Chương 2: Trình tự, thủ tục đăng ký, thẩm xét hồ sơ và thông báo chấp nhận đăng ký sản phẩm mới

CIRCULAR

GUIDING THE ORDER OF AND PROCEDURES FOR REGISTRATION OF LIKELY UNSAFE NEW PRODUCTS UNDER THE MANAGEMENT OF THE MINISTRY OF SCIENCE AND TECHNOLOGY

THE MINISTRY OF SCIENCE AND TECHNOLOGY

Pursuant to the November 21, 2007 Law on Product and Goods Quality;
Pursuant to the Government's Decree No. 28/2008/ND-CP of March 14, 2008, defining the functions, tasks, powers and organizational structure of the Ministry of Science and Technology;
Pursuant to 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;
The Minister of Science and Technology guides the order of and procedures for registration of likely unsafe new products under the management of the Ministry of Science and Technology as follows:

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1. This Circular guides the order of and procedures for registration of likely unsafe new products under the management of the Ministry of Science and Technology under Point o. Clause 2, Article 32 of the Governments Decree No. 132/2008/ND-CP of December 31, 2008,detailing a number of articles of the Law on Product and Goods Quality, which cover the order of and procedures for registration and examination of dossiers, approval of the registration of new products, and responsibilities of related parties.

2. This Circular applies to organizations and individuals (below referred to as enterprises) that produce and import likely unsafe new products under the management of the Ministry of Science and Technology and concerned state management agencies in charge of product and goods quality within the Ministry.

3. For new products in specialized domains which are governed by separate legal documents, these legal documents apply.

Article 2. Interpretation of terms

1. In this Circular, the terms below are construed as follows:

2. Likely unsafe products or goods mean products and goods which, though under reasonable and proper transport, storage, preservation and use conditions, are likely to harm humans, animals, plants, property or the environment.

3. Likely unsafe new products (below referred to as new products) include:

a/ Products and goods used and sold for the first time in Vietnam which are likely unsafe and under the management of the Ministry of Science and Technology: or,

b/ Products and goods on the list of likely unsafe products and goods under the management of the Ministry of Science and Technology, promulgated together with the Science and Technology Minister's Circular No. 01/2009/TT-BKHCN of March 20, 2009, whose properties have been modified as a result of changes in structure, material quality or manufacturing technology.

3. Examination of new product registration dossiers means the examination of technical dossiers and documents of producing or importing enterprises to determine the completeness and validity of the registration dossiers, the scientificity and accuracy of proofs evidencing that the new products satisfy quality, safety, health and environmental requirements.

Article 3. General principles

1. Enterprises producing or importing new products for circulation on the market shall furnish scientific proofs evidencing that such products have a quality meeting their use or consumption purposes and ensuring safety for humans, animals, plants, property and the environment, and pledge to the accuracy of these proofs: and lake responsibility for the quality and safety of these products for humans, animals, plants, property and the environment.

2. The agency receiving registrations of new products from enterprises shall examine registration dossiers and report examination results to the Ministry of Science and Technology for issuing notices to approve the registration of new products and issue registration identification numbers to the enterprises.

3. In the process of examination, depending on the specific characteristics of new products, the registration-receiving agency defined in Article 9, Chapter III of this Circular may. when necessary, conduct inspection at producing enterprises' establishments (for domestically produced new products) or may request the enterprises to seek opinions of experts or request the pilot use of new products before approving the registration of these products.

4. Twelve months after being approved for registration and put into circulation on the market, new products will be regarded as ordinary products and have their quality managed under the law on product and goods quality if no complaint or feedback is filed about harm-, caused to humans, animals, plants, property or the environment.

Article 4. Conditions on producing and importing enterprises putting new products into circulation on the market

1. Having conducted researches and experiments to prove that new products have a quality meeting their use purposes and ensuring safety for humans, animals, plants, property and the environment.

