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Law 34/2005/qh11: Pharmacy

Original Language Title: Luật 34/2005/QH11: Dược

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Pharmaceutical LAW _ _ based on the Constitution of the Socialist Republic of Vietnam in 1992 was amended and supplemented by resolution No. 51/2001/QH10 on 25 December 2001 of the National Assembly session, 10 X key;
This law regulates the activity in the field of pharmacy.
Chapter I GENERAL PROVISIONS article 1. Scope, application object 1. This law regulates the drug business; registration, circulation of drugs; the use of drugs; drug supply; information, drug ads; clinical drug on trial; addictive medication management, mental direction, drug precursors used for smoking and smoking; quality standard of drugs and drug testing.
2. This law applies to agencies, organizations, individuals in the country and abroad in Vietnam.
The case of the international treaties to which the Socialist Republic of Vietnam is a member have other regulations with the provisions of this law shall apply to the provisions of international treaties.
Article 2. Explanation of terms In this law, the terms below are interpreted as follows: 1. Pharmacy is smoking and drug-related activities.         
2. Is the substance or mixture of substances used for the purpose of prevention, cure, diagnosis or adjust physiological function body includes smoking finished products, raw materials for making drugs, vaccines, biological medical products, except food functions.
3. The vaccine Antigen-containing preparations is created for the body immune response capabilities, is used for the purpose of prevention.
4. B. health product is a product of biological origin are used for prevention, diagnosis and cure for the people.
5. Make the drug is involved in product composition in the drug production process.
6. Drug (also known as active ingredient) is the substance or mixture of substances containing active treatment is used in the manufacture of drugs.
7. Smoking is smoking products have passed through all the stages of production, including packaging in the final packaging and labelling.
8. Drugs from pharmaceutical drug is produced from raw materials of natural origin from animals, plants or minerals.
The drug has a pure active substances extracted from medicinal herbs, medicinal combination medications with no synthetic chemicals called the drug from medicinal herbs.
9. Oriental medicine is medicine from medicinal herbs, are manufactured according to the reasoning and methods of traditional medicine of the Eastern countries.
10. Smoking prescription drug is not true if the use of the prescription then can be dangerous to life, health; When allocated, retail, used prescription and must be specified in the category group prescription drug.
11. non-prescription Drugs is smoking when allocated, sell and use do not need a prescription.
12. Smoking is addictive drugs if prolonged use can lead to addiction, are defined in the addictive drug by the Minister of Health issued and in accordance with the international treaties to which the Socialist Republic of Vietnam is a member.
13. Smoking mental direction is smoking there are effects on CNS, if used incorrectly is likely dependent on drugs, are prescribed in the formulary mental direction by the Minister of Health issued and in accordance with the international treaties to which the Socialist Republic of Vietnam is a member.
14. Precursor chemicals are not used in the process of preparation, production of addictive drugs, smoking, mental direction was the participation in the formula of addictive substances, mental direction, substances are defined in the category of money by the Minister of Health issued and in accordance with the international treaties to which the Socialist Republic of Vietnam is a member.
15. Smoking is radioactive drugs contain one or more radioactive material, used to diagnose or treat disease.
16. essential Drugs are drugs that meet the health care needs of the majority of the people, are specified in the list of essential drugs by the Minister of health.
17. Smoking the drug is mostly satisfies the needs of treatment in medical establishments and treatment consistent with the structure of disease in Vietnam is prescribed in the list of drugs primarily used in medical treatment facility by the Minister of health.
18. the new Drug is a medication that contains the new drug, a new combination of medicines the medicinal substances were circulating.
19. Miscellaneous is the trade name drugs by drug manufacturing facility, the other with the original name or common name.
20. the harmful reactions of drugs is the unwanted harmful effects to health, can appear in the normal dose.
21. the expiration of the drug's use of time is assigned to a batch of the drug that after the deadline are not allowed to use the drug.
22. drug quality standards include the regulation on technical requirements, criteria, methods of testing, packaging, labelling, transportation, storage and other requirements related to the quality of the drug.
Quality standard of drugs was expressed in the form of technical writing.
23. poor quality Drugs as the drug did not meet the quality standards registered with the competent authorities.
24. Counterfeit product is produced in the form of smoking with your cheater, in one of the following cases: a) has no substance;
b) Have substance but not properly registered content;
c) Have different drug substance indicated on the label;
d) Impersonating the name, industrial designs registered drug's industrial property protection of other production facilities.
25. the drug business is making one, some or all stages of the investment process, from production to consumption of drugs or the provision of services relating to medicines on the market aimed at profitable.  
26. The practice of pharmacy is the personal use of its pharmaceutical expertise to the drug business.
27. Good practice are the principles, standards of production, storage, testing, drug traffic, cultivating, harvesting and processing of medicinal herbs by the Ministry of Health issued.
28. Try the drug money is the clinical science research aims to assess the effects of the drug, proven performance and safety of the drug on animals to do procedures for the clinical trial.
