This Circular stipulates the procedures for announcing conformity assessment and confirming declarations of compliance for tobacco products and related items. Organizations and individuals must conduct regular inspections and tests to ensure product compliance.
Đối tượng áp dụng
This applies to organizations and individuals producing, importing, and trading in tobacco products and related items in Vietnam.
Các điểm cốt lõi
- Organizations and individuals must announce conformity assessment or confirm declarations of compliance for tobacco products and related items.
- The re-registration period for the declaration is once every three years.
- Requirement to conduct regular inspections and tests to ensure product compliance.
- The Food Safety Administration is responsible for receiving and confirming announcements of conformity assessment or declarations of compliance.
- Regulations on the application form for reissuing the Conformity Assessment Notification Receipt or Declaration of Compliance Confirmation Certificate.
🌐 Tác động xã hội từ văn bản này
- Ensuring the quality and safety of tobacco products and related items.
- Strengthening state management over the production, importation, and trading of tobacco products.
❓ Câu hỏi thường gặp
What is the re-registration period for the announcement of conformity assessment or declaration of compliance?
Organizations and individuals must re-register the announcement of conformity assessment or declaration of compliance every three years.
Who is responsible for receiving and confirming announcements of conformity assessment or declarations of compliance?
The Food Safety Administration is responsible for receiving and confirming announcements of conformity assessment or declarations of compliance.
If the product no longer meets technical standards, what actions should be taken?
Organizations and individuals need to immediately notify the regulatory authority and initiate product recall procedures.
Toàn văn
CIRCULAR
REGULATIONS ON COMPLIANCE DECLARATION AND CONFORMITY DECLARATION FOR TOBACCO PRODUCTS
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Pursuant to the Law on Prevention and Control of Harmful Effects of Tobacco Pursuant to Decree No. 87
Pursuant to the Law on Product Quality and Commodities dated November 21, 2007 and Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions of the Law on Product Quality and Commodities; Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006 and Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing implementation of certain provisions of the Law on Standards and Technical Regulations; Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Health;
The Minister of Health issues this Circular regulating compliance declaration and conformity declaration for tobacco products;This Circular regulates procedures and documents for compliance declaration and conformity declaration for tobacco products; responsibilities of the agency receiving registration of declarations (hereinafter referred to as the registration agency) and organizations and individuals declaring products (hereinafter referred to as organizations and individuals); post-declaration product inspection.Conformity assessment of tobacco products is the determination that tobacco products meet technical characteristics and management requirements specified in national technical standards for cigarette (hereinafter referred to as national technical standards) or Vietnamese regulations in cases where such products do not have national technical standards, or meet international regulations in cases where Vietnam has no regulations. Detailed information about tobacco products
is a technical specification document about tobacco products (with common name, brand, quality standard) declared by organizations and individuals in accordance with national technical standards or Vietnamese regulations in cases where such products do not have national technical standards, or in accordance with international regulations in cases where Vietnam has no regulations.Article 3. Contents of conformity assessment of tobacco products
At the proposal of the Director of the Food Safety Administration;
1. In cases where there are corresponding national technical standards: Conformity assessment of tobacco products with such standards (hereinafter referred to as compliance assessment) shall be conducted according to the contents of compliance assessment prescribed in the corresponding national technical standards. consistent 2. In cases where there are no corresponding national technical standards: Conformity assessment of tobacco products (hereinafter referred to as conformity assessment) shall be based on the following requirements: a) Vietnamese regulations or international regulations in cases where Vietnam does not have such regulations;
PART I
GENERAL PROVISIONS
b) Labeling and health warning printing on tobacco packaging shall comply with the provisions of Joint Circular No. 05/2013/TTLT-BYT-BCT dated February 8, 2013 of the Ministers of Health and Industry and Trade guiding labeling and health warning printing on tobacco packaging;
Article 2. Interpretation of Terms
In this Circular, the following terms are understood as follows:
1. c) Record-keeping system and production process control system. PROCEDURES AND DOCUMENTS FOR COMPLIANCE DECLARATION AND CONFORMITY DECLARATION FOR TOBACCO PRODUCTS
2. Article 4. Documents and Procedures for Compliance Declaration Based on Third-Party Certification Results 1. Documents for Compliance Declaration
a) Compliance Declaration Form, implemented in accordance with Model No. 01 issued together with this Circular;
c) Third-party certification certificate of conformity accompanied by testing results (original or certified copy or photocopy with original for comparison);
d) Business Registration Certificate.
