Circular No. 48/2011/TT-BCT on quality management of group-2 products and goods

• Official number: 48/2011/TT-BCT
• Legislation Type: Circular
• Organization: The Ministry Of Industry And Trade
• Signer: Vu Huy Hoang
• Issued Date: 30/12/2011

THE MINISTRY OF INDUSTRY AND TRADE -------	THE SOCIALIST REPUBLIC OF VIETNAM Independence– Freedom – Happiness ---------------
No. 48/2011/TT-BCT	Hanoi, December 30, 2011

CIRCULAR

ON QUALITY MANAGEMENT OF GROUP-2 PRODUCTS AND GOODS UNDER THE MINISTRY OF INDUSTRY AND TRADE’S MANAGEMENT

Pursuant to the Government’s Decree No. 189/2007/ND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Industry and Trade; and Decree No. 44/2011/ND-CP of June 14, 2011, amending and supplementing Article 3 of Decree No.189/2007/ND-CP of December 27, 2007;

Pursuant to the November 21, 2007 Law on Product and Goods Quality and the Government’s Decree No. 132/2008/ND-CP of December 31, 2008, detailing a number of articles of the Law on Product and Goods Quality;

Pursuant to the June 29, 2006 Law on Standards and Technical Regulations and the Government’s Decree No. 127/2007/ND-CP of August 1, 2007, detailing a number of articles of the Law on Standards and Technical Regulations;

The Minister of Industry and Trade provides the quality management of group-2 products and goods under the Ministry of Industry and Trade’s management as follows:

Chapter I

GENERAL PROVISIONS

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This Circular provides the quality management of likely unsafe products and goods (below referred to as group-2 products and goods) under the Ministry of Industry and Trade’s management and applies to:

1. Organizations and individuals manufacturing, trading in and using group-2 products and goods managed by the Ministry of Industry and Trade.

2. State management agencies in charge of quality of group-2 products and goods under the Ministry of Industry and Trade and other related agencies and organizations.

3. Conformity assessment organizations designated or recognized by the Ministry of Industry and Trade.

Article 2. Interpretation of terms

1. Group-2 products and goods means products and goods which, under proper transportation, storage, preservation and use conditions, are still likely to cause harms to humans, animals, plants, property and the environment.

2. State examination of product and goods quality means a state agency’s consideration and re-evaluation of product and goods quality, production or service provision process which has been assessed by a conformity assessment organization or for which other quality control measures have been taken by manufacturers or traders.

3. Product and goods quality examination agency of the Ministry of Industry and Trade means a unit assigned or decentralized to perform the state management of the quality of products and goods under the Ministry of Industry and Trade’s management.

4. Imported group-2 product and goods quality examination agency means an organization designated by the Ministry of Industry and Trade under law. The list of these agencies is published on the website of the Ministry of Industry and Trade for importers to select.

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Chapter II

QUALITY MANAGEMENT OF GROUP-2 PRODUCTS AND GOODS

Section 1: QUALITY ASSURANCE CONDITIONS FOR GROUP-2 PRODUCTS AND GOODS

Article 3. Quality assurance conditions for group-2 products and goods in manufacture

1. Applying a quality control system to ensure product quality’s conformity with relevant technical regulations and labeling products before market sale under the law on goods labeling.

2. Being certified and announced for conformity with relevant technical regulations. Regulation conformity announcement complies with Section 2 of this Circular. For group-2 products and goods having a particular manufacture process, manufacturers shall apply national technical regulations on manufacture process conditions and they must be certified for regulation conformity by designated certification organizations.

3. For group-2 products and goods with likely unsafe new properties under proper transportation, storage, preservation and use conditions which have not been covered by relevant national technical regulations or likely unsafe products marketed in Vietnam for the first time, manufacturers shall prove those products’ safety to humans, animals, plants, property and the environment under the Ministry of Industry and Trade’s regulations.

4. Submitting to the examination by agencies examining the quality of products and goods in manufacture under Article 20 of this Circular.