29. Research on scientific activity is clinical drug research in a systematic way on people, which aims to verify clinical effectiveness, identify, detect harmful reaction due to the impact of research products; ability absorption, distribution, metabolism, except waste of that product with the goal of determining the safety and efficacy of the drug.
30. information gathering activities and is providing news related to smoking for organizations, individuals active in direct pharmaceutical, medical or drug users.
31. drug testing is the sampling, review the technical standards, conduct the experiment respectively and needed to determine raw materials, semi-finished products, finished products meet technical standards to decide whether accept or elimination of the drug.
32. Declaration of drug price is the basis of drug trading reports to the competent State agencies on import prices, wholesale prices, retail prices expected under the provisions of the law on prices.
Article 3. The State's policy in the field of Pharmacy State made the following policy in the field of Pharmacy: 1. development of pharmacy into a technical-economic sector the spearhead, pharmaceutical industrial development priorities.
The project application of advanced technology to produce the drug, drug, drug materials mainly imported medicine, alternative medicine, drug prevention and social diseases, vaccines, drugs, medical products from medicinal herbs, Oriental medicine enjoy investment incentives in accordance with the law;

2. Encourage organizations and individuals in the country and abroad, who settled in Vietnam offshore development in scientific research about the technology of manufacture, biotechnology for the production of the new drug; investing in the production of drug materials, drugs and product line with the structure of disease and drug use needs of people;
3. Encourage research, the successor and the experience of East medicine, combines Oriental medicine with modern medicine; search engines, exploit, use new medicinal, pharmaceutical exports; policy incentives, support cultivating medicinal herbs, natural medicinal exploits, ensuring and developing medicinal genetic resources; modernization of the production of medicines from medicinal herbs;
4. support of smoking by the proper form for the objects in the policy area, the ethnic minority, the socio-economic conditions particularly hard, the social-economic conditions are difficult;
5. development of network traffic, distribution and supply of drugs, guarantee sufficient quality drugs that meet the needs of drug use;
6. Protection of the rights, legitimate interests of organizations, individuals in business, research and the use of drugs in Vietnam.
Article 4. The national stockpile of drugs 1. The State of implementation of the national drug stockpile for use in the following purposes: a), fight disease and overcome the consequences of natural disasters, the disaster;
b) ensure national defense and security;
c) involved drug market stabilization.
2. The construction, organization, management, administration and use of the national reserves of the drug was made under the provisions of the law.
Article 5. State management on prices of drugs 1. State management on drug prices under the principle of the production, export, import, trafficking of self evaluation, competition on price and is responsible under the provisions of the law; use measures to stabilize the price of the drug on the market to meet the demand to serve people's health care.
2. Government regulation on the management of drug price details match the socio-economic situation in each particular period according to the following rules: a) Smoking before circulating on the market must be the basis of production, import declaration reviews and when changing the price of medication must be declared to the competent State agencies sure, drug prices no higher than the price of drugs in the countries in the region have medical conditions, similar to the Vietnam trade;
b) production base, importing the drug responsible before the law about the price Declaration;
c) wholesale prices, retail prices of drugs have to be listed;
d) competent State agencies publicly reported drug prices is declared; periodically announced maximum prices for the drugs because of the State budget and pay for health insurance;
DD) Ministry of health coordinated with the Ministry of finance, Ministry of industry, Ministry of Commerce, Ministry of planning and investment and the other relevant State agencies implement managed state on drug prices as assigned by the Government.
Article 6. State administration of medicine 1. The unified government administration of pharmaceuticals.
2. The Ministry of health is responsible before the Government implement state management of pharmacy.
3. Ministries, ministerial-level agencies responsible for coordinating with the Ministry of health in implementing State management of pharmacy as assigned by the Government.
4. the people's Committee of the level of implementation of State management of pharmacy within the local government hierarchy.
Article 7. Pharmaceutical drug Inspector Inspector in the inspection of the Ministry of health have specialized inspection functions of the pharmacy.
Organization, functions, duties and powers of the pharmaceutical inspection is made under the provisions of the law on the Ombudsman.
Article 8. Assembly and Association about the medicine 1. Assembly and Association about the pharmacy's social organization-the profession of pharmacist and those active in the field of pharmacy.
2. Pharmacists and those active in the field of Pharmacy has the right to join and establish the Association, Association of pharmacy.
3. Organization and activities of the Association, the Association of medicine made according to the provisions of the law.
Article 9. The prohibited acts 1. Drug business without the certificate of eligible drug business.
2. Practicing pharmacy without the practice of pharmacy.
3. drug business of unknown origin, origin, smoking, poor quality drugs, drug use, drug expiration list smoking banned imports, clinical reagents, drugs have not been allowed to circulate, drug samples used to register or refer to physician.
4. Fake, rent, lend, lease, lend, pharmacy practice certificate certificate of eligible drug business.
5. information, drug ads untrue, misleading for the consumer; drug ads left with history, culture, ethics, Maple plain, United States of America of the peoples of Vietnam.
6. Sell the drug in those places is not the basis of the legal drug sale.
7. exclusive advantage in business to profit drug dumping, illegal drugs, drug price increases stipulated by law.
8. drug promotion rules of law.
