Circulars on the management of drug quality pursuant to Decree No. 188/2007/ND-CP on December 27, 2007 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
Pursuant to the law on Pharmacy 14/6/2005;
Pursuant to the law of standards and technical regulation on 29/6/2006;
Pursuant to the law of product quality, the goods on 21/11/2007;
Pursuant to Decree No. 79/2006/ND-CP dated 9/8/2006 detailing the Government's implementation of some articles of the law on Pharmaceuticals;
Pursuant to Decree No. 127/2007/ND-CP dated 3/8/2007 detailing the Government's implementation of some articles of the law on technical regulation and standards;
Pursuant to Decree No. 132/2008/ND-CP dated 31/12/2008 detailing the Government's implementation of some articles of the law on product quality, the goods;
To ensure the quality of drugs in production, import, and use of, ensuring compliance with the provisions of the law, the law on technical regulation and standards, product quality Law, goods and other legal documents relevant for the quality of medicines, in line with international practices , meet the requirements of international integration of pharmacy, Ministry of health guidelines for quality management in the production process or import, circulation and use in Vietnam.
Chapter I GENERAL PROVISIONS article 1. Scope this circular regulates the activities of drug quality management in the production, export, import, and use in Vietnam; the rights and responsibilities of businesses, consumers and organizations and individuals related to the quality of the drug.
Article 2. The object that applies to this circular apply to organizations and individuals (hereinafter referred to as the base) and trading agencies, organizations and individuals (hereinafter referred to as units) are related to the activity of drug quality management in Vietnam.
Article 3. Explanation of terms In this circular, some terms below are interpreted as follows: 1. 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 for functional food.
2. xinlà Vaccine Antigen-containing preparations made for the body immune response capabilities, is used for the purpose of prevention.
3. B. health product is a product of biological origin are used for prevention, diagnosis and cure for the people.
4. Make the drug is involved in product composition in the drug production process.
5. Drug (also known as active ingredient) is the substance or mixture of substances containing active treatment is used in the manufacture of drugs.
6. Drug product is the form of the drug has passed all the stages of production, including packaging in the final packaging and labelling.
7. 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.
8. Technical Regulation is the regulation of the limit of the technical characteristics and regulatory requirements that medications, drug-related activities such as the manufacture, testing, preservation, transport must comply with in order to ensure the quality and effectiveness of drugs, safety, hygiene, human health; protection of animals, plants, the environment; protection of national security and interests, the interests of consumers and other essential requirements.
Technical regulation of drugs by the Minister of Health issued as text to force applied.
9. Limit the use of drugs is the time used to be assigned to a batch of the drug that after the deadline are not allowed to use the drug.
Limit the use of drugs is often credited by number or by letter on the drug label.
10. The lot is a definite amount of original material, packaging, raw materials or products are processed in a single process or a series of processes and uniform quality.
The production batch number is denoted by the number or text, or a combination of both letters and numbers in order to get to know the plot and allowed considering the entire background of a batch of drugs including all stages of the production process, quality control and distribution of the drug batches.
11. Smoking is drug quality standards registered quality standards of Pharmacopoeia standards or manufacturer's facility.
12. Smoking poor quality is substandard quality medicines is registered with the competent authorities.
13. fake Drug products are 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.
14. Good practice are the principles, standards of production, storage, testing, drug traffic; cultivation, harvest and processing of medicinal herbs by the Ministry of Health issued.
15. 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 quality standards not to decide the acceptance or eliminate smoking there.
Article 4. Unit and unit measuring equipment and measuring, the measuring instruments used in pharmaceutical industry in compliance with the provisions of the law on metrology.
Chapter II BUILD, PUBLISH and APPLY the STANDARD of QUALITY SMOKING article 5. Quality standard of drugs 1. National standards: Vietnam Pharmacopeia is the national standards on the drug.
2. standard: the standard is due to manufacturing, blending, applicable to the products due to production facilities, blending.
3. criteria for the quality of medicines has been the Health Ministry allowed the circulation of value as a commitment by business establishments, concocted for the quality of medicines are produced, blending, and use; is grounds for regulators, drug quality inspection agency identified and conclusions about drug quality in the process of production, circulation and use.
In the process of production, circulation management, businesses can apply for internal quality standards, including the standard of quality of medicines has been the Ministry of health review and the additional quality criteria.
4. The regulation on applying Vietnam Pharmacopeia: a) The production, mixing drugs can apply or build Vietnam Pharmacopeia standards base for products produced on the basis of the regulations in Vietnam and Pharmacopeia laws relate;
b) requirements on quality criteria and quality levels are defined in each treatise of medicine quality standard Vietnam Pharmacopeia is required to apply. The Health Ministry recommended the basis of application of the test method given in each treatise drug quality standards prescribed in Vietnam Pharmacopoeia;
c) requirements on quality criteria, quality level and general test methods are defined in the annex of the Vietnam Pharmacopeia is required to apply. Any discrepancy must be proved, against a minimum guarantee to the equivalent provisions in Vietnam Pharmacopoeia;
d) standard minimum drug establishments must meet the requirements on quality criteria and quality levels are defined in the standard treatise of medicine quality Vietnam Pharmacopoeia;
DD) The production base, dispensing medication to update the quality standards of drugs produced, blending consistent with the latest version of the pharmacopoeia Vietnam.
5. The provisions on the application of international standards, foreign Pharmacopoeia: a) in Vietnam business establishments are allowed to apply directly the pharmacopoeia is used in the international pharmaceutical trade: Europe, uk, Usa, international, Japan. The application must include the entire regulations on quality criteria , quality level and the test method specified in Pharmacopoeia;
b) base case apply the drug business other Pharmacopoeia the pharmacopoeia mentioned in point a of this paragraph, or the base standard, the standard of quality applies must meet the minimum requirements on quality criteria and quality levels are defined in the standard treatises of the respective quality Vietnam Pharmacopoeia or the pharmacopoeia of usage specified in point a, paragraph 5 of this Article;
c) where the common Pharmacopoeia provisions in point a, paragraph 5 of this treatise drug quality standards, business establishments, smoking can apply other Pharmacopoeia or standard basis, but must be evaluated according to the rules and the Ministry of health review;
d) drug business establishments must be promptly updated drug quality standards meet the provisions of the latest version of the pharmacopoeia.
