The PRIME MINISTER'S DECISION On the promulgation of regulations to manage biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms, the PRIME Government Organization Law base on December 25, 2001;
Pursuant to the law on environment protection 27 December 1993;
Considering the recommendation of the Minister of natural resources and the environment, decision: article 1. Attached to this decision management regulation biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms. Article 2. The Minister of natural resources and the environment, in cooperation with the ministries and relevant local instructions and regulations organization attached to this decision.
Article 3. This decision has the effect after 15 days from the date The report.
The Ministers, heads of ministerial agencies, heads of government agencies, the Chairman of the people's committees of provinces and cities under central and individual organization concerned is responsible for the implementation of this decision.
 
REGULATION of biological safety management with respect to genetically modified organisms;
products, goods derived from genetically modified organisms (attached to decision No. 212/2005/QD-TTg dated 26 August 2005 from the Prime Minister's) chapter I GENERAL PROVISIONS article 1. Scope this regulation regulates the management of biological safety in our activities: scientific research, technological development and assay; production, sales and use; import, export, store and transport; assessment, risk management and certified biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms in order to protect human health, the environment and biodiversity.
Article 2. The object to apply these rules apply to organizations, individuals and organizations, foreign individuals (hereafter referred to as the organization or individual) has activities related to genetically modified organisms; products, goods derived from genetically modified organisms, on the territory of Vietnam.
In the case of international treaties to which the Socialist Republic of Vietnam signed or joined other provisions with the provisions of this Regulation shall apply in accordance with the international treaties.  
Article 3. Explanation of terms In this regulation, the terms below are interpreted as follows: 1. biological safety is safety management measures in their activities: scientific research, technological development and assay; production, sales and use; import, export, store and transport of genetically modified organisms; products, goods derived from genetically modified organisms. 2. The gene is the unit of heredity, a segment of genetic material the rules of genetic traits in organisms.
3. Dna (deoxyribonucleic acid) is the genetic material of living organisms, has a double helix shape, including many genes (heredity).
4. gene transfer technology is the transfer of genes of an organism to other organisms, for a mandatory DNA of organisms that are receiving the new gene.
5. genetically modified organisms as animals, plants, micro-organisms are genetically altered structures by gene transfer technology. 6. Products, goods derived from genetically modified organisms are the products or goods are created in whole or in part from genetically modified organisms. The release of genetically modified organisms is the initiative to put genetically modified organisms into the environment.
8. Risk assessment is to identify potentially dangerous nature and extent of the damage was or will happen in the activities related to genetically modified organisms, especially in the use and release of genetically modified organisms; to goods, products derived from genetically modified organisms for human health, the environment and biodiversity.
9. Risk management is implementing safety measures to prevent, treat and overcome risks in activities related to genetically modified organisms; products, goods derived from genetically modified organisms for human health, the environment and biodiversity.
10. assay activity is calibrated level of biosafety of genetically modified organisms; products, goods derived from genetically modified organisms in specific conditions of Vietnam before put into production, trade and use.
CHAPTER II the SCIENTIFIC RESEARCH, TECHNOLOGY DEVELOPMENT and ASSAY article 4. Scientific research, technological development 1. Scientific research activities, technological development of genetically modified organisms; products, goods derived from genetically modified organisms must comply with the current rules on the management of science and technology and the provisions of other relevant laws.
2. The organization, individuals are only allowed to conduct scientific research activities, technological development of genetically modified organisms; products, goods derived from genetically modified organisms when it is full the conditions on the basis of technical material, equipment, technology and professional personnel with suitable scientific research activities, developing technology for each type of genetically modified organisms; products, goods derived from genetically modified organisms. 3. Individual organization when conducting scientific research activities, technological development of genetically modified organisms; products, goods derived from genetically modified organisms must be registered with the Ministry of science and technology and the Ministry of industry, the field of management on this issue.
4. organizations and individuals conducting scientific research activities, technological development of genetically modified organisms; products, goods derived from genetically modified organisms are responsible to preserve, conserve, not to loss of genetically modified organisms and related materials into the environment hazardous.