9. Sell the drug in the national target program, the aid to which the prescribed drugs not be sold; humanitarian aid and the drug imported African drug trade.
10. Retail prescription drugs without prescriptions.
11. Taking advantage of the medication to the shaft.
12. Destroy the precious medicinal resources.
13. other acts prohibited in the works about medicine as prescribed by law.
Chapter II BUSINESS SMOKING ITEM 1 article 10 MEDICINE BUSINESS CONDITIONS. Form of business trading medicine includes the forms of production, export, import, wholesale, retail, service and drug testing services.
Article 11. Conditions, the certification authority eligible drug business 1. Drug trading's business condition. Agencies, organizations, personal trading (hereinafter collectively referred to as business establishments, smoking) must have the certificate of eligible drug business.
2. Base business is certified eligible drug business must have the following conditions: a) the facilities, technical and personnel have the necessary qualifications for each form of business smoking;
b) professional manager of Pharmacy was granted the certificate of practice medicine consistent with business forms.
3. certification authority eligible drug business are defined as follows: a) the Ministry of Health issued a certificate of eligibility for the drugs business of drug production, drug preservation service, do drug testing services;
b) province, City Health Department centrally certification eligible drug business for business establishments in other business forms, except in cases specified in point a of this paragraph.
4. the competent State agencies specified in paragraph 3 of this article are responsible for the certification of qualified business smoking within thirty days from the date of the application; the case does not have to supply a written reply stating the reason.
5. Government regulations specific conditions for each form of business smoking; deadlines, procedures, records, Supplement, change, renew, revoke the certificate of eligible drug business.
Article 12. Certificate of eligible drug business 1. Certificate of eligible drug business must specify the name, location, professional managers, business forms, business scope of business establishments and the duration of effect of certificate of eligible business.

2. Business establishments, smoking only works properly registered location and business scope has stated in the certificate of eligible drug business; the case expanded the business scope or business location changes to procedures for the addition or change of the certificate of the eligible business.
Article 13. Practice of Pharmacy 1. The practice of Pharmacy certificate must have the following conditions: a) has the qualifications, professional certificate in accordance with the requirements of each business form of medication;
b) took over the practice at least from two years to five years in legal medicine facility for each form of business;
c) Have professional ethics;
d) have enough health to pharmacy practice.
2. the following Persons cannot be certified to practice medicine: a) banned the practice of Pharmacy under the judgment, the decision of the Court;
b) are being prejudice criminal liability;
c) Are in the Executive judgment time, the Criminal Court's decision, or decide to apply administrative processing measures taken on the basis of education, curative establishments or administrative probation;
d) are in time were the discipline from the form of caution over relevant to medical expertise, pharmacy;
DD) Lost the capacity for civil acts or limited capacity for civil acts.
3. certificate of competence to practise pharmacy shall be as follows: a) the Minister of health to grant a certificate of practice for pharmacy practice pharmacy registration personally invested abroad;
b) Director of the Department of health certified pharmaceutical practice for individuals to register to practice pharmacy, except in cases specified in point a of this paragraph;
4. specific government regulations regarding qualifications, professional certificates, time practice in pharmaceutical facility for each form of business smoking; records, procedures, change, renew, revoke the certificate in pharmaceutical practice.
Article 14. The fee for certification of eligible drug business, practice of Pharmacy basis of drug business suggest the certification qualifies individuals to drug business suggest practising pharmacy certificate fees as prescribed by the law.
Section 2 article 15 DRUG PRODUCTION. Control of drug production facilities 1. Enjoy the privileges of capital, land, tax and other incentives to produce drugs in the areas defined in article 3 of this law and the provisions of relevant laws.
2. information, advertising the drug as prescribed by the law on advertising to introduce, promote the consumption of the product due to the manufacturing facility.
3. Other rights prescribed by law.
Article 16. Obligations of drug production facilities 1. Comply with the rules of good practice in the manufacture, distribution, maintenance, drug testing and regulation of relevant expertise.
2. production of medicines according to the production process and quality standards registered; reporting to the competent State agencies when there are changes in the production process.
3. Responsible for the quality of medicines due to the manufacturing base and only allowed to ship the drug quality standards registered.
4. Has the technical means and expertise to meet the requirements of drug quality control and management of medicines due to the manufacturing facility.
5. Retention of samples of the drug batches produced within a period of at least one year since the drug expires; the production of documents and other materials required for the checks and reviews of the entire drug manufacturing operations under the provisions of the law.
6. Monitor the quality of medicines due to the production facility in circulation on the market and recovered the drug according to the provisions of this law.
7. registration of medicines; drug price declaration before circulating the drug on the market.
8. Compensation for the use of the drug in the event of damage caused by the fault of the production base.
9. other obligations prescribed by law.
Article 17. The drug dispensing in pharmacies, medical establishments, healing 1. The medication dispensing under the application in pharmacy, medicine dispensing in medical establishments, cure drug registration, not only is allocated or retail basis. Drug dispensing records to be kept during a year from the date the drug was concocted.