Article 4. Quality assurance conditions for imported group-2 goods

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2. Imported group-2 goods which fail to satisfy the condition provided in Clause 1 of this Article shall, upon their importation, be assessed at the border gate of exportation or importation by an assessment organization designated by the Ministry of Industry and Trade or recognized under Article 26 of the Law on Product and Goods Quality.

3. Receiving quality examination upon importation under Article 21 of this Circular.

4. Importers of group-2 goods subject to technical regulations regarding the conditions for manufacture of such products or goods shall additionally provide certificates related to the manufacture conditions issued by a designated or recognized certification organization.

5. Importers of group-2 goods with likely unsafe new properties under proper transportation, storage, preservation and use conditions which have not been covered by relevant technical regulations or of likely unsafe goods imported into Vietnam for the first time shall prove those goods’ safety to humans, animals, plants, property and the environment under the Ministry of Industry and Trade’s regulations.

6. Quality of goods manufactured by export-processing zone enterprises for domestic sale shall be managed like imports.

Article 5. Quality assurance conditions for exported group-2 goods

Exported group-2 products and goods comply with Article 32 of the Law on Product and Goods Quality and Article 9 of the Government’s Decree No. 132/2008/ND-CP of December 31, 2008, detailing a number of articles of the Law on Product and Goods Quality.

Article 6. Quality assurance conditions for group-2 goods on market sale

1. Satisfying quality assurance conditions applicable to products and goods in manufacture or import.

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3. Submitting to the examination by agencies examining the quality of marketed products and goods under Article 23 of this Circular.

4. Group-2 products and goods subject to strict safety requirements in transportation for circulation must satisfy safety requirements in transportation and fire and explosion prevention and fighting under the law on fire and explosion prevention and fighting.

Article 7. Quality assurance conditions for group-2 goods in use

1. Observing manufacturers’ instructions and relevant national technical regulations on safety upon use, transportation, storage, preservation, repair and maintenance.

2. For group-2 goods on the list of goods subject to inspection during use, being used only after obtaining an inspection certificate granted by a designated inspection organization.

3. Submitting to the examination by agencies examining the quality of products and goods in use under Article 24 of this Circular.

Section 2: REGULATION CONFORMITY ANNOUNCEMENT AND CERTIFICATION AND DESIGNATION OF CONFORMITY ASSESSMENT ORGANIZATIONS

Article 8. Announcement of group-2 products’ and goods’ conformity with technical regulations

1. Manufacturers and traders of group-2 products and goods shall announce their products’ and goods’ conformity with relevant technical regulations.

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Article 9. Dossiers of announcement of group-2 products’ and goods’ conformity with technical regulations

A dossier of announcement of a group-2 product’s or goods’ conformity with technical regulations comprises:

1. Regulation conformity statement made according to a set form.

2. Copy of the certificate of the goods’ or product’s conformity with relevant technical regulations granted by a conformity certification organization.

3. Written general description of the product or goods.

4. Standards directly related to the product or goods (TCVN, TCCS or foreign standards) or other technical regulations.

5. Written instruction for use of the product or goods.

Article 10. Procedures for receiving and announcing regulation conformity

1. Manufacturers and traders of group-2 products and goods shall have their products and goods assessed for conformity with relevant technical regulations by conformity certification organizations designated by the Ministry of Industry and Trade.

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Regulation conformity assessment results serve as a basis for organizations or individuals to announce regulation conformity.

2. When announcing regulation conformity, manufacturers, traders and importers shall register their regulation conformity statements at provincial- level Industry and Trade Departments of the localities in which they register operation, production and business.

3. Within five (5) working days after receiving a complete dossier of announcement of technical regulation conformity of an organization or individual, the provincial-level Industry and Trade Department shall send to that organization or individual a written certification of regulation conformity announcement, made according to a set form.