Article 5. Organization of the assay, assay personal conduct with respect to genetically modified organisms; products, goods derived from genetically modified organisms must comply with the following provisions: 1. registration conditions assay: a) Has adequate technical facilities, equipment, technology and expertise match the assay activity for each type of genetically modified organisms; products, goods derived from genetically modified organisms to be able to control and handle risk effectively according to the regulations of the Ministry of industry, the field of management in this regard;
b) genetically modified organisms; products, goods derived from genetically modified organisms should proceed to assay is a result of the process of scientific research and has been the competent State agency reviews trials;
c) surveillance measures and risk management process in the assay;
d) area to conduct the assay must be isolated from residential areas, nature conservation area under the provisions of the Ministry of industry, the field of management on this issue.
2. Registration documents include: a) assay application;
b) comments agree with the text of the provincial people's Committee, the central city where the expected deployment of the assay;
c) proof of eligibility stipulated in paragraph 1 of this article;
d) The other necessary related information required by the registration authorities.
3. Order procedure: a) send subscribe to assay The industry management, field;
b) within a period of 60 days from the date of receipt of a valid application, the Ministry of industry, the field of management in this regard are responsible for appraisal of records and the decision to allow the assay for eligible cases; the case does not authorise the assay, industry Manager, the profile reception areas must reply in writing and stating the reason.

4. industry, field Manager is responsible to report to the Ministry of natural resources and the environment, the Government's lead agency know while allowing organizations and individuals to conduct the assay.
CHAPTER III production, TRADING and USE of article 6. Production and trading conditions 1. The Organization, individuals are only conducted the production, trading and use of genetically modified organisms; products, goods derived from genetically modified organisms when the following conditions: a) genetically modified organisms; products, goods derived from genetically modified organisms on was certified biosafety;
b) genetically modified organisms; products, goods derived from genetically modified organisms on are in the category of genetically modified organisms, products or goods originating from genetically modified organisms allowed for production, trading, use by the Ministry of industry, management of regulatory fields.
2. organizations, individual manufacturing, trading and put to use genetically modified organisms; products, goods derived from genetically modified organisms must have registration certificate manufacturing, trading of respective fields.
Article 7. Labeling of goods the Organization, individual products or goods is genetically modified organisms or products or goods originating from genetically modified organisms, circulation, trade on the market, in addition to the implementation of the provisions of the current legislation on the labelling of goods have to be added to the inscription on the packaging : "a product of using gene transfer technology" to consumers considering options.
Article 8. Tracking, monitoring and reporting of the Organization, the individual production, genetically modified organisms, business; products, goods derived from genetically modified organisms must be regularly monitored, monitoring the level of safety with respect to human health, the environment, biological diversity; When to happen risks must be reported immediately to the Ministry of natural resources and environment and the Ministry of industry, the field of management on this issue.
CHAPTER IV on the IMPORT, export, STORE and TRANSPORT article 9. The condition of importing genetically modified organism 1. Genetically modified organisms imported into Vietnam for the purpose of research must comply with the following conditions: a) already allows the use of exporting countries with the same purpose on the territory of that country;
b) take measures to manage risk effectively.
2. the genetically modified organisms imported into Vietnam aims to assay, production, trading, use must comply with the following conditions: a) already allows the use of exporting countries with the same purpose on the territory of that country;
b) Have evaluated the risks in specific conditions of that country; imported cases for the purposes of production, trading, use of genetically modified organisms, also make sure has been risk assessment in specific conditions of Vietnam;
c) exporter has set up safety management mechanism viable genetically modified organisms. 
Article 10. Conditions for import of goods, products derived from genetically modified organisms 1. Products, goods derived from genetically modified organisms imported into Vietnam for the purpose of research must comply with the provisions in paragraph 1 article 9 of this regulation.
