Circular No. 560/TT-KCM guiding the implementation of Decree No. 86/CP dated December 8, 1995 of the Government on the division of responsibilities for state management of product quality.

CIRCULAR

Guidelines for Implementing Decree No. 86/CP dated December 8, 1995 of the Government on the Allocation of Responsibilities for State Management of Product Quality 

On December 8, 1995, the Government issued Decree No. 86/CP stipulating the allocation of responsibilities for state management of product quality. While the relevant ministries prepare the contents and measures to manage the quality of specific products as provided in Article 4 of the Decree, based on Clause 10 of Decree No. 86/CP, the Ministry of Science, Technology, and Environment issues this Circular to guide the allocation of responsibilities for state management regarding standardization work, quality registration, organization of testing and trial of specific products, and quality inspection of products including export and import goods. The organization of inspections and handling of violations related to product quality circulating in the market are specified in Section 8 of this Circular. Other detailed contents will be specifically guided in joint Circulars between the Ministry of Science, Technology, and Environment and the relevant specialized ministries.

1. Regarding products under the responsibility of the Ministry of Health

1.1. Pharmaceuticals and medicinal herbs:

Regulations concerning pharmaceuticals and medicinal herbs used for human treatment are organized and promulgated by the Ministry of Health in the form of the Vietnamese Pharmacopoeia according to international practice.

New pharmaceuticals and medicinal herbs used for human treatment must undergo trials, clinical evaluations, and production registration as prescribed by the Ministry of Health before being brought to market.

The importation of such pharmaceuticals and medicinal herbs must be permitted and subject to inspection as prescribed by the Ministry of Health.

1.2. Cosmetics:

The Ministry of Health publishes a list of cosmetics that directly affect human health and require quality registration, organizes the issuance of quality registration certificates for cosmetics on this list, and specifies hygiene, safety requirements, trials, tests, and designates agencies responsible for issuing quality registration certificates for cosmetics.

The two Ministries of Health and Science, Technology, and Environment designate agencies to carry out quality inspections of imported cosmetics.

1.3. Medical equipment and devices:

The Ministry of Health proposes a list and quality levels of medical equipment and devices produced domestically that require quality registration, which the Ministry of Science, Technology, and Environment will promulgate and implement. Provincial and municipal Standardization, Metrology, and Quality Control Bureaus (hereinafter referred to as TDC Bureaus) issue quality registration certificates for these products.

The two Ministries of Health and Science, Technology, and Environment designate agencies to carry out quality inspections of imported medical equipment and devices.

1.4. Food hygiene and safety, drinking water, alcohol, and tobacco:

Health authorities at provincial and municipal levels inspect and issue certificates of compliance with hygiene requirements for food production facilities, drinking water, alcohol, and tobacco according to regulations of the Ministry of Health. Provincial and municipal TDC Bureaus issue quality registration certificates for domestically produced processed foods after the production facility has obtained the aforementioned certificate.

The Ministry of Health proposes a list of imported foods requiring sanitary and safety inspections, methods, contents, and requirements for such inspections, which the Ministry of Science, Technology, and Environment will promulgate and implement.

The two Ministries of Health and Science, Technology, and Environment designate agencies to carry out sanitary and safety inspections of imported foods.

2. Regarding products under the responsibility of the Ministry of Agriculture and Rural Development

2.1. Plant seeds, animal breeds:

Management of plant seeds (excluding aquatic plant seeds) is carried out according to Decree No. 07/CP dated February 5, 1996 of the Government.

Management of animal breeds (excluding aquatic animal breeds) is carried out according to regulations of the Ministry of Agriculture and Rural Development.

2.2. Pesticides:

The Ministry of Agriculture and Rural Development proposes a list of pesticides requiring quality registration, which the Ministry of Science and Technology will promulgate and implement. Provincial and municipal TDC Bureaus issue quality registration certificates according to this list.