Article 11. Conditions on designated testing organizations

A designated testing organization must fully satisfy the following conditions:

1. Obtaining a certificate of meeting national standard TCVN ISO/IEC 17025:2007 or international standard ISO/IEC 17025:2005.

2. Having registered testing operation with the Ministry of Science and Technology under regulations.

3. For each specialized field, having at least 2 testers with professional qualifications relevant to the testing of relevant products and goods and with working experience of 3 years or more.

4. Having sufficient technical documents, necessary standards and testing processes conformable with relevant technical regulations.

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Article 12. Conditions on designated assessment organizations

A designated assessment organization must fully meet the following conditions:

1. Having registered assessment operation under the Commercial Law, the Government’s Decree No. 20/2006/ND-CP of February 20, 2006, detailing the Commercial Law regarding commercial assessment service business, and the Trade Ministry’s Circular No. 06/2006/TT-BTM of April 11, 2006, guiding the registration of seals of commercial assessment service providers.

2. Having assessment capacity meeting national standard TCVN ISO/IEC 17020:2001 or international standard ISO/IEC 17020:1998.

3. For each specialized field, having at least 2 assessors with professional qualifications relevant to the assessment of relevant products and goods and with working experience of 3 years or more.

4. Having sufficient technical documents, necessary standards and testing processes conformable with relevant technical regulations.

5. An assessment organization possessing an accreditation certificate granted by a lawful Vietnamese accreditation organization or a lawful foreign accreditation organization being a member of the Pacific Accreditation Cooperation (PAC) and the International Accreditation Forum (IAF) may be prioritized for consideration and designation.

Article 13. Conditions on designated inspection organizations

A designated inspection organization must fully meet the following conditions:

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2. Having testing laboratories meeting national standard TCVN ISO/IEC 17025:2007 or international standard ISO/IEC 17025:2005.

3. For each specialized field, having at least 2 inspectors with professional qualifications relevant to the inspection of relevant products and goods and with working experience of 3 years or more.

4. Having sufficient technical documents, necessary standards and testing processes conformable with relevant technical regulations.

5. An inspection organization possessing an accreditation certificate granted by a lawful Vietnamese accreditation organization or a lawful foreign accreditation organization being a member of the Pacific Accreditation Cooperation (PAC) and the International Accreditation Forum (IAF) may be prioritized for consideration and designation.

Article 14. Conditions on designated certification organizations

A designated certification organization must fully meet the following conditions:

1. Having registered certification operation with the Ministry of Science and Technology under regulations.

2. Its management system and operation capacity conforming with national or international standards and international guidelines applicable to each type of operation below:

a/ National standard TCVN 7457:2004 or international standard ISO/IEC Guide 65:1996 and relevant guidelines of the International Accreditation Forum (IAF), for certification of products and goods;

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c/ Its assessment capacity meeting national standard TCVN ISO 19011:2003 or international standard ISO 19011:2002.

3. Having at least 5 evaluators on official payroll (civil servants or employees working under labor contracts of an indefinite term or a term of 12 months or more) with a tertiary or higher degree and expertise relevant to the certification of relevant products, goods, processes and environment, and working experience of 3 years or more.

4. Having sufficient technical documents, standards and testing processes conformable with relevant technical regulations.

Article 15. Order and procedures for designating conformity assessment organizations

1. A conformity assessment organization wishing to operate in quality testing, assessment, inspection or certification of group-2 products and goods in a particular field shall make and submit a registration dossier to the Science and Technology Department of the Ministry of Industry and Trade.

2. If submitting the dossier by post, the organization shall submit certified copies of the documents specified at Points b and g, Clause 3 of this Article.

3. A registration dossier comprises:

a/ Written registration for conformity assessment designation, made according to a set form;

b/ Copy of the operation registration certificate of testing, assessment, inspection or certification;

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d/ List of technical documents, standards and processes for testing, assessing, inspecting or certifying group-2 products and goods for designation registration, made according to a set form;

e/ Forms of testing result notice, assessment certificate, inspection certificate and certificate;

f/ Accreditation certificate of testing, assessment or inspection or certification granted by an accreditation organization (if any);

g/ Results of testing, assessment or inspection or certification operations in the registered field of the most recent year (if any).

