Nghị định 80/2001/ND-CP

DECREE

GUIDING THE CONTROL OF LAWFUL DRUG-RELATED ACTIVITIES IN THE COUNTRY

THE GOVERNMENT

Pursuant to the Law on Organization of the Government of September 30, 1992;
Pursuant to the Law on Drug Prevention and Fight of December 9, 2000;
At the proposal of the Minister of Public Security,

DECREES:

Chapter I

GENERAL PROVISIONS

Article 1.- This Decree details and guides the control of lawful drug-related activities in the country, including the permitted monitoring, inspection and supervision of activities of researching, expertising, producing, preserving, storing, transporting, purchasing, selling, distributing, using, treating and exchanging narcotics, addictive drugs, psychotropic medicines and pre-substances in the fields of health care, industry, analysis, test, scientific research, professional training, drug-related crime investigation, as well as the preclusion and prevention of the abuse of such activities for other purposes.

The control of lawful drug-related activities for defense and security purposes shall not be governed by this Decree.

Article 2.-

1. It is strictly prohibited to use in the medical field raw materials, finished products and semi-finished products containing substances specified in List I enclosed with the Government’s Decree No.67/2001/ND-CP of October 1, 2001 promulgating lists of narcotics and pre-substances. In cases where such substances are used for analysis, test, scientific research and drug-related crime investigation, such must be permitted by the Minister of Health or the Minister of Public Security.

2. The research into, expertise, production, transport, preservation, storing, purchase, sale, distribution, use, handling and exchange of narcotics and pre-substances specified in Lists II, III and IV (promulgated together with the Government’s Decree No.67/2001/ND-CP of October 1, 2001) in the fields of health care, industry, analysis, test, scientific research, professional training and drug-related crime investigation must be strictly controlled. The production of these substances shall not imply the planting of narcotic substance-bearing trees.

Article 3.-

1. The competent agencies shall, within the ambit of their tasks and powers, have to coordinate with one another in rigorously controlling the lawful drug-related activities in the country.

2. Individuals, agencies and organizations that conduct lawful drug-related activities in the country shall have to abide by the provisions of the Law on Drug Prevention and Fight, this Decree and other relevant legal documents, and be subject to the inspection and supervision by the competent agencies under the provisions of law.

Chapter II

CONTROL OF THE PRODUCTION AND PREPARATION OF ADDICTIVE DRUGS, PSYCHOTROPIC MEDICINES AND PRE-SUBSTANCES

Article 4.- Only the following organizations and individuals are allowed to produce and prepare addictive drugs, psychotropic medicines and pre-substances in medical and industrial domains:

1. Enterprises with functions of producing drugs, which satisfy all professional and technical conditions prescribed by the Ministry of Health and are licensed by the latter to produce raw materials, finished products, semi-finished products of addictive drugs, psychotropic substances and pre-substances.

2. Hospitals and research institutes, which have patient beds and are allowed to prepare finished addictive drugs, psychotropic medicines and pre-substances for in-patients and out-patients.

3. Enterprises, which are designated by the Ministry of Industry to produce pre-substances for industrial use.

4. Individuals, who fully meet the conditions prescribed by the Ministry of Health and the Ministry of Industry.

Article 5.- The Ministry of Health shall specify the order and procedures for licensing the production and preparation of addictive drugs, psychotropic medicines and pre-substances for medical use.

The Ministry of Industry shall specify the order and procedures for licensing the production of pre-substances for industrial use.

The Ministry of Health and the Ministry of Industry shall, within the ambit of their respective tasks and powers, guide and make dossiers for monitoring the quantity, quality, use duration and process of producing and preparing addictive drugs, psychotropic medicines and pre-substances for medical and industrial use, and the observance of the statistical, reporting and preserving regimes. Dossiers shall be kept for a duration prescribed by the Ministry of Health or the Ministry of Industry.

Chapter III

CONTROL OF THE DELIVERY, RECEPTION, STORING AND TRANSPORT OF NARCOTICS, ADDICTIVE DRUGS, PSYCHOTROPIC MEDICINES AND PRE-SUBSTANCES

Article 6.-

1. The Ministry of Health, the Ministry of Industry and the Ministry of Public Security shall, within the ambit of their respective tasks and powers, define persons fully qualified for direct delivery, reception, storing and transport of narcotics, addictive drugs, psychotropic medicines and pre-substances for medical and industrial use, analysis, test, scientific research, professional training and drug-related crime investigation.

2. Goods consignees prescribed in Clause 1 of this Article must have necessary papers and be responsible for the quality, quantity and categories of such substances in the course of transportation, and deliver them in full to the persons in charge of direct management.

3. Goods deliverers prescribed in Clause 2 of this Article must check and compare the concentration degrees, contents, quantity, quality, goods lot numbers and use duration of delivered goods. Upon completing the delivery and reception, the deliverers and consignees must sign and clearly inscribe their full names on ex-warehousing and warehousing vouchers.