Testing, quality inspection, residue testing, and trials of pesticides before production are conducted according to Decision No. 150/NN-BVTV/QD dated March 10, 1995 of the Ministry of Agriculture and Food Industry, now the Ministry of Agriculture and Rural Development.

Production approval, processing, export, import, storage, transportation, use, labeling, packaging, and advertising of pesticides are carried out according to Decision No. 100/NN-BVTV/QD dated February 28, 1995 of the Ministry of Agriculture and Food Industry, now the Ministry of Agriculture and Rural Development.

All imported pesticides must undergo national quality inspections. The two Ministries of Agriculture and Rural Development and Science, Technology, and Environment designate organizations to conduct quality inspections of imported pesticides.

2.3. Veterinary drugs:

The Ministry of Agriculture and Rural Development is responsible for the quality management of veterinary drugs from production registration, export and import, to circulation on the market according to the Animal Health Ordinance dated February 15, 1993 and Decree No. 93/CP dated November 27, 1993 guiding the implementation of the Animal Health Ordinance.

2.4. Fertilizers:

Industrial fertilizers must register their quality with provincial and municipal TDC Bureaus.

Domestic fertilizers must undergo trials before quality registration, mass production, and use, following Decision No. 32/NN/QLCN/QD dated November 17, 1995 of the Ministry of Agriculture and Rural Development.

New fertilizers and microbial preparations must undergo trials like domestic fertilizers before being imported into Vietnam. Only new fertilizers confirmed through trials and approved by the Ministry of Agriculture and Rural Development can be imported into Vietnam. The two Ministries of Agriculture and Rural Development and Science, Technology, and Environment designate agencies to carry out quality inspections of imported fertilizers.

2.5. Livestock feed:

The Animal Feed Control Bureaus of provinces and cities shall issue quality registration for animal feed only according to the level of quality and the results of testing and the production permit decision of the Ministry of Agriculture and Rural Development.

3. Regarding goods under the management responsibility of the Fisheries Department

3.1. Drugs for aquatic animals:

The Fisheries Department shall stipulate the list of drugs that must be registered for quality, tested, and experimented with, and organize the inspection of the quality of domestically produced and imported veterinary drugs for aquatic animals.

3.2. Live aquatic animals and aquatic animal breeds:

The management of live aquatic animals and aquatic animal breeds concerning quarantine and quality (testing, selection, recognition, registration, and import management) shall be regulated by the Fisheries Department.

3.3. Aquatic products:

Aquatic products that have been industrially processed must register their quality at the provincial and municipal Quality Control Bureaus.

The list and quality levels of aquatic products for export and import that require quality checks shall be announced by the Ministry of Science, Technology and Environment based on the proposal of the Fisheries Department.

The two Departments of Fisheries and Science, Technology and Environment shall designate organizations to conduct quality checks on exported and imported aquatic products.

3.4. Fishing vessels:

The list and quality levels of fishing vessels that need to be managed shall be stipulated by the Fisheries Department. The provincial and municipal Quality Control Bureaus shall issue quality registration for these fishing vessels.

The two Departments of Fisheries and Science, Technology and Environment will designate agencies to carry out quality inspections on imported fishing vessels.

4. Regarding goods under the management responsibility of the Ministry of Transport

4.1. Transportation vehicles.

The Ministry of Transport shall organize the management of the quality of inland waterway transportation vehicles through inspection activities and issuance of circulation permits.

4.2. Infrastructure transport works.

The Ministry of Transport shall organize the management of infrastructure transport works in accordance with Decree No. 177/CP dated October 20, 1994 on the promulgation of the Investment Management Regulations and Construction and other government regulations.

4.3. Lifting equipment weighing one ton or more, boilers, and pressure vessels used in transportation:

The Ministry of Transport shall organize the management of the quality of such equipment through safety inspection activities and issuance of usage permits.

