of 18 traditional Chinese medicine formulas.

3. Process Control:

a) Establish quality control procedures for intermediate and finished products according to the processing procedures.

b) Record all inspection results during processing and environmental monitoring.

4. Labeling and Packaging:

a) A separate area for packaging and labeling activities must be established, mechanically separated to prevent confusion between products and packaging materials.

b) Samples of labels and packaging materials must be kept in batch records.

Article 18. Finished Product Storage

Finished products (processed medicinal materials) must be stored in a finished product warehouse meeting the conditions specified in Clause 2 and Clause 3 of Article 9 of this Circular. The minimum total area for finished product storage is 200 square meters, and the volume is 600 cubic meters.

Article 19. Sanitation and Hygiene Conditions²The facility must implement principles ensuring factory sanitation and personal hygiene throughout the processing of medicinal materials, including factory sanitation, personal hygiene, machine and equipment sanitation, raw material packaging, and packaging material sanitation. Implement sanitation and hygiene conditions as required by Article 6 of Circular No. 16/2011/TT-BYT dated April 19, 2011, issued by the Minister of Health on production principles for drugs from medicinal materials and the implementation timeline for "Good Manufacturing Practice" (GMP) principles for facilities producing drugs from medicinal materials.³.

Article 19. Sanitation and Hygiene Conditions

The entity must implement principles to ensure factory sanitation and personal hygiene throughout the processing of medicinal materials, including factory cleaning, personal hygiene, machine and equipment cleaning, packaging material and container hygiene. Implement sanitation requirements and hygiene conditions as stipulated in Article 6 of Circular No. 16/2011/TT-BYT dated April 19, 2011 of the Minister of Health on the principles of producing drugs from medicinal materials and the implementation timeline for the "Good Manufacturing Practice" (GMP) standards for drug manufacturing entities using medicinal materials.

Article 20. Recordso on processing

1. The record for each batch of processing must clearly specify: the name, quantity of the product; the date of processing; batch number, lot number; the full formula of the batch/lot; standard operating procedures (SOPs) for each processing stage carried out; standard operating procedures for operation and cleaning of major equipment used; all samples and test results during processing, environmental condition test results, equipment test results before starting and during processing, packaging, and final label sample retention.

2. For each processing stage, there must be records for all raw materials and auxiliary materials used; SOPs; each batch and/or each lot of processing and distribution; equipment, including operation, cleaning, maintenance, and inspection; records for sanitation, maintenance, and environmental control work in the processing area.

3. All records must be dated and signed by the person responsible for carrying out the work and must be stored at the workplace until the expiration date of the product.

Chapter IV

AUTHORITY, RECORDS, PROCEDURES FOR ISSUING THE CERTIFICATE OF SUITABILITY TO OPERATE PHARMACEUTICAL BUSINESS

FOR DRUGS, EXPORT AND IMPORT LICENSE FOR DRUGS

Section 1

AUTHORITY, RECORDS, PROCEDURES FOR ISSUING THE CERTIFICATE OF SUITABILITY

SUITABLE CONDITIONS FOR OPERATING PHARMACEUTICAL BUSINESS FOR DRUGS

Article 21. Authority to issue, reissue, extend, and supplement the scope of business in the certificate of suitability for operating pharmaceutical business for drug trading enterprisesin trading in herbal medicines

1. The Ministry of Health shall issue, reissue, extend, and supplement the scope of business in the certificate of suitability for operating pharmaceutical business for drug trading enterprises providing herbal medicine storage services.

2. Provincial/Municipal Department of Health shall issue, reissue, extend, and supplement the scope of business in the certificate of suitability for operating pharmaceutical business for drug trading enterprises trading in herbal medicines other than those specified in Clause 1 of this Article.

Article 22. Records for issuing, reissuing, extending, and supplementing the scope of business in the certificate of suitability for operating pharmaceutical business for drug trading enterprises providing herbal medicine storage services, wholesale, and retail herbal medicine enterprisesperiodng doanh in the certificate of suitability for operating pharmaceutical business for drug trading enterprises providing herbal medicine storage services, wholesale, and retail herbal medicine enterprisesi1. The application record for issuing, reissuing, extending, and supplementing the scope of business in the Certificate of Suitability for Operating Pharmaceutical Business for drug trading enterprises providing herbal medicine storage services, wholesale, and retail herbal medicine enterprises shall be conducted according to Clause 6, Article 1 of Decree No. 89/2012/ND-CP. Specifically, the application form in the application record shall be implemented according to Appendices 01a, 01b, 01c, and 01d issued together with this Circular.