2. The landlord, the Manager of pharmaceutical expertise on the basis of consultations, healing must take responsibility for the quality of medicines concocted at the facility; compensation for the use of the drug in the event of damage caused by drug processing error.
3 entries for EXPORT, importing medications for 18. Rights and obligations of the exporters, importers of drugs 1. Export, import, mandated and entrusted to export and import the drugs prescribed by the Ministry of health.
2. Comply with the rules of good practice in the preservation, drug distribution, to declare the price of drugs.
3. export and import only the drug quality standards, monitoring and responsibility for the quality of drugs circulating on the market due to the export and import business.
4. Compensation for the use of the drug in the event of damage caused by the fault of the export and import business.
5. The other rights and obligations under the provisions of the law.
Article 19. Mandated drug import export 1. Drug business establishments have the right to export mandate, imported drugs.
2. The mandated drug imports, exports made under the provisions of the commercial law and the provisions of relevant laws.
Article 20. The scope and import of drugs 1. The drug has the registration number in Vietnam are imported with no restrictions on the number, excluding vaccines, drugs and medical products in the category is a special control under the provisions of article 63 of this law.
2. Yet there are import registration number with the number in the following cases: a) containing substance not yet have registered or had registered but not yet meet all the demands for treatment;
b) meet the urgent need for prevention of disease, disaster recovery, disaster and demand special treatment;
c) serves for the program the national health objectives;
d) aid, humanitarian aid;
Clinical Trials), to do the registration form, participants exhibited, fair;
e) bring to heal itself;
g) phi forms other trade.
3. Prime the specific regulations for the importation of drugs prescribed in clause 2 of this Thing.
ITEM 4 Article 21 DRUG WHOLESALERS. The basis of drug wholesalers, wholesale drug establishments include: 1. The business of drugs;
2. Cooperative, individual business households producing, trafficking, Oriental medicine, medicinal drugs from medicinal herbs;
3. sale agent vaccine, medical products.
Article 22. Rights of the wholesale drug establishments 1. Buy the ingredients for the drug, the drug products, vaccines, biological medical products from the production facility or wholesale basis.
2. Sell ingredients for drugs, drug products, vaccines, biological medical products for business functions and the base doctor, healing.
Article 23. Obligations of the wholesale drug establishments 1. Storage according to the conditions indicated on the label of the drug.
2. Keep intact packaging of medications, not change the packaging and label of the drug. Case change the label, the packaging of medicines have been registered, they must be authoritative drug production facilities and the Ministry of health agreed to in writing.
3. Ensure the delivery, receiving, storage must be by people with expertise about pharmacy.
4. Retention of documents, documents related to each batch of drugs within a period of at least a year, since the drug expires.            
5. Listed on the wholesale price of drugs and compliance with the provisions on the management of drug prices.
6. Compensation for the use of the drug in the event of damage caused by the fault of the wholesale drug establishments.
7. In compliance with the rules of good practice in the preservation, drug delivery, drug recovery and the provisions of relevant laws.

DRUG RETAIL section 5 article 24. Retail drug establishments 1. Retail drug establishments include: a) pharmacies;
b) drug Counters;
c) resellers of enterprise;
d) medical station's medicine cabinet.
2. The base doctor, healing and wholesale drug establishments want to establish drug retail retail drug establishments.
3. The Minister of health of local rules on open drug retail establishments according to the form of the counter medicines, resellers of business and medicine cabinets of medicine clinics with suitable socio-economic conditions, the reality of the medical staff and treatment needs of people in each stage.
Article 25. The professional conditions of retail drug establishments, retail people smoking 1. The professional conditions of retail drug establishments are defined as follows: a) the pharmacy must do pharmacists have academic standing home base name;
b) drug Counters by qualified pharmacists from middle school stands named home base;
c) resellers of enterprise by people with expertise from the nurse over the stand owners name;
d) of medicine cabinet clinics are by people with expertise from the nurse over the stand owners name; the case has not yet had someone with expertise from the older nurse must have the qualified professional people from nurse over stand name;
DD) retail drug establishments specializing in sale of Oriental medicine, the drug from medicinal herbs are due to high qualified pharmacists and over or who have a diploma, a certificate of traditional medicine or pharmacy name traditional home base.
2. the retail People retail facility smoking smoking rules at points a, b, c and paragraph 1 of this article must have a qualification from the nurse; in point d of paragraph 1 of this article must have expertise on medicine, pharmacy.
Article 26. The scope of activities of retail drug establishments 1. The scope of activities of retail drug establishments are defined as follows: a) the pharmacy retail drug finished product are; dispensing drugs according to the menu;
b) retail drug Counter Drugs products;
c) resellers of retail drug enterprises are under the category of essential drugs;
d) of nursing medicine cabinet sold the drug under the essential drug list used for online social health;
retail establishments) Oriental medicine, medicines from medicinal herbs sold Oriental medicine, medicines from medicinal herbs.
2. retail facility smoking regulations in points b, c, d and DD clause 1 of this article may not sell drugs, radioactive drugs.
Drug retail premises not being sold raw pharmaceutical chemistry medicinal.
