Circular No. 57/2018/TT-BCT detailing certain provisions of Decrees related to tobacco trade.

CIRCULAR
Detailed regulations on certain provisions of Decrees related to tobacco business
liên quan đến kinh doanh thuốc ||| RELATED TO THE SALE OF MEDICINESJune 2024;

  

Pursuant to Decree No. 98/2017/NĐ-CP dated August 18, 2017, of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Industry and Trade;

Decree No. 67/2013/ND-CP dated June 27, 2013 of the Government detailing certain provisions and measures for implementing the Law on Prevention and Control of Harmful Effects of Tobacco regarding tobacco business and Decree No. 106/2017/ND-CP dated September 14, 2017 amending and supplementing certain provisions of N |||Decree number 67/2013/ND-CP dated June 27, 2013 of the Government;

Pursuant to Decree No. 08/2018/NĐ-CP dated January 15, 2018, issued by the Government, amending certain Decrees related to investment conditions within the scope of management by the Ministry of Industry and Trade;

At the proposal of the Director of the Industry Department,

The Minister of Industry and Trade promulgates this Circular detailing certain provisions of Decrees related to tobacco business as follows:

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

2. Guidelines for reporting systems, reporting forms; list of specialized equipment for tobacco; guidelines for registration forms for importing cigarette paper, tobacco threads, tobacco leaf raw materials and regulations on inspecting activities related to tobacco business.

Article 2. Applicability

This Circular applies to organizations and individuals engaged in tobacco business and other activities related to tobacco business within the territory of Vietnam.

Article 3. Importation of tobacco raw materials, cigarette paper

1. Based on the annual tariff quota volume, production volume of enterprises, domestic supply capacity of raw materials, and enterprise registration demand for producing tobacco products for domestic consumption, the Ministry of Industry and Trade will consider approving enterprises to use tobacco raw materials and cigarette paper for specific purposes without exchange or sale in any form. Enterprises submit registration files according to Appendix No. 1 attached to this Circular.

2. Enterprises importing tobacco raw materials and cigarette paper for producing tobacco products for export or processing tobacco products for export submit registration applications according to Appendix No. 2 attached to this Circular to the Ministry of Industry and Trade.

3. Enterprises importing tobacco raw materials for exporting processed tobacco raw materials or processing tobacco raw materials for export submit registration applications according to Appendix No. 3 attached to this Circular to the Ministry of Industry and Trade.

Chapter II
APPLICATION FORMS, LISTS FOR REQUESTING ISSUANCE OF CERTIFICATES,
LICENSES AND SAMPLE CERTIFICATES, LICENSES

1. Application form for requesting issuance of Certificate of Sufficient Conditions for Investment in Tobacco Plant Cultivation according to Appendix No. 4 attached to this Circular.

2. List summarizing area under tobacco cultivation, estimated yield of tobacco leaf raw materials according to Appendix No. 5 attached to this Circular.

3. List of tobacco growers, locations, areas with confirmation from the People's Committee of the commune according to Appendix No. 6 attached to this Circular.

Application form for requesting issuance of License for Buying and Selling Tobacco Raw Materials according to Appendix No. 8 attached to this Circular.

Article 6. Application form and list for requesting a Processing Raw Tobacco Materials Permit

1. The application form for requesting a Processing Raw Tobacco Materials Permit according to Appendix 10 attached to this Circular.

2. List of specialized machinery and equipment for the processing stage of raw tobacco materials, quality inspection equipment before and after processing according to Appendix 11 attached to this Circular.

3. List of equipment: ventilation system, fire prevention and extinguishing equipment, hygrometers, thermometers, pest control tools; racks or stands for cigarette leaf packages according to Appendix 12 attached to this Circular.

Article 7. Application form and list for requesting a Tobacco Product Manufacturing Permit

1. The application form for requesting a Tobacco Product Manufacturing Permit according to Appendix 14 attached to this Circular.

2. Report on the results of production and business activities of the enterprise in the last three years (if available) and projected production volume for the next five years according to Appendix 15 attached to this Circular.

3. List of machinery and equipment for rolling cigarettes and packaging tobacco products according to Appendix 16 attached to this Circular.

