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The Decree 102/2016/nd-Cp: Business Conditions Smoking Regulations

Original Language Title: Nghị định 102/2016/NĐ-CP: Quy định điều kiện kinh doanh thuốc

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GOVERNMENT-------the SOCIALIST REPUBLIC of VIETNAM independence-freedom-happiness---------------number: 102/2016/ND-CP on Jul. 01, 2016 DECREE REGULATING DRUG BUSINESS CONDITIONS pursuant to the law the Government Organization on June 19, 2015;
Pharmaceutical Law base on June 14, 2005;
Pursuant to the law on investment on November 26, 2014;
According to the recommendation of the Minister of health;
The Government issued the decree regulating drug business conditions.
Chapter I GENERAL PROVISIONS article 1. Scope and objects 1. This Decree regulates the business conditions.
2. This Decree shall apply to agencies, organizations, individuals in State and foreign operations in the pharmaceutical sector in Vietnam.
Article 2. Explanation of terms In this Decree, the terms below are interpreted as follows: 1. The basis of legitimate pharmaceuticals is the basis of activities in the field of Pharmacy was established under the provisions of the law, including: a) drug business establishments;
b) pharmaceutical division of medical establishments;
c) The school has specialized training in pharmacy;
d) The Pharmaceutical Research Institute, and Institute drug testing center;
DD) State administration of medicine;
e) representative offices of foreign traders operating in the pharmaceutical sector in Vietnam;
g) The other pharmaceutical facility under the provisions of the law.
2. Smoking finished products combined form containing active substances are drugs addictive products that meet the following conditions simultaneously: a) containing the active ingredient active ingredient is not addictive, not the mental direction of active substances and precursors are not used;
b) containing the active substance, or containing drug activities in coordination with active ingredient mental direction, or containing drug activities in collaboration with the precursors used, or containing drug activities in collaboration with the mental direction and active substances used as precursors of drugs;
c) concentrations, the concentration of drug activity, mental direction, active substances used as precursors of drugs are both less than or equal to the concentration, the amount specified in the list by the Minister of health.
3. the finished Drug form of coordination that contains the active ingredient of mental direction is smoking finished products that meet the following conditions simultaneously: a) containing the active ingredient active ingredient is not addictive, not the mental direction of active substances and precursors are not used;
b) containing the active ingredient of mental direction or contains the active ingredient of mental direction in collaboration with precursor used;
c) concentration, amount of the active ingredient of mental direction, money used substances are less than or equal to the concentration, the amount specified in the list by the Minister of health.
4. Smoking combined form products containing precursors is smoking finished products that meet the following conditions simultaneously: a) containing the active ingredient active ingredient is not addictive, not the mental direction of active substances and precursors are not used;
b) containing precursors used in smaller amounts, concentrations or levels of concentration, defined in the catalog by the Minister of health.
5. Smoking is the chemistry of drugs containing the active ingredient has been identified, the formula, purity.
6. Pharmaceutical drug materials is derived naturally from plants, animals, minerals and standard drugs.
Not include the medicinal products drugs from medicinal herbs.
7. drug products from medicinal herbs are medicinal drugs from materials as high, Nuggets, powder, tincture, extracts, essential oils and are used in the production of medicines from medicinal herbs.
8. Medicinal (pharmaceutical) is of natural origin ingredients from plants, animals, minerals may be used but is not yet over, preliminary processing.
9. traditional medications Gentlemen's medicinal herbs are processed according to the reasoning and methods of traditional medicine used to produce Oriental medicine or used for prevention and treatment.
10. Preliminary processing is checked and classified medicinal, remove impurities, soaking, washing, drying, exposure, annealed, cleaned, dried, powdered or approval.
11. processing is the process of changing the quality and quantity of medicinal or pharmaceutical has preliminary into the traditional medicine according to the reasoning and methods of traditional medicine.
Article 3. Forms of business organization smoking 1. Production facilities include: a) drug production business;
b) cooperatives, business households produce medicinal herbs, Oriental medicine and medicines from medicinal herbs.
2. wholesale drug establishments include: a) wholesale drug business;
b) cooperative, wholesale pharmaceutical business households, Oriental medicine and medicines from medicinal herbs;
c) Wholesale Agent vaccine, medical products.
3. retail establishments include the forms of business organization specified in clause 1 article 24 of the law on pharmaceuticals; the facility specializes in Oriental medicine, retail drugs from pharmaceutical as defined in point 1 article 26 of law clause Mutan medicine.