3. Minister of health regulations on conditions of pharmacies are dispensing drugs according to the menu.
Article 27. Rights of drug retail and retail establishments of smoking 1. The retailer had the following rights: a) Are drug retail for users;
b) refused to sell prescription drugs when listed incorrect prescriptions or drug buyers are not likely to receive the necessary instructions;
c) the retailer is pharmacist college level have the right to replace the drug with other medications a have the same active ingredient, dosage form, the same dosage when the consent of the buyer;
d) make the rights of owners of retail establishments in the scope is authorized.
2. Home base of retail drug has the following rights: a) Has the rights specified in point a and point b of paragraph 1 of this Article;
b) buying drugs from wholesale drug establishments for retail, buy raw materials for drug processing according to the menu;
c) authorize employees have professional level equivalent over operating when absent.
Article 28. Obligations of the reseller and retail establishments of smoking 1. The retailer had the following obligations: a) check prescriptions before selling;
b) stating the name of the drug, the concentration on packaging for smoking when smoking non-retail packaging in containers outside of the drug;
c) Sell right in the prescription drugs, except in cases specified in point c of paragraph 1 of article 27 of this Law;
d) where alternative medicine as prescribed in point c paragraph 1 article 27 of this law shall specify the name of the drug, the concentration, the concentration, the amount of the drug, how to use the drug has replaced application and is responsible for the alternative medicine;
DD) responsible to the home base of retail drugs about his behavior in the authorized range.
2. retail facility Owners smoking has the following obligations: a) directly managing, operating every operation of the facility;
b) listed the time selling drugs; the retail price listed on the product, except where the retail price is printed on the product; not be sold higher prices;
c) responsible before the law for all activities of the facility, including, in the case of authorization.
3. The retailer home retail establishments, smoking must compensation for people who use drugs in the event of damage caused by his fault.
SECTION 6 STORAGE SERVICE Article 29. Conditions for business to do business storage services as a service preserve the drug must reach the standards of good practice in conservation medicine.
Article 30. The right of preservation services do business smoking 1. Get storage for organizations or individuals under contract to preserve.
2. Shipping and delivery of the drug for the individual organization when the party rental service maintenance authorizations.
3. Enjoy the Feds do drug preservation services.
Article 31. The obligation of doing business storage services 1. Preserving the right to require preservation of recorded on the label and the contract between the two parties.
2. Compensation for damage caused by the violation of regulations in the process of preserving and transporting drugs.
Section 7 DRUG TESTING SERVICES Article 32. Conditions for business doing drug testing service business doing drug testing services must reach the standards of good practice in drug testing. Laboratory case of drug business enterprises want to do drug testing services, the business must make additional function as drug testing services in the certificate of eligible drug business under the provisions of the law.
Article 33. The right of enterprises to do drug testing services 1. Raw material testing as drugs, drug products, drug products.
2. Answer the test results for drug samples were tested.
3. Enjoy the Feds do drug testing services.
Article 34. The obligation of business to do drug testing services 1. Responsible for test results for drug samples were tested.
2. the compensation prescribed by law for the Organization, the individual suffers damage due to incorrect test results.
Chapter III registration, CIRCULATION SMOKING Article 35. Drug registration 1. Grounds for drug registration include: a) clinical trial results on the effectiveness and safety of drugs, drug clinical trial exemption unless the provisions of article 55 of this law;
b) technical documents about smoking;
c) national policy on smoking of Vietnam.
2. The basis of drug registration fees when filing under the provisions of the law.
3. within six months from the date of receipt of a valid application, the Minister of Health issued the registration number of the drug; no case level must have text answers and stating the reason.
4. Minister of health detailing the procedure, drug registration documents, the time limit for the validity of drug registration and revocation of registration.
Article 36. Circulation of drugs 1. Drugs circulating on the market to ensure the following conditions: a) quality standards registered;
b) meets the requirements for labeling of goods according to the provisions of article 37 of this law and other provisions of the law;         
c packaging materials) and type of packaging must meet the requirements for ensuring the quality of medicines;
d) Has the registration number or the registration number yet but are imported as specified in point a and point b paragraph 2 of article 20 this law;

DD) Must be declared drug prices under the provisions of this law; If the drug is imported, the price of imported drugs not be higher than the price of the drugs imported into the country in the areas of health, trade conditions similar to Vietnam at the same time.
2. The drug production in the country for a national health program, imported drugs prescribed in points c, d, e and e clause 2 of article 20 of this Law must be used for your purposes, objects; drug labels must meet the provisions of article 37 of this law; on the packaging of the medication must be in the words "not for sale", unless otherwise specified in point e of article 20 of this law, item 2.
Article 37. Label the drugs circulating on the market 1. Label the drugs circulating on the market are full of content: a) the name of the drug;
b) dosage form;
c) composition of the drug;
d) packing;
DD) name, address of the manufacturing facility;
e) the registration number, production lot number, date of manufacture, expires;
g) conditions of storage and other necessary information.
In the case of miscellaneous is the substance must record the original name or the common name under the name international miscellaneous.