4. List of investment in tobacco plant cultivation according to Appendix 17 attached to this Circular.

1. The application form for requesting a Tobacco Product Distribution Permit according to Appendix 19 attached to this Circular.

2. The application form for requesting a Wholesale Tobacco Product Sales Permit according to Appendix 21 attached to this Circular.

3. The application form for requesting a Retail Tobacco Product Sales Permit according to Appendix 23 attached to this Circular.

4. A commitment from the trader to ensure full compliance with fire prevention and extinguishing requirements and environmental protection according to Appendix 25 attached to this Circular.

Article 9. Sample Certificates and Permits

3. Sample Permit for Processing Raw Tobacco Materials according to Appendix 13 attached to this Circular.

4. Sample Permit for Manufacturing Tobacco Products according to Appendix 18 attached to this Circular.

Chapter III
APPLICATION FOR REQUESTING AMENDMENT, SUPPLEMENT, AND RENEWAL
CERTIFICATE, PERMIT AND SAMPLE OF AMENDED, SUPPLEMENTED
RENEWAL CERTIFICATE, PERMIT

1. Application form for requesting amendment, supplement for the Certificate of Eligibility for Investment in Tobacco Plant Cultivation, Permit for Trading Raw Tobacco Materials, Permit for Processing Raw Tobacco Materials, Permit for Manufacturing Tobacco Products, Permit for Trading Tobacco Products according to Appendices 26, 28, 30, 32, 42, 44, and 46 attached to this Circular.

2. Amended and supplemented certificate for the Certificate of Eligibility for Investment in Tobacco Plant Cultivation, Permit for Trading Raw Tobacco Materials, Permit for Processing Raw Tobacco Materials, Permit for Manufacturing Tobacco Products, Permit for Trading Tobacco Products according to Appendices 27, 29, 31, 33, 43, 45, and 47 attached to this Circular.

Clause 1. The application form for requesting reissue of the Certificate of Eligibility for Investment in Tobacco Plant Cultivation, the License for Buying and Selling Tobacco Raw Materials, the License for Processing Tobacco Raw Materials, the License for Producing Tobacco Products, and the License for Buying and Selling Tobacco Products that have been issued and expired according to the model in Appendix 4, 8, 10, 14, 19, 21, and 23 attached to this Circular.

Clause 2. The application form for requesting reissue of the Certificate of Eligibility for Investment in Tobacco Plant Cultivation, the License for Buying and Selling Tobacco Raw Materials, the License for Processing Tobacco Raw Materials, the License for Producing Tobacco Products, and the License for Buying and Selling Tobacco Products that have been issued and lost, destroyed entirely or partially, torn, damaged, or burned according to the model in Appendix 34, 36, 38, 40, 48, 50, and 52 attached to this Circular.

Clause 3. The certificate for reissuing the Certificate of Eligibility for Investment in Tobacco Plant Cultivation, the License for Buying and Selling Tobacco Raw Materials, the License for Processing Tobacco Raw Materials, the License for Producing Tobacco Products, and the License for Buying and Selling Tobacco Products that have been issued and lost, destroyed entirely or partially, torn, damaged, or burned according to the model in Appendix 35, 37, 39, 41, 49, 51, and 53 attached to this Circular.

Chapter IV
FORMS AND REPORTING REGULATIONS

Clause 1. Every six months, the Department of Industry and Trade shall report to the Ministry of Industry and Trade on the business operation situation and the issuance of the Certificate of Eligibility for Investment in Tobacco Plant Cultivation, the License for Buying and Selling Tobacco Raw Materials, the Wholesale License for Tobacco Products, the Retail License for Tobacco Products, and the business operation of tobacco products by traders within its jurisdiction, no later than twenty days from the end of the reporting period according to the model in Appendix 54, 56, and 57 attached to this Circular.

Clause 2. Before January 15 each year, the Department of Industry and Trade shall report to the Ministry of Industry and Trade on the investment situation in tobacco plant cultivation within its jurisdiction according to the model in Appendix 55 attached to this Circular.