Article 7.- Narcotics, pre-substances, addictive drugs and psychotropic medicines must be preserved at separate places in warehouses or in separate warehouses, and the safety thereof must be ensured.

Article 8.-

1. Narcotics, pre-substances, addictive drugs and psychotropic medicines must, in the course of transportation, be packed and sealed up, with the delivering and receiving places, their names and quantity clearly inscribed on the packing, and accompanied by monitoring dossiers. In all circumstances, trunks, cases and/or boxes used for packing must be stuck with packing bills clearly stating the names, concentration, content (if any) and quantity of substances, packing date and names of packers, in order to facilitate the inspection and identification.

Individuals, agencies and organizations that have their goods transported must apply measures to ensure the safety thereof, not to let them be lost and take responsibility for the quantity and quality of their goods.

2. The Ministry of Public Security shall specify the transport of substances prescribed in Clause 1 of this Article in service of the fight against drug-related crimes. The Ministry of Health and the Ministry of Industry shall, within the ambit of their respective tasks and powers, specify the transport of substances prescribed in Clause 1 of this Article in service of medical and industrial needs, analysis, test and scientific research.

Chapter IV

CONTROL OF THE DISTRIBUTION, PURCHASE, SALE, USE AND EXCHANGE OF NARCOTICS, ADDICTIVE DRUGS, PSYCHOTROPIC MEDICINES AND PRE-SUBSTANCES

Article 9.-

1. The Ministry of Health shall specify the regimes of distribution, purchase, sale, use and exchange of narcotics, addictive drugs, psychotropic medicines and pre-substances for medical use, analysis, test and scientific research.

2. The Ministry of Industry shall specify the regimes of distribution, purchase, sale, use and exchange of pre-substances for industrial use.

3. The Ministry of Public Security shall specify the regimes of distribution, purchase, sale, use and exchange of narcotics, pre-substances, addictive drugs and psychotropic medicines in service of research, expertise, professional training and drug-related crime investigation.

Article 10.- Medical establishments under the People’s Army and the People’s Police are allowed to purchase addictive drugs and psychotropic medicines at the Central Pharmaceutical Company or provincial-level pharmaceutical companies according the estimation plans already approved by the competent bodies of the Ministry of Health.

Article 11.-

1. Addictive drugs and psychotropic medicines must be labeled and preserved in strict compliance with regulations. Drug labels must be clearly inscribed with their names, composition, concentration, content, indications and contra-indications, use duration and manufacturing establishments.

2. Pre-substances for medical and industrial use, analysis, test and scientific research must be labeled and preserved in strict compliance with regulations. Substances labels must be clearly inscribed with their names, composition, concentration, content, use duration and manufacturing establishments.

Article 12.- Agencies, organizations and units that wish to use addictive drugs, psychotropic medicines and pre-substances in medical or industrial field, analysis, test or scientific research shall have to make estimations according to the set form. The Ministry of Health shall approve estimations of addictive drugs and psychotropic medicines for each administration level according to its annual demand. Agencies, organizations, units and individuals that wish to use pre-substances in the industrial field shall have to work out and report their plans to the Ministry of Industry.

Chapter V

RECORDING AND REPORTING REGIMES

Article 13.-

1. Establishments engaged in the production of narcotics, pre-substances, addictive drugs and psychotropic medicines must open books according to the set form, make dossiers for monitoring quantity, quality, use duration, production process, and observe the preserving, reporting and statistical regimes prescribed by the Ministry Health and the Ministry of Industry. Books and vouchers must be kept for a duration prescribed by the Ministry Health and the Ministry of Industry. Upon expiry of the duration for keeping books and vouchers, the units’ heads shall have to set up councils for destruction of such books and vouchers and make written records on such destruction.

2. Establishments engaged in the purchase, sale and/or dispensing of narcotics, pre-substances, addictive drugs and psychotropic medicines must open books for monitoring the ex-warehousing and warehousing. The bills on ex-warehousing or warehousing of such substances must not be inscribed with other kinds of goods or supplies.

3. Within 10 days after narcotics, pre-substances, addictive drugs and/or psychotropic medicines are warehoused, the managing units shall have to report such to their respective managing ministries.

Article 14.-

1. Drugstores, private clinics and establishments attached to district-level medical centers shall send monthly reports on activities related to addictive drugs and psychotropic medicines to the latter. Drugstores attached to provincial-level drug trading enterprises shall send monthly reports to the latter. Reports shall be sent on the 25th of every month.

2. Provincial-level and district-level hospitals, drug trading enterprises, convalescent homes for war invalids, branch hospitals and medical establishments located in provinces shall have to send monthly reports on activities related to addictive drugs and psychotropic medicines to provincial Health Services. Reports shall be sent on the 25th of every month.