2. Committing no violation of the laws on product and goods quality and intellectual property.

3. Registering new products and having such registration approved by the Ministry of Science and Technology.

Chapter II

ORDER OF AND PROCEDURES FOR REGISTRATION AND EXAMINATION OF DOSSIERS AND NOTIFICATION OF APPROVAL OF REGISTRATION OF NEW PRODUCTS

Article 5. Dossiers of registration of new products

1. Producing or importing enterprises shall compile registration dossiers and send them to the registration-receiving agency defined in Article 9, Chapter III of this Circular. Such a dossier comprises:

a/ A written registration, made according to the form provided in Appendix I to this Circular (not printed herein).

b/ Technical documents of new products:

- Commercial names of the products: their codes, models and types: goods labels;

- Explanations about new products, enclosed with technical documents (properties, materials, specific components or formulas of the products, design drawings, production technologies, experiment methods, and process of inspecting operation properties, etc.);

- Announced standards applicable to new products, enclosed with their expressions (on goods labels: goods packings: or documents attached to products or goods):

- Instructions on installation, operation, use, transport and preservation:

- Warnings that products and goods are likely to become unsafe, and precautions:

- Reports on results of experiment and assessment conducted by a capable foreign conformity-assessment organization designated by a competent Vietnamese agency or of a lawfully registered domestic conformity-assessment organization, regarding quality, safety, health and environmental indicators of new products.

c/ Explanations about the plan to control product quality during production process (for enterprises producing new products).

e/ A written commitment to refrain from infringing upon intellectual property rights to marks, industrial designs or inventions or utility solutions;

f/ Other relevant technical documents (if any). 2. For imported new products for which registrations have been granted by the exporting country's competent management agency, enterprises shall submit certified copies of the registration approval notices, enclosed with the written registrations made according to the form provided in Appendix I to this Circular (not primed herein).

Article 6. Examination of registration dossiers

1. After receiving a complete and valid dossier of registration of new products from a producing or importing enterprise, the registration-receiving agency shall examine this dossier within 20 working days, depending on each type of product.

When a new product has complicated properties, requiring a longer time for dossier examination than 20 working days, the registration-receiving agency shall notify such to the enterprise, clearly stating the reason in writing.

2. The registration-receiving agency shall report dossier examination results, enclosed with its recommendations, to the Ministry of Science and Technology.

Article 7. Notification of approval of registrations

Based on dossier examination reports and recommendations of the registration-receiving agency, if the dossiers satisfy the prescribed requirements, the Ministry of Science and Technology shall notify in writing its approval of the registration of new products and issue product registration identification numbers to enterprises, made according to the form provided in Appendix II to this Circular (not printed herein). If rejecting registration, the Ministry of Science and Technology shall clearly state the reason in writing.

Chapter III

RESPONSIBILITIES OF ENTERPRISES AND MANAGEMENT AGENCIES

Article 8. Responsibilities of enterprises

Enterprises having their new products approved for registration shall:

1. Observe legal provisions on production and trading of new products.

2. Take responsibility for the quality and safety of new products in the process of their production, import and circulation on the market.

3. Pay compensation under the law on product and goods quality for new products already approved for registration if, though being used in a reasonable and proper manner, these products are still likely to harm humans, animals, plants, property or the environment.

4. Print the issued registration identification numbers on goods labels within the time limit indicated in the registration approval papers.

5. Publicize the production or import of new products on their websites (if any) and relevant documents.

6. When receiving feedback on harms caused to humans, animals, plants, property or the environment as a result of the use of new products, immediately stop the supply of these products; study and apply appropriate solutions and report thereon to the Ministry of Science and Technology.

7. Submit to competent state agencies' examination and inspection of the production and trading of new products. Any violations shall, depending on their nature and severity, be handled under law.

Article 9. Agency receiving registrations of new products

The Directorate for Standards and Quality shall act as the focal point in receiving, processing and examining dossiers of registration of new products under management of the Ministry of Science and Technology.

Article 10. Responsibilities of the agency receiving registrations of new products

1. To organize the implementation of this Circular.

2. To supervise and sum up the situation of registered new products and biannually report thereon to the Ministry of Science and Technology.

3. To publicize on their websites lists of new products already approved for registration.

4. To conduct examination and inspection and propose measures to handle violations committed by enterprises producing or importing new products under this Circular and current relevant regulations.

Chapter IV

ORGANIZATION OF IMPLEMENTATION

Article 11. Effect

This Circular takes effect 45 days from the date of its signing.

Article 12. Organization of implementation

Any problems arising in the course of implementation should be promptly reported to the Ministry of Science and Technology for consideration and settlement.-

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