4. Receipt and processing of registration dossiers:

a/ Within twenty (20) working days after receiving a complete and valid dossier, the Ministry of Industry and Trade shall consider the dossier, set up a council to assess the actual capacity of the applicant and issue a decision on designation of a conformity assessment organization, made according to a set form. The validity of this decision does not exceed 3 years.

b/ In case of refusal, the Ministry of Industry and Trade shall issue a notice of the reason for refusing the designation to the applicant.

c/ Three (3) months before its designation decision ceases its effect, a conformity assessment organization shall carry out re-registration procedures under Clause 1 of this Article.

d/ A conformity assessment organization designated by the Ministry of Industry and Trade to operate in testing, assessment or inspection shall carry out registration procedures again under Clause 1 of this Article when changing or increasing its scope or field of operation.

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QUALITY EXAMINATION OF GROUP-2 PRODUCTS AND GOODS

Article 16. Provisions on quality examination of products and goods

1. Quality examination of group-2 products and goods shall be conducted by the Ministry of Industry and Trade’s product and goods quality examination agencies.

2. Exemption from or reduction of quality examination of products and goods which have been certified and announced for regulation conformity or certified to have applied advanced management systems by international or regional standards must be approved by the Ministry of Industry and Trade.

3. Dossiers of request for exemption from or reduction of quality examination of products and goods already certified and announced for regulation conformity or certified for application of advanced management systems by international or regional standards shall be sent to the Science and Technology Department of the Ministry of Industry and Trade. A dossier comprises:

a/ Application for exemption or reduction;

b/ Business registration certificate (notarized or certified);

c/ Goods import contract (notarized);

d/ Certificate of regulation conformity and regulation conformity announcement, certificate of application of advanced management systems by international or regional standards granted by foreign authorities, enclosed with Vietnamese translations (notarized);

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Article 17. Examination grounds

1. Relevant technical regulations, regulations on goods labeling and other related laws on assurance of quality, safety, hygiene, human health and environment applicable to each type of products or goods.

2. For group-2 products and goods without applicable technical regulations, standards (TCVN, TCCS or foreign) or other technical regulations currently applied for conformity announcement until technical regulations applicable to those products and goods are promulgated.

Article 18. Methods of quality examination of group-2 products and goods in manufacture, export, market sale and use

1. Examination under annual plans approved by competent state agencies

a/ Grounds for annual planning:

- Exported products and goods which fail to meet quality assurance requirements under Articles 3, 5, 6 and 7 of this Circular;

- Information on products’ and goods’ failure to meet quality requirements in manufacture, export, market sale or use;

- Domestic, foreign, regional and international warnings about product and goods quality.

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- Products and goods to be examined;

- Place of examination;

- Time of examination;

- Funds for examination;

- Organization of examination.

2. Unexpected quality examination of products and goods

Grounds for unexpected quality examination of products and goods in production and business at the request of related functional agencies or superior authorities:

a/ Request of inspection or quality control agencies;

b/ Complaints and denunciations about product and goods quality;

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d/ Domestic, foreign, regional and international warnings about goods quality.

3. Upon having examination results, a product and goods examination agency shall publish these results on its website and notify them to the unit with examined products and goods.

Article 19. Testing samples for quality examination of group-2 products and goods

1. Goods samples shall be taken at random at manufacturers or on the market for testing at conformity assessment organizations designated by the Ministry of Industry and Trade.

2. Sampling order and procedures:

a/ An examination agency takes samples of products or goods based on standards on testing methods or technical regulations on conformity assessment;

b/ Samples are sealed with the signatures of the sample taker and representative of the establishment at which samples are taken;

c/ A sampling record is made according to a set form.

If the representative of the establishment at which samples are taken does not sign the record, the record remains legally valid with the signatures of the sample taker and the examination team head;

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Inspection and testing results of a designated conformity assessment organization serve as a basis for an examination agency’s further handling.