Article 6. Compilation of national standard about drugs, issued the applicable Vietnam Pharmacopeia.
1. The Council mission Vietnam Pharmacopeia research organization composed of national standard about drugs as planned standardization of Health Ministry and periodically review, Supplement, modify national standards on the drug.
2. Drug Administration do the clue of consideration, ideas, and organizations co-operated with the Council complete Pharmacopeia profile draft national standards about smoking; transfer of the Ministry of science and technology evaluation and publication of national standard about drugs; the Minister of Health issued a Vietnam on the basis of The Pharmacopeia national standards on the drug.
Sequence editor, announced The evaluation of national drug standards, and issuing Vietnamese pharmacopoeia in accordance with the provisions in circular No. 11/2008/TTLT/BYT-BKHCN on 29/12/2008 the Ministry of health and Ministry of science and technology assessment, building guidelines, announced The national standards on the drug and issued Vietnam Pharmacopoeia published.
Article 7. The construction, announced the standard of quality of the drug in circulation 1. Production facilities can apply the base standard or standards applied pharmacy.

The case applied to the standard basis, the manufacturing facility to research, build quality standard (standard form the basis of reference in annex 1) and to conduct due diligence, demonstrate the suitability of the test methods stated in the standard basis.
Applicable standards, pharmaceutical production facility to conduct reviews of the suitability of the test methods applicable to smoking due to the manufacturing facility.
2. With regard to the drug culture, biological medicine, Oriental medicine, medicines from medicinal herbs: a) The drug manufacturing facility achieves the principle, standard "good manufacturing practice" (GMP) send a quality standard attach the profile of drug registration to the Ministry of health to consider;
b) base case production chemistry, medical products not yet reach the principles, standard "good manufacturing practice": drug manufacturing facility submitted a quality standard and samples of drugs to one of the State's testing base on the drug in the central or the business doing drug testing service has been issued a certificate of eligibility to the pharmacy business intend to confirm the suitability of the test method applied before sending drug registration documents to the Ministry of health;
c) base case production of Oriental medicine, the drug from medicinal herbs have not yet reached the principle, standard "good manufacturing practice": production base to send a sample and quality standard of drugs to the State's testing base on the drug or service business of drug testing has been issued a certificate of eligibility to the pharmacy business appraisal confirming the suitability of the method France tested applied before sending drug registration documents to the Ministry of health.
3. for vaccines, medical products is the serum contains antibodies used to prevent disease, cure for people: production base to send a drug sample and quality standards to national testing of vaccines and medical products to confirm conformity assessment of quality standards and testing methods , the safety and effectiveness of the product before sending drug registration documents to the Ministry of health.
4. for diagnostic products Invitro: a) production reached base principles, standards of "good manufacturing practice" or ISO 13485 ISO standards send a quality standard of drug registration records attached to the Ministry of health to consider;
b) base case production has not yet reached the principle, standard "good manufacturing practice" or ISO 13485: ISO standard production facilities must submit a standard of quality and product samples to the national testing of vaccines and medical products to verify, confirm the suitability of testing methods and the assessment of the efficacy of diagnostic products before send documents to the Ministry of health.
5. With regard to the drug in drug filing domestic production registered at the local health department: a) production facilities reached principles, standards of "good manufacturing practice" to send a quality standard of drug registration records attached to the Department of health, the central cities in order to consider;
b) base case production has not yet reached the principle, standard "good manufacturing practice": production base to send a sample and quality standard of drugs to the State's testing base on the drug or service business of drug testing has been issued a certificate of eligibility to the pharmacy business appraisal confirming the suitability of testing methods applied before send drug registration records to the Department of health, the central cities.
6. The amendment of drug quality standards must be conducted according to the sequence, procedures have been defined in clause 2, clause 3, clause 4 and clause 5 of this and according to the current rules on registration of drugs.
Article 8. Construction of the base standard, promulgated the standard processing base of the pills concocted in the base (semi-finished products, finished products awaiting packaging, smoking, smoking by blending blending used in hospitals, research institutes have baby beds disease) due to the construction of base and unit heads are reviewed and issued.
The pills concocted not distributed, circulated on the market.
Chapter III management, DRUG QUALITY CONTROL in the MANUFACTURE, MIXING, CIRCULATION and USE of article 9. Drug quality assurance conditions in production facilities, production processing, dispensing medication to make the requirements on drug quality management in production are as follows: 1. Apply the principles, standards of "good practice" in the production, distribution, storage, testing and/or other appropriate management systems to ensure the quality of products produced consistent with the quality standards of drugs has registered and been accepted medical Kit (for circulation) or published (for drug dispensing use).
2. register the medication prescribed in the law on pharmaceuticals, the relevant legal provisions and labeling according to provisions of law on goods labels.
3. In compliance with the technical standards relating to the production, processing, quality control, preservation, quality standards and other related regulations.
4. Subject to the checking of the management agency, the State quality control of drugs according to the content of the test in article 24 of this circular.
Article 10. Drug quality assurance conditions in facilities for export, import, wholesale, retail, storage maintenance, transportation, using the export facility, import, wholesale, retail, storage maintenance, transporting the drug to perform quality management requirements for the following: 1. Application of the principles , the standard of "good practice" in preservation, drug distribution and other appropriate measures in order to maintain the quality of medication consistent with the quality standards of drugs has registered and been accepted to the Health Ministry use: a) the recruitment and training of human layout professional qualified as prescribed;
b) equipped with the means of preserving, transporting the drug to ensure preservation conditions as required in the process of preserving, transporting the drug;
c) deploy, maintain the profile mode, the books trace the flow of drugs by business establishments.
For imported drugs, in addition to compliance with the provisions mentioned above, the basis of imported drugs must be in full compliance with the provisions regarding quality assurance of medicines under the regulation on imported drugs.
2. Subject to the quality control of drugs of the governing body, the State quality control of drugs according to the content of the test in article 24 of this circular.
Article 11. Quality control of drugs in the drug business establishments 1. All drugs (including raw materials, packaging) are to be inspected; only when the quality standard and in accordance with the relevant provisions of the new law was put into production, mixing and circulation.
2. The head of the person in charge and the expertise of the business base, dispensing, drug use is responsible for quality management and quality control of drugs at the facility and is responsible for the quality of medicines by business establishments, blending is used.
3. The business base, dispensing, drug use is responsible for the Organization and implementation of inspection, quality control of drugs at the facility.
4. The production base, dispensing medication to test work organization with the technical means and appropriate professional staff to test, identify, assess the quality of medicines in the production process, the factory.
5. Encourage the export basis, import, sales, storage, use, depending on the scope of activities, organize drug testing work to ensure the track is the quality of its drugs business.
6. Business establishments (the basis of drug registration, the basis of imported drugs) is responsible for providing a drug quality standards have been accepted to the Ministry of health the authority to check the quality of medicines in the local circulation of drugs when required.
Article 12. The content of drug quality control of drug business establishments depending on the scope, content, operation of the base, the base business conduct drug test drug quality according to the content of the quality control according to the provisions of article 25 of this circular and the internal regulations of the establishment in order to ensure the quality of medicines production , business.
Chapter IV PROVISIONS on SUSPENSION of CIRCULATION, recovered the DRUGS and DRUG VIOLATION PROCESSING QUALITY of article 13. The drug case was released, recovered 1. The drug was released, recovered in the following cases: a) Smoking is not correct type due to a confusion in the allocator process, delivery;
b) substandard Drugs registered quality;
c) Smoking does not meet the requirements for labeling of goods according to the provisions of article 37 of the law on Pharmaceuticals and the other provisions of the relevant legislation;
d) packaging material and medication packaging format does not meet the requirements for ensuring the quality of medicines;
DD) Smoking without permission or registration number;
e) Drugs have reported the recovery of production facilities, authorities, organs of State quality control of drugs of Vietnam or abroad:-Smoking smuggled counterfeit drugs, drugs of unknown origin, origin;
-Smoking produces incorrect profile import, registration or permit;
-Smoking prohibited substances used in the production of, or contain substances with concentrations exceeding the limit permitted concentration, concentration;
-Smoking finished products manufactured from the raw materials did not meet quality standards or material not sourced legally (smuggled raw material production base, does not yet have a certificate of eligibility or pharmaceutical raw materials are not used for the purpose of people or material not yet licensed for human use);
-The drug manufactured in the facilities have not been certified eligible business or does not meet the conditions of production (not meeting the standard principles of "good manufacturing practice" or other regulations of the pharmaceutical business conditions);
-Vaccines are incorrect according to the conditions of preservation of the request;
-Expired Medication use;
g) The case of voluntary withdrawal of the drug business establishments or by decision of the governing body, the State quality control of drugs.
2. revocation forms:

a) voluntary withdrawal: base business auto detect, recover the drug does not meet regulations.
When the detection of drugs of inferior quality basis, there is confusion or problems, the head of the drug business establishments must immediately report the pharmaceutical Management Agency (drug administration, the Health Department of the province or city level) about the causes, the extent of the violation, the hazardous level evaluation and expected recovery levels. After obtaining the opinion of the governing body, the facility must be reported to the recovery where smoking and conduct operations to ensure recovery recovery of most drugs on the market; at the same time tracking, address the consequences of smoking violation cause.
b) recovery required: When regulators, check the State of the requested authority, pharmaceutical business establishments (who own the licences in circulation, production, export, import, import authorization) must proceed to revoke immediately the smoking was determined to be in breach or suspected breach critical impact to health of users and of the community.
3. Regulations on the level of violation: a) classification level base offense: The offense level of quality are classified on the basis of assessing the severity of the breach, the risk of affecting the effectiveness of treatment, the safety of the user and unwanted reactions of medicines.
b) classify the offending levels:-level 1: dangerous violations could affect the lives of drug users, serious injury or death.
-Level 2: violations can affect the effectiveness of the treatment and safety when used.
-Level 3: non-violation or at least affect the therapeutic effect and safety when used.
4. The level of the suspension notice and made recovery of the drug a) level 1: made for the breach of the level 1. The suspension notice was sent emergency medicine circulation to the person who owns the license of circulation, production, export, import, wholesale, retail, Faculty of pharmacy of the base using the drug, and reported on the mass media to all business establishments, use and drug users know. Business establishments have the offending drug must urgently implement measures to revoke the offending medication thoroughly in the shortest time in order to limit the adverse consequences occur.
b) level 2: made for the breach of the level 2, the suspension notice issued is sent to the person who owns the license of circulation, production, export, import, wholesale, retail.
c) level 3: made for the breach of the level 3, announced the suspension of circulation is sent to production, import, import authorization and wholesale establishments.
d) the suspension and revocation of smoking can be done for a batch or a batch number or identify a drug product or the entirety of the products of one or more drug manufacturing facility.
5. The Authority notice to revoke a) Drug Administration out of the suspension notice issued and recovered the drugs within the country. Notifications are sent to the provincial health department, central cities, health sectors and production base, import, import authorization.
b) the Department of health in the province, central cities, the health sector:-Out suspension notice issued and revoked in the scope of management for the drug quality control agency in local drug/drug detection test industry in violation of;
-Out of the suspension notice issued and recovered to make the recovery notice of drug administration, processing the violation under the provisions of the law and report on drug administration.
c) manufacturing, export and import, import authorization revocation notice for voluntary revocation cases.
6. drug withdrawal liability: a) production facilities, facilities for export, import, import authorization, wholesale drug establishments responsible for radical withdrawal of drugs recovered. The base when the revocation or of the notice of withdrawal from the governing body, the State quality control of drugs or drug supply base from right:-notice of withdrawal to the basis of the wholesale, retail and where the drug circulation;
-Proceed to recover quickly and thoroughly the items or batches of the drug violation;
-Establishment of drug withdrawal. Drug withdrawal records must show sufficient evidence of the supply of the drug, evidence of the implementation of the recovery of smoking establishments for wholesale, retail, using purchased drugs according to the form in annex 3;
-Recovery progress report, results of the recovery and disposal of recovered drug batches according to the form in annex 4 of drug administration and the relevant authorities. The time limit for reporting is 72 hours for the recovery of the level 1 and 30 days for recovery of the level 2 and 3;
-Resolve evolution and consequences due to substandard drugs caused.
b) retail drug establishments and facilities of drug use when the notice of revocation (drug withdrawal information in writing or through the mass media) to urgently implement and return the recovered drugs for supply base.
c) The production, export, import, wholesale, retail sale of medicines must be responsible for receiving the drug withdrawn returned from the business establishment, use and users have to buy drugs.
d) Ministry of health (pharmaceutical Management Bureau, Inspector of the Ministry of health), the provincial health department, central cities, health inspection and supervision sectors of business establishments, the use of drugs made the recovery.
e) Drug Administration have written detailed instructions on the process handle, drug recovery, efficient implementation of drug withdrawal notice of the production base, the drug business.
Article 14. Cancel the drug (drug violation processing) 1. The poor quality medicines, the drug labeling violations, depending on the level of violation can be recycled, processed or cancelled. The base has a smoking violation want recycling to do form attached to the recycling process of sending drug administration. The recycling is done only after the opinion agrees with the text of drug administration.
2. The fake drugs, smuggled drugs, drugs of unknown origin, drug use, drug expiration containing the banned substance use, the drug produced from raw materials did not meet quality standards, the drug produced in the conditions do not meet regulations, model drug store when the time runs out to save must be cancelled. Business establishments are drug violations are responsible for the cost of destroying medicines.
3. The Heads of establishments have smoking need to cancel a decision to cancel the Council established medicine. The Council has at least 3 people, which must have the unit officers and responsible pharmacist expertise.
4. The cancellation of the drug must assure long for people, animals and avoid environmental pollution according to the regulations of the law on the protection of the environment.
5. Cancellation addictive drugs, mental direction, drug precursors used, radioactive drugs must follow strictly the regulations on cancellation of the drug in the guide of the activities related to the addictive drug; mental direction and precursor drugs used as medicines; radioactive drug. Cancel finished report drugs attached to the minutes cancel smoking to direct administration by the form in Appendix 5.
Chapter V management, QUALITY CONTROL of VACCINES and medical PRODUCTS article 15. Common rules for all the agencies, organizations, individuals and enterprises engaged in the activities of the State management, production, trading, use of vaccines and medical products must comply with the regulations regarding the management, testing, manufacturing, trading of this circular and the other provisions of the relevant laws.
Article 16. Provisions on the quality control of vaccines, biological medical is the serum contains antibodies used to prevent disease, cure for the 1. The Ministry of health allocated for national testing of vaccines and medical products is responsible for audit, evaluation of the quality, safety, efficiency and production licensing, introduced, used for vaccines and medical products is the serum contains antibodies used to prevent healing for people.
2. Production facilities, sales of medical products and vaccines to send sample and record vaccine production, medical products is the serum contains antibodies used to prevent disease, cure for people to vaccine testing and medical products for reviews before , introduced, use. Procedures and records submitted sample inspection is stipulated in article 18 of this circular.
Production base, importing vaccines and medical products to be marketed, introduced, using the batch of vaccine, medical products is the serum contains antibodies used to prevent disease, cure for people after a permit issued by the national testing of vaccines and medical grade products batch validation, vaccines, biological medical products quality standards, ensuring safe, effective.
Article 17. Procedures and records submitted audit quality assessment template,, for vaccines and medical products is the serum contains antibodies used to prevent disease, cure for the 1. For vaccines and medical products is the serum contains antibodies used to prevent disease, cure for the domestic production: production facilities must submit resumes and samples of manufacturing production (finished products, semi-finished products) to the national testing of vaccines and medical products including : a) auditing sample votes sent;
b) vaccine, medical products to test (the number of samples required for each type of vaccine, health products);
c) summary records of production and quality control of the batch of vaccines, biological (copies are stamped by the manufacturer);
d) testing of the production batch of Votes.
2. for vaccines and medical products is the serum contains antibodies used to prevent disease, cure for the import: import facility must submit records and samples of production batches of the product to the national testing of vaccines and medical products include: a auditing send Votes);
b) vaccine, medical testing products (the number of samples required for each type of vaccine, health products);
c) summary records of production and quality control of batches of vaccines, imported products (stamped copies certified by the manufacturer);
d) licence issued by the competent bodies of water in or other equivalent body attached to the batch product import (stamped copies certified by the Director of import business);

e) proof of the conditions of preservation (cold chain) in the process of transporting imports.
Chapter VI TESTING SYSTEM TESTING ACTIVITY and DRUG Medications 18. drug testing system 1. The State's testing base on the drug-in Central: central drug testing Institute, drug testing Institute in Ho Chi Minh City, national testing of vaccines and medical products and pharmaceutical products testing center, cosmetic area.
-In local: pharmaceutical testing centre, the cosmetics, the central cities.
2. Laboratory of the drug business.
3. The business doing drug testing services: independent business as a service or laboratory testing of drug business establishments have the function do drug testing services.
Article 19. Quality assurance in drug testing drug testing facilities depending on the scale of operation to implement apply the principles, standards of "good laboratory practice" and/or other appropriate management systems (e.g. ISO/IEC 17025, ...) in order to ensure the accuracy of the test results sample analysis, smoking.
Article 20. Activities of drug testing facility 1. The State's testing base on the drug in Central: a) check, evaluate the quality of help the Minister of health in determining the quality of drugs on a national scope as assigned by the Minister of health.
Evaluation standard of quality of drugs and other products at the request of the Ministry of health.
b) scientific research; directs technical expertise for the State's testing base on the drug locally.
c) training and retraining of officers tested on technical expertise tested.
d) perform testing services.
DD) proposed to the Minister of health technical measures to manage the quality of medicines with suitable conditions for socio-economic development of the country.
e) other activities under the provisions of the relevant laws.
2. the State's testing base on the drug locally made a) drug quality control help health department director in determining the quality of drugs circulating within the province, the city of centrally managed.
b) appraise the quality standards for medicines from medicinal herbs, pills in drug filing domestic production registered in the Department of health under the guidance drug registration current.
c) perform testing services.
d) other activities under the provisions of the relevant laws.
3. Laboratory of production facilities, business: a) laboratory of production facilities, business is parts tested, test the quality of the facility, responsible for the drug quality control activities at the facility;
b) perform the analysis, testing determines the quality of the raw material, semi-finished products in the production process, the drug product and the participation in the activities related to the evaluation, control the conditions of other drug quality assurance according to the rules of the facility.
4. The business doing drug testing service: a service business) tested the drug must meet 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.
b) operating range: analysis services, testing of raw materials, semi-finished products in the production process, the drug product for the production facility, the drug business.
Business case to do drug testing services participating in the activity analysis, drug testing service for the management, check the State of the quality of medicines, business must do the registration field operations reviews the fit with the Ministry of health and Ministry of science and technology as defined in circular 08/2009/TT-BKHCN on 8/4/2009 of the Faculty learning technologies guide on request, order, registration field of conformity assessment and the relevant regulations.
Article 21. Rules of application of the quality standards in drug testing 1. The drug testing is conducted in accordance with the quality standards of drug production base, base of registered importers, permission to circulate and be The medical (Drug Administration) approved.
Cases of application of other methods not according to the method in the registered standards must then be approved by the Ministry of health. The Ministry of health assigned to the central drug testing Institute, Institute of Ho Chi Minh City drug evaluators and decided to accept the method applied.
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. The head of the drug testing facility is responsible for the results of drug testing his facility before the law.
Article 22. Determines the sampling of drugs to quality control, test results, reply, save the form and profile related documents 1. Drug samples to check quality: a) the sampling to medicine agency quality control quality control of drugs prescribed in clause 1, article 24 of this circular;
b) sampling of drugs to determine the quality should be of the correct "circulars to determine drug sampling in quality" by the Ministry of Health issued;
c) drug quality control agency to pay drug samples taken to test the quality prescribed by the law.
2. The time limit for answering test analysis results of samples of drugs: a) for drug samples taken for the Agency's quality control management, Agency Agency quality control: the time limit to answer analytical results, tested a maximum of 30 working days from the date of testing facility receive samples of the drug. Within 2 days, since the promulgation of the vote analysis, testing, drug testing facility to notify the results of analysis, testing to regulators, drug quality control agency and to production facilities, business smoking are sampled. The vote analysis or test votes must be made at least 3 a: 7 a save at the base, testing a send to drug quality control agency and 01 sent to production facilities, business smoking are sampled.
For the case of need appraisal or evaluation or quality standards again reviews test results; lack of machinery and equipment, chemicals, reagents, standard quality; There is no doubt about the composition and quality of medicines must apply different testing method with the write method in the registered quality standards ... deadline to answer the analysis results, testing can last longer. Testing facility to have explanations about this case;
b) for model smoking due to the Organization, the individual sent for analysis, testing or evaluation of drug quality standards: time to answer analytical results, tested by agreement of the parties, or by the internal regulation of production facilities, business.
3. save the form: a) the pills after checking the quality and quality has been concluded is stored samples. Drug samples stored must be sealed and preserved in appropriate conditions indicated on the label.
b) long form:-for the production, export, import of drugs, drug samples of finished products must be stored for at least 12 months after the expiration of the drug;
-For the raw materials as active ingredients for the production of the drug, the production base to save raw material samples for at least 12 months after the expiration of the products manufactured from raw materials;
-For the drug testing agency, time saving template not be under two years (24 months) from the date of sampling or submit the form to the base;
-For the Agency to receive the form used to register the drug, after the drug was granted registration number must not save the template under 6 months from the date of registration.
3. save the record, the document: a) records, documents relating to the work of quality control of medicines must be kept under the regulations;
b) records and documents pertaining to addictive drugs, mental direction, drug precursors used drugs and radioactive drugs: time archive for at least 2 years after the expiration of the drug;
c) profile, document when the time runs out of storage are handled according to the current rules.
Article 23. The cost of drug sampling and testing identified the quality of drugs 1. The expense of sampling and testing of drug samples cost to drug quality control in the manufacture, mixing and circulation on the market because the drug quality control agency decided the sampling and sample testing pay as specified in circular No. 28/2010/TTLT-BTC-BKHCN on 3/3/2010 of the Ministry of finance and science and technology and management guide use of funds for the operation of the State inspection of product quality, the goods.
2. In the case of drug samples tested to be drug quality inspection agency concluded did not meet quality standards, production facilities, business smoking quality violations are liable to refund the full cost of sampling, testing and funding model for quality control agency as defined in articles 10 , Article 12, article 14, article 16 and article 41 of the law on product quality, goods in 2007, circular No. 28/2010/TTLT-BTC-BKHCN on 3/3/2010 of the Ministry of finance and science and technology management guide and the use of funds for the operation of the State inspection of product quality goods and other legal texts concerned.
3. in case of smoking were complaints, accusations about the quality inspection agency concluded the complaints, accusations about drug quality is not true then the complainant, the accused must pay to reimburse the cost of sampling and analysis costs, testing samples for inspection bodies specified in paragraph 1 of this article.

4. Funding drug samples to check quality, funding drug sample testing was arranged in the estimation of funding activities of bodies of State quality control of medicines in accordance with circular No. 28/2010/TTLT-BTC-BKHCN on 3/3/2010 of the Ministry of finance and science and technology management guide and use the funding for operation check the State of quality of products, commodities.
Chapter VII, STATE INSPECTORS CHECK on QUALITY Medications. Check the State of quality smoking 1. Drug quality control agency: a) drug quality control agency in Central: Drug Administration-Ministry of health;
b) drug quality control agencies in local: Department of health province, central cities;
c) Drug Administration has responsibility for directing the Department of health, in collaboration with the provinces, the central cities and other agencies involved in the quality control of drugs.
2. Every year, drug administration (in collaboration with the Institute of the central drug testing, drug testing Institute in Ho Chi Minh City, national testing of vaccines and medical products) and the provincial Department of health, the central cities on the basis of the collected information about the risk of not ensuring the quality of medicines situation of drug quality, production, import and export, circulation in the market, sampling plans to check the quality of the Health Ministry or the people's committees of provinces and cities under central review, approval and implementation of budget arrangement plans under the authority.
3. The State inspection of quality of drugs made by the test group or by quality controllers. Powers and duties of inspectors and inspections Division of the quality specified in articles 48, 49, 50 and 51 of the law on product quality, goods in 2007.
a) test Group by the head of quality control of drugs (drug administration, the Department of health, the central cities) decided to establish on the basis of the program, test plans have been approved or, in the case of manufacturing, blending, the drug business has had violations of the computer system or serious violations of quality smoking or event production, trading or in the event of sudden requests. Content inspection as prescribed in paragraph 1 and paragraph 2, article 25 of this circular;
b) drug quality controllers to perform the quality control of drugs production, import and export, circulation on the market. Content inspection as specified in paragraph 2, article 25 of this circular.
25. the content of the Agency's quality control quality control of drugs 1. Drug quality control in the manufacture, mixing: a) check the application of the principles, standards of "good practice" in the production, testing, storage and regulation of relevant legislation;
-Check the preparation of production: the quality and origin of raw materials, supplies, materials, packaging before put into production;
-Check the condition of the production, testing and implementation of technological process of production and testing processes, factory machinery, sanitation and personal hygiene;
-Tested semi-finished products, packaging and finished product waiting;
-Check the product before entering the warehouse, factory;
-Check the observance of regulations on import, storage, stock, allocate, drug quality assurance.
b) examined the implementation of drug registration, stability studies, product development research, labeling the drug as prescribed.
c) conducting sampling and testing of drug samples taken according to quality standard or base standards apply (for blending by blending or drug use in hospitals) and other regulations concerned.
2. Check the quality of medicines for export, import, distribution and circulation on the market: a) check for compliance with the principles, standards of "good practice" in the distribution, storage and preservation, the conditions for quality assurance and the rules relating to the conditions for preservation, transportation the distribution and circulation of drugs. Check out the rules and implementing provisions on inspection and control of the origin, the quality of the drug in the course of warehousing, storage, transport, and export the repository;
b) check on drug registration number or drug import license and compliance of the drug labeling, drug user guide;
c) check the compliance with the notice to revoke the Agency's drug test the quality and of the production base, import, import, wholesale trust;
d) conducted sampling for analysis, testing determines the quality and execution of the model drug testing according to the standard of quality of the drug in the drug registration/profile profile import drugs without the registration number has been Ministry of Health approved.
Article 26. Specialized inspection of quality smoking 1. The inspection of the quality of medicines by pharmaceutical inspection done.
2. pharmaceutical Inspector is responsible for: a) check, inspection of the observance of the law on the quality of medicines, recommended precautions, remedy and termination of violations of the legislation on the quality of medicines;
b) review, dispute resolution, complaints, accusations about drug quality;
c) processing, sanctioning administrative violations the Organization, individuals are violations of the provisions of the law.
3. The Department of health of the province of the central cities, and health sectors examined, inspected the management of drug quality, handle the violations within the province, the city, its industry management.
4. procedures, order, inspect, measure and form processing, sanctioning administrative violations must comply with the provisions of the law on the handling of administrative violations.
Article 27. Responsibility of the management, inspection, quality control of drugs in the prevention of counterfeit drugs: 1. Make the information reflected from all organizations and individuals involved. Publish the necessary contacts (phone number, email, fax, etc.).
2. Communication, common to the people, the business about the harmful effects of smoking, the evidence, measures to avoid buying fake drugs and how to inform the State Administration about suspected cases of fake pills.
3. reporting cases of counterfeit drugs discovered on the market, the result of processing the cases detected.
4. Perform or coordinate with the relevant authorities to perform market surveillance inspections, timely detect fake drugs circulating on the market.
5. Coordinate and assist the relevant authorities investigate the traceability of counterfeit drugs.
6. Handling the manufacturing violations, trafficking counterfeit drugs of unknown origin, smuggled drugs prescribed.
7. Drug Administration is clue to coordinate, communicate, Exchange information on counterfeit drugs with related international organizations (WHO....) and the pharmaceutical management agency in the country.
Chapter VIII RESPONSIBILITIES of the STATE ADMINISTRATION of QUALITY SMOKING Article 28. The responsibilities of the State administration of quality central drug drug administration responsible to the Minister of health to perform state management on the quality of drugs: 1. building planning, plans on drug quality management to the Minister of health approval and implementation according to the approved plan.
2. construction and the Minister of Health issued the regulation on quality management, quality assurance (principles, standards of "good practice"), technical regulation, standards, quality instruction to check the implementation of the text on.
The clue of consideration, investigation, turning the Ministry of science and technology evaluation, announced The national standards on the drug; the Minister of Health issued apply Vietnam Pharmacopeia.
Clue the Health Minister issued the national Vietnam mail Pharmacy.
3. Manage the registration of medicinal products, standards organizations, individual business activities allowed smoking.
Provide scientific and technical information related to the quality assurance of medicines.
4. Responsible for quality control of drug production, processing, circulation and usage across the country. Directs, oversees the drug testing system nationwide. Conclusions about the quality of drugs on the basis of the results of the drug test testing facility of the State on smoking and related records.
Tracking, statistics, general management of drug quality.
5. check and gain certification guidelines, the standard of "good manufacturing practice" for manufacturing facilities; "Good laboratory practices" for drug testing facility and "good practice" for storage preservation services facility medication.
6. Focal and coordinating with the concerned authorities of propaganda, the dissemination and organization of legal instructions; support organizations, individual drug production business to learn information about the quality of drugs.
Direction, guidance for managers of health industry drug quality, training organizations and professional training on standards, measurement and quality drugs.
7. In collaboration with the Ministry of health inspectors perform functional testing, State Inspector of quality drugs and handle breach of the law for the quality of medicines according to the authority.
8. In collaboration with the relevant authorities implement international treaties, international agreements on the mutual acknowledgment of conformity assessment: certification guidelines, the standard of "good manufacturing practices", clinical trial results, admitted the result try biological equivalent and b. available ... Things 29. The responsibilities of the State administration of quality local drugs 1. Medical direction of comprehensive quality management in local medicine.
-Actively organize and perform the check and handle the problem of the quality of local drug prescribed by law.
-Responsible for the quality control of drug production, processing, circulation and use on the area. Conclusions about the quality of drugs on the basis of the results of sample testing of drug testing facility the State on smoking and related records.

2. Dissemination, guide and implement the laws on drug quality management in local, statistics tracking, general situation of drug quality management in local. Periodically report the situation to management, the quality of the medical drugs (Drug Administration).
Reports of the Ministry of health (pharmaceutical Management Bureau) of the cases detected, the recovery of poor quality drugs, counterfeit drugs on the area.
3. Perform functional testing, State Inspector of quality drugs and handle breach of the law for the quality of medicines in the local scope.
Chapter IX RIGHTS and RESPONSIBILITIES of BUSINESS ESTABLISHMENTS, SMOKING RIGHTS of CONSUMERS on QUALITY medications for 30. The rights and responsibilities of business establishments 1. The business establishments must implement, apply the principles, standards of good practice in the manufacture, quality control, storage and quality management measures are appropriate under the provisions of article 9 and article 10 of this circular to ensure drug quality in the production process import, storage, preservation, distribution, circulation guarantees quality medications as scheduled to the hands of users.
2. Production, import, import authorization to ensure the drug batches produced, imported registered standards, disclosure of information about the quality of drugs and is responsible for the quality of medicines due to the manufacturing, import, import authorization.
3. The basis of wholesale, retail sale of drugs is only originated drugs business legal, quality and standards must be responsible before the law and the customer about the quality of information disclosure, honest about the quality of drugs. Timely stop of sales when the drug did not meet the quality standards or the notice of regulators, drug quality control agency.
4. The production facilities, business smoking: a) subjected to inspection, inspection of the quality of the management, inspection, quality control of the State and must strictly implement the requirements of the inspection bodies, the inspection;
Must repay the expense form, expense analysis, testing samples of the drug after the Agency management, drug quality inspection agency concluded the drug sample quality or wrong accusations, complaints about the quality of the drug as prescribed in paragraph 2 and paragraph 3, article 23 of this circular.
b) is entitled to complain to the agency conducting the inspection, the inspector or the superior governing body of analytical results, tested drug samples are taken to check the quality by the governing body, the State quality inspection, complaints about quality and conclusions about the Agency's handling of measure Manager , drug quality control agency.
To compensation for damages under the provisions of section 2 of chapter V of the law on quality of goods and products and the other provisions of the relevant laws.
Article 31. The responsibility of the business establishments in fake drug prevention 1. Just be buying drugs in the legitimate pharmaceutical establishments, receipts from identified sources.
Sell drugs have bills enclosed vouchers.
2. Medicines must have the registration number or the import license of the Ministry of health.
3. false Medication when detected in the drug supply network must be separated immediately from the other medications and should be recorded. The counterfeit or suspect is counterfeit must be labeled clearly, safekeeping separately in order to avoid the confusion brought out re-circulation distribution.
4. Immediately notify the authorities, drug quality control, other State agencies and related production facilities, drug supply base on the drug was identified or suspected counterfeit drugs.
5. Provide accurate, truthful information and to coordinate with the authorities in identifying the origins of fake medicines.
Article 32. Rights of consumers consumers have the right to be informed about the quality of drugs and manual, medication; comply with the instructions for use of reasonable safety and storage of drugs; complaint and request the production base, trafficking drugs to compensation under the provisions of the law because the drug production, traffic does not guarantee the quality of the cause.
Chapter X PROCESSING of breach of article 33. Handling violations in the process of drug quality control in the production process in product quality control in production, when the producers not to comply the requirements of conditions related to the production, testing, storage of drugs; about drug quality standards; about the labeling of the medicine and the respective technical regulation for medicinal products, then the processing is done according to the following rules: 1. check Holdings trayêu globe producers made the repair, remedy to ensure the quality of drugs before making the market;
2. where there are production facilities in violation of the principles of standard business conditions (principles, standards of good practice in the manufacture, maintenance, drug testing), or test results determine the product does not meet quality standards, threatening the safety, life of the user , drug quality control agency announced the suspension and recovery products, withdraw the registration number in circulation, to temporarily suspend the production of substandard product quality and recommendations of competent administration pause or revoke the certificate of eligible pharmaceutical business.
3. No case agreed with the sample test results during the 3 days of the date of the notice of the results of sample testing the drug did not meet quality standards, manufacturing facilities might suggest a management agency, the State quality control specify the other testing facility conducted the analysis , testing determines the quality of drug testing results on the basis of the principle that the testing conditions the minimum standard equivalent to the initial testing facility.
Article 34. Handling violations in the process of checking the quality of imported drugs in process quality control of imported medicines, when drug findings did not meet labeling requirements, the registration number, ask about the conditions related to the process of preserving, transporting medicines and quality management measures according to the respective technical regulation for drugs then processed as follows : 1. import Drugs, have tested votes determine the quality of smoking but do not meet the requirements of trademark Agency shall check the quality of products, goods import facility requirements, entrust import to fix before confirming to import procedures with customs.
2. where is the Department of health to allow imports, meet the requirements of the record nhãnnhưngphiếu test determines the quality of drugs not full quality standard criteria or signs is not intact, the packaging is damaged, are heterogeneous, change of perception or not guaranteed preservation conditions require thìcơ product quality inspection agency goods require import facility choice among authorities that have been assigned or admit nhậnthực is currently evaluating and testing voucher level determines the quality of the drug at the gate to enter.
3. In the case of test results, quality of goods determined smoking do not meet quality standards, according to the nature and extent of the violation, the Agency examined petition the competent State agency applied a or following disposal measures: a) import facility requirements re export or destruction of such goods;
b quality control agency) consider strengthening the check at the gate or petition the competent State agency decision to pause or stop the import, withdraw the registration number of the offending drug circulation or the whole of the production of drugs, drug supply in violation; at the same time take measures to handle the production establishments, facilities offered and the basis of imports under the current rules.
Article 35. Handling violations in the process of quality control of drugs circulating on the market 1. In the process of quality control of drugs circulating on the market, when the product does not meet the requirements of drug labeling, drug registration number and quality management measures according to the respective technical regulation with respect to smoking and ask about the conditions regarding the preservation process drug distribution, then processed according to the following steps: a) check, control Group members required quality base business pause the selling of drugs and within no more than 24 hours must be reported with the drug quality control agency to handle according to the authority;
b) drug cases violates the regulations on drug labeling, drug registration, quality of medicines, the Agency requires manufacturers, import and export, import trustee performs processing measures, fix, repair or recovery of smoking;
 c) cases where business establishments had the drug in violation of the applicable regulations, standards of pharmaceutical business conditions (the standard principles of good practice in the business of smoking), influenced the quality of the drug business, conservation, test and control group members the quality of written report of recommendations governing body , competent inspections halted operations and require the facility to conduct repair fix before continuing operation. The base case does not fix, repair the breach, the competent authority to withdraw the certificate of eligible drug business of violations according to the current rules on administrative sanctions in the field of health.
2. In the case of the model drug testing results did not meet quality standards or licensing, please, or the rules related to the quality of the drugs, then depending on the nature and extent of the violation, the Agency examined the quality of the recovery notice in writing, require the manufacturing facility import, export, import, wholesale trustee proceed to revoke the drug violation prescribed in chapter IV of this circular.

3. No case agreed with the sample test results during the 3 days of the date of the notice of the results of sample testing the drug did not meet quality standards, business establishments may recommend the governing body, the State quality control specify the other testing facility conducted the analysis , testing determines the quality of drug testing results on the basis of the principle that the testing conditions the minimum standard equivalent to the initial testing facility.
Article 36. Handle personal business organisation, counterfeit drugs, drugs of unknown origin, smuggled drugs 1. The organizations and individuals who produce fake drugs trafficking, depending on the level will be handled administratively or prejudice criminal liability.
2. Organizations and individuals trafficking in drugs of unknown origin, does not have a valid voucher bills, smuggled drugs, smoking is not allowed in circulation will be dealt administrative sanction, according to the terms of sanctions and additional sanctions measures in accordance with the law.
Chapter XI ENFORCEMENT PROVISIONS Article 37. Transitional provisions 1. The State's testing agency about smoking in Central and the central cities, continue to perform the sampling of drugs to determine the quality until the quality controllers to force the drug levels are appointed.
a central drug testing Institute), drug testing Institute in Ho Chi Minh City, national testing of vaccines and medical products, according to the functions, duties and scope of activities are assigned, is responsible for conducting drug sampling testing to determine quality of drugs produced, circulation , used nationwide;
b) testing centre pharmacy, cosmetics testing centre, area pharmacy, the cosmetics, the central cities is responsible for conducting drug sampling testing to determine quality of drugs produced, circulated, used on the area.
2. In the time continue to implement the provisions of paragraph 1 of this Article, the funding for the operation of sampling, sample testing of drugs by drug testing agencies plan and receive use.
Article 38. Effect 1. This circular has effect from 1/7/2010.
Annuls decision No 2480/1998/QD-BYT on 15/9/1998 of the Minister of health on drug quality management regulation.
2. the Director of the Drug Administration has the responsibility to guide the implementation of this circular.
3. He/she: Chief of the Department of health, the Chief Inspector of the Ministry of health, Director of the science and training, planning and finance, Director of the drug administration, Director of the Central Institute for drug testing, drug testing Institute in Ho Chi Minh City, national testing of vaccines and medical products , Director of the Health Department of the province or city level, heads of health departments, General Director Of Vietnam pharmaceutical companies, organizations, individuals and business units, individuals are responsible for implementation of this circular.
4. in the process if there are problems and obstacles, suggest units, timely personal reflection on the Ministry of health (pharmaceutical Management Bureau) to consider and resolve.