2. Technical documents in the record according to Point c, Clause 6, Article 1 of Decree No. 89/2012/ND-CP are detailed as follows:

a) For drug trading enterprises providing herbal medicine storage services:

- Layout and design diagram of the storage warehouse;

- List of storage equipment of the enterprise and objects stored in the warehouse.

b) For wholesale enterprises:

- Storage record for herbal medicines: Layout and design diagram of the storage warehouse; List of storage equipment of the enterprise and objects stored in the warehouse.

- Distribution record for herbal medicines: Organizational layout diagram of the enterprise including: distribution system organization (enterprise, branch, warehouse, agent). The diagram must clearly show the name, position, professional qualifications of key personnel of the enterprise and departments; List of transportation and distribution equipment of the enterprise. In case the transportation of herbal medicines is carried out under a contract, there must be a document introducing the legal entity, equipment, transportation, and preservation facilities of the contracting party.

- Declaration list of personnel according to the model prescribed in Appendix 02 issued together with this Circular.

c) For retail enterprises:

- Layout and design diagram of the display area and herbal medicine storage area

3. For enterprises applying for a Certificate of Suitability covering multiple business scopes including finished pharmaceutical products, other raw materials, and herbal medicines, only one set of records as stipulated in Clauses 1 and 2 of this Article is required and will be issued jointly in one Certificate of Suitability for Operating Pharmaceutical Business.

c) For retail enterprises:

3. For entities applying for a Certificate of Compliance for multiple business scopes including finished drug products, other raw materials, and medicinal materials, only one set of application documents as specified in Clauses 1 and 2 of this Article is required, and a single Certificate of Compliance for Drug Business will be issued.

Article 23. Procedures for Issuing Certificates of Adequate Conditions for Medicinal Plant Preservation Services Business Operations

Clause 1. A medicinal plant preservation services business must submit one set of application files for issuance, reissuance, extension, or expansion of the scope of business operations in the Certificate of Adequate Conditions for Medicinal Plant Business Operations in accordance with Article 22 of this Circular to the Traditional Medicine Management Department under the Ministry of Health.

Clause 2. Upon receiving the application files for issuance, reissuance, supplementation, or extension of the Certificate of Adequate Conditions for Medicinal Plant Business Operations, the receiving authority shall issue a receipt for the application file according to the model specified in Appendix No. 03 issued together with this Circular.

Clause 3. In cases where the application files for issuance, reissuance, supplementation, or extension of the Certificate of Adequate Conditions for Medicinal Plant Business Operations are not valid, within ten working days from the date of receipt of the files, the receiving authority must notify the organization or individual making the application in writing to supplement and complete the files.

Clause 4. Within ten working days from the date of receipt of valid application files, the Traditional Medicine Management Department under the Ministry of Health must establish an inspection team to review the application files and inspect the conditions at the medicinal plant preservation service provider, and prepare a report on the inspection.

Clause 5. Within ten working days after the completion of the inspection report, the Director of the Traditional Medicine Management Department shall issue, reissue, extend, or supplement the Certificate of Adequate Conditions for Medicinal Plant Business Operations for the medicinal plant preservation service provider. If the certificate is not issued, reissued, supplemented, or extended, the Traditional Medicine Management Department must provide a written response stating the reasons.

Article 24. Procedures for Issuing Certificates of Adequate Conditions for Medicinal Plant Business Operations for Wholesale and Retail foundation Medicinal Plants

Clause 1. A wholesale and retail medicinal plants business must submit one set of application files for issuance, reissuance, extension, or expansion of the scope of business operations in the Certificate of Adequate Conditions for Medicinal Plant Business Operations in accordance with Article 22 of this Circular to the Health Department of the province or centrally administered city where the business headquarters is located.

Clause 2. Upon receiving the application files for issuance, reissuance, supplementation, or extension of the Certificate of Adequate Conditions for Medicinal Plant Business Operations, the receiving authority shall issue a receipt for the application file according to the model specified in Appendix No. 03 issued together with this Circular.

Clause 3. In cases where the application files for issuance, reissuance, supplementation, or extension of the Certificate of Adequate Conditions for Medicinal Plant Business Operations are not valid, within ten working days from the date of receipt of the files, the receiving authority must notify the organization or individual making the application in writing to supplement and complete the files.