Article 20. Order, procedures and contents of quality examination of group-2 products and goods in manufacture

The quality examination of group-2 products and goods in manufacture shall be conducted by examination teams of group-2 product and goods quality examination agencies according to the following order, procedures and contents:

1. The examination team announces the examination decision, made according to a set form.

2. The examination team examines:

a/ The observance of requirements under relevant technical regulations on manufacture process conditions and quality control methods in manufacture;

b/ Conformity assessment results, goods labels, regulation conformity marks and documents enclosed with products to be examined;

c/ Inspection and testing results;

d/ Contents and presentation of warnings about the possibility of product or goods unsafety;

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3. An examination record is made according to a set form with the signatures of the representatives of the examined establishment and the examination team. In case the representative of the examined establishment does not sign this record, the record remains valid with the signatures of the examination team head and members.

4. The examination team makes an examination report according to a set form and its recommendations to the examination agency.

Article 21. Order, procedures and contents of quality examination of imported group-2 goods

The quality examination of imported group-2 goods shall be conducted by agencies examining the quality of imported group-2 goods according to the following order, procedures and contents:

1. The examination agency receives the importer’s quality examination registration dossier, made according to a set form. A dossier comprises:

a/ Written registration for imported goods quality examination, made according to a set form;

b/ Copies of the goods import contract and packing list;

c/ Copy(ies) of goods quality certificate (certified);

d/ Other related technical documents: Copies (certified by the importer) of the bill of lading and invoice; import declaration; certificate of origin (if any); photo or description of goods; specimens of imported goods labels stuck with regulation conformity marks and subsidiary labels (if principal labels do not contain all required information).

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3. The examination agency issues to the importer a notice, made according to a set form, of the products’ or goods’ compliance with regulations applicable to imported goods for the latter to carry out temporary customs clearance procedures. An importer that has not completed the quality examination of imported goods under this Circular may not market those goods.

4. The examination agency:

a/ Examines the conformity of the quality certificate of the imported goods lot with required technical regulations, announced applicable standards, and conformity assessment results, goods labels, regulation conformity marks and documents enclosed with the products or goods to be examined;

b/ Tests samples according to announced applicable standards or relevant technical regulations.

5. An examination record is made according to a set form.

6. When examination results show products or goods meet the requirements stated in the examination grounds, the examination agency issues to the importer a notice of quality examination of imported goods, certifying that the imported goods lot satisfies the import requirements. This notice, made according to a set form, serves as a basis for the importer to complete customs clearance procedures.

When examination results show products or goods fail to meet the requirements stated in the examination grounds, the examination agency issues to the importer a notice of quality examination of imported goods according to a set form, stating that the goods lot fails to meet the import requirements, and concurrently sends a report, made according to a set form, to the Ministry of Industry and Trade.

Article 22. Order, procedures and contents of quality examination of exported group-2 goods

The quality examination of exported goods complies with Article 10 of the Government’s Decree No. 132/2008/ND-CP of December 31, 2008, detailing a number of articles of the Law on Product and Goods Quality.

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The quality examination of group-2 products and goods on market sale shall be conducted by examination teams. The order, procedures and contents of quality examination of goods on market sale comply with market control forces’ professional processes for examination, control and handling of administrative violations provided in the Industry and Trade Ministry’s Circular No. 26/2009/TT-BCT of August 26, 2009, on market control forces’ professional processes for examination, control and handling of administrative violations.

Article 24. Order, procedures and contents of quality examination of group-2 goods in use

The quality examination of group-2 products and goods in use complies with the following order, procedures and contents:

1. The examination agency announces the examination decision made according to a set form.

2. The examination agency examines:

a/ The observance of relevant technical regulations on use conditions and measures for state management of the quality of products and goods in use;

When necessary, the examination agency may request experts or a designated conformity assessment organization to conduct assessment based on applicable technical regulations.

b/ The observance of requirements on inspection and inspection results and use manuals enclosed with goods to be examined;

c/ When finding that the requirements provided at Points a and b of this Clause are not fully observed and there are signs of failing to meet quality requirements, the examination agency considers testing of the products or goods by a designated conformity assessment organization.

