✦ Smart summary
Circular No. 09/2010/TT-BYT guides the management of drug quality in Vietnam. The document stipulates activities related to drug quality management during production, importation, circulation, and use; rights and responsibilities of drug business establishments, consumers, and relevant organizations. Notably, it applies Good Manufacturing Practice (GMP) principles and regulations on drug quality testing.
Scope of application
Organizations and individuals engaged in drug business, production facilities, importers, storage and preservation units, users; consumers.
Key points
- Drug business establishments must apply Good Manufacturing Practice (GMP) principles during production, compounding, quality inspection, and labeling of drugs.
- Drugs shall be suspended from circulation or recalled when they fail to meet registered quality standards, show signs of counterfeiting, have expired, or violate storage and transportation regulations.
- Drug business establishments are responsible for drug quality and must comply with regulations on quality inspection and control at their premises.
- Violations during drug quality inspection will be handled according to regulations, including recalling non-compliant products or suspending circulation.
- State management agencies are responsible for developing and issuing legal documents on drug quality management.
🌐 Social impact of this document
- Positive impact: Ensures safe and effective drug use for the public; prevents the circulation of counterfeit and substandard drugs in the market.
- Negative impact: May impose financial burdens on businesses due to compliance with testing and quality management regulations.
❓ Frequently asked questions
What principles should drug business establishments apply?
Drug business establishments must apply Good Manufacturing Practice (GMP) principles during production, compounding, quality inspection, and labeling of drugs.
When are drugs suspended from circulation?
Drugs shall be suspended from circulation when they fail to meet registered quality standards, show signs of counterfeiting, have expired, or violate storage and transportation regulations.
What actions must drug business establishments take to ensure quality?
Drug business establishments must conduct quality inspections at their premises, organize testing work with appropriate technical equipment and specialized staff.
How are violations during drug quality inspection handled?
Violations will be handled according to regulations, including recalling non-compliant products or suspending circulation. Drug business establishments must bear the cost of sample collection and testing if the drug samples do not meet quality standards.
What powers do state management agencies have?
State management agencies have the authority to develop plans and programs for drug quality management; issue legal documents and conduct nationwide drug quality inspections.
Full text
CIRCULAR
Guidelines for the management of drug quality
Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to the Drug Law dated June 14, 2005;
BASED ON THE LAW ON STANDARDS AND TECHNICAL REGULATIONS dated June 29, 2006;
Pursuant to the Law on Product Quality and Goods dated November 21, 2007;
Based on Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Drug Law;
Pursuant to Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing the implementation of certain provisions of the Law on Standards and Technical Regulations;
Pursuant to Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing the implementation of certain provisions of the Law on Product Quality and Goods;
To ensure drug quality during production, importation, circulation, and use, to comply with the regulations stipulated in the Drug Law, the Standard and Technical Regulation Law, the Product Quality Law, and other relevant regulatory documents concerning drug quality, and to align with international practices, meeting international integration requirements in the pharmaceutical sector, the Ministry of Health provides guidelines for managing drug quality during production, importation, circulation, and use in Vietnam.
PART I
GENERAL PROVISIONS
Article 1. Scope of Regulation
This Circular sets forth activities related to the management of drug quality during production, exportation, importation, circulation, and use in Vietnam; rights and responsibilities of drug business establishments, consumers, and organizations and individuals related to drug quality.
Article 2. Applicability
This Circular applies to organizations and individuals (hereinafter referred to collectively as establishments) engaged in drug business operations and agencies, organizations, and individuals (hereinafter referred to collectively as units) involved in drug quality management activities in Vietnam.
Article 3. Explanation of Terms
In this Circular, certain terms are understood as follows:
1. Drugs are substances or mixtures of substances intended for human use for the purpose of preventing, treating, diagnosing diseases, or adjusting physiological functions of the body, including finished drugs, raw materials for drugs, vaccines, medical biological products, excluding functional foods.
2. Vaccineare preparations containing antigens that enable the body to develop immune responses, used for disease prevention purposes.
3. Medical biological products are biological origin products used for disease prevention, treatment, and diagnosis in humans.
4. Raw materials for drugs are substances participating in the composition of products during the drug production process.
5. Active ingredients (also called active substances) are substances or mixtures of substances with therapeutic activity used in drug production.
6. Finished drugs are drug forms that have undergone all stages of production, including final packaging and labeling.
7. Drug quality standards include specifications, technical requirements, testing methods, packaging, labeling, transportation, storage, and other requirements related to drug quality.
Drug quality standards are expressed in the form of technical documents.
8. Technical regulations for drugs are provisions regarding the limits of technical characteristics and management requirements that drugs and related activities such as production, testing, storage, and transportation must comply with to ensure drug quality and efficacy, safety, hygiene, public health; protection of animals, plants, the environment; national security interests, consumer rights, and essential requirements.
Technical regulations for drugs are issued by the Minister of Health in the form of documents for mandatory application.
9. Drug expiration date is the usage period set for a batch of drugs beyond which the drugs may not be used.
The drug expiration date is usually marked on the drug label in numbers or letters.
10. Batch is a defined quantity of initial raw material, packaging raw material, or processed product produced through a single process or a series of processes and has uniform quality.
Production batch number is a symbol in numbers or letters, or a combination of both, used to identify a batch of drugs and allow tracing the entire history of the batch, including all stages of the production process, quality inspection, and distribution of that batch.
11. Qualified drugs are drugs that meet registered quality standards according to pharmacopoeia standards or manufacturer's base standards.
12. Substandard drugs are drugs that do not meet registered quality standards with the competent authority.
13.Counterfeit drugs are products manufactured in the form of drugs with the intent to deceive, falling under one of the following cases:
a) Containing no active ingredient;
b) Containing active ingredients but not at the registered dosage;
c) Containing different active ingredients from those listed on the label;
d) Imitating the name or industrial design of registered drugs protected by another manufacturer's intellectual property rights.
14. Good practices are sets of principles and standards for drug production, storage, testing, circulation; cultivation, harvesting, and processing of medicinal herbs issued by the Ministry of Health.
15. Drug testing involves sampling, examining technical standards, conducting corresponding and necessary tests to determine whether raw materials, semi-finished products, finished products meet quality standards, thereby deciding whether to accept or reject the drug.
Article 4. Units and Measuring Instruments
Units of measurement and measuring equipment used in the pharmaceutical industry must comply with the provisions of the law on measurement.
Chapter II
CONSTRUCTION, ANNOUNCEMENT AND APPLICATION OF DRUG QUALITY STANDARDS
Article 5. Drug Quality Standards
1. National standards: The Vietnamese Pharmacopoeia is the national standard for drugs.
2. Basic standards: These are standards compiled and applied by production and compounding establishments for products they produce or compound.
3. Drug quality standards that have been approved by the Ministry of Health for circulation shall be deemed as the commitment of business and compounding establishments regarding the quality of produced, compounded, circulated, and used drugs; they serve as the basis for management agencies and drug quality inspection agencies to determine and conclude on drug quality during production, circulation, and use.