2. Procedures for Compliance Declaration
a) Step 1: Compliance Assessment
FILES AND PROCEDURES FOR ANNOUNCING COMPLIANCE WITH REGULATIONS AND ANNOUNCEMENT OF COMPLIANCE WITH REGULATIONS FOR TOBACCO PRODUCTS
Article 4. Files and procedures for announcing compliance based on the results of compliance certification by designated third-party certification organizations
1. Files for announcing compliance
a) The announcement of compliance, implemented according to Model No. 01 issued together with this Circular;
b) Detailed information about tobacco products along with label design containing all mandatory labeling contents, implemented according to Model No. 02 issued together with this Circular;
c) Third-party conformity certification certificate along with testing results (original or certified copy or photocopy accompanied by the original for comparison);
d) Business registration certificate.
2. Procedures for announcing compliance
a) Step 1: Compliance evaluation
Article 5. Documents and procedures for announcing compliance based on self-assessment results of organizations and individuals producing and trading tobacco products (the first party)
1. Files for announcing compliance
a) The announcement of compliance, implemented according to Model No. 01 issued together with this Circular;
b) Detailed information about tobacco products along with label design containing all mandatory labeling contents, implemented according to Model No. 02 issued together with this Circular;
c) The testing results of tobacco within a 12-month period from the designated or recognized laboratory, including all indicators required by national technical regulations (original or certified copy or apostilled copy or photocopy with the original attached for comparison);
d) A regular monitoring plan, implemented according to Model No. 03 issued together with this Circular;
đ) A compliance assessment report, implemented according to Model No. 04 issued together with this Circular;
e) Business registration certificate.
2. Procedures for announcing compliance
a) Step 1: Compliance evaluation
Article 6. Documents and procedures for announcing compliance
1. Documents for announcing compliance The documents for announcing compliance include:
a) The announcement of compliance, implemented according to Model No. 05 issued together with this Circular;
b) Detailed information about tobacco products along with label design containing all mandatory labeling contents, implemented according to Model No. 02 issued together with this Circular;
c) The testing results of tobacco within a 12-month period from the designated or recognized laboratory, including all indicators required by Vietnamese regulations or international regulations if Vietnam has not established such regulations (original or certified copy or apostilled copy or photocopy with the original attached for comparison);
d) A regular monitoring plan, implemented according to Model No. 03 issued together with this Circular;
đ) Business registration certificate.
2. Procedures for announcing compliance
a) Step 1: Compliance evaluation
Article 7. Authority to accept registration and issue the Certificate of Receipt for Compliance Announcement and the Confirmation Certificate for Compliance Announcement
1. The Food Safety Administration under the Ministry of Health shall handle the acceptance of registration documents for compliance announcements, issue the Certificate of Receipt for Compliance Announcement (hereinafter referred to as the Receipt Certificate) and the Confirmation Certificate for Compliance Announcement (hereinafter referred to as the Confirmation Certificate) for imported tobacco products and domestically produced tobacco products.
2. Within seven working days from the date of receiving complete and valid documents, the Food Safety Administration under the Ministry of Health shall be responsible for issuing the Receipt Certificate according to Model No. 06 issued together with this Circular. In case the Receipt Certificate is not issued, the Food Safety Administration under the Ministry of Health must provide a written response stating the reasons.
4. Within sixty working days from the date of receiving the notification letter explaining the reasons for not issuing the Receipt Certificate or the Confirmation Certificate from the registration authority, if the organization or individual announcing the product does not supplement or complete the documents as requested, the registration authority will cancel the announcement documents.