5. Regarding goods under the management responsibility of the Ministry of Construction

The Ministry of Construction shall organize the management of construction project quality according to Decree No. 177/CP dated October 20, 1994 on the promulgation of the Investment Management Regulations and Decision No. 20/BXD-GD dated June 10, 1995 of the Ministry of Construction on the promulgation of the Construction Project Quality Management Regulations.

6. Regarding goods under the management responsibility of the Ministry of Culture and Information

The task of managing the quality of goods for publications, musical instruments, and other cultural products is a new responsibility assigned to the Ministry of Culture and Information, which has officially proposed to gradually establish goals, plans, and measures for quality management in the future.

7. Regarding goods under the management responsibility of the Ministry of Industry

The Ministry of Industry shall stipulate the list of industrial explosives that must be tested before production permission is granted, organizing the testing of industrial explosives (specifying requirements regarding procedures, processes, contents of testing, and designating testing organizations).

The two Ministries of Industry and Science, Technology and Environment shall designate organizations to conduct quality checks on imported industrial explosives.

8. Regarding the management of goods quality circulating in the market

The Ministry of Commerce shall lead efforts to combat counterfeit and low-quality goods circulating in the market and business practices violating quality management rules; notify relevant cases involving special goods mentioned below to specialized inspection agencies of related ministries for coordination in inspection, organization of testing, and determination of penalties according to current laws.

For special goods mentioned in Article 4 of Decree No. 86/CP, specialized inspection agencies of ministries directly responsible shall organize inspections, controls, and handling of violations concerning the quality of goods circulating in the market, specifically:

- For pharmaceuticals, medicinal herbs for human treatment, cosmetics directly affecting human health, food safety and hygiene of fresh, handcrafted, and industrially processed foods, various types of drinking water, alcohol, tobacco: specialized inspection agency of the Ministry of Health.

- For plant and animal seeds (excluding aquatic animals), fertilizers, veterinary drugs, plant protection chemicals, animal feed, animal health hygiene (excluding aquatic animals): specialized inspection agency of the Ministry of Agriculture and Rural Development.

- For the quality and animal health hygiene of aquatic products: specialized inspection agency of the Fisheries Department.

In the future, after the Ministries of Health, Agriculture and Rural Development, and Fisheries announce specific lists of goods requiring management and the content of management according to their assigned responsibilities, the Ministry of Science, Technology and Environment will work with the Ministry of Commerce and other ministries to allocate the management of goods quality circulating in the market for overlapping objects.

9. Responsibilities of the Ministry of Science, Technology and Environment

9.1. Standardization Work

The Ministry of Science, Technology and Environment shall authorize the General Bureau of Standards, Metrology and Quality to issue decisions establishing Technical Committees after consulting relevant ministries and agencies, providing guidance on organization, operation, and creating conditions for technical committees in standard compilation.

The General Bureau of Standards-Metrology-Quality shall compile plans for building Vietnamese standards according to quality management requirements and proposals from ministries and sectors; specify procedures for drafting and reviewing projects to build Vietnamese standards, submit them to the Minister of Science, Technology and Environment for approval and issuance of Vietnamese standards.

The relevant ministries shall prescribe the mandatory application of Vietnamese Standards to objects under their jurisdiction. Decisions on the mandatory application of Vietnamese Standards shall be concurrently sent to the Ministry of Science, Technology, and Environment. The General Bureau of Standards-Measurement-Quality Control is responsible for compiling a list of mandatory Vietnamese Standards, notifying quality registration agencies, quality inspection agencies, and providing it to sectors, localities, agencies, and organizations that request it.

9.2. Quality Registration of Goods.

The Ministry of Science, Technology, and Environment shall compile a list of goods that must undergo quality registration, proposed by relevant ministries, together with goods directly managed by the Ministry of Science, Technology, and Environment according to Article 6 of Decree No. 86/CP, and publish them collectively in September each year to take effect from January 1 of the following year.