During the management of drug production and circulation, business establishments may apply internal quality standards, including drug quality standards reviewed by the Ministry of Health and additional quality criteria.
4. Provisions on the application of the Vietnamese Pharmacopoeia:
a) Pharmaceutical production and compounding establishments may apply the Vietnamese Pharmacopoeia or develop basic standards for their products based on the provisions of the Vietnamese Pharmacopoeia and related legal documents;
b) The requirements for quality criteria and quality levels specified in each monograph of the Vietnamese Pharmacopoeia are mandatory requirements. The Ministry of Health encourages establishments to apply the testing methods recorded in each monograph of the Vietnamese Pharmacopoeia;
c) The requirements for quality criteria, quality levels, and common testing methods stipulated in the Appendices of the Vietnamese Pharmacopoeia are mandatory requirements. Any differences must be proven and compared to ensure at least equivalent to the provisions of the Vietnamese Pharmacopoeia;
d) Basic standards for drugs must at least meet the requirements for quality criteria and quality levels specified in the corresponding monographs of the Vietnamese Pharmacopoeia;
e) Pharmaceutical production and compounding establishments must update the quality standards for their produced and compounded drugs in accordance with the latest effective version of the Vietnamese Pharmacopoeia.
5. Provisions on the application of international standards and foreign pharmacopoeias:
a) Domestic drug business establishments are permitted to directly apply widely used pharmacopoeias in international pharmaceutical trade: Europe, UK, USA, International, Japan. Application must include all provisions on quality criteria, quality levels, and testing methods specified in those pharmacopoeias;
b) In cases where domestic drug business establishments apply other pharmacopoeias than those mentioned in point a, Clause 5 of this Article or basic standards, the applied quality standards must at least meet the requirements for quality criteria and quality levels specified in the corresponding monographs of the Vietnamese Pharmacopoeia or of the widely used pharmacopoeias specified in point a, Clause 5 of this Article;
c) In cases where widely used pharmacopoeias specified in point a, Clause 5 of this Article do not have corresponding monographs on drug quality standards, domestic drug business establishments may apply other pharmacopoeias or basic standards, but must be evaluated according to regulations and approved by the Ministry of Health;
d) Domestic drug business establishments must promptly update drug quality standards to comply with the latest versions of the pharmacopoeias.
Article 6. Compilation of the National Standard for Drugs, issuance and implementation of the Vietnamese Pharmacopoeia.
1. The Vietnamese Pharmacopoeia Council shall be responsible for organizing research and compilation of the National Standard for Drugs according to the standardization plan of the Ministry of Health, and periodically reviewing, supplementing, and amending the National Standard for Drugs.
2. The Drug Administration shall act as the lead entity to review, seek opinions, organize verification, and coordinate with the Pharmacopoeia Council to complete the draft dossier of the National Standard for Drugs; transfer it to the Ministry of Science and Technology for examination and publication of the National Standard for Drugs; and submit to the Minister of Health for issuance of the Vietnamese Pharmacopoeia based on the National Standard for Drugs.
The procedures for compiling, examining, and publishing the National Standard for Drugs, and issuing the Vietnamese Pharmacopoeia shall comply with the provisions set forth in Circular Jointly Issued No. 11/2008/TTLT-BYT-BKHCN dated December 29, 2008, issued by the Ministry of Health and the Ministry of Science and Technology, guiding the construction, examination, and publication of the National Standard for Drugs and the issuance and publication of the Vietnamese Pharmacopoeia.
Article 7. Construction and Publication of Quality Standards for Circulating Drugs
1. Production facilities may apply either the basic standard or the pharmacopoeia standard.
In cases where the basic standard is applied, the production facility must organize research and construction of quality standards (refer to the model of the basic standard in Appendix 1) and conduct verification and proof of the suitability of the testing methods recorded in the basic standard.
In cases where the pharmacopoeia standard is applied, the production facility must assess the suitability of the testing method applicable to the drugs produced by the facility.
2. For chemical drugs, medical biological products, traditional medicine, and herbal drugs:
a) Production facilities that meet the principles and standards of "Good Manufacturing Practice for Pharmaceuticals" (GMP) shall attach the quality standard to the drug registration dossier and submit it to the Ministry of Health for review;
b) In cases where production facilities for chemical drugs and medical biological products have not met the principles and standards of "Good Manufacturing Practice for Pharmaceuticals": the production facility shall send the quality standard and samples of the drug to one of the state drug testing centers at the central level or pharmaceutical service testing enterprises that have been certified to operate pharmaceutical businesses for verification, confirming the suitability of the testing method before submitting the drug registration dossier to the Ministry of Health;
c) In cases where production facilities for traditional medicine and herbal drugs have not met the principles and standards of "Good Manufacturing Practice for Pharmaceuticals": the production facility shall send the quality standard and samples of the drug to the state drug testing center or pharmaceutical service testing enterprises that have been certified to operate pharmaceutical businesses for verification confirming the suitability of the testing method before submitting the drug registration dossier to the Ministry of Health.
3. For vaccines and medical biological products containing antibodies used for disease prevention and treatment: the production facility shall send the quality standard and samples of the drug to the National Institute for Vaccine and Medical Biological Product Control for verification, confirming the suitability of the quality standard and testing method, safety, and efficacy of the product before submitting the drug registration dossier to the Ministry of Health.
4. For in vitro diagnostic reagents:
a) Production facilities that meet the principles and standards of "Good Manufacturing Practice for Pharmaceuticals" or the TCVN ISO 13485 standard shall attach the quality standard to the drug registration dossier and submit it to the Ministry of Health for review;
b) In cases where production facilities have not met the principles and standards of "Good Manufacturing Practice for Pharmaceuticals" or the TCVN ISO 13485 standard: the production facility must send the quality standard and sample products to the National Institute for Vaccine and Medical Biological Product Control for verification, confirming the suitability of the testing method and evaluating the diagnostic effectiveness of the product before submitting the drug registration dossier to the Ministry of Health.
5. For domestically produced drugs listed in the domestic production directory submitted for registration at local health departments:
a) Production facilities that meet the principles and standards of "Good Manufacturing Practice for Pharmaceuticals" shall attach the quality standard to the drug registration dossier and submit it to the provincial or centrally-administered municipal health department for review;
b) In cases where production facilities have not met principles and standards of "Good Manufacturing Practice for Pharmaceuticals": the production facility shall send the quality standard and samples of the drug to the state drug testing center or pharmaceutical service testing enterprises that have been certified to operate pharmaceutical businesses for verification shall confirm the suitability of the testing method before submitting the drug registration dossier to the provincial or centrally-administered municipal health department.
6. Amendments to drug quality standards must be carried out according to the procedures and formalities stipulated in Clauses 2, 3, 4, and 5 of this Article and in accordance with current regulations on drug registration..
Article 8. Construction and Issuance of Basic Standards for Compounded Drugs
The basic standards for compounded drugs within the facility (unfinished products, finished products awaiting packaging, compounded drugs according to prescriptions, compounded drugs used in hospitals, research institutes with beds) shall be constructed by the facility and approved and issued by the head of the unit.