2. products, goods derived from genetically modified organisms imported into Vietnam aims to assay, production, trading, use must comply with the following conditions: a) already allows the use of exporting countries with the same purpose on the territory of that country;
b) Have evaluated the risks in specific conditions of that country;
c) exporter has set up safety management mechanism viable products, goods derived from genetically modified organisms;
d) case between exporting countries and Vietnam had written about mutual recognition of products, goods derived from genetically modified organisms, the import conditions shall apply according to the text.
Article 11. The procedure to import the import of genetically modified organisms; products, goods derived from genetically modified organisms must comply with the applicable provisions of the law on import, it also must perform the following procedure: 1. organizations and individuals importing importing please send text accompanied by the necessary information according to the form prescribed in annex I to this regulation to The industry management , fields to be reviewed;
2. The management of the industry, the field of review and a decision in writing on the issue of safety in the import of genetically modified organisms; products, goods derived from genetically modified organisms and notified to the Ministry of natural resources and the environment to the same track.
Article 12. Exports the export of genetically modified organisms; products, goods derived from genetically modified organisms abroad must comply with the regulations on the export of Vietnam, the country's laws and the international treaties to which the Socialist Republic of Vietnam has signed or joined.
Article 13. Stored, shipped 1. Genetically modified organisms; products, goods derived from genetically modified organisms when storing, shipping must be packed carefully and implement security measures, not to the crash losses in transit; recorded and labeled in accordance with the current provisions of the law of Vietnam and international practices.
2. in case of carriage in the water, before shipping genetically modified organisms; products, goods derived from genetically modified organisms, the owner of the goods must be notified in writing to the Ministry of industry, the field of management, which stated the information on packaging labels, where the production, storage, preservation, methods of transport, the place of departure, destination, measures to ensure safety during transportation and specific shipping deadlines.
3. transit cases genetically modified organisms; products, goods derived from genetically modified organisms through the territory of Vietnam which are unloaded down the Harbor, the shippers must submit the text with the necessary information according to the form prescribed in annex I to this regulation to The industry, management of areas to be reviewed. General Department of customs only conducted the relevant procedure after comments on Biosafety of industry managers, the field for the aforementioned goods, products.
4. transit cases genetically modified organisms; products, goods derived from genetically modified organisms through the territory of Vietnam without unloading down, shippers must notify in writing to The management of the industry, the field of security measures in the transit process to review the decision. General Department of customs only conducted the relevant procedure after the opinion of the Ministry of industry, the field of management on this issue.
Chapter V RISK ASSESSMENT, RISK MANAGEMENT and CERTIFIED BIOSAFETY article 14. Risk assessment 1. Organizations and individuals before putting genetically modified organisms; products, goods derived from genetically modified organisms into the environment or production, trading, use to conduct risk assessment to determine the potential risks caused by genetically modified organisms; products, goods derived from genetically modified organisms pose for human health, the environment and biodiversity, according to the regulations of the Ministry of industry, the field of management on this issue.
2. The risk assessment must be conducted in accordance with the scientific and technical methods of risk assessment were recognized, according to the information specified in annex II to this regulation and the scientific evidence is relevant.
3. The risk assessment must be done under the supervision of one or more specialized scientific bodies have been industry-Manager, field recognition capacity monitoring.

4. risk assessment results are shown in the risk assessment report by the Organization, individuals conducting risk assessment established according to the form prescribed in annex II to this regulation.  
Article 15. Risk management 1. Scientific research activities, technological development, assay; production, trading, use; import, export, store, transport of genetically modified organisms; products, goods derived from genetically modified organisms must adhere to strict prevention measures, handling and overcoming risk. 2. The Organization, the individual scientific research, technology development, genetically modified organisms assay; products, goods derived from genetically modified organisms must have a responsibility to help organizations and individuals concerned adopt precautionary measures, handle and overcome risks during the assay, genetically modified organisms applications; products, goods derived from genetically modified organisms because they create.