Clause 4. Within ten working days from the date of receipt of valid application files, the Health Department must establish an inspection team to review the application files and inspect the conditions at the wholesale and retail medicinal plants business, and prepare a report on the inspection.

Clause 5. Within ten working days from the date of completion of the inspection report, the Director of the Health Department shall issue, reissue, supplement, or extend the Certificate of Adequate Conditions for Medicinal Plant Business Operations for the wholesale and retail medicinal plants business. If the certificate is not issued, reissued, supplemented, or extended, the Health Department must provide a written response stating the reasons.

Section 2

LICENSE APPLICATIONS, AUTHORITY, PROCEDURES FOR ISSUING IMPORT PERMITS MEDICINAL PLANTS

Article 25. Application Files for Import Permit for Medicinal Plants

Clause 1. An import order form according to the model specified in Appendix No. 04 issued together with this Circular. For consignment imports, the name of the consignee must be indicated on the import order form.

Clause 2. Quality standards and testing methods for medicinal plants, provided by the manufacturer, or a copy of the quality standards from the pharmacopoeia.

Clause 3. For medicinal plants containing narcotic, psychotropic, or precursor substances, a stock inventory report according to the model specified in Appendix No. 05 issued together with this Circular must be submitted.

Article 26. Competence and Procedures for Issuing Import Permits for Medicinal Materials

1. The Director of the Department of Traditional Medicine Management under the Ministry of Health shall issue import permits for medicinal materials.

2. The importing entity shall submit one set of application documents in accordance with Article 25 of this Circular to the Department of Traditional Medicine Management under the Ministry of Health.

3. In cases where the application documents for importing medicinal materials are not valid, within ten working days from the date of receipt of the documents, the receiving agency must notify the entity in writing to supplement and complete the documents.

4. Within seven working days from the date of receipt of complete and valid documents, the Department of Traditional Medicine Management under the Ministry of Health shall examine and issue the import permit for medicinal materials according to the model specified in Appendix No. 06 issued together with this Circular. If the permit is not granted, the Department of Traditional Medicine Management under the Ministry of Health shall provide a written response to the enterprise and specify the reasons.

5. The import permit for medicinal materials is valid for a maximum of one year from the date of issuance.

Chapter VI

EFFECTIVE DATE

Article 27. Effective Date

1. This Circular takes effect from March 6, 2016.

2. Abolish the provisions on export and import of medicinal materials stipulated in Circular No. 47/2010/TT-BYT dated December 29, 2010 of the Minister of Health guiding the activities of exporting and importing medicines and direct contact packaging, and Circular No. 38/2013/TT-BYT dated November 15, 2013 of the Minister of Health amending and supplementing some articles of Circular No. 47/2010/TT-BYT dated December 29, 2010 of the Minister of Health guiding the activities of exporting and importing medicines and direct contact packaging.

Article 28. Transitional Provisions

1. Business entities dealing in medicinal materials that have been granted certificates of qualification for pharmaceutical business, certificates of "Good Storage Practices for Medicines" or "Good Distribution Practices for Medicines" before the effective date of this Circular shall continue their operations until the expiration date of the certificate.

2. In cases where the certificate of "Good Storage Practices for Medicines" or "Good Distribution Practices for Medicines" expires earlier than the certificate of qualification for pharmaceutical business, the re-evaluation and issuance of the certificate of qualification for pharmaceutical business shall be carried out in accordance with the guidelines of this Circular.

3. For applications for certificates of "Good Storage Practices for Medicines" submitted before the effective date of this Circular, they shall be considered and resolved in accordance with the provisions of Circular No. 45/2011/TT-BYT dated December 21, 2011 of the Minister of Health.

4. For applications for certificates of "Good Distribution Practices for Medicines" submitted before the effective date of this Circular, they shall be considered and resolved in accordance with the provisions of Circular No. 48/2011/TT-BYT dated December 21, 2011 of the Minister of Health.

Article 29. References

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 30. Responsibility for Implementation

1. The Director of the Department of Traditional Medicine Management shall be responsible for organizing the implementation, inspection, and evaluation of the implementation of this Circular nationwide.

2. The Director of the Provincial Department of Health under centrally governed cities shall be responsible for organizing the implementation, inspection, and evaluation of the implementation of this Circular at the local level.

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./.