These compounded drugs shall not be distributed or circulated in the market.
Chapter III
MANAGEMENT AND QUALITY CONTROL OF DRUGS IN PRODUCTION, COMPOUNDING, DISTRIBUTION, AND USE
Article 9. Conditions for Ensuring the Quality of Medicines at Production and Compounding Facilities
Production and compounding facilities must implement quality management requirements for medicines during production as follows:
1. Apply Good Manufacturing Practices principles and standards in production, distribution, storage, testing of medicines and/or other suitable management systems to ensure that the products produced meet the registered medicine quality standards accepted by the Ministry of Health (for marketed medicines) or announced (for compounded medicines for use).
2. Register medicines in accordance with the Law on Medicines, relevant legal regulations, and label in accordance with the law on product labeling.
3. Comply with technical standards related to the production, compounding, quality inspection, storage, quality standards, and other relevant regulations.
4. Be subject to inspection by management agencies and state quality control agencies for medicines according to the inspection contents stipulated in Article 24 of this Circular.
Article 10. Conditions for Ensuring the Quality of Medicines at Export, Import, Wholesale, Retail, Storage, Transportation, and Usage Facilities
Export, import, wholesale, retail, storage, transportation facilities must implement the following quality management requirements:
1. Apply Good Manufacturing Practices principles and standards in storage and distribution of medicines and other appropriate measures to maintain the quality of medicines consistent with the registered quality standards accepted by the Ministry of Health until they reach the user:
a) Recruitment, training, and deployment of personnel with sufficient professional capacity as prescribed;
b) Provision of equipment for storage and transportation of medicines to ensure storage conditions during storage and transportation;
c) Implementation and maintenance of record-keeping systems to track the circulation of medicines by the business facility.
For imported medicines, in addition to complying with the above regulations, the importing facility must fully comply with all regulations related to ensuring the quality of medicines as stipulated in the regulations on importing medicines.
2. Be subject to quality inspections by management agencies and state quality control agencies for medicines according to the inspection contents stipulated in Article 24 of this Circular.
Article 11. Quality Inspection of Medicines at Medicine Business Facilities
1. All medicines (including raw materials and packaging) must be inspected for quality; only when they meet the quality standards and comply with relevant legal regulations can they be used in production, compounding, and circulation.
2. The head and the person in charge of the business, compounding, and usage facilities must be responsible for quality management and quality inspection work at their facilities and be accountable for the quality of medicines sold, compounded, and used by their facilities.
3. Business, compounding, and usage facilities have the responsibility to organize and carry out quality inspection and control work at their facilities.
4. Production and compounding facilities must organize testing work with appropriate technical means and specialized staff to test, determine, and evaluate the quality of medicines during production and before shipment.
5. Encourage export, import, trading, storage, and usage facilities, depending on their scope of activities, to organize testing work to monitor the quality of medicines they handle.
6. Medicine business facilities (facilities registering medicines, facilities importing medicines) have the responsibility to provide the quality standards of medicines accepted by the Ministry of Health to local quality control agencies when requested.
Article 12. Content of drug quality inspection by pharmaceutical business establishments
Depending on the scope and content of their activities, pharmaceutical business establishments shall conduct self-inspection of drug quality according to the quality inspection contents stipulated in Article 25 of this Circular and internal regulations of the establishment to ensure the quality of produced and traded drugs.
Chapter IV
PROVISIONS ON SUSPENDING CIRCULATION, RECALLING DRUGS AND HANDLING DRUGS VIOLATING QUALITY REQUIREMENTS
Article 13. Cases of suspending circulation and recalling drugs
1. Drugs shall be suspended from circulation and recalled in the following cases:
a) Drugs that are not of the correct type due to confusion during distribution or handover;
b) Drugs that do not meet registered quality standards;
c) Drugs that do not fully comply with labeling requirements for pharmaceutical products as stipulated in Article 37 of the Medicine Law and other relevant laws;
d) Drugs whose packaging materials and packaging forms do not meet quality assurance requirements;
đ) Drugs without registration numbers or not permitted for import;;
e) Drugs subject to recall announcements by the manufacturing establishment, management agencies, or state drug quality control agencies in Vietnam or abroad:
- Counterfeit drugs, smuggled drugs, drugs of unknown origin or source;
- Drugs manufactured or imported not in accordance with registration files or import permits;
- Drugs containing prohibited substances in production or substances exceeding permitted levels;
- Finished drugs produced from substandard raw materials or raw materials of illegal origin (smuggled, raw material manufacturers without valid pharmaceutical business licenses or raw materials not intended for human use or without permission for human use);
- Drugs produced at establishments without valid pharmaceutical business certificates or failing to meet production conditions (not meeting Good Manufacturing Practice principles or other business conditions);
- Vaccines improperly stored contrary to required storage conditions;
- Drugs past their expiration date;
g) Voluntary recalls by pharmaceutical business establishments or pursuant to decisions of management agencies or state drug quality control agencies.
2. Forms of recall:
a) Voluntary recall: Business establishments voluntarily discover and recall drugs that do not meet regulations.
Upon discovering substandard drugs, confusion, or incidents, heads of pharmaceutical business establishments must immediately report to the drug management agency (the Drug Administration of Vietnam, Health Departments of provinces and centrally administered cities) about the cause, extent of violation, risk assessment, and planned recall scale. After receiving the agency's opinion, the establishment must issue a recall notice to places where the drugs are circulating and implement recall activities to ensure all affected drugs are removed from the market; simultaneously monitor and address consequences caused by the non-compliant drugs.
b) Mandatory recall:
When authorized state drug management and quality control agencies require it, business establishments (holders of circulation permits, manufacturers, importers/exporters, entrusted importers) must immediately recall drugs confirmed to be in violation or suspected of serious violations affecting user health and public safety.
3. Provisions on violation levels:
a) Basis for classifying violation levels: Quality violation levels are classified based on the severity of the violation, risks to treatment effectiveness, user safety, and unwanted drug reactions.
b) Classification of violation levels:
- Level 1: Violations that may endanger users' lives, cause severe injury, or death.
- Level 2: Violations that may affect treatment effectiveness and safety during use.
- Level 3: Violations that do not affect or minimally affect treatment effectiveness and safety during use.
4. Levels of announcing suspension of circulation and implementing drug recalls
a) Level 1: Implemented for Level 1 violations. Urgent notices suspending circulation are sent to holders of circulation permits, manufacturers, importers/exporters, wholesalers, retailers, and pharmacy departments of using establishments, while also announced through mass media so that all business establishments, users, and consumers are aware. Business establishments with non-compliant drugs must urgently implement measures to thoroughly recall non-compliant drugs within the shortest time possible to minimize adverse effects.
b) Level 2: Implemented for Level 2 violations, notices suspending circulation are sent to holders of circulation permits, manufacturers, importers/exporters, wholesalers, and retailers.
c) Level 3: Implemented for Level 3 violations, notices suspending circulation are sent to manufacturers, importers, and entrusted importers and wholesalers.
d) Suspension of circulation and recall can be implemented for a batch or several batches of drugs or a product or all products of one or more drug manufacturing establishments.