Article 8. Reissuing the Receipt Certificate or Confirmation Certificate
1. In cases where there is no change or changes in production processes that do not affect product quality indicators and do not violate safety limits compared to the announcement, organizations and individuals producing and trading tobacco products must periodically re-register the compliance announcement or compliance announcement:
a) Every five years for production facilities with quality management system certification;
b) Every three years for production facilities without quality management system certification.
2. The re-registration of the compliance announcement or compliance announcement shall be carried out at the Food Safety Administration under the Ministry of Health.
3. Documents for requesting reissue of the Receipt Certificate and Confirmation Certificate include:
a) Application for reissuing the Receipt Certificate or Confirmation Certificate according to Model No. 08 issued together with this Circular (with confirmation from the organization or individual);
b) The latest Receipt Certificate or Confirmation Certificate (certified copy);
c) Regular testing results of tobacco from the designated or recognized laboratory (original or certified copy or apostilled copy or photocopy with the original attached for comparison).
4. Within seven working days from the date of receiving complete application documents, the Food Safety Administration under the Ministry of Health shall be responsible for reissuing the Receipt Certificate according to Model No. 09 issued together with this Circular or the Confirmation Certificate according to Model No. 10 issued together with this Circular. If it is not reissued, a written response must be provided stating the reasons.
5. When any changes during production or processing affect quality indicators and violate safety limits compared to the announcement, organizations and individuals producing and trading tobacco products must reannounce compliance or compliance according to Articles 4, 5, and 6 of this Circular.
Documents for announcing compliance include:
Organizations and individuals conduct compliance assessments through conformity assessment bodies designated by the Ministry of Health.
Organizations and individuals announcing compliance prepare documents according to Clause 1 of this Article and submit them online to the registration authority as stipulated in Article 7 of this Circular.
Organizations and individuals access the Food Safety Administration under the Ministry of Health's website www.congbosanpham.vfa.gov.vn to make online announcements.
Documents for announcing compliance include:
Organizations and individuals conduct self-assessments of compliance according to the conformity assessment methods specified in technical standards.
Organizations and individuals announcing compliance prepare documents according to Clause 1 of this Article and submit them online to the registration authority as stipulated in Article 7 of this Circular.
Organizations and individuals access the Food Safety Administration under the Ministry of Health's website www.congbosanpham.vfa.gov.vn to make online announcements.
Organizations and individuals test products at designated or recognized laboratories; assess compliance based on testing results and implement the contents stipulated in Clause 2 of Article 3 of this Circular.
Organizations and individuals announcing compliance prepare documents according to Clause 1 of this Article and submit them online to the registration authority as stipulated in Article 7 of this Circular.
Organizations and individuals access the Food Safety Administration under the Ministry of Health's website www.congbosanpham.vfa.gov.vn to make online announcements.
Chapter III
RESPONSIBILITIES OF THE REGISTRATION AUTHORITY AND ORGANIZATIONS AND INDIVIDUALS ANNOUNCING PRODUCTS
The Food Safety Administration - Ministry of Health shall have the following responsibilities:
1. Organize the receipt of dossiers for declaration of conformity or compliance with regulations for tobacco products;
2. Issue, reissue, and revoke the validity of Receipt Certificates and Confirmation Certificates;
3. Within seven working days from the date of issuance of the Receipt Certificate or Confirmation Certificate, the registration authority shall publicly announce the tobacco product that has been issued the Receipt Certificate or Confirmation Certificate on the Food Safety Administration - Ministry of Health's electronic information website vfa.gov.vn;
4. Organize the management and use of fees and charges for the issuance of Receipt Certificates and Confirmation Certificates in accordance with the provisions of the law.