4. export and import business.
5. maintenance service business.
6. do business of drug testing services.
7. Basis as a service research on the clinical.
Chapter II BUSINESS SMOKING Items 1. CONDITIONS of CERTIFICATION of ELIGIBLE DRUG BUSINESS article 4. The object to be certified eligible drug business 1. Certificate of eligible drug business was granted to the drug business establishments that meet the conditions for each form of business of drugs prescribed in this chapter.
2. Business establishments, smoking just to be active in the correct location and business scope prescribed in the certificate of eligible drug business.
Article 5. Conditions of certification of eligible drug business for drug production facilities 1. Professional pharmacy managers must have the certificate of practice medicine consistent with each form of business organization of drug manufacturing facility.
2. drug production facilities must meet the following conditions: a) the number of qualified personnel, and is consistent with the assigned tasks;
b) workshop, auxiliary systems and devices are fitted, layout, design, construction, evaluation, evaluation, use and maintenance of suitable for the purpose of use;
c) quality control area meet appropriate quality control production scale;
DD) conservation area ensuring conditions of preservation and conservation activities to match the scale of production;
DD) has a quality management system, based on the document profiles standard, formulas, tutorials, covering procedures for the operations to be performed.
Article 6. Conditions of certification of eligible drug business wholesale drug establishments 1. Professional pharmacy managers must have the certificate of practice medicine consistent with each form of business organization wholesale drug establishments.
2. wholesale drug establishments must meet the following conditions: a) the number of qualified personnel, and is consistent with the assigned tasks;
b) warehouses, ancillary systems shall be designed, built, use and maintenance of suitable for the purpose and scale of use, make sure to preserve the correct preservation conditions indicated on the label of the drug; have a private area to preserve the order of the different product types; reception area, allocated must be able to protect the drug from adverse weather conditions; preservation areas concerned must have proper signage, obviously;
c) equipment maintenance and transport equipment must be fitted, layout, design, evaluate, evaluation, use and maintenance of suitable for the purpose of use, make sure the conditions of preservation and conservation activities;
d) preservation Repository is the broadcasting system and backup power for the operation of the cold;

DD) Have guaranteed drug transport preservation conditions, requirements of security, safety of medicines due to business establishments;
e) quality management systems, document profile, the Guide, the process of covering for the activity to be performed.
Article 7. Conditions of certification of eligible drug business for retail drug establishments 1. Home retail drug establishments must have a certificate of practice medicine consistent with each form of business organization of drug retail premises.
2. retail drug establishments, except medicinal, retail establishments must meet the following conditions: a) must be fixed, separate locations; arranged in high place drain, cool, safe, far from the source of pollution and has prescribed signs;
b) retail locations are built sturdy, dust ceiling, walls and floors are easy to clean, but not light enough to smoking being a direct impact of sunlight; ensure the maintenance of conditions of preservation indicated on the label of the drug;
c) area consistent with the scale of the business, to be areas to showcase, preserve and area to drug buyers contact and exchange of information on the use of the drug with the retailer;
d) must be positioned more area for other activities: processing area according to the menu if there is organized according to the menu blending; out of area travelers the drugs no longer have the packaging in direct contact with the drug to the patient directly for retail; hand-washing place for retail buyer and people smoking; private consultation areas for patients and chairs for people who buy drugs in the meantime;
DD) Must have the cabinets, storage shelves meet the requirements regarding storage conditions, the requirement of ensuring security, safety for smoking;
e) business case more functional food, cosmetics, medical devices must have a private sector, not sold along with medication and do not affect the smoking, article 8. Conditions of certification of eligible drug business for exporters, importers of drugs 1. Professional pharmacy managers must have the certificate of practice medicine consistent with each form of business organization of the export base, importing the drug.
2. Basis of imported drugs, drug export basis must meet the following conditions: a) the number of qualified personnel, and is consistent with the assigned tasks;
b) warehouses, ancillary systems shall be designed, built, use and maintenance of suitable for the purpose and scale of use;
c) equipment maintenance and transport equipment must be fitted, layout, design, evaluate, evaluation, use and maintenance of suitable for the purpose of using the guarantee conditions of preservation and conservation activities;
d) quality management systems, document profile, the Guide, the process of covering for the activity to be performed.