5. Authority to announce recalls
a) The Drug Administration of Vietnam issues nationwide notices suspending circulation and recalling drugs. Notices are sent to Health Departments of provinces and centrally administered cities, sectoral health departments, and manufacturing/importing/trusted importing establishments.
b) Provincial/Central City Health Departments, Sectoral Health Departments:
- Issue notices suspending circulation and recalling within their jurisdiction for drugs identified as non-compliant by local/sectoral drug quality control agencies;
- Issue notices suspending circulation and recalling within their area to implement national recall notices issued by the Drug Administration of Vietnam, handle violations according to the law, and report back to the Drug Administration of Vietnam.
c) Manufacturing/importing/trusted importing establishments issue recall notices for voluntary recalls.
6. Responsibilities for recalling drugs:
a) Production facilities, export facilities, import facilities, consignment import facilities, wholesale drug establishments shall be responsible for thoroughly recalling recalled drugs. When these facilities recall drugs or receive recall notifications from state management agencies, quality control agencies regarding drugs, or from drug supply establishments, they must:
- Notify the recall to wholesale and retail establishments and places where drugs are circulating;
- Promptly and thoroughly carry out the recall of non-compliant items or batches of drugs;
- Prepare a drug recall record. The drug recall record must fully reflect evidence of drug supply, evidence of drug recall implementation at wholesale and retail establishments, and usage of purchased drugs according to the form in Appendix 3;
- Report on the progress, results, and handling of recalled drug batches according to the form in Appendix 4 to the Drug Administration and relevant authorities within 72 hours for level 1 recalls and 30 days for level 2 and 3 recalls;
- Address the developments and consequences caused by substandard drugs.
b) Retail drug establishments and drug user facilities upon receiving recall notifications (written recall information or through mass media) must promptly implement and return recalled drugs to the drug supply establishment.
c) Production, export, import, wholesale, and retail drug establishments must accept returned recalled drugs from business and user facilities and end-users who have purchased the drugs.
d) The Ministry of Health (Drug Administration, Health Ministry Inspectorate), provincial and centrally-administered city health departments, and health sectors shall inspect and supervise drug business and user facilities in implementing drug recalls.
e) The Drug Administration shall issue detailed guidelines on the procedures for handling, recalling drugs, and evaluating the effectiveness of recall notifications issued by drug production and business establishments.
Article 14. Destruction of Drugs (Handling of Non-compliant Drugs)
1. Substandard drugs and drugs violating labeling, depending on the degree of violation, may be processed, recycled, or destroyed. Establishments with non-compliant drugs wishing to recycle them must submit a request along with the recycling process to the Drug Administration. Recycling can only be carried out after obtaining written approval from the Drug Administration.
2. Counterfeit drugs, smuggled drugs, drugs of unknown origin, expired drugs, drugs containing prohibited substances, drugs produced from substandard raw materials, drugs produced under conditions not meeting regulations, and samples stored beyond their storage period must all be destroyed. Drug business establishments with non-compliant drugs must bear the cost of drug destruction.
3. The head of the establishment requiring drug destruction shall issue a decision to establish a Drug Destruction Committee. The committee must consist of at least three members, including a unit manager and a pharmacist responsible for professional matters.
4. Drug destruction must ensure long-term safety for people and animals and prevent environmental pollution in accordance with laws on environmental protection.
5. The destruction of addictive drugs, psychotropic drugs, precursor substances used in drugs, and radioactive drugs must comply with the provisions on drug destruction in guidelines related to addictive drugs; psychotropic drugs and precursor substances used in drugs; and radioactive drugs. Upon completion of drug destruction, a report accompanied by a destruction record must be submitted to the direct supervisory authority according to the form in Appendix 5.
Chapter V
MANAGEMENT AND QUALITY CONTROL OF VACCINES AND MEDICAL BIOPRODUCTS
Article 15. General Provisions
All state management agencies, organizations, individuals, and businesses participating in state management activities, production, business operations, use of vaccines and medical products must comply with regulations on management, inspection, production, business operations, and drug use set forth in this Circular and other relevant laws.
Article 16. Regulations on Quality Testing of Vaccines and Medical Products Containing Antibodies for Disease Prevention and Treatment
1. The Ministry of Health shall assign the National Institute of Vaccine and Medical Product Quality Control to be responsible for testing, evaluating quality, safety, efficacy, and issuing certificates for vaccine and medical product batches containing antibodies for disease prevention and treatment before they are released for circulation and use.
2. Vaccine and medical product production and business establishments must submit samples and production records of vaccine and medical product batches containing antibodies for disease prevention and treatment to the National Institute of Vaccine and Medical Product Quality Control for testing and evaluation prior to release for circulation and use. Procedures and documentation for sample submission for testing are stipulated in Article 17 of this Circular.
Vaccine and medical product production and import establishments may only release, circulate, and use batches of vaccines and medical products containing antibodies for disease prevention and treatment after receiving a release certificate from the National Institute of Vaccine and Medical Product Quality Control confirming that the batch meets quality standards and ensures safety and efficacy.
Article 17. Procedures and Documentation for Sample Submission for Quality, Safety, and Efficacy Testing of Vaccines and Medical Products Containing Antibodies for Disease Prevention and Treatment
1. For domestically produced vaccines and medical products containing antibodies for disease prevention and treatment: Production establishments must submit production records and samples of the batch (finished or semi-finished products) to the National Institute of Vaccine and Medical Product Quality Control including:
a) Sample submission form for testing;
b) Samples of vaccines and medical products for testing (quantity according to regulations for each type of vaccine and medical product);
c) Summary production and quality control records of the batch (certified copy stamped by the manufacturer);
d) Batch test report.
2. For imported vaccines and medical products containing antibodies for disease prevention and treatment: Import establishments must submit production records and samples of the batch to the National Institute of Vaccine and Medical Product Quality Control including:
a) Sample submission form for testing;
b) Samples of vaccines and medical products for testing (quantity according to regulations for each type of vaccine and medical product);
c) Summary production and quality control records of the imported batch (certified copy stamped by the manufacturer);
d) Release certificate issued by the competent authority of the exporting country or equivalent agency for the imported batch (certified copy stamped by the importing company's director);
e) Evidence ensuring storage conditions (cold chain) during the transportation of the imported batch.
Chapter VI
DRUG TESTING SYSTEM AND DRUG TESTING ACTIVITIES
Article 18. Pharmaceutical Testing System
1. State pharmaceutical testing facilities
- At the central level: The Central Institute for Pharmaceutical Testing, the Ho Chi Minh City Institute of Pharmaceutical Testing, the National Institute for Vaccine and Biomedical Product Quality Control, and regional pharmaceutical and cosmetic testing centers.
- At the local level: Provincial and centrally-administered city pharmaceutical and cosmetic testing centers.
2. Pharmaceutical testing laboratories of drug business establishments.
3. Enterprises providing pharmaceutical testing services: independent enterprises providing testing services or testing laboratories of drug business establishments with the function of providing pharmaceutical testing services.