In addition to the responsibilities of organizations and individuals declaring conformity as stipulated in Article 16 of Circular No. 28/2012/TT-BKHCN dated December 12, 2012 of the Minister of Science and Technology regarding declaration of conformity and methods for assessing compliance with standards and technical regulations, organizations and individuals producing and trading in tobacco products must perform the following responsibilities:
1. Declare conformity or declare compliance with regulations for tobacco products in accordance with this Circular;
2. Label and print health warnings on tobacco product packaging in accordance with Joint Circular No. 05/2013/TTLT-BYT-BCT dated February 8, 2013 of the Ministers of Health and Industry and Trade guiding the labeling and printing of health warnings on tobacco product packaging;
3. In cases where only changes are made to the contents of the Detailed Information Sheet on Tobacco Products concerning label design, packaging format, packaging design, headquarters address of the organization or individual, or place of production, or name of the organization or individual (in case of change in the Business Registration Certificate), the organization or individual shall submit a notification letter detailing the changes along with a sample of the product they are responsible for to continue using the previously issued Receipt Certificate or Confirmation Certificate;
4. Pay fees and charges for the issuance, reissuance of Receipt Certificates and Confirmation Certificates in accordance with the provisions of the law.
Chapter IV
POST-PUBLICATION PRODUCT INSPECTION
The Food Safety Administration - Ministry of Health or the Provincial Food Safety Supervision Agency at the locality where the tobacco production and trading facility is located shall have the authority to organize inspections of the implementation of legal regulations and periodic testing regimes for tobacco products that have been declared.
Article 12. Periodic sampling and testing of tobacco products
2. Frequency of periodic testing:
a) Once per year for production facilities with a quality management system certification;
b) Once every six months for production facilities without a quality management system certification.
3. The criteria for periodic testing of tobacco products are the quality and safety indicators published in the Detailed Information Sheet on Tobacco Products.
4. Testing results of tobacco products conducted by inspection teams, state inspections of imported tobacco products can be used as periodic testing results if they meet the criteria specified in Clause 3 of this Article.
Chapter V
IMPLEMENTING PROVISIONS
Article 13. Effective Date
This Circular takes effect from January 25, 2016.
Article 14. Transitional Provisions
Product standard certificates issued under Decision No. 42/2005/QĐ-BYT dated December 8, 2005 of the Minister of Health on the regulation for declaring food product standards remain valid until their expiration date as indicated in the Product Standard Certificate.
Article 15. Reference Provisions
In cases where referenced documents in this Circular are amended, supplemented, or replaced, the amended, supplemented, or replaced documents shall apply.
Article 16. Implementation Organization
1. Relevant agencies, organizations, and individuals are responsible for implementing this Circular.
During the implementation process, if there are difficulties or issues, relevant agencies, organizations, and individuals should reflect them to the Ministry of Health (Food Safety Administration) for consideration and resolution./.
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Place of Receipt: |
DEPUTY MINISTER |
Form No. 01
(Issued together with Circular No. ……/2015/TT-BYT dated ... month ... year 2015 of the Minister of Health)
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SOCIALIST REPUBLIC OF VIET NAM
ANNOUNCEMENT CONFORMITY DECLARATION Number … Legal Representative of the Organization or Individual: … Address: … Telephone: …Fax: … E-mail … Goods Product: … Origin: name and address, telephone, fax, email of the manufacturer (for imported products, the country of origin must be included) ……………………………………………………………………………………………………………. Compliant with technical regulations (code, symbol, name)No. Method of conformity assessment: ……………………………………………………………………………………………………………. We hereby commit to implementing the current periodic inspection and testing regime and fully assume responsibility for the compliance of the declared product. ……………………………………………………………………………………………………………. , day …month …
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Model- Column (3) Record in the form of exporter traders: Self-mining and processing (KTCB); Processing from other sources (CB), Entrusted (UT), Trade (TM), Processing from imported sources (GC), Temporary import for re-export (TNTX), Temporary export for re-import (TXTN), others (K).
(Issued together with Circular No. ……/2015/TT-BYT dated ... month ... year 2015 of the Minister of Health)
NAME OF THE ADMINISTRATIVE AUTHORITY
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Name of organization or individual - Flavor: |
Product Name |
No.: … |
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- Taste: |
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1. Technical Requirements:
1.1 Sensory indicators:
- Weight:
- Burn rate:
- Color of strands:
1.2. Safety criteria
Name of criterion
level of declaration
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No. |
Tar content Nicotine contentu |
Unit calculation |
2. Composition (list all raw materials and additives used in tobacco production in descending order by weight). |
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1 |
3. Packaging specifications. |
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2 |
4. Processing procedure description (describe the production process diagram and processing technology, including detailed processing technologies for each component and blending technology, packaging): Included in the appendix of the Detailed Information Sheet on the product. |
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5. Measures to distinguish genuine from counterfeit (if applicable).