2. Smoking should have instructions for use by the Vietnamese.
Article 38. Recovery of smoking 1. Drugs circulating on the market recovered in the following cases: a) is not the correct type due to a confusion in the allocator process, delivery;
b) does not meet the conditions specified in points a, b, c and d of paragraph 1 of this Law 36 Thing;
c) Has announced the revocation of drug production base, the State administration of Medicine of Vietnam or abroad.
2. in case of withdrawal of drugs prescribed in point b and point c of paragraph 1 of this article shall, before withdrawing to have decided to suspend the circulation of the State administration of Medicine of Vietnam.
3. When the notice of the revocation of drug production base or decided to suspend the circulation of State administration on the Vietnam pharmaceutical organizations, personal trading, basis of examination and treatment, the prescription and drug users must immediately suspend the business , information, advertising, prescription, and use of medicines were reported recovered.
4. Basis of import, manufacture, registration, drug supply is responsible for organizing the suspended drug withdrawal and the compensation of the consequences caused by the provisions of the law.
State administration of medicine is responsible for examining the Organization of drug withdrawal.
5. Minister of health specifies the order and procedure for withdrawing the drug, classified the level of recovery, the scope of the suspension of drug circulation and handling of drugs recovered.
Chapter IV Oriental medicine and DRUGS FROM PHARMACEUTICAL Article 39. Drug crops and breeding animals as drugs cultivation, animal husbandry and harvesting processes cholin, mining products to make drugs must comply with standards of good practice in aquaculture, harvesting of medicinal herbs.           
Article 40. The quality of medicinal herbs medicinal herbs production and processing or weight to lift to quality assurance in accordance with the regulations. The Organization, individuals are responsible for providing the source and quality of medicinal herbs by themselves supply.
Article 41. Preserving medicinal 1. Medicinal herbs must be processed and preserved properly after extraction, harvesting. The level of chemical residue conservation and plant protection, chemical preservatives do not exceed permitted levels.
The Minister of health stipulates the conditions of processing, preserving existing levels, medicinal plant protection chemicals residue, chemical preservatives allowed in medicinal herbs.
2. When transporting, medicinal herbs must be packaged. On the packaging must be of medicinal medicinal name record label, where the produce, the quality, the packaging date.
Article 42. Sale of Oriental medicine and medicines from medicinal herbs at the base hospital, cure doctor Oriental medicine, Oriental medicine doctors, Liang y are working at the base hospital, healing is Oriental medicine retail and smoking from medicinal herbs at the base hospital, healing.
43 things. Drug registration, circulation of Oriental medicine and medicinal drugs from 1. The registration of Oriental medicine and medicines from medicinal herbs are made according to the provisions of article 35 of this law and the provisions of the following: a) Oriental medicine and medicinal drugs from domestic production or import to circulate on the market are required to register;
b) clear weight according to the menu at the base hospital, Oriental medicine healing, medicinal drug, the lamina is not registered. Home Retail base, home base doctor, healing must take responsibility for the quality of the drug.
2. The circulation, recovery of Oriental medicine and medicines from medicinal herbs are made according to the provisions of article 36 and article 38 of this law.
3. the combination of medicinal herbs with pure active substances extracted from the natural origin or with chemical active substances carried under the provisions of this law and is not registered as oriental medicine and medicines from medicinal herbs.
Article 44. The production of Oriental medicine and medicinal drugs from 1. The basis of the production of Oriental medicine and medicines from medicinal herbs from the manufacture of finished products to the packaging must comply with the rules on good manufacturing practice Oriental medicine, medicines from medicinal herbs and made according to the provisions of section II of chapter II of this Law.
2. Oriental medicine and medicines from medicinal herbs that contain medicinal herbs have toxic, addictive substances, mental direction, precursor substances must specify the concentration, concentration, standard test methods, the medicinal herbs in the technical dossier.
3. The Secretary of the Ministry of Health issued regulations and list the medicinal herbs that contain toxins, drugs, mental direction, precursor substances.
Article 45. Export, import, wholesale, retail sale in Oriental medicine and medicinal drugs from the export, import, wholesale, retail sale in Oriental medicine and medicines from medicinal herbs is done according to the rules in section III, section IV and section V of chapter II of this law.
Chapter V the PRESCRIPTION and USE of DRUGS Article 46. Prescriptions 1. The prescription is legitimate base to sell drugs, medications, medicine, medicine processing and the use of drugs. Drug name stated in the menu to the root name or common name, unless smoking has many active substances.   
2. Minister of health specific rules about prescription drug group, and the sale of prescription drugs.
Article 47. The use of drugs 1. Drug users have a choice to buy drugs retail establishments.
2. When using prescription drugs, drug users should follow the instructions noted in the prescription. Non-prescription drug use, the user must follow the right sheets, manual instructions of the retailer.
3. When using the drug, if the body has other signs of unusual, people who use drugs should immediately notify the nearest medical facility, the medication or drug retailer to take measures promptly.
4. Who prescribe drugs, drug retail facility owners have the responsibility to inform the competent health authorities about the unusual signs of drug users. The medication must be liable before application.
Chapter VI SUPPLY DRUGS in MEDICAL ESTABLISHMENTS, healing thing for 48. Drug supply conditions 1. The supply of drugs in medical treatment facility must comply with the rules of good practice in distribution, storage and the other provisions of the relevant laws.
2. The dispensation in the base doctor, healing must take medications according to medical prescription or order, stating the name of the drug, the concentration on the drug packaging and instructions to the user.

3. Physicians, doctors, nurses, midwives, nurses are not selling drugs for the sick, except in cases specified in article 42 of this law.
Article 49. Secure the drug supply 1. The base doctor, cure has the responsibility to ensure sufficient supply of quality drugs in the formulary is primarily used in the base doctor, healing service for emergency needs, medical examination and treatment at the facility.
The Minister of health regulations and list of emergency drugs, the drug is mainly used in the base doctor, healing and supplying drugs at State health facilities, except for the purchase of drugs prescribed in clause 2 of this Thing.
2. The purchase of drugs in the formulary of the State health facilities and smoking due to the State budget to pay made under the provisions of the law of tenders, ensure the following principles: a) the priority to buy pills produced in water of the same type, quality and price no higher than the imported drugs;
b) drug prices are not higher than the bid price by the competent State agencies periodically announced as specified in point d of this Law article 5 clause 2.
The Minister of health in collaboration with the Ministry of planning and investment and the Minister of Finance shall guide the purchase of drugs prescribed in this paragraph.
Article 50. Dispensing of medication in the base doctor, cure 1. The base doctor, cure meet standards, conditions of dispensing the drug allowed single drugs concocted for the treatment needs of the facility as defined in article 17 of this law.
2. Minister of health standard regulations, conditions of dispensing drugs in medical treatment facility.
Chapter VII information, DRUG ADS Article 51. Drug information 1. Drug information aims to guide rational drug use, safety for health officials and drug users.
2. drug information is complete, accurate, impartial, honest, easy to understand, not to be misleading.
3. responsibility of drug information are specified as follows: a) the basis of production, purchase, sale and supply of medicines is responsible for drug information for officers, medical staff and users;
b) medical facility is responsible for the management and dissemination of drug information within his unit;
c) officers, medical staff are responsible for the relevant drug information for people who use drugs in consultation processes;
d) State administration of medicine is responsible for publicizing information about the drug.
4. Responsible for tracking harmful drug reactions are defined as follows: a) the basis of examinations, cure, officials, medical staff have the responsibility to monitor and report to the person in charge of the premises, the competent authority of drug management on the harmful effects of smoking;
b) in the process of circulation of medicines, production facilities, distribution of drugs to track, report to the person in charge of the facility and the competent authority of drug management of harmful drug reactions due to its base of production, distribution.
5. organizations, individual drug information must take responsibility for the information provided by themselves.
6. The Minister of health is responsible for the Organization of drug information systems and monitoring of harmful reaction of drugs in order to ensure the rational use of drugs, the safety of the people; regulations on drug information activities at the medical facility.
Article 52. Drug ads 1. The drug ads by business establishments, smoking or advertising services business people make and must comply with the provisions of the law on advertising.
2. do not use the physical benefits, taking advantage of individual organizations, correspondence, results of clinical studies have yet to be recognized by the Ministry of health and the same form to drug ads.
Article 53. Drug advertising scope 1. Prescription drugs cannot be advertised to the public in any form.
2. non-prescription Drugs to be advertised on the advertising media; the case of advertising on radio, television must meet the following conditions: a) is the active ingredient in the list is allowed to advertise on radio, television, issued by the Ministry of health;
b) Have registered in Vietnam are still in force.
Chapter VIII RESEARCH on CLINICAL Article 54. Clinical reagents 1. New drugs must be clinical trials.
2. clinical reagents must ensure the following requirements: a) has been studied in clinical stage;
b) has a stable form;
c) quality standard according to clinical trial registration records.
3. clinical reagents to Label inscription: "production for clinical trials. All spaces used for other purposes ".
Article 55. Smoking clinical trial exemption or remission of a clinical trial phase number 1. The drug carries the original name.
2. foreign Medicines have not yet been issued the number registered in Vietnam but has been circulating for at least five years of legal in that country; has been widely used for many patients, are the competent State authorities of the country of origin certifying drugs are safe and effective; have the same use, and content specified in Vietnam like specify in that country.
3. The article Oriental medicine has been recognized by the Ministry of health.
4. Minister of health specifies those cases be free of drug clinical trial or free of some of the clinical trial stage.
Article 56. Conditions of clinical trial participants 1. Clinical trial participants to be volunteers, respond to requests for expertise and must sign a contract with the receiving organization of clinical trials, except for people with limited capacity for civil acts, lost the capacity for civil acts or doesn't have the capacity for civil acts.
2. where the clinical trial is yet to come of age, with limited capacity for civil acts or lost the capacity for civil acts it must be consent of the representative in accordance with the law.
3. Minister of health regulations for clinical trials is a woman who is pregnant.
Article 57. Rights of participants in clinical trials 1. Provided complete and truthful information before attempting clinical trials and the risk can occur.