3. The enterprise has the certificate of eligible drug business with the wholesale drug forms.
Article 9. Conditions of certification of eligible drug business for enterprise storage service 1. Professional pharmacy managers must have the certificate of practice medicine consistent with business forms service maintenance medication.
2. doing business storage services must meet the conditions specified in paragraph 2 article 8, point d article 19 paragraph 1 of this Decree and to ensure the accountability for party rental service on the quality, quantity, value and guaranteed to party rental service make liability for smoking due to the receiving facility maintenance.
Article 10. Conditions of certification of eligible drug business for business doing drug testing services 1. Professional pharmacy managers must have the certificate of practice medicine consistent with corporate forms of doing drug testing services.
2. The business of drug testing services must meet the following conditions: a) a sufficient number of qualified personnel, and is consistent with the assigned tasks;
b) laboratory must be of appropriate design, layout, the layout is spacious enough to separate the various testing activities, enough room for professional equipment, record the document and the workspace for employees;
c) the equipment, machinery, tools must be equipped with suitable methods, enterprise's business purposes and consistent with the sampling, analysis, calibration and data processing;
d) fully equipped chemical, reagents, standard quality, technical documents that meet the purpose test;
DD) has a quality management system, records documents, guidelines, process embraces the operations to be performed.
Article 11. Certification conditions eligible for business service facility to try medicine on the clinical 1. Professional pharmacy managers must have the certificate of practice medicine consistent with base form as a service to try smoking on clinical, specifically: a) the Manager of the pharmacy business professional to do drug testing on the service must have the clinical University pharmaceutical or medical industry in General and has 3 years professional practice in appropriate pharmacy or facility the Institute, the Institute has a hospital bed except in cases specified in point b of this paragraph;
b) people management expertise on making service business pharmaceutical drugs on clinical trial of the drug from medicinal herbs are available in University and pharmaceutical or medical industry or general medicine or traditional medicine and have 3 years professional practice in appropriate pharmacy facility or hospital the Institute has a hospital bed.
2. Basis as a service research on clinically must meet the following conditions: a) a sufficient number of qualified personnel, consistent with the assigned tasks;
b) has the location, clinical trials, laboratory equipment, biology is the design, construction, and has an area of active drug testing suit clinically;
c) quality management system document profile based on these standards, formulas, processes, guidelines for clinical drug trial activities.
Section 2. BUSINESS CONDITIONS PHARMACEUTICAL article 12. General conditions for the export basis, import, wholesale, retail and services preserve medicinal 1. The basis of the export, import, wholesale, retail and services for preservation of medicinal herbs must be certified eligible business smoking medicinal business scope.
2. Conditions for the certification of qualified business smoking medicinal business scope: a) the Manager of a professional basis must have the certificate of practice of pharmacy, except in the case prescribed in clause 2 article 17 of this Decree;
b) have qualified respectively for each type of business regulation in articles 13, 14, 15 and 16 of this Decree.
Article 13. Export, import of pharmaceuticals 1. Basis of import medicinal herbs must have the following conditions: a) has been granted the certificate of eligible drug business with the pharmaceutical wholesale range;
b) meets guidelines, good conservation practice standards for pharmaceutical drugs;
c) medicinal business establishments not yet eligible to import directly must sign contracts with import trustee of establishments that qualify as regulated imports and import trust facility name must be on the order of import.
2. The enterprise has the certificate of eligibility with a business scope production of medicines from medicinal herbs and has achieved certificate for good manufacturing practice guidelines (GMP) are imported medicinal herbs to serve the needs of corporate production and sale to the other drug manufacturing facility , the base doctor, cure prescribed by law.
3. The facility must have sufficient medicinal exports the following conditions:

a) the conditions specified in point a of paragraph 1 of this article;
b) The regulation of the conditions in the country of import medicinal herbs (if available).
Article 14. Conditions for wholesale pharmaceutical facility meets guidelines, good conservation practice standard medication for pharmaceutical principles, standards and good practice for pharmaceutical drug distribution specified in point g and h clause 1 of this Decree 19 Ostrich.
Article 15. Conditions for retail pharmaceutical establishments 1. On campus: a) has a fixed location, the area consistent with the scale of the business, separately; arranged in high place drain, cool, safe, far from the source of pollution, ensure the prevention of fire and explosion; to display area, the area of the preservation of medicinal herbs;
b) Has equipment to preserve the drug to avoid the adverse effects of light, heat, humidity, pollution, the intrusion of insects, including: cabinets, shelving, counters for sure, smooth, easy, convenient to showcase, preserve the drug; thermometer, humidity, air conditioner, dehumidifier to control the temperature, humidity in the retail pharmaceutical facility, lighting, exhaust fans. Preserving equipment consistent with preservation requirements indicated on the label. Preservation conditions at room temperature to maintain no more than 30° C, humidity does not exceed 75%.
2. Personnel: a) Have suitably qualified staff with work assigned, of which at least one person from nurse;
b) direct retail pharmaceutical People are regularly trained, professional training, update the new laws about preservation, medicinal management.
3. retail establishments just sold the medicinal herbs that are purchased at the base are qualified pharmaceutical business; have clear and origin have packaging, labelling as specified by the Minister of health on drug labeling guidelines; not sell the pharmaceutical toxins in unprocessed toxic medicinal use as drugs in Vietnam by the Minister of health.
Article 16. Conditions for business as a service to preserve medicinal 1. Professional pharmacy managers must have the certificate of practice medicine consistent with corporate form as a service to preserve medicinal herbs.
2. service business to preserve medicinal herbs must meet the following conditions: a) the number of qualified personnel, and is consistent with the assigned tasks;
b) warehouses, ancillary systems shall be designed, built, use and maintenance of suitable for the purpose and scale of use;
c) equipment maintenance and transport equipment must be fitted, layout, design, evaluate, evaluation, use and maintenance of suitable for the purpose of using the guarantee conditions of preservation and conservation activities;
d) quality management systems, document profile, the Guide, the process of covering for the activity to be performed.
Article 17. Medicinal business in villages, traditional villages, traditional medicinal business city 1. Form of the export, import, wholesale, service, preservation of medicinal herbs in traditional village, village, city, business, traditional medicinal herbs are in accordance with the regulations for the conditions of type of business respectively in articles 13, 14, 15 and 16 of this Decree.
2. Form of retail business pharmaceutical in villages, traditional villages, traditional medicinal business city must follow the provisions of article 15 of this Decree. The person in charge of the professional or retail facility owners in villages, traditional villages, traditional medicinal business city must have one of the qualifications, the certificate specified in point c of paragraph 3 article 15 of Decree 79/2006/ND-CP of the Government detailing the implementation of a number of articles of the law on pharmacy or certificate or certificate training in pharmacy , traditional medicine due to the base-level training function.
Article 18. Conditions for active facility for processing medicinal herbs 1. Has the certificate of eligible drug business with the pharmaceutical business scope.
2. The person in charge of professional pharmaceutical processing facilities must have a university degree or college diploma pharmacy about traditional medicine and have time to practice for at least 2 years in pharmaceutical facility.
3. People directly involved in the processing of medicinal herbs must be regular trainings, update professional knowledge of the processing of medicinal herbs.
4. The factory, the equipment must be designed, build, repair and maintenance in accordance with the operation in the course of processing and processing of scale basis, namely: a) conservation area pharmaceutical inputs must meet the conditions of location of warehouses for preservation and safekeeping repositories meet the design principles , good conservation practice standards for pharmaceutical drugs;
b) processing area: depending on the scale for processing medicinal processing areas are arranged to facilitate the way of material during the processing consists of two areas: the area of preliminary processing, complex area.
The area of complex, medicinal preparations are wide enough, ventilation, easy hygiene, ensuring the safe and convenient operation, have clean water supply system serves for processing medicinal herbs;
c) quality control area: the area of quality control of raw materials and finished products must be separate from the processing sector. Quality control area must be designed in accordance with the inspection activities;
d) conservation area in medicinal herbs were in processing must meet guidelines, good conservation practice standards for pharmaceutical drugs.
5. auxiliary systems: a) air conditioning systems: base system installation to handle the air conditioner or separate for the area;
b) water treatment system: depending on the requirements of each form of medicinal processing methods, the source of water used for processing at least must reach the national technical regulation on running water;
c) wastewater treatment system, emissions and solid waste: the basis must be the appropriate measure of waste water, waste gas and waste during processing, ensure safe and sanitary;
d) system of fire: the base is equipped with sufficient tools, fire equipment, fire under the regulations on fire prevention.
6. The facility must have adequate equipment necessary for processing of medicinal herbs. This equipment must ensure safe operation, ease of cleaning and maintenance, cross infection, avoid the accumulation of dust and dirt, to avoid the adverse impacts that affect product quality. The base is built and full compliance with the operating instructions, for equipment.
7. quality control area must be equipped with the machines, equipment and instruments suitable for the sampling, analysis, calibration and data processing. The analysis must match the method tested and must meet the requirements of quality inspection units.
8. Before processing medicinal herbs for at least 30 days, the facility must be informed of the Health Ministry. The Ministry of Health held a qualifying facility inspection and processing of medicinal herbs periodically 3 years or irregular.
Article 19. Conditions of applying the principles, standards of good practice 1. In addition to meet the conditions specified in articles 5, 6, 7, 8, 9, 10, 11, 14, 16 and paragraph 1 article 13 of this Decree, the drug business establishments must meet the principles of good practice standards, the minimum World Health Organization updated post on the electronic portal of the Ministry of health that corresponds to each form and the following business scope : a) principles, standards of good manufacturing practice (GMP) for the manufacturing of drugs;
b) principles of good practice standards, drug distribution (GDP) wholesale drug establishments;

c) principles, standards of good practice pharmacy (GPP) retail drug establishments;
d) principles, good conservation practice standards (GSP) for the base service maintenance medication and drug export base;
DD) principles, the standard of good practice (GLP) drug testing for the basis of drug testing service;
e) principles, standards of good practice to try smoking on clinical (GCP) for business establishment services clinical drug on trial;
g) principles, good conservation practice standards for pharmaceutical drugs (GSP) applied to the basis as a service to preserve pharmaceutical and pharmaceutical import export base;
h) principles, the standard of good practice for pharmaceutical drug distribution (GDP) applied to the wholesale pharmaceutical facility.
2. Record the certification procedures, good practice prescribed in clause 1 of this article is made according to the provisions of Decree No. 79/2006/ND-CP dated 9 August 2006 from the Government detailing the implementation of a number of articles of the law on pharmaceuticals; Decree No. 89/2012/ND-CP dated 24 October 2012 of the Government revising, supplementing a number of articles of Decree No. 79/2006/ND-CP dated 9 August 2006 from the Government detailing the implementation of some articles of the law and the relevant legal texts.
Category 3. ADDICTIVE DRUGS BUSINESS CONDITIONS, MENTAL DIRECTION, DRUG PRECURSORS USED, the FINISHED DRUG FORM of COORDINATION that CONTAINS the ACTIVE DRUG, MENTAL DIRECTION, PRECURSORS to article 20. Conditions for production facilities 1. Addictive drug manufacturing facility, mental direction, drug precursors used must meet the provisions of article 5 of this Decree and the regulations of the following: a) meets guidelines, good manufacturing practices standard smoking consistent with each dosage form for at least 2 years;
b) preserving storekeeper addictive drugs are university graduates and have time to practice for at least 10 years or more in drug production facilities;
c) store keeper to preserve mental direction, drug precursors used the medicine must graduate from high school or pharmacy pharmacy over authorized (authorized facility heads in writing each authorization period, not exceeding 12 months);
d) key personnel responsible for the record mode, the report is a graduate of pharmacy have time to practice for at least 10 years or more in drug production facilities;
DD) record, books: addictive drug manufacturing facility, mental direction, drug precursors used to set up and recorded the track window type the following: addictive drugs concocted Book, mental direction, drug precursors used, as appears, enter addictive drugs, mental direction, drug precursors used the Windows console, semi-finished products, finished products in the production process, addictive drug warehouse card, mental direction, drug precursors used the medicine made according to the regulations of the Minister of health.
2. drug product manufacturing facility combined form containing the active substance, drug product format combined contain active ingredient of mental direction, drug products containing precursors coordination format must meet the following rules: a) meets guidelines, good manufacturing practices standard smoking consistent with each dosage form for at least 2 years;
b) store keeper to preserve raw materials, semi-finished products containing the active substance must graduate of pharmacy have time to practice for at least 10 years or more in drug production facilities;
c) store keeper to preserve raw materials, semi-finished products containing active substances mental direction, raw materials, semi-finished products containing precursors must graduate from high school or pharmacy pharmacy over authorized (authorized facility heads in writing each authorization period, not exceeding 12 months);
d) key personnel responsible for the record mode, the report is a graduate of pharmacy have time to practice for at least 10 years or more in drug production facilities;
DD) record, books: drug production facilities and product coordination form containing the active substance, drug product format combined contain active ingredient of mental direction, drug products containing precursor forms of coordination to the full notes on the import, export, as the finished drug form of coordination that contains the active substance the finished drug form of coordination, containing the active ingredient of mental direction, drug products containing precursors coordination form prescribed by the Minister of health.