Article 19. Ensuring Quality at Pharmaceutical Testing Facilities
Depending on their scale of operation, pharmaceutical testing facilities must implement the principles and standards of "Good Laboratory Practice" and/or other suitable management systems (such as ISO/IEC 17025, etc.) to ensure the accuracy of testing and analysis results of drug samples.
Article 20.Activities of pharmaceutical testing facilities
1. Central state pharmaceutical testing facilities shall perform:
a) Quality inspection and evaluation to assist the Minister of Health in determining the quality of drugs nationwide according to the division of labor by the Minister of Health.
Reviewing drug quality standards and other products upon request of the Ministry of Health.
b) Scientific research; directing technical expertise to local state pharmaceutical testing facilities.
c) Training and retraining staff in technical laboratory testing expertise.
d) Providing testing services.
đ) Proposing technical measures to the Minister of Health for managing drug quality in accordance with the country's economic and social development conditions.
e) Other activities as prescribed by relevant laws.
2. Local state pharmaceutical testing facilities shall perform:
a) Quality inspection to assist the Director of the Department of Health in determining the quality of circulating drugs within the province or centrally-administered city under their management.
b) Reviewing quality standards for drugs from medicinal materials and drugs listed in the national drug production registration list submitted to the Department of Health according to current registration guidelines..
c) Providing testing services.
d) Other activities as prescribed by relevant laws.
3. Pharmaceutical testing laboratories of production and business establishments:
a) The pharmaceutical testing laboratory of production and business establishments is a testing unit responsible for self-inspection of drug quality at the establishment, accountable for quality inspection activities at the establishment.
b) Conducting analysis and testing to determine the quality of raw materials, excipients, intermediates during production, finished drugs, and participating in other activities related to evaluating and controlling drug quality conditions as stipulated by the establishment.
4. Enterprises providing pharmaceutical testing services:
a) (Attached to the letter No. of the Department of Information and Communications [province/city]) must meet good practice standards in pharmaceutical testing. In cases where pharmaceutical testing laboratories of drug business enterprises wish to provide pharmaceutical testing services, the enterprise must complete supplementary procedures to include the service function in the Drug Business Qualification Certificate according to legal provisions. b) Scope of operations: conducting analysis and testing of raw materials, intermediates during production, and finished drugs for drug production and business establishments.
In cases where pharmaceutical testing enterprises participate in analytical and testing activities serving state management and inspection work on drug quality, the enterprise must complete registration procedures for conformity assessment fields with the Ministry of Health and the Ministry of Science and Technology according to Circular 08/2009/TT-BKHCN dated April 8, 2009, issued by the Ministry of Science and Technology guiding requirements, procedures, and registration processes for conformity assessment fields and related regulations.
In the case where a business providing pharmaceutical testing services participates in analytical and testing activities for drug quality management and state inspection work, the business must complete registration procedures for conformity assessment fields with the Ministry of Health and the Ministry of Science and Technology in accordance with Circular No. 08/2009/TT-BKHCN dated April 8, 2009, issued by the Ministry of Science and Technology, guiding requirements, procedures, and registration processes for conformity assessment fields and related provisions.
Article 21. Provisions on the application of quality standards in drug testing
1. Drug testing must be conducted in accordance with the registered quality standards of the production facility or import facility that have been approved for circulation by the Ministry of Health (the Drug Administration Department).
In cases where methods other than those specified in the registered standards are applied, such methods must be approved by the Ministry of Health. The Ministry of Health shall entrust the Central Institute of Drug Testing and the Ho Chi Minh City Institute of Drug Testing to review and decide on the acceptance of such methods.
2. In cases where there is doubt about the components or quality of drugs, state drug testing facilities may apply different methods from those specified in the registered standards to conduct tests and issue quality test results.
3. The heads of drug testing facilities shall be responsible for the drug testing results of their own facilities under the law.
Article 22. Provisions on sampling drugs for quality testing, responding to test results, sample retention, and related documentation
1. Sampling drugs for quality testing:
a) The sampling of drugs for quality testing shall be carried out by the quality control agency as stipulated in Clause 1, Article 24 of this Circular;
b) The sampling of drugs to determine quality must comply with the "Circular guiding the sampling of drugs to determine quality" issued by the Ministry of Health;
c) The quality control agency must pay for the samples taken for quality testing in accordance with the provisions of the law.
2. Time limit for responding to analytical test results:
a) For samples taken by management agencies and quality control agencies for quality testing: The maximum time limit for responding to analytical and testing results is 30 working days from the date the testing facility receives the sample. Within two days from the issuance of the analysis or testing report, the drug testing facility must notify the analytical and testing results to the management agency, quality control agency, and the drug manufacturing and trading entity whose sample was taken. The analysis or testing report must be made in at least three copies: one copy retained at the testing facility, one copy sent to the quality control agency, and one copy sent to the drug manufacturing and trading entity whose sample was taken.
In cases requiring re-evaluation of quality standards or re-assessment of testing results; lacking equipment, chemicals, reagents, reference materials; suspecting the components and quality of drugs and applying testing methods different from those registered in the quality standards... the response time for analytical and testing results may be extended. The testing facility must provide explanations for these cases;
b) For samples submitted by organizations and individuals for analysis, testing, or re-evaluation of quality standards: the time limit for responding to analytical and testing results shall be agreed upon by the parties or determined internally by the manufacturing and trading entity.
3. Sample retention:
a) Drugs that have been tested for quality and concluded must be retained as samples. Retained samples must be sealed and stored under conditions suitable as indicated on the label.
b) Sample storage period:
- For production, export, and import facilities, finished product samples must be retained for at least 12 months after the expiration date of the drug;
- For active ingredients used in drug production, the production facility must retain raw material samples for at least 12 months after the expiration date of the finished product produced from such raw materials;
- For drug testing facilities, the retention period must not be less than two years (24 months) from the date of sampling or receipt of the sample;
- For entities receiving samples for drug registration, after the drug registration number is issued, the sample must be retained for at least six months from the date of issuance of the registration number.
3. Documentation retention:
a) All documentation related to drug quality control activities must be retained in accordance with regulations;
b) Documentation related to narcotic drugs, psychotropic drugs, precursor substances used as drugs, and radioactive drugs: the storage period must be at least two years after the expiration date of the drug;
c) Documentation when the retention period expires must be handled in accordance with current regulations.
Article 23. Costs for sampling and testing to determine the quality of drugs
1. The cost of sampling and the cost of testing drug samples for quality control during production, compounding, and circulation on the market shall be paid according to the provisions of Circular Joint No. 28/2010/TTLT-BTC-BKHCN dated March 3, 2010 issued by the Ministry of Finance and the Ministry of Science and Technology guiding the management and use of funds for state inspection activities regarding product and commodity quality.
2. In cases where the drug sample test results are concluded by the drug quality inspection agency as not meeting quality standards, the drug manufacturing and trading entity violating quality standards must bear full responsibility for refunding the entire cost of sampling and the cost of testing drug samples to the drug quality inspection agency according to Articles 10, 12, 14, 16, and 41 of the Product and Commodity Quality Law 2007, Circular Joint No. 28/2010/TTLT-BTC-BKHCN dated March 3, 2010 issued by the Ministry of Finance and the Ministry of Science and Technology guiding the management and use of funds for state inspection activities regarding product and commodity quality, and other relevant regulatory documents.