2. Is the Organization, individuals have clinical reagents in damages if due cause clinical trial.
3. Confidentiality of the personal information involved.
4. Is not responsible when the unilateral termination of the contract of participation in clinical trials.
5. Complaints, accusations about the violation of the law of the Organization, individuals have clinical reagents and receive clinical trial.
Article 58. The Organization's rights, individuals have clinical reagents 1. Choose the organization meet regulations regarding facilities and professional staff to test drugs on clinical.
2. Be owned the entire results of the clinical trial drug research.
Article 59. Obligations of the Organization, individuals have clinical reagents 1. And was the Minister of health agreed in writing prior to clinical trials.
2. Compensation for clinical trial participants if the risk occurs because the clinical trial in accordance with the law. 
3. The contract regarding drug testing on the receiving organization clinical drug trials on the clinical.
Article 60. The Organization's rights to receive clinical drug on trial 1. Held, individuals have clinical reagents supplied drugs, funding to conduct the clinical trial in accordance with the provisions of the law.
2. using the results of research on clinical drug trial under an agreement with the Organization, individuals have clinical reagents.
Article 61. The obligation of the organization receiving the drug on clinical trials 1. Compliance with the regulations good practice in clinical drug trials; report on the process, clinical trial results and the report of an emergency in case of need with the Ministry of health.
2. The contract regarding the clinical trials of drugs on individuals with clinical and reagents to clinical trial participants.
Article 62. The stages and procedures of clinical drug trials

1. Try smoking on clinical must be done according to the stages and must follow the rules of good practice in clinical drug trials.
2. Minister of health specified conditions, record, sequence and the stages of clinical trials on the drug.
Very ADDICTIVE DRUG MANAGEMENT programs, MENTAL DIRECTION, DRUG PRECURSORS USED DRUGS and RADIOACTIVE DRUGS Article 63. Medication list to the special control 1. Addictive drugs, mental direction, drug precursors used drugs and radioactive drugs are those drugs in the category is a special control.
2. The Minister of Health issued a drug formulary are special controls consistent with international treaties to which the Socialist Republic of Vietnam is a member.
Article 64. Business conditions, the use of drugs in the category is a special control 1. Business establishments, blending, medications list to special control must satisfy the conditions prescribed drug business of the Government.
2. The import, export and transport of drugs in the category of special control must be made in accordance with the law.
3. Smoking in the category is a special control is used for the purpose of prevention, cure, diagnosis, tuning the body and physiological function of scientific research and may not be used for other purposes.
Article 65. The responsibility of the business establishment, blending, medications list to special control 1. Business base, dispensing and medications list to special control is responsible for: a) sudden or periodic reports to the competent State management;
b) retention of documentation, relevant documents for each drug after expiry drugs used for at least two years.
2. Canceling the drug list is a special control is performed in the correct sequence, regulatory procedures and comply with the provisions of the law.
Chapter X the QUALITY STANDARD of DRUGS and the DRUG TESTING Article 66. Quality standard of drugs 1. Vietnam's drug quality standards including national standards and facility standards.
2. National standards for the quality of medicines and drug testing methods specified in Vietnam Pharmacopeia.
The base standard because drug production facilities and construction announced. The base standard not lower than that of the national standard for the quality of medicines.
3. Government regulations the promulgation of Vietnam Pharmacopeia, Pharmacopoeia foreign adoption, international Pharmacopeia in Vietnam.
Article 67. Drug testing 1. The drug testing is conducted in accordance with the quality standards of medicine production base has registered. Cases of application of other methods not according to the method in the registered standards must then be approved by the Ministry of health.
2. where there is doubt regarding the composition or quality of the drug, the State's testing base on the drug is applied other methods with the methods in the standard have registered to test and give the test results for the quality of medicines.  
3. Minister of health specifies the order and procedure of sampling, save the form and content of the test drug quality.
Article 68. The basis of drug testing drug testing facility includes the State's testing base on the drug, making service business of drug testing, laboratory of business establishments.
Article 69. The State's testing base on the drug 1. The State's testing base on the drug to help state regulators about pharmacy in determining the quality of the drug.
2. the State's testing base on the drug have such rights and obligations the rights and obligations of the business do drug testing services are specified in article 33 and article 34 of this law.
3. Government regulation system of organization and operation of the State's testing base on the drug.
Article 70. Complaints about the quality of drugs conclusions 1. The drug business establishments have the right to complain about the quality of drugs conclusions of State administration of medicine.
2. Government Regulation sequence, procedure, complaints about Agency concluded the quality of drugs.
Chapter XI Article 71 ENFORCEMENT TERMS. Transitional rules the Organization, individuals are issued a certificate of eligibility to practice medicine before this Act in force that is still the time limit shall not apply for the license.
Article 72. Effect of this Law has effect from 1 October 2005.
The previous regulations contrary to this law are abrogated.
Article 73. Detailing and guiding the implementation of government regulations and detailed guidelines for implementing this law.
This law was the National Assembly of the Socialist Republic of Vietnam, the POKER session key 7 through June 14, 2005.