Clause 3. Every six months, the Industrial Trade Office or Economic Office (specialized agency under the People's Committee of districts, counties, towns, and provincial cities hereinafter referred to as the Industrial Trade Office) shall report to the Department of Industry and Trade on the business operation situation and the issuance of the Retail License for Tobacco Products by traders within its jurisdiction, no later than ten days from the end of the reporting period according to the model in Appendix 58 attached to this Circular.

Clause 2. Every six months, tobacco product manufacturing enterprises shall submit reports to the Ministry of Industry and Trade on the importation of tobacco raw materials and cigarette paper, no later than ten days from the end of the reporting period according to the model in Appendix 60 attached to this Circular.

Clause 3. Every six months, tobacco product manufacturing enterprises must submit reports to the Ministry of Industry and Trade on the domestic buying and selling of tobacco raw materials for producing domestically consumed tobacco products and for export production, no later than ten days from the end of the reporting period according to the model in Appendix 61 attached to this Circular.

Chapter V
PROVISIONS ON INSPECTION

Article 14. Periodic Inspection

1. Based on actual circumstances and requirements for inspecting compliance with laws on tobacco business, competent state agencies shall develop annual periodic inspection plans for each organization and individual.

2. The annual periodic inspection plan must include the following main contents: Purpose and requirements of the inspection; objects and scope to be inspected; contents to be inspected; time and place of conducting the inspection; inspection budget; inspection force; assignment of responsibilities for organizing and implementing the inspection; reporting system.

3. Prior to conducting the inspection, the inspection agency must notify the inspection plan to the organizations and individuals at least 15 (fifteen) days before the inspection date.

Article 15. Surprise Inspection

The inspection agency shall conduct surprise inspections in the following cases:

2. Information from mass media with licenses issued by competent state agencies, information from complaints and reports or tips from organizations and individuals.

3. At the request of higher-level state management agencies with authority.

4. The inspection agency does not need to notify the inspection plan to the organizations and individuals in advance.

1. Inspect files for issuing Certificates of Eligibility for Investment in Tobacco Plant Cultivation, Licenses for Buying and Selling Tobacco Raw Materials, Licenses for Processing Tobacco Raw Materials, Licenses for Producing Tobacco Products, Licenses for Buying and Selling Tobacco Products as prescribed in Decree No. 67/2013/ND-CP and amended and supplemented decrees.

2. Inspect compliance with conditions: Investment in tobacco plant cultivation, buying and selling tobacco raw materials, processing tobacco raw materials, producing tobacco products, buying and selling tobacco products as prescribed in Decree No. 67/2013/ND-CP and amended and supplemented decrees.

3. Inspect compliance with regulations on investment in modernizing equipment and technology; investment in producing tobacco for export, processing tobacco for export; planning; investment in processing tobacco raw materials, foreign investment in producing tobacco products as prescribed in Decree No. 67/2013/ND-CP and amended and supplemented decrees.

4. Inspect compliance with regulations on using specialized machinery and equipment for producing tobacco, tobacco raw materials, cigarette paper, and product labels as prescribed in Decree No. 67/2013/ND-CP and amended and supplemented decrees.

Article 17. Handling Inspection Results

1. Based on the inspection results, the inspection team shall immediately prepare an inspection record according to Model Appendix 73 and 74 attached to this Circular after completing the inspection at the inspection site, and notify the inspection results to the inspection agency and the inspected organizations and individuals.

2. Based on the inspection results, depending on the level of violation, the inspection team shall recommend the inspection agency to impose penalties or proceed to transfer the violation case file of the organization or individual to the competent authority for administrative penalty in accordance with the law on administrative penalties.

Article 18. Responsibilities and Authorities of the Inspection Authority

The inspection authority for business operations has the following responsibilities and authorities:

1. To develop an inspection plan to be submitted to the competent authority for approval.

2. Decide to establish an Inspection Team to carry out inspection work according to the regular or ad hoc inspection plan.

3. To issue a decision on handling within the latest seven working days from the date of receiving the report from the Inspection Team regarding the temporary suspension of tobacco business activities.