3. organizations and individuals importing, exporting, using genetically modified organisms; products, goods derived from genetically modified organisms are responsible for applying the appropriate management measures aimed at the prevention, timely detection of risks to handle and overcome the consequences of risk; When to risk occurs in the course of conducting its activities, the Organization, the individual must promptly report to the Ministry of natural resources and environment, industry Manager, field said.
Article 16. Certification of biological safety 1. Genetically modified organisms; products, goods derived from genetically modified organisms have through assay and risk assessment, if enough conditions on biological safety as defined in paragraph 2 of this Article shall be the Ministry of industry, management of areas considered for certification of biological safety and put into the category of genetically modified organisms; products, goods derived from genetically modified organisms allowed for production, trading, use. Industry-Manager, field level biosafety certificates for genetically modified organisms; products, goods derived from genetically modified organisms shall have the right to revoke that certificate.
2. the genetically modified organisms; products, goods derived from genetically modified organisms recognized Biosafety should have enough of the following conditions: a) without risk of causing allergy or toxicity to human health;
b) does not cause adverse impact to the environment and biodiversity.
3. industry, field Manager is responsible to report to the Ministry of natural resources and the environment, the Government's lead agency when safety certificates for genetically modified organisms; products, goods derived from genetically modified organisms are eligible.
CHAPTER VI STATE MANAGEMENT DUTIES on BIOSAFETY article 17. Content management on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms 1. Construction, issued strategies, mechanisms, policies, plans and legal documents on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms;
2. construction and development of information systems, database on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms;
3. Verify the registration of the assay, release, production, sales, use, export, import, store, transport of genetically modified organisms; products, goods derived from genetically modified organisms; granted, revoke the certificate, license is related to biological safety of objects on;
4. training, advocacy and education to raise awareness for the Organization, individuals on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms;
5. International cooperation, participate in the implementation of international treaties related to genetically modified organisms; products, goods derived from genetically modified organisms;
6. Inspection, checking for compliance with and implementation of provisions of the law on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms. Article 18. The Mission of the Ministry of natural resources and the environment 1. As the Government's focal agency on management of biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms, have a duty to help the Government implement the unified state management on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms on the nationwide;
2. Build process issued or issued under the authority of the strategies, mechanisms, policies, planning, legal text on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms;
3. To organize and direct the active coordination between the bodies concerned in the implementation of the tasks of managing the State on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms;
4. Coordination with the ministries concerned to training, advocacy and education to raise awareness for the Organization, individuals on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms;
5. Reception, processing information, data on genetically modified organisms; products, goods derived from genetically modified organisms due to the sector Manager, domains and organization, the individual concerned provides; construction, development of information systems and databases on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms; do clue join mechanism with the international exchange of information on this issue;
6. test, inspection and handling of violations related to genetically modified organisms; products, goods derived from genetically modified organisms. Article 19. The Mission of the Ministry of science and technology 1. Make the task of managing the State of scientific research, technology development with regard to genetically modified organisms; products, goods derived from genetically modified organisms;
2. Build process issued or issued under the authority of the mechanisms, policies, legal documents related to the study of science, technological development with respect to genetically modified organisms; products, goods derived from genetically modified organisms;
3. Guidelines for the Organization, the individual procedures, specific conditions of registration of scientific research, technology development related to genetically modified organisms; products, goods derived from genetically modified organisms. Evaluation, selection, approval and steer the implementation of the program, the subject of scientific research projects, technological development related to genetically modified organisms; products, goods derived from genetically modified organisms;
4. building and developing potential in serving the scientific research, technology development related to genetically modified organisms, products or goods originating from genetically modified organisms;
5. Provide information regularly, data related to genetically modified organisms; products, goods derived from genetically modified organisms for the Ministry of natural resources and the environment, the Government's lead agency on this issue.
Article 20. The Mission of the Ministry of industry management, field 1. The General task of the Ministry of industry, a sector management) ensures the necessary conditions for the activities of the specialized agencies; build and develop the capacity of the Agency for assessment, evaluation of biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms in the range management;

b) organizing and directing the activities of State management on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms in the range management;
c) formulated and issued under the authority of the legal text, the industry standard on the management of biological safety for genetically modified organisms; products, goods derived from genetically modified organisms in the range management;
d) Regulation sequence, procedure and conditions of conducting risk assessment for activities related to genetically modified organisms; products, goods derived from genetically modified organisms in the range management;
) specify the specialized scientific bodies make the monitoring process of risk assessment for activities related to genetically modified organisms; products, goods derived from genetically modified organisms in the range management;
e) appraise the registration assay, release, production, sales and use, export, import, store, transport of genetically modified organisms; products, goods derived from genetically modified organisms in the range management;
g) appraisal, grant, revoke the certificate of biosafety for genetically modified organisms; products, goods derived from genetically modified organisms and created list of genetically modified organisms; products, goods derived from genetically modified organisms are allowed to produce, in the scope of business management;
h) test, inspection for compliance with and implementation of provisions of the law on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms in the range management;
I) directing the processing, to fix the issue, risks for the environment and human health caused by the activity related to genetically modified organisms; products, goods derived from genetically modified organisms pose in range management;
k) provides the information, the data related to genetically modified organisms; products, goods derived from genetically modified organisms for the Ministry of natural resources and the environment, the Government's lead agency on this issue.
2. The Mission of some particular Sets a) Ministry of agriculture and rural development has the task of managing the State on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms in agriculture and forestry;
b) Ministry of fisheries has the task of managing the State on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms in the fisheries sector;
c) Health Ministry has the task of managing the State on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms in the medical industry; about biosafety and food safety for genetically modified organisms; products, goods derived from genetically modified organisms used as food, pharmaceuticals and cosmetics.
d) Ministry of industry have the task of managing the State on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms in the industry.
Article 21. The Mission of the people's Committee of the central cities, 1. Implement state management activities on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms locally;
2. the dissemination, advocacy and education to raise awareness for the Organization, individuals on Biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms locally;
3. In coordination with the ministries, organizations and individuals involved in the implementation of the provisions with regard to the activities related to genetically modified organisms; products, goods derived from genetically modified organisms locally;
4. Planning of the assay, the production of genetically modified organisms; products, goods derived from genetically modified organisms locally;
5. Inspection, testing and processing the violation under the jurisdiction with regard to the activities related to genetically modified organisms; products, goods derived from genetically modified organisms.
CHAPTER VII TREATS breach of article 22. Handle violation 1. The Organization, individuals are violations of regulations on management of biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms in this regulation depending on the nature and extent of the violation will be disciplined, sanctioning administrative violations; If the damage is compensated according to the provisions of the law.
Violations causing serious consequences, the individual will suffer prejudice criminal liability under the law.
2. The person who would take advantage of the Office, the powers that be violations of the provisions of the law on management of biosafety with respect to genetically modified organisms; products, goods derived from genetically modified organisms, then depending on the nature and extent of the violation being disciplined or arrested save for criminal liability, if damage is compensated according to the provisions of the law.
Article 23. Handle violation of import activities 1. In contract to import genetically modified organisms; products, goods derived from genetically modified organisms into the territory of Vietnam, importing party must request the export side committed excesses when there is damage caused by using the product, imported goods their cause; committed to contribute financially and technically to process, overcoming the adverse consequences for human health, the environment and biological diversity at risk. 2. In the case of imported non-party agreement was with the exporting Party regarding security measures as specified and when the compensation commitment to the problem that still intentionally imported genetically modified organisms; products, goods derived from genetically modified organisms, if any risk caused by using the product, imported goods, cause damage to human health, the environment, biological diversity, economy, the society, the importing party shall bear the compensation responsibility and bear all costs for the processing , remedial. The case caused serious consequences, personal imports being prejudice criminal liability under the law.
CHAPTER VIII TERMS OF IMPLEMENTATION article 24. Terms of implementation in the process of implementation of this regulation, if the content should be added, modified, the ministries, the local reflection on the Ministry of natural resources and environment for the Prime Minister to review the decision.