6. Labeling content (or currently circulating labels) must comply with legal regulations on product labeling and labeling, warning printing.
7. Origin and trader responsible for product quality:
5. Measures to distinguish genuine from counterfeit products (if any).
6. Labeling content (or labels currently in circulation) must comply with legal regulations on product labeling and labeling, warning printing.
7. Origin and trader responsible for product quality:
a) For imported cigarettes:
- Origin: name of manufacturer and country of origin.
- Name and address of the organization or individual announcing, importing, and exclusively distributing.
b) For domestic products:
- Name and address of the organization or individual announcing, producing, and exclusively distributing.
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…….., date ….. Regarding the announcement of priority products and services year ….. |
Modelnumber 03
(Issued together with Circular No. ……/2015/TT-BYT dated ... month ... year 2015 of the Minister of Health)
Purchase and sale contract number dated Month Day Year with industrial alcohol producing enterprise: ………………………………………………………………………………..
Fax: …………………………………………………………………………………………………..
PLAN FOR REGULAR SUPERVISION FREQUENCY OF INSPECTION
Product: …
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SAMPLINGm |
Test criterion |
Unit TESTING UNIT |
month ….. |
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………., date ….. year ……. number 04 |
ModelNAME OF ORGANIZATION
(Issued together with Circular No. ……/2015/TT-BYT dated ... month ... year 2015 of the Minister of Health)
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NAME OF THE ADMINISTRATIVE AUTHORITY - Column (7): Land area in land allocation decisions, lease decisions, or documents of the competent authority or actual land area managed and used (applicable to assets that are buildings and land). |
SOCIALIST REPUBLIC OF VIET NAM |
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No.: … |
…………..REPORT ON COMPLIANCE ASSESSMENT month ... of the Minister of Labor, Invalids, and Social Affairs; |
1. Date of assessment: …
2. Assessment location: …
3. Product name: …
4. Technical standard number applied: …
5. Name of product testing organization: …
6. Evaluation of test results according to the applied technical standards and the effectiveness of implementing production procedures: …
7. Other contents (if any): …
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
8. Conclusion:
£ The product complies with technical standards.
£ The product does not comply with technical standards.
Assessor
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(signature) |
NOTICE OF COMPLIANCE WITH REGULATIONS |
ModelNumber 05
(Issued together with Circular No. ……/2015/TT-BYT dated ... month ... year 2015 of the Minister of Health)
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SOCIALIST REPUBLIC OF VIET NAM
In compliance with regulations Number … Legal Representative of the Organization or Individual: … Address: … Telephone: …Fax: … E-mail … Goods Product: … Origin: name and address, telephone, fax, email of the manufacturer (for imported products, the country of origin must be included) ……………………………………………………………………………………………………………. (number number 6 Method of conformity assessment: ……………………………………………………………………………………………………………. , day …month …
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ModelFOOD SAFETY ADMINISTRATION
(Issued together with Circular No. ……/2015/TT-BYT dated ... month ... year 2015 of the Minister of Health)
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MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIET NAM |
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CERTIFICATE OF ACCEPTANCE OF COMPLIANCE NOTICE |
HanoiREPORT ON COMPLIANCE ASSESSMENT month ... REPRESENTATIVE OF THE ORGANIZATION |
The Food Safety Administration confirms receipt of the Compliance Notice for: ………
(name of the organization or individual) address … telephone, ……… Fax … Email … for the product: … produced by … (name and address of the place of production and country of origin) …produced, in compliance with technical standards (technical standard number) This notice only records the company's commitment and has no value as certification for the product's compliance with corresponding technical standards. The company must be fully responsible for the compliance of the announced product. …………………………..
Every three years, organizations or individuals must re-register the compliance notice.
- Archive.
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number 07 |
ModelNumber: ……/ATTP-XNCB
(Issued together with Circular No. ……/2015/TT-BYT dated ... month ... year 2015 of the Minister of Health)
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MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIET NAM |
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CONFIRMATION OF COMPLIANCE WITH REGULATIONS |
HanoiREPORT ON COMPLIANCE ASSESSMENT month ... REPRESENTATIVE OF THE ORGANIZATION |
………address … telephone, ……… Fax … Email … for the product: … produced by …
(name of the organization or individual) address … telephone, ……… Fax … Email … for the product: … produced by … …produced, in compliance with regulations. …produced, in compliance with technical standards Organizations or individuals are responsible for implementing regular inspection and testing regimes as prescribed and must be fully responsible for the compliance of the announced product.
Every three years, organizations or individuals must re-register the compliance notice.
OF THE AUTHORIZING BODY
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number 07 |
ModelAPPLICATION FOR RENEWAL OF CERTIFICATE OF ACCEPTANCE OF COMPLIANCE NOTICE OR CERTIFICATE OF COMPLIANCE WITH REGULATIONS
(Issued together with Circular No. ……/2015/TT-BYT dated ... month ... year 2015 of the Minister of Health)
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NAME OF THE ORGANIZATION, INDIVIDUAL |
SOCIALIST REPUBLIC OF VIET NAM |
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No.: … |
……………REPORT ON COMPLIANCE ASSESSMENT month ... REPRESENTATIVE OF THE ORGANIZATION |
To: Food Safety Administration
"Name of organization or individual" …has been issued Certificate of Acceptance of Compliance Notice or Certificate of Compliance with Regulations number …, dated ….. month ….. year ……… by the Food Safety Administration - Ministry of Health.
Now, we submit this application requesting your agency to issue a new Certificate of Acceptance of Compliance Notice or Certificate of Compliance with Regulations.
The application includes:
1. Application for renewal of Certificate of Acceptance of Compliance Notice or Certificate of Compliance with Regulations.
2. Periodic testing result form for cigarettes.
3. Previously issued Certificate of Compliance with Regulations on food safety or Certificate of Acceptance of Compliance Notice.
We hereby respectfully request your agency to issue a new Certificate of Compliance with Regulations or Certificate of Acceptance of Compliance Notice.
We commit to ensuring the compliance of cigarettes as declared.
number 09
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………, date ….. Regarding the announcement of priority products and services year ….. |
ModelNumber: .../ATTP-TNCB
(Issued together with Circular No. ……/2015/TT-BYT dated ... month ... year 2015 of the Minister of Health)
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MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIET NAM |
The Food Safety Administration confirms receipt of the Compliance Notice for: ………
First issuance: date...month...year...
Renewal:
time...: date ...month...year...The Food Safety Administration confirms receipt of the Compliance Notice for: …
address …telephone, …Fax …Email …for the product: …produced by ……… address … telephone, ……… Fax … Email … for the product: … produced by … (name and address of the place of production and country of origin) Every ... year, organizations or individuals must re-register the Compliance Notice. (technical standard number) This notice only records the company's commitment and has no value as certification for the product's compliance with corresponding technical standards. The company must be fully responsible for the compliance of the announced product. …………………………………………
Every three years, organizations or individuals must re-register the compliance notice.
number 10
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number 07 |
ModelNumber: .../ATTP-XNCB
(Issued together with Circular No. ……/2015/TT-BYT dated ... month ... year 2015 of the Minister of Health)
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MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIET NAM |
………address … telephone, ……… Fax … Email … for the product: … produced by …
The Food Safety Administration confirms compliance with regulations for: ………
Renewal:
time...: date ...month...year...The Food Safety Administration confirms receipt of the Compliance Notice for: …
Every … year, organizations or individuals must re-register the Compliance Notice. address … telephone, ……… Fax … Email … for the product: … produced by … …produced, in compliance with regulations. …produced, in compliance with technical standards Organizations or individuals are responsible for implementing regular inspection and testing regimes as prescribed and must be fully responsible for the compliance of the announced product.
Every three years, organizations or individuals must re-register the compliance notice.
Annually, organizations and individuals must re-register the announcement in accordance with the prescribed regulations.
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number 07 |
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