4. To handle violations during the inspection of business activities according to relevant laws.

5. To notify organizations and individuals of the results of the inspection and related conclusions.

6. Resolve complaints and denunciations concerning decisions of the Inspection Team and actions of members of the Inspection Team in accordance with the law on complaints and denunciations.

Article 19. Responsibilities and Authorities of the Inspection Team

In the course of inspection, the Inspection Team shall have the following responsibilities and authorities:

1. To conduct inspections of tobacco business activities according to the Decision establishing the Inspection Team approved by the competent authority.

2. To comply with the law and fully implement all inspection contents stipulated in Article 18 of this Circular and other relevant laws concerning tobacco business activities.

3. To compile and report the inspection situation and results of tobacco business activities to the Provincial People's Committee and the Ministry of Industry and Trade.

4. To request organizations and individuals being inspected to present relevant files and documents when necessary.

5. To require organizations and individuals engaged in tobacco business that do not comply with legal regulations on tobacco business to take corrective measures.

Article 20. Responsibilities and Authorities of Organizations and Individuals Engaged in Tobacco Business

1. To cooperate with the Inspection Team and the inspection authority during the inspection of tobacco business activities at the inspection location.

2. To provide files and documents related to tobacco business activities as stipulated in Article 18 of this Circular.

3. To comply with inspection activities conducted by the inspection authority and the Inspection Team, and decisions on handling violations issued by the competent authority.

4. To submit reports:

a) On the situation of rectifying violations during business operations to the inspection authority;

b) On compliance with legal regulations on tobacco business activities upon request of the competent authority.

5. To maintain conditions ensuring tobacco business activities in accordance with the law.

6. To rectify deficiencies noted in the inspection record as required by the inspection authority and the Inspection Team.

7. To appeal the conclusion of the Inspection Team in accordance with the law.

Chapter VI
IMPLEMENTING PROVISIONS

Article 21. Organization of Implementation

a) To organize the acceptance of applications, inspection, supervision, evaluation, and issuance of tobacco product trading licenses according to this Circular;

b) To develop inspection plans and organize guidance and inspection of organizations and individuals implementing the provisions of Decree No. 67/2013/ND-CP and subsequent amendments and supplements, this Circular, and related laws.

a) To organize the acceptance of applications, inspection, supervision, evaluation, and issuance of certificates of eligibility for tobacco planting investment, trading licenses for tobacco raw materials, wholesale licenses for tobacco products within its jurisdiction according to this Circular;

b) To organize guidance and inspection of the Department of Industry and Trade in issuing retail licenses for tobacco products according to this Circular;

c) To develop inspection plans and organize guidance and inspection of organizations and individuals in the province in implementing the provisions of Decree No. 67/2013/ND-CP and subsequent amendments and supplements, this Circular, and related laws.

b) To develop inspection plans and organize guidance and inspection of organizations and individuals implementing the provisions of Decree No. 67/2013/ND-CP and subsequent amendments and supplements, this Circular, and related laws.

7. Responsibilities of Organizations and Individuals Engaged in Tobacco Business

a) To comply with the provisions of Decree No. 67/2013/ND-CP and subsequent amendments and supplements, this Circular, and related laws.

b) To fully and promptly fulfill reporting requirements as stipulated in this Circular.

c) If organizations and individuals engaged in tobacco business fail to fully comply with the provisions of this Circular, it will serve as grounds for competent authorities to consider granting or revoking certificates and licenses in accordance with the law.

Article 22. Effectiveness

1. This Circular takes effect from February 19, 2019, except for the provisions set out in Clause 2 of this Article.

3. The Circular No. 21/2013/TT-BCT dated September 25, 2013, detailing certain provisions of the Government Decree No. 67/2013/NĐ-CP dated June 27, 2013, on detailing certain provisions and measures to implement the Law on Prevention and Control of Harmful Effects of Tobacco concerning tobacco business shall be abolished from the date this Circular takes effect, except for the provisions set out in Clause 4 of this Article.

5. During implementation, individuals and organizations are requested to promptly reflect difficulties and obstacles to the Ministry of Industry and Trade so that the Ministry of Industry and Trade can resolve them and consider amending this Circular within its authority./.