3. In cases where drugs are complained about or reported for quality issues, but the inspection agency concludes that the complaints or reports about drug quality are incorrect, the complainant or reporter must pay back the costs of sampling and the costs of analysis and testing of drug samples according to Clause 1 of this Article.
4. The cost of sampling for quality control and the cost of testing drug samples shall be allocated within the budget for the activities of the state drug quality inspection agency according to the provisions of Circular Joint No. 28/2010/TTLT-BTC-BKHCN dated March 3, 2010 issued by the Ministry of Finance and the Ministry of Science and Technology guiding the management and use of funds for state inspection activities regarding product and commodity quality.
Chapter VII
STATE INSPECTION AND SUPERVISION REGARDING DRUG QUALITY
Article 24. State Inspection Regarding Drug Quality
1. Drug quality inspection agencies:
a) Central drug quality inspection agency: The Drug Administration under the Ministry of Health;
b) Local drug quality inspection agency: Provincial Department of Health, municipal departments directly under the central government;
c) The Drug Administration is responsible for directing and coordinating with provincial Departments of Health and other related agencies in conducting drug quality inspections.
2. Annually, the Drug Administration (in coordination with the Central Institute for Pharmaceutical Control, Ho Chi Minh City Institute for Pharmaceutical Control, National Institute for Vaccine and Biologic Control) and provincial Departments of Health, based on collecting information about risks of non-compliance with drug quality, the situation of drug production, import/export, circulation on the market, develop plans for sampling to inspect quality, submit these plans to the Ministry of Health or the People's Committee of provinces/municipalities directly under the central government for review, approval, and budget allocation for implementation according to their respective authorities.
3. State inspection regarding drug quality is carried out by inspection teams or quality control officers. The powers and responsibilities of inspection teams and quality control officers are stipulated in Articles 48, 49, 50, and 51 of the Product and Commodity Quality Law 2007.
a) Inspection teams are established by the head of the drug quality inspection agency (the Drug Administration, Provincial Department of Health) based on approved inspection programs or plans, or in cases where drug manufacturing, compounding, and trading entities have systematic violations or serious violations concerning drug quality or conditions for drug production and trading, or in cases of urgent requirements. The content of the inspection is implemented according to Clause 1 and Clause 2, Article 25 of this Circular;
b) Quality control officers conduct inspections of drug quality in production, import/export, and circulation on the market. The content of the inspection is implemented according to Clause 2, Article 25 of this Circular.
Article 25.Content of drug quality inspection by drug quality inspection agencies
1. Drug quality inspection in production and compounding:
a) Inspect the application of "Good Manufacturing Practices" principles and standards in drug production, testing, storage, and related legal regulations;
- Inspect the preparation for production: the quality and origin of raw materials, excipients, packaging materials before being put into production;
- Inspect production, testing conditions, and the implementation of production technology procedures and testing procedures, factory hygiene, machinery hygiene, and personal hygiene;
- Test semi-finished products, products awaiting packaging, and finished products;
- Inspect products before warehousing and dispatch;
- Inspect compliance with regulations on import/export, storage, inventory, distribution, and ensuring drug quality.
b) Inspect the implementation of drug registration, stability studies, product development, and drug labeling as prescribed.
c) Conduct sampling and testing of drug samples according to registered quality standards or basic standards applied (for compounded drugs or hospital compounded drugs) and other relevant regulations. Inspect the quality of exported, imported, and distributed drugs on the market:
2. From the date this Circular takes effect, Decision No. 90/2003/QD-BBCVT dated May 15, 2003 of the Minister of Posts and Telecommunications on the issuance of regulations regarding the issuance of commemorative postage stamps ceases to be effective.a) Inspect compliance with "Good Distribution Practices" principles and standards in
distribution, storage, and drug preservation, conditions ensuring drug quality and regulations related to storage, transportation, and distribution. Inspect the establishment and implementation of regulations on source verification and quality control of drugs during warehousing, storage, transportation, and dispatch; b) Inspect drug registration numbers or import permits and compliance with drug labeling and usage instructions;
c) Inspect compliance with drug recall notifications from the quality inspection agency and from the manufacturing, importing, entrusted importing, and wholesale entities.
c) Inspect compliance with drug recall notifications from quality control agencies and from production establishments, importers, entrusted importers, and wholesalers;
d) Conduct sampling for analysis and testing to determine the quality of drugs and perform drug sample testing according to the quality standards of the drug in the registration dossier/drug importation dossier without a registration number that has been accepted by the Ministry of Health.
Article 26. Specialized inspection on drug quality
1. Drug quality inspection shall be carried out by the Drug Inspectorate.
2. The Drug Inspectorate shall be responsible for:
a) Inspecting and supervising compliance with laws on drug quality, proposing preventive measures, remedial actions, and cessation of violations of laws on drug quality;
b) Considering and resolving disputes, complaints, and reports regarding drug quality;
c) Handling and imposing administrative penalties on organizations and individuals who violate the law according to the provisions of the law.
3. Provincial Departments of Health under central cities and Health Departments of sectors shall inspect and supervise drug quality management work and handle violations within their respective jurisdictions.
4. Procedures, methods for conducting inspections and supervision, and forms of handling and imposing administrative penalties must comply with the provisions of the law on handling administrative violations.
Article 27. Responsibilities of management, inspection, and supervision agencies in combating counterfeit drugs:
1. Receiving information reflecting from all relevant organizations and individuals. Announcing necessary contact addresses (direct phone numbers, emails, faxes...).
2. Communicating and disseminating to the public and businesses about the dangers of counterfeit drugs, identifying signs, preventive measures against purchasing counterfeit drugs, and methods to report suspected counterfeit drugs to state management agencies.
3. Reporting cases of counterfeit drugs discovered in the market and the results of handling such cases.
4. Implementing or coordinating with related functional agencies to carry out market monitoring work to promptly detect counterfeit drugs circulating in the market.
5. Cooperating and supporting related functional agencies in investigating and tracing the origin of counterfeit drugs.
6. Handling cases of violating the production and sale of counterfeit drugs, drugs of unknown origin, and smuggled drugs according to regulations.
7. The Drug Administration is the focal point for coordinating, contacting, and exchanging information on counterfeit drugs with relevant international organizations (WHO...) and drug management agencies of other countries.
hChapter VIII
RESPONSIBILITIES OF STATE MANAGEMENT AGENCIES ON DRUG QUALITY
Article 28. Responsibilities of central state management agencies on drug quality
The Drug Administration is responsible to the Minister of Health for implementing state management over drug quality:
1. Developing planning and plans for drug quality management to submit to the Minister of Health for approval and organizing implementation according to the approved plan.
2. Drafting and submitting to the Minister of Health for promulgation legal regulatory documents on drug quality management, ensuring quality (good practice principles), technical standards, drug quality standards, and guidelines for checking the implementation of these documents.