3. Medical units under the Ministry of Communications and Transport shall report directly to provincial Communications and Transport Health Departments on activities related to addictive drugs and psychotropic medicines.

4. Hospitals and medical establishments under the People’s Police Force shall report directly to the Medical Department of the Ministry of Public Security. The army medical units shall report directly to the Army Medical Department of the Ministry of Defense.

The Ministry of Communications and Transport, the Ministry of Public Security and the Ministry of Defense shall, within the ambit of their respective tasks and powers, specifically guide the reporting regime to suit the pharmaceutical management work in their respective branches.

Article 15.- On June 25 and December 25 every year, all establishments that produce, store, distribute, purchase, sell, use and/or exchange narcotics, addictive drugs, psychotropic medicines and pre-substances shall have to inventory goods in stock and make biannual and annual reports to be sent to their immediate superior managing agencies. Medical units under the Ministry of Health, the provincial/municipal Health Services, the Army Medical Department of the Ministry of Defense, the Medical Department of the Ministry of Public Security and the provincial/municipal Health Departments of the Ministry of Communications and Transport shall send biannual reports to the Ministry of Health. The industrial units shall send biannual reports to the Ministry of Industry.

Article 16.- All establishments that produce, prepare, store, transport, distribute, purchase, sell, use, treat and/or exchange narcotics, addictive drugs, psychotropic medicines and pre-substances in the medical or industrial field, analysis, test, scientific research, professional training or drug-related crime investigation, shall have to urgently report to their immediate managing agencies on cases of confusion, poisoning and loss of such substances for any reasons.

Article 17.- When narcotics, addictive drugs, psychotropic medicines and pre-substances not prescribed in Clauses 1 and 2, Article 24 of the Law on Drug Prevention and Fight need to be handled, the managing units shall have to report to the immediate superior agencies, clearly stating the reasons for handling and proposing handling measures. The handling shall be effected only after the competent superior agencies approve it in writing. The units’ heads shall have to set up handling councils and make written records thereon according to the set form. When the handling is completed, they shall send written records and reports to the immediate superior managing agencies.

Chapter VI

ORGANIZING THE CONTROL OF LAWFUL DRUG-RELATED ACTIVITIES IN THE COUNTRY

Article 18.- The Ministry of Public Security shall have to:

1. Coordinate with the concerned agencies in guiding, urging and inspecting agencies, organizations, individuals and localities in the observance of legal documents on the control of lawful drug-related activities in the country, with a view to preventing and precluding the abuse of such activities for illegal purposes.

2. Synthesize plans and results of implementation of the overall long-term plan and annual plans of ministries and branches for controlling lawful drug-related activities in the country, then submit them to the Government.

3. Promulgate and organize the implementation of the regulation on management, inspection and control of narcotics and pre-substances in service of the fight against drug-related crimes.

Article 19.- The Ministry of Health shall have to promulgate the list and regulation on management of addictive drugs, psychotropic medicines and pre-substances for medical use, analysis, test and scientific research and organize the implementation of such regulation.

It shall also guide, urge and inspect the ministries, branches, organizations, individuals and localities in observing legal documents on the control of lawful drug-related activities in the country.

Article 20.- The Ministry of Industry shall have to promulgate the list of pre-substances for industrial use; promulgate and organize the implementation of the regulation on management of such pre-substances.

Article 21.-

1. The ministries, ministerial-level agencies and agencies attached to the Government shall, within the ambit of their respective tasks and powers, have to control and coordinate with the concerned agencies in controlling lawful drug-related activities in the country.

2. The People’s Committees of all levels shall, within the ambit of their respective tasks and powers, have to effect the control of lawful drug-related activities in their localities.

Article 22.- The agencies defined in Articles from 18 to 26 of this Decree shall, within the ambit of their respective tasks and powers, have to organize the performance of their assigned tasks, and inspect the observance of regulations on the control of lawful drug-related activities in the country; and handle violations according to the provisions of law.

Chapter VII

IMPLEMENTATION PROVISIONS

Article 23.- Funds for the control of lawful drug-related activities in the country shall be balanced by the State budget and incorporated in annual budget estimates of the Ministry of Public Security, the Ministry of Health and the Ministry of Industry.

Funds for the control of lawful drug-related activities in the country of localities shall be balanced in their annual budgetary expenditure estimates.

Article 24.- The Ministry of Health, the Ministry of Industry and the Ministry of Public Security shall define the specialized management agencies in charge of the control of lawful drug-related activities in the country.

Article 25.- This Decree takes effect 15 days after its signing. The previous stipulations, which are contrary to this Decree, are hereby annulled.

Article 26.- The ministers, the heads of the ministerial-level agencies, the heads of the agencies attached to the Government and the presidents of the People’s Committees of the provinces and centrally-run cities shall have to implement this Decree.