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4. The examination agency reports on examination results under regulations.

Chapter IV

ORGANIZATION OF IMPLEMENTATION

Article 25. Responsibilities of management agencies of the Ministry of Industry and Trade

1. The Science and Technology Department of the Ministry of Industry and Trade shall:

a/ Advise the Ministry of Industry and Trade in performing the state management of the quality of group-2 products and goods;

b/ Advise the Ministry of Industry and Trade in designating conformity assessment organizations to test, assess, inspect and certify the quality of group-2 products and goods. Examine and supervise designated conformity assessment organizations;

c/ Assume the prime responsibility for, and coordinate with related agencies in, managing the quality of group-2 products and goods;

d/ Make annual plans on quality examination of group-2 products and goods in manufacture and export;

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f/ Urge, guide and examine the implementation of this Circular.

2. The Market Control Department shall organize and direct provincial- level Market Control Sub-Departments in examining, controlling and handling violations of regulations on the quality of group-2 products and goods on market sale under law.

3. The Industrial Safety Techniques and Environment Agency shall assume the prime responsibility for, and coordinate with related agencies in, examining the quality of group-2 products and goods in use.

Article 26. Responsibilities of provincial-level Industry and Trade Departments

Provincial-level Industry and Trade Departments shall receive regulation conformity announcement registrations and coordinate with provincial- level Science and Technology Departments in examining enterprises in their localities in observing regulations on quality management of group-2 products and goods.

Article 27. Responsibilities of designated conformity assessment organizations

1. To perform the rights and obligations under the Law on Product and Goods Quality and related laws.

Designated testing organizations shall, within the validity duration of designation decisions, participate in the proficiency testing and interlaboratory comparison program once.

2. Annually or upon request, to send reports, made according a set form, on conformity assessment operations as designated to the designating agencies for summarization.

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Article 28. Responsibilities of organizations and individuals for quality assurance of group-2 products and goods

1. To announce regulation conformity of group-2 products and goods under Article 8 of this Circular.

2. In the course of manufacture and sale of group-2 products and goods, manufacturers, exporters or importers shall promptly report to the Ministry of Industry and Trade when manufacture conditions fail to conform with announced standards or products are detected to fail to conform with technical regulations, and concurrently:

a/ Suspend the release and ex-warehousing of and recall unconformable products currently on market sale;

b/ Take measures to remedy such unconformity.

3. After remedying the unconformity, manufacturers, exporters or importers of group-2 products and goods shall report such to the Ministry of Industry and Trade before marketing those products or goods again.

4. After announcing regulation conformity, manufacturers and importers of products and goods shall constantly maintain their products’ conformity with relevant regulations and quality control, testing and regular supervision at enterprises and take full responsibility for such conformity before management agencies and consumers.

5. To assure control of manufactured products through the system of signs and codes inscribed on labels of products and goods.

6. To keep conformity announcement dossiers as a basis for state management agencies’ examination and inspection.

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Article 29. Reporting on quality examination of group-2 products and goods

Group-2 product and goods examination agencies shall submit to the Ministry of Industry and Trade reports (according to set forms) on the situation and results of quality examination of goods quarterly and biannually (before July 15) and annually (before January 20 of the subsequent year) or upon request.

Chapter V

ORGANIZATION OF IMPLEMENTATION

Article 30. Effect

This Circular takes effect on February 15, 2012.

Article 31. Implementation responsibilities

1. Group-2 product and goods quality examination agencies and related organizations and persons shall implement this Circular.

2. When standards or legal documents invoked in this Circular are revised or replaced, the revised or replacing documents prevail.

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MINISTER OF INDUSTRY AND TRADE




Vu Huy Hoang