The General Bureau of Standards-Measurement-Quality Control shall compile a list of goods that must undergo quality registration announced by ministries, a list of designated agencies authorized to issue quality registrations, and a list of organizations designated to conduct testing and clinical trials, to provide these lists to agencies that require them.

For the time being, while relevant ministries prepare proposals for lists of goods that must undergo quality registration to be implemented from January 1, 1997, quality registration of goods will continue to be carried out according to the list of goods required to undergo quality registration issued with Decision No. 119/QD dated February 24, 1992, of the State Science Council, now the Ministry of Science, Technology, and Environment, and the Regulations on Quality Registration of Goods issued pursuant to Decision No. 55/TDC-QD dated March 2, 1994, of the General Bureau of Standards-Measurement-Quality Control.

Provincial and municipal Standard-Measurement-Quality Control Bureaus shall issue quality registrations for goods listed by the Ministry of Science, Technology, and Environment.

9.3. Quality Inspection.

The Ministry of Science, Technology, and Environment shall compile a list of goods subject to state quality inspection, the basis for inspection, and the inspecting agency for imported and exported goods, and domestically produced goods that must undergo state quality inspection, based on proposals from relevant ministries, and publish them collectively in September each year to take effect from January 1 of the following year.

The Ministry of Science, Technology, and Environment shall notify the list of goods to the General Customs Department and related ministries for coordinated management of quality. Enterprises engaged in import-export and domestic production of goods shall organize their business activities in accordance with the law based on these provisions. Export and import consignments of goods listed for state quality inspection may only be processed for clearance by customs when they have a certificate confirming compliance with the prescribed standards issued by a designated quality inspection agency. In cases where customs at the port suspects and discovers that the quality of the consignment does not comply with the prescribed standards or the certificate issued, customs shall report this to the competent quality management authority of the Ministry of Science, Technology, and Environment, the relevant specialized ministry, and the General Customs Department for joint handling.

For the time being, while relevant ministries prepare proposals for lists of goods that must undergo state quality inspection to be implemented from January 1, 1997, quality inspection of imported and exported goods will continue to be carried out according to the list of imported and exported goods required to undergo state quality inspection issued with Decision No. 514/QD dated September 27, 1993, of the Ministry of Science, Technology, and Environment, and the Regulations on State Quality Inspection of Imported and Exported Goods issued pursuant to Decision No. 397/QD dated June 10, 1992, of the State Science Council, now the Ministry of Science, Technology, and Environment.

9.4. Management of Quality Inspection Organizations.

The management procedures for quality inspection organizations shall be specifically stipulated in the Circular jointly issued by the Ministry of Science, Technology, and Environment and the Ministry of Trade.

9.5. Organization and Coordination of Quality Management.

The Ministry of Science, Technology, and Environment shall coordinate with relevant ministries to review and improve existing quality management and inspection agencies; submit regulations on the functions, tasks, authorities, and operational methods of these agencies to the Prime Minister for promulgation. The coordination mechanism for quality management among these agencies will be detailed in inter-ministerial circulars.

9.6. Lead Agency:

The Ministry of Science, Technology, and Environment shall entrust the General Bureau of Standards-Measurement-Quality Control with overseeing, urging, and inspecting the implementation of quality management activities in ministries, sectors, and localities.

Provincial and municipal Science, Technology, and Environment Departments shall assist provincial and municipal People's Committees in overseeing, urging, and inspecting the implementation of quality management activities in their jurisdictions and organizing coordination with related agencies located in the locality.

10. Implementation Organization:

The Ministry of Science, Technology, and Environment shall entrust the General Bureau of Standards-Measurement-Quality Control with compiling the situation of goods quality and quality management work of relevant ministries for reporting to the Government as prescribed.

This Circular takes effect from the date of signature. For new issues arising during the implementation of this Circular, the Ministry of Science, Technology, and Environment shall consult with relevant ministries to resolve them specifically.