Article 21. Conditions for import, export base 1. Export and import facility smoking addictive, mental direction, drug precursors used must meet the provisions of article 8 of this Decree and the regulations of the following: a) has at least 5 years experience in exporting, importing drugs;
b) within 5 years before the date of the additional proposal export activities, importing the drug addictive drug, mental direction, the precursors used, facilities for export, importing the drug business is not violated in quality by the State administration of quality smoking or no conclusion or acts arbitrarily fix the profile , documents, legal documents of the competent authorities of Vietnam or abroad; do not use false or forged seals or signatures of import facility, production facilities and related facilities in the profile of exports, imports of drugs;
c) Have private warehouses meet the principles, standards of good practice to preserve the drugs to preserve addictive drugs, mental direction, drug precursors used match the scale of the business base but the minimum 100 m2 in area and volume of a minimum of 300 m3. The repository must have locked the door, sure, there are measures to ensure safety, not for losses;
d) have a minimum of 3 business locations that meet guidelines, standards of good practice in distribution 3 northern, Central and southern;
DD) tracking software systems manage smoking addictive, mental direction and precursor drugs used as medicines and measures to ensure the security, avoid losses;
e) personnel: the store keeper, who is in charge of the report, the person in charge must have expertise with Graduate Pharmacy and have time to practice for at least 10 years or more in production facilities, business and medicine.
The individuals involved in active trading, import and export have to be training on the legal texts related to the addictive drug management, mental direction and precursor drugs used as medicines by the training institutions were entrusted with the Ministry of health;
g) records, the books: business directory, import the addictive drug, mental direction, drug precursors used to set up and record the record type, the following track: books as addictive drugs import export, mental direction, drug precursors used; Addictive drugs output votes, mental direction, drug precursors used the medicine made according to the regulations of the Minister of health; the documents relating to the export, import, purchase and sale of drugs, drug addiction-causing mental direction, amount of substance use as drugs.
2. The facility meet the drug business conditions as defined in chapter II of this Decree and Drug Laws are export, import of the drug into the combined form products containing the active substance, drug product format combined contain active ingredient mental direction, drug products containing precursor forms of coordination; to set up and recorded the following records: a) as import, export of finished drug form of coordination that contains the active drug, the drug product format combined contain active ingredient of mental direction, drug products containing precursors combined form made according to the regulations of the Minister of health;

b) documents relating to the export, import, purchase and sale of medicinal products containing active substances combined form addictive, smoking combined form products containing active substances toward mental and drug products containing precursors coordinate format.
Article 22. Conditions for wholesale businesses 1. The pharmaceutical business, central cities (including unincorporated enterprises and joint stock enterprises were equitized) was buying, selling addictive, drug products drug products drug products, mental direction precursors meet the provisions of article 6 of this Decree and the regulations after the : a) to have the repository meet guidelines, good conservation practice standards, including storage warehouse of finished products addictive drug, mental direction, drug products and product must be sure key precursors, have security measures, not to the losses. If no individual repository product addictive drugs, drugs, drugs-oriented products and product quality to money to a separate area in the repository that meets guidelines, standards of good practice to preserve the drugs;
b) HR: storekeepers are university graduates and have time to practice for at least 10 years or more in drug trading company;
c) records, the books: tracking window appears, enter the addictive drugs, smoking, mental direction precursor used as drugs, addictive drug output Votes, mental direction, drug precursors used the medicine made according to the regulations of the Minister of health; the documents relating to the export, import, purchase and sale of drugs, drug addiction-causing mental direction, amount of substance use as drugs.
2. The facility meet the drug business conditions as defined in chapter II of this Decree and Drug Laws are buy, sell the finished drug form of coordination that contains the active drug, the drug product format combined contain active ingredient of mental direction, drug products containing precursor forms of coordination; to set up and recorded the following records: a) as drug import export finished products contain active ingredients combined form addictive, smoking combined form products containing active substances, mental direction and product coordination form containing precursors made as specified by the Minister of health;
b) documents related to the sales of the finished drug form of coordination that contains the active drug, the drug product format combined contain active ingredient of mental direction, drug products containing precursors coordinate format.
Article 23. Conditions of retail establishments 1. Retail basis products addictive drugs, smoking, mental direction production product precursor drugs must meet the provisions of article 7 of this Decree and the regulations of the following: a) is the drug meets guidelines, good pharmacy practice standards;
b) Must register with the Department of health;
c) landlord, professional managers are directly managed retail and product addictive drugs;
d) Pharmacy School over management and drug retail and product direction, finished drug precursors;
DD) Are created, recorded and stored the following record types as specified by the Minister of health: tracking Window appears, enter the addictive drug, mental direction, drug precursors used, as details of customers, addictive drugs, output Slip smoking mental direction, quality used money of the place offers smoking; Prescription drugs, mental direction saved at the facility after the sale; Minutes of receiving the drug addictive products due to the patient's return.
2. retail facility smoking finished products contain active ingredients combined form addictive, smoking combined form products containing active substances, afferent smoking combined form products containing precursors must meet the provisions of article 7 of this Decree and the regulations of the following: a) Is a good practice to meet pharmacy pharmacy;
b) Must have the window tracking, inventory, report the amount of the purchase, import, inventory, quantities exported and the selling, customer address 6 months, annually as prescribed by the Minister of health.
Item 4. RADIOACTIVE DRUG BUSINESS CONDITIONS article 24. Business conditions business base the radioactive drug in addition to satisfying the conditions of drug business under the provisions of Chapter II of the law on pharmaceuticals and section 1 of chapter II of this decree must also meet the following conditions: 1. That permits about radiation safety guaranteed by the Ministry of science and technology.
2. The person responsible for radiation safety must be knowledge training on safety and radiation must have safety training certificate of radiation due to the basis of the Ministry of science and technology allows levels of training.
Article 25. Blending, use radioactive drugs 1. The blending, use radioactive drugs is only done in the basis of nuclear medicine the Ministry of science and technology on radiation safety.
2. nuclear medicine facility licensee wishing to use radioactive drugs must set the table planned according to the form prescribed to the Ministry of health review; at the same time report the Ministry of science and technology to track.
Chapter III the TERMS of the IMPLEMENTATION of Article 26. Transitional provisions 1. For the practice of Pharmacy was granted with the 5-year period, when expired, the individual must do the procedures to practice pharmacy in the State bodies are competent.
2. for a certificate of eligibility issued drug business with the 5-year period, when expired, business procedures in the competent State bodies.
3. The facility is producing, export, import, wholesale, retail, drug addiction drugs mental direction, the precursors used, medicinal products containing active substances combined form addictive, smoking combined form products containing active substances, mental direction of finished products containing precursors combined form was continued in operation until the 2016 Pharmacy Law.
Article 27. Effect 1. This Decree takes effect from July 1, 2016.
2. Articles 20, 21, 22, 23, 24, 25, 26 and 27 of chapter IV, section 2 of chapter V of Decree No. 79/2006/ND-CP dated 9 August 2006 from the Government detailing the implementation of a number of articles in pharmaceutical Law expired from the date of the Decree has effect.
Article 28. Responsible for implementation 1. The Minister of health is responsible for guiding, organizing the implementation of this Decree.
2. Ministers, heads of ministerial agencies, heads of government agencies, the Chairman of people's Committee of the province, central cities and agencies, organizations and individuals concerned is responsible for the implementation of this Decree./where:-the Secretariat of the Communist Party;
-Prime Minister, the Deputy Prime Minister;
-Ministries, ministerial agencies, government agencies;
-The PEOPLE, the provinces and cities under central:-Central Office and the Board of the party;
-The Office of the Secretary-General;
-The Office of the President;
-Ethnic Council and committees of Parliament;
-The Office of the National Assembly;
--The Supreme People's Court;
--The Supreme People's Procuracy;
-State Auditor;
-The Monitoring Committee national finance;
-Social policy Bank;
-Vietnam Development Bank;
-The Central Committee of the Vietnam Fatherland Front;
-Central bodies of the unions;
-VPCP: BTCN, the PCN, Assistant CEO, TTg, the Portal Service, Bureau, subdivisions, Gazette;
-Save: VT, KGVX (3) TM. The GOVERNMENT Of PRIME MINISTER Nguyen Xuan Phuc