The focal point for reviewing, examining, transferring to the Ministry of Science and Technology for appraisal, and announcing the national drug standard; submitting to the Minister of Health for promulgation and application of the Vietnamese Pharmacopoeia.
The focal point for submitting to the Minister of Health for promulgation of the Vietnamese National Formulary..
3. Managing the registration of quality standards for drug products of organizations and individuals permitted to engage in drug business activities.
Providing scientific and technological information related to ensuring drug quality.
4. Being responsible for inspecting the quality of drugs produced, compounded, circulated, and used nationwide. Directing and supervising the national drug testing system. Concluding on drug quality based on the results of drug testing by the central state drug testing facility and related dossiers.
Monitoring, statistics, and summarizing the situation of drug quality management.
5. Inspecting and issuing certificates of compliance with good manufacturing practice principles for drug production facilities; good laboratory practice principles for drug testing facilities; and good storage practice principles for drug service storage facilities.
6. Being the focal point and coordinating with related functional agencies to promote and organize guidance on laws; supporting organizations and individuals engaged in drug production and business to understand information on drug quality.
Directing and guiding professional duties for health sector drug quality management staff; organizing training and upgrading skills on standards, measurement, and drug quality.
7. Coordinating with the Ministry of Health's Inspectorate to perform state inspection functions on drug quality and handle violations of drug quality laws within their authority.
8. Coordinating with related functional agencies to implement international treaties and agreements on mutual recognition in conformity assessment: certification of compliance with good manufacturing practice principles, clinical trial results, recognition of bioequivalence and bioavailability test results...
Article 29. Responsibilities of State Management Agencies for Drug Quality at Local Level
1. The Department of Health shall direct comprehensive management of drug quality at the local level.
- Proactively organize and implement inspections and handle issues related to drug quality within their jurisdiction in accordance with the law.
- Be responsible for inspecting the quality of drugs produced, compounded, circulated, and used within their jurisdiction. Conclude on the quality of drugs based on the results of drug sample testing from the national drug inspection agency at the local level and relevant documents.
2. Popularize, guide, and organize the implementation of legal documents concerning drug quality management at the local level.
Monitor, statistically analyze, and compile the situation of drug quality management at the local level. Regularly report on the management situation and drug quality to the Ministry of Health (Drug Administration).
Report to the Ministry of Health (Drug Administration) about cases where substandard or counterfeit drugs are discovered and recalled within their jurisdiction.
3. Carry out the function of inspecting and supervising state quality control of drugs and handling violations of drug quality laws within their jurisdiction.
Chapter IX
RIGHTS AND RESPONSIBILITIES OF DRUG BUSINESS ESTABLISHMENTS; CONSUMER RIGHTS REGARDING DRUG QUALITY
Article 30. Rights and responsibilities of business establishments
1. Business establishments must implement and apply good manufacturing practices, quality control standards, storage methods, and appropriate quality management measures as stipulated in Articles 9 and 10 of this Circular to ensure drug quality during production, importation, storage, preservation, circulation, and distribution, ensuring that drugs reach consumers as expected in terms of quality.
2. Production, importation, and entrusted importation establishments must ensure that batches of drugs leaving the factory or imported meet registered standards, truthfully disclose information about drug quality, and be responsible for the quality of drugs produced, imported, or entrusted for importation.
3. Wholesale and retail establishments may only deal in legally sourced drugs meeting quality standards and must bear legal and customer responsibility for drug quality, truthfully disclose information about drug quality. Promptly cease sales when substandard drugs are detected or upon notification from quality control agencies.
4. Drug production and trading establishments:
a) Must undergo quality inspections by management, supervision, and quality control agencies, and strictly comply with the requirements of these agencies;
Shall reimburse the costs of sampling, analysis, and testing of drug samples when the management or quality control agency concludes that the drug sample does not meet quality standards or when complaints or reports about incorrect drug quality information are made according to Clause 2 and Clause 3, Article 23 of this Circular.
b) Have the right to appeal to the inspection or supervisory agency or higher-level management agency regarding the analytical and testing results of drug samples taken for quality control by the state management or quality control agency, appeals against conclusions on drug quality, and the measures taken by the management or quality control agency.
Are entitled to compensation for damages as provided in Section 2, Chapter V of the Law on Product Quality and other relevant legal provisions.
Article 31. Responsibilities of Business Entities in Preventing and Combating Counterfeit Medicines
1. Only purchase medicines from legitimate pharmaceutical business entities with clear supply source invoices and certificates.
Sell medicines accompanied by invoices and certificates.
2. Medicines must have registration numbers or import permits issued by the Ministry of Health.
3. Counterfeit medicines discovered within the medicine supply network must be immediately separated from other medicines and recorded. Suspected counterfeit medicines must be clearly labeled and stored separately to prevent confusion and re-distribution.
4. Immediately notify relevant management agencies, quality control agencies, state agencies involved, and the production and supply entities about medicines determined or suspected to be counterfeit.
5. Provide truthful and accurate information and cooperate with competent authorities in determining the origin of counterfeit medicines.
Article 32. Consumer Rights
Consumers have the right to be informed about the quality of medicines and usage instructions; to follow safe and reasonable usage and storage instructions; and to lodge complaints and demand compensation for damages caused by substandard medicines produced or circulated, according to the law.
Chapter X
HANDLING VIOLATIONS
Article 33. Handling Violations During Quality Control Inspections in Production
During quality control inspections in production, if it is found that the producer does not comply with requirements related to production conditions, testing, and storage of medicines; quality standards of medicines; labeling of medicines and corresponding technical regulations for medicinal products, the following handling measures shall be implemented:
1. The inspection team requires the producer to take corrective actions to ensure the quality of medicines before releasing them to the market.
2. In cases where the production entity violates principles and standards related to pharmaceutical business conditions (Good Manufacturing Practices, storage, and testing standards for medicines), or if test results determine that the product does not meet quality standards and poses a threat to the safety and lives of users, the quality control agency shall issue a notice to suspend circulation and recall the product, revoke its registration number, temporarily halt production of non-compliant products, and recommend the competent authority to temporarily suspend or revoke the certificate of compliance for pharmaceutical business operations.
3. If there is disagreement with the test results, within three days from receiving the notification of non-compliance with quality standards, the production entity may request the national quality control agency to designate another testing facility to conduct analysis and testing to determine the quality of the medicine on the principle that this facility meets minimum standard conditions equivalent to the initial testing facility.
Article 34. Handling Violations During Quality Control Inspections of Imported Medicines
During quality control inspections of imported medicines, if medicines do not meet requirements regarding labeling, registration numbers, conditions related to storage and transportation, and quality management measures according to corresponding technical regulations, the following actions shall be taken:
1. Imported medicines with quality test certificates but failing to meet labeling requirements, the product and goods quality control agency shall require the importing entity or entrusted importer to rectify before confirming the import procedures with customs authorities.
2. In cases where medicines permitted by the Ministry of Health for importation meet labeling requirements but the quality test certificate does not fully meet the quality standards or the medicines show signs of damage, packaging defects, sensory changes, or failure to meet storage conditions, the product and goods quality control agency shall require the importing entity to choose one of the designated or recognized organizations to conduct evaluation and issue a quality test certificate at the port of entry.
3. In cases where test results determine that medicines do not meet registered quality standards, depending on the nature and degree of violation, the quality control agency shall recommend the competent authority to apply one or more of the following measures:
a) Require the importing entity to re-export or destroy the goods.
b) The quality control agency shall consider strengthening inspections at the port of entry or recommending the competent authority to issue a decision to temporarily suspend or stop imports, revoke the registration number of the violating medicine or all medicines from the violating production or supply entity; while taking measures against the production, supply, and importing entities according to current regulations.
Article 35. Handling Violations During the Inspection of Drug Quality Circulating on the Market
1. During the inspection of drug quality circulating on the market, when discovering products that do not meet the requirements for drug labeling, registration number, and quality management measures according to relevant technical regulations applicable to drugs, as well as conditions related to storage and distribution processes, the following steps shall be taken for handling:
a) The inspection team and quality control officers shall require the business entity to temporarily suspend the sale of drugs and report to the drug quality inspection authority within no more than 24 hours for handling within their jurisdiction.
b) In cases where drugs violate regulations concerning drug labeling, registration, and quality, the inspection authority shall require the production, import-export, and entrusted import entities to take measures to address, rectify, repair, or recall the drugs.
c) In cases where the drug business entity violates the application of regulations and standards regarding pharmaceutical business conditions (Good Distribution Practice principles), affecting the quality of marketed and stored drugs, the inspection team and quality control officers shall submit a written recommendation to the competent management and inspection authorities to temporarily halt the drug business operations and require the entity to make corrections before resuming activities. If the entity fails to correct the violations, the competent authority shall revoke the certificate of qualification for drug business operations according to current administrative penalties regulations in the health sector.
2. In cases where the test results of drug samples do not meet the registered quality standards or the relevant regulations concerning drug quality, the drug quality inspection authority shall issue a notice to recall the drugs and request the production, import-export, entrusted import, and wholesale entities to recall the non-compliant drugs in accordance with Chapter IV of this Circular.Upon receipt of the drug recall notification, require production establishments, import-export entities, entrusted importers, and wholesalers to carry out the recall of non-compliant drugs in accordance with Chapter IV of this Circular.
3. In cases where there is disagreement with the test results of the sample, within three days from receiving the notification of the non-compliance of the drug sample quality, the business entity may request the state management and inspection authorities to designate another testing facility to conduct analysis and testing to determine the drug quality test results based on the principle that such facility meets the minimum standard equivalent to the initial testing facility.
Article 36. Handling Organizations and Individuals Engaged in Fake Drugs, Drugs of Unknown Origin, and Smuggled Drugs
1. Organizations and individuals producing and selling fake drugs will be subject to administrative penalties or criminal prosecution depending on the severity of the violation.
2. Organizations and individuals trading in drugs of unknown origin without valid invoices, smuggled drugs, or drugs not permitted for circulation shall be subject to the highest administrative penalties and supplementary sanctions as stipulated by law.
Chapter XI
IMPLEMENTING PROVISIONS
Article 37. Transitional Provisions
1. National and provincial drug testing agencies shall continue to collect drug samples to determine quality until the appointment of quality control officers at all levels.
a) The Central Institute for Drug Testing, the Ho Chi Minh City Institute for Drug Testing, and the National Institute for Vaccine and Biomedical Product Control, based on their assigned functions, tasks, and operational scope, shall be responsible for collecting drug samples to test and determine the quality of produced, circulated, and used drugs nationwide.
b) Regional Drug and Cosmetic Testing Centers and Provincial and Municipal Drug and Cosmetic Testing Centers shall be responsible for collecting drug samples to test and determine the quality of produced, circulated, and used drugs within their respective jurisdictions.
2. During the period of continuing the provisions of Clause 1 of this Article, the annual budget for sampling and testing drug samples shall be planned and utilized by the drug testing agencies.
Article 38. Effective Date
1. This Circular takes effect from July 1, 2010.
Repeals Decision No. 2412/1998/QĐ-BYT dated September 15, 1998, issued by the Minister of Health on the issuance of the Drug Quality Management Regulations.
2. The Director of the Department of Drug Administration shall be responsible for guiding the implementation of this Circular.
3. The Heads of the Ministry of Health's Office, the Inspectorate of the Ministry of Health, the Departments of Science and Training, Planning and Finance, the Director of the Department of Drug Administration, the Directors of the Central Institute for Drug Testing, the Ho Chi Minh City Institute for Drug Testing, the National Institute for Vaccine and Biomedical Product Control, the Directors of Health Services of provinces and centrally-administered cities, the Heads of Health Services of sectors, the General Directors of the Vietnam Pharmaceutical Corporation, organizations and individuals engaged in drug business and related units and individuals are responsible for implementing this Circular.
4. Any issues encountered during implementation should be promptly reported to the Ministry of Health (Department of Drug Administration) for consideration and resolution./.
The original file of this document is being updated. Please read the full text and check back later.
Download
The original file of this document is being updated. Please read the full text and check back later.
Relations map
↑ Basis & documents that affect this document
Referenced by 4
31/2014/TT-BYT
Thông tư số 31/2014/TT-BYT Quy định bảng tiêu chuẩn đánh giá về mặt kỹ thuật tại hồ sơ mời thầu mua thuốc
Expired
37/2013/TT-BYT
Thông tư số 37/2013/TT-BYT Hướng dẫn lập hồ sơ mời thầu mua thuốc trong các cơ sở y tế
Expired
09/2011/TT-BYT
Thông tư số 09/2011/TT-BYT Hướng dẫn điều kiện và phạm vi chuyên môn của cơ sở y tế điều trị bằng thuốc kháng HIV
In effect
03/2016/TT-BYT
Thông tư số 03/2016/TT-BYT Quy định về hoạt động kinh doanh dược liệu
Expired
09/2010/TT-BYT
Circular No. 09/2010/TT-BYT guiding the management of drug quality
Expired
↓ Documents affected by this document
Guides 6
127/2007/NĐ-CP
Nghị định số 127/2007/NĐ-CP Quy định chi tiết thi hành một số điều của Luật Tiêu chuẩn và Quy chuẩn kỹ thuật
In effect
34/2005/QH11
Luật Dược số 34/2005/QH11
Expired
68/2006/QH11
Nghị quyết số 68/2006/QH11 Về dự toán ngân sách nhà nước năm 2007
In effect
132/2008/NĐ-CP
Nghị định số 132/2008/NĐ-CP Quy định chi tiết thi hành một số điều của Luật chất lượng sản phẩm, hàng hóa
In effect
79/2006/NĐ-CP
Nghị định số 79/2006/NĐ-CP Quy định chi tiết thi hành một số điều của Luật Dược
Expired
05/2007/QH12
Luật Chất lượng sản phẩm, hàng hoá số 05/2007/QH12
In effect
Click a document to open. A red border = a relation that changes validity.
Translations
This document is available in the following languages: