Ngày 04/5/2018, Bộ Y tế ban hành Thông tư 11/2018/TT-BYT quy định về chất lượng thuốc, nguyên liệu làm thuốc. Theo đó, thuốc thuộc một trong các trường hợp sau phải được kiểm nghiệm bởi cơ sở kiểm nghiệm do Bộ Y tế chỉ định trước khi lưu hành: - Vắc xin, sinh phẩm là huyết thanh có chứa kháng thể; - Sinh phẩm là dẫn xuất của máu và huyết tương người; - Thuốc nhập khẩu theo Điều 70 Nghị định 54/2017/NĐ-CP ngày 08/5/2017; - Thuốc được sản xuất bởi cơ sở sản xuất thuốc nước ngoài thuộc Danh sách cơ sở sản xuất có thuốc vi phạm chất lượng do Bộ Y tế công bố. Trường hợp cơ sở kiểm nghiệm không đủ điều kiện để thử một hoặc một số phép thử thì phải thông báo, phối hợp với cơ sở sản xuất, nhập khẩu gửi mẫu để thử nghiệm các phép thử này tại cơ sở có đủ điều kiện thực hiện phép thử. Thông tư 11/2018/TT-BYT có hiệu lực thi hành từ ngày 20/6/2018, bãi bỏ Thông tư 09/2010/TT-BYT và Thông tư 04/2010/TT-BYT ngày 12/02/2010. MINISTRY OF HEALTH ---- SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness --- No: 11/2018/TT-BYT Hanoi, May 4, 2018 CIRCULAR ON DRUG/DRUG INGREDIENT QUALITY Pursuant to the Law No. 34/2005/QH11 dated June 14, 2005 on Pharmacy; Pursuant to the Government’s Decree No. 54/2017/ND-CP on detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy dated May 8, 2017; Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining Functions, Tasks, Powers and Organizational Structure of Ministry of Health; At the quest of the Director General of the Drug Administration, The Ministry of Health promulgates the Circular on Drug/Drug Ingredient Quality. Chapter I ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Article 1. Scope This Circular provides for application of quality standards of drugs (modern drugs, herbal drugs, vaccines and biological) and drug ingredients (except herbal ones); drug/drug ingredient tests and procedures for recall and handling of unconformable drugs. Article 2. Definitions For the purpose of this Circular, the terms below shall be construed as follows: 1. Drug/drug ingredient quality standards are documents regulating technical characteristics of drugs and drug ingredients, including quality criteria, quality levels, test methods and other administrative requirements. 2. GLP stands for Good Laboratory Practice. 3. WHO stands for World Health Organization. 4. ICH stands for International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Chapter II ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Article 3. General provisions 1. Pharmacy business establishments and drug preparing facilities shall apply drug/drug ingredient quality standards by way of pharmacopeia or internal standards for drugs and drug ingredients produced and prepared by those facilities. 2. Pharmacy business establishments and drug preparing facilities must carry out evaluations of test methods stated in drug/drug ingredient quality standards published and applied by the drug manufacturers. Assessment and evaluation of test methods are carried out in accordance with guidelines for assessment of analytic processes by ASEAN or ICH, specified in the Circular on Registration of Drugs and Drug Ingredients promulgated by the Minister of Health. 3. The Ministry of Health organizes document assessment and approval of drug/drug ingredient quality standards, in accordance with regulations on drug/drug ingredient registration, issuing permits for drugs /drug ingredients which do not have prior registrations for circulation. Article 4. Application of pharmacopeia 1. Application of Vietnam’s pharmacopeia and reference pharmacopeias:
... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 2. Application of pharmacopeias other than the ones specified in Point a of this Clause: If the pharmacy business establishment or drug preparing facility decides to apply a pharmacopeia other than ones specified in Point a of this Clause, the applied quality standards must at least:
Article 5. Application of internal standards 1. The internal drug/drug ingredient standards must conform to the regulations specified in Point b, Clause 2, Article 102 of the Law on Pharmacy, as follows:
2. The internal standards of drugs prepared in medical facilities are formed and evaluated for appropriateness by the facility, and promulgated by the facility's head. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 1. When applying for circulation (or circulation extension) of a drug/drug ingredient: The quality standards of that drug/drug ingredient must conform to one of the following pharmacopeias at the time of application:
2. In the case of drugs or drug ingredients that have already been allowed for circulation: For a maximum of two years from the effective date of the pharmacopeia’s latest edition, the applier or manufacturer have the responsibility to update the standards of drugs/drug ingredients as regulated by that edition. 3. During drug/drug ingredient circulation, if the applier or manufacturer finds any factor that severely affect drug safety, quality or efficacy or is requested by the Ministry of Health (Drug Administration), the manufacturer must the update the drug/drug ingredient standards’ criteria in order to bring that factor under control. Chapter III DRUG/DRUG INGREDIENT TESTS Article 7. Drug/drug ingredient tests 1. The test must be carried out in accordance with the approved and updated drug/drug ingredient quality standards. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 If the drug is prepared in a medical facility, the test is carried out in accordance with the drug quality standards formed and promulgated by the facility. 2. The collection of drug/drug ingredient samples for testing is carried out in accordance with Appendix I and the sample collection form in Template No. 1 of Appendix III issued together with this Circular. 3. Presenting drug/drug ingredient test/analysis results:
- There is information on severely adverse effects of the drug; - The drug comes from a facility committing serious violations against good practice; - Additional samples of the drug are collected in the cases mentioned in Point b, Clause 1 and Point b, Clause 2 of this Circular's Article 14.
... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - The drug does not fit any of the cases mentioned in Points b and d of this Clause.
- The drug/drug ingredient has test methods that require long testing time; - The drug/drug ingredient requires re-testing or reevaluation of results. - The drug/drug ingredient has dubious contents or quality, which require test methods other than the ones stated in the registered quality criteria; - The drug/drug ingredient requires test methods that the testing facility is incapable of conducting (e.g. lack of equipment, chemical, reagents, reference material). dd) If the deadlines mentioned in Points b, c and d of this Clause are not met, the testing facility has to explain the reason for lateness in a document attached to the test/analysis report;
If the drug/drug ingredient sample does not meet the quality standards, in 24 hours from the time the test/analysis report is issued, the testing facility must notify the Ministry of Health (Drug Administration) of that sample in writing with the test/analysis report attached, both physical and electronic copies (the latter, which is scanned, can be sent to the email address [email protected] or via messaging to the Drug Administration's phone number, with both methods of correspondence using the testing facility's official email address and phone number). A similar notification must also be sent to the Department of Health whose jurisdiction is where the tested drug/drug ingredient comes from. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 4. Filing and handling of complaints about test results:
5. Retention of samples:
- In the case of drug/drug ingredient production and importers: the finished product's sample must be retained for a minimum of 12 months after product's expiry date; the active ingredient’s sample must be retained for a minimum of 12 months after the expiry date of the finished product prepared from that ingredient. - In the case of drug testing facilities: the sample retention period is at least 12 months after the drug’s expiry date, or 24 months after the sample collection date for drug samples collected for quality inspection; or after the date of receipt for additional collected samples specified in Point b, Clause 1 and Point b, Clause 2, Article 14 of this Circular. 6. Archiving records and documents: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 8. Pre-circulation test for drugs specified in Clause 4, Article 103 of the Law on Pharmacy 1. Drugs that belong to one of the following categories must undergo testing carried out by a testing facility designated by the Ministry of Health (Drug Administration) before circulation:
2. Regulations on drug quality tests: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - The samples of the drugs specified in Points a, b, c, Clause 1 of this Article shall be collected by manufacturers (in case of domestic drugs) or importers (in case of imported drugs); - The facilities importing he drugs specified in Point d of this Article shall request the state’s quality inspection or testing authority for to collect samples of those drugs.
3. The Ministry of Health (Drug Administration) shall designate a testing facility which is granted certificates of eligibility for pharmacy business including drug testing, or testing facilities specified in Clause 1, Article 35 of the Law of Medicine meeting GLP requirements, to carry out drug tests specified in Clause 1 of this Article. If the testing facility does not have sufficient capacity for carrying out one or multiple test methods, the testing facility must notify the production/importer and cooperate with the latter in sending samples to other GLP-compliant testing facilities or laboratories compliant to ISO/IEC 17025 which have capacity for carrying out those test methods. 4. The designated testing facility report testing activities to the Ministry of Health (Drug Administration) on a monthly basis, following Template No. 7 of Appendix III issued together with this Circular. 5. The Ministry of Health (Drug Administration) publishes and updates the list of designated testing facilities mentioned in Clause 3 of this Article on the Drug Administration’s website. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
7. Tests on vaccines, biologicals which are antisera, derivatives of human blood and plasma are carried out in accordance with Articles 10 and 11 of this Circular. Article 9. The testing periods for facilities on the list of manufacturers with drugs that do not conform to quality standards and withdrawal from that list 1. The testing period starts from the first drug batch's import date after the Ministry of Health (Drug Administration) publishes the list of manufacturers with drugs that do not conform to quality standards and lasts:
... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 2. A manufacturer will be withdrawn from the list of manufacturers with drugs that do not conform to quality standards after meeting the following requirements:
The drug manufacturer/registrant files reports which follow Template No. 7 of Appendix III issued together with this Circular, with proof of test on all imported drug batches carried out during the implementation of Clause 1 of this Article;
3. On a monthly basis, the Ministry of Health (Drug Administration) publishes and updates the list of manufacturers with drugs that do not conform to quality standards, drops the names of facilities complying with the regulations this Article's Clause 2 from the list based on reports from testing facilities that participate in testing activities, drug manufacturers and registrants. Article 10. Test on vaccines, biologicals which are antisera, derivatives of human blood and plasma 1. The production/importer must send the samples and production records of vaccines, biologicals which are antisera, derivatives of human blood and plasma to the National Institute for Control of Vaccines and Biologicals for testing and evaluation before circulation. The sample sending documents are specified in Article 11 of this Circular. The production/importer must only circulate vaccines, biologicals which are antisera, derivatives of human blood and plasma after the National Institute for Control of Vaccines and Biologicals confirms the vaccine/biological batches' quality, safety and efficacy and issues quality certificates. 2. Within the time limit specified in Clause 3, Article 7 of this Circular, from the date all samples and documents specified in Article 11 of this Circular are received, National Institute for Control of Vaccines and Biologicals shall: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 11. Test samples and records for evaluation of quality, safety and efficacy of vaccines, biologicals which are antisera, derivatives of human blood and plasma 1. For local vaccines, biologicals which are antisera, derivatives of human blood and plasma: The manufacturer shall send the production records and samples from the product batches (either finished semi-finished products) to the National Institute for Control of Vaccines and Biologicals, including:
2. For imported vaccines, biologicals which are antisera, derivatives of human blood and plasma: The importer shall send the production records and samples from the product batches to the National Institute for Control of Vaccines and Biologicals, including: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
dd) The table of data on preservation conditions (cold storage) during the imported batch’s transport (certified by the importer) from automatic temperature recorders, freeze indicators (if any). 3. The manufacturer and importer must be responsible for their documents' legality. Chapter IV REGULATIONS ON RECALL AND HANDLING OF NONCONFORMABLE DRUGS Article 12. Compulsory drug recall procedure 1. Receiving information on unconformable drugs: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
dd) Information on unconformable drugs from public security, customs and market surveillance;
2. Identification of the violation’s seriousness:
If the drug registration advisory board's opinion is requested for identification of the violation’s seriousness, as specified in Section IV, Appendix II issued together with this Circular, the time limit of identification of violation's seriousness will be 7 days. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. Issuance of drug recall decision:
4. Notification of drug recall decision:
Departments of Health announce drug recall decisions on their websites immediately after receiving those decisions. Domestic drug manufacturers and importers must notify the information about recalled drugs to drug traders/users which purchased those drugs. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 5. Recalling drugs:
The drug trader/provider that fails to recall drugs or receiving returned drugs shall be notified by facilities and individuals purchasing those drugs to the local Department of Health and face actions.
6. Drug recall report, evaluation and additional measures:
- Summary drug recall report, which follows Template No. 5 of Appendix III issued together with this Circular. - List of drug traders/users (including those receiving drugs from the facility in charge of recalling unconformable drugs, or from distributors) with their addresses, phone numbers, email addresses (if any), amount of drugs received, amount of drugs recalled; ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - Drug recall self-evaluation form; - Investigation results, evaluation of causes, evaluation of risks in the unconformable drug's other batches and/or other drugs coming from the same production line.
Article 13. Voluntary drug recall procedure 1. The pharmacy business establishment that carries out voluntary drug recall shall evaluate and identify the seriousness of the drug's violation and report on the unconformable drug, seriousness of violation, reason for recall and handling measure proposal to the Ministry of Health (Drug Administration) in writing, as specified in Clauses 3 and 4, Article 15 of this Circular. 2. In three days from the date the pharmacy business establishments’ report is received, the Ministry of Health (Drug Administration) consider the report and identify the seriousness of the drug's violation as specified in Appendix II issued together with this Circular.
... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Article 14. Handling of drugs not meeting quality standards by place of collection 1. In the case of unconformable drug samples collected from retailers, level-III and level-IV medical facilities:
- Report its drug distribution to the Ministry of Health (Drug Administration); - Request the quality inspection authorities to collect additional samples from domestic drug manufacturers or importers, and from at least two wholesalers, with one of them already supplied drugs to the facility where the samples are collected from; - Send samples to central testing facilities in order to have the unfulfilled criteria tested.
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- Report its drug distribution to the Ministry of Health (Drug Administration); - Request the quality inspection authorities to collect at least two additional samples from other wholesale establishments, with one of them already supplied drugs to the facility where the samples are collected from; - Send samples to central testing facilities in order to have the unfulfilled criteria tested.
3. If the sample is collected from manufacturers, importers and preservation service providers, or the sample's quality violation is identified to be caused by the production process, the Ministry of Health (Drug Administration) shall identify the violation’s seriousness and draw the conclusion on recalling the unconformable drug as specified in Appendix II issued together with this Circular, and issue the drug recall decision as specified in Clause 3, Article 12 of this Circular. The recall's scope and time limit is specified in Clause 3, Article 63 of the Law on Pharmacy. Article 15. Handling of recalled drugs ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 2. The recalled drug must be destroyed if it has: First- or second-degree violation;
3. Procedure for proposing rectification of recalled drugs:
4. Procedure for proposing re-export of recalled drugs: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5. The rectification and re-export of recalled drug shall only be carried out after the written agreement of the Ministry of Health (Drug Administration) is issued. 6. Drug destruction:
7. The recalled drug handling period shall not exceed 12 months from the recall’s date of completion, as specified in Points a, b and c, Clause 3, Article 63 of the Law on Pharmacy. Article 16. Responsibilities for drug recall ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. Responsibilities of the Drug Administration:
dd) Produce documents providing detailed guidelines for the processes of drug recall and handling, evaluation of drug recall in drug manufacturers and pharmacy business establishments. 3. Responsibilities of Departments of Health: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
dd) Participate in or carry out evaluations of pharmacy business establishments’ drug recall in the Departments’ jurisdictions, under the Ministry of Health’s (Drug Administration’s) direction. Report any drug manufacturer, importer, wholesalers which are distribution hubs that fail to, or insufficiently, recall drugs to the Ministry of Health (Drug Administration)
Chapter V IMPLEMENTATION PROVISIONS Article 17. Effect 1. This Circular is in effect from June 20, 2018. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 18. Implementation 1. The Drug Administration has the responsibility to:
Collect drug samples for quality inspection and update the Ministry of Health’s drug quality inspection database with information on collected drug/drug ingredient samples (including: name of drug/drug ingredient, concentration, content, type of preparation, batch number, expiry date, circulation registration number or import permit number, manufacturer, importer, sample collector) and the drug/drug ingredient’s quality inspection results;
Provide the National Institute of Drug Quality Control and the Institute of Drug Quality Control Ho Chi Minh City with label templates and the quality standard of the drug/drug ingredient that is issued circulation registration certificate or import permit (the updated standard if any changes occur). In the case of vaccines and biological, the label template and quality standard shall be sent to the National Institute for Control of Vaccines and Biologicals; ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 dd) Preside over or participate in carrying out state inspections, inspect and take action against violations against the law in drug quality within the Administration's competence. 2. Departments of Health have the responsibility to:
3. Responsibilities of the drug testing system:
- Analyze and test samples to identify the quality of manufactured, circulated and used drugs/drug ingredients; report the test results to the Ministry of Health (Drug Administration) and the local Department of Health; - Research, establish and publish on websites of the institute and the Drug Administration the list of reference materials (including those of impurities) for analyses and tests on manufactured, imported, circulated and used in Vietnam; ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - The National Institute for Control of Vaccines and Biologicals, on an annual basis, review and evaluate vaccine/biological quality trends and present the evaluation to the Ministry of Health for consideration, and formation of guidelines for testing finished vaccines, biologicals which are antisera, derivatives of human blood and plasma (including reviewing vaccine/biological batch quality certificate’s test criteria). Update information about quality certificate issuance for vaccines, biologicals which are antisera, derivatives of human blood and plasma on websites of the institute and the Drug Administration.
- Analyze and test samples to identify the quality of manufactured, circulated and used drugs/drug ingredients; - Report the test results to the Department of Health and the Ministry of Health (Drug Administration). 4. Traders have the responsibility to:
... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- Formulate plans to collect drug samples for testing and surveillance of drug/drug ingredient quality; reserve, receive and use the annual budget for sample collection and tests on drug/drug ingredient samples; - Collect drug/drug ingredient samples in accordance with the approved plans at establishments doing pharmacy business and using drugs; - Update the Ministry of Health’s drug quality inspection database with information on drug/drug ingredient samples collected for quality inspection and those samples’ test results; - Report the test results to the Ministry of Health (Drug Administration) and the local Department of Health if the drug/drug ingredient samples do not meet the quality standards as specified in Clause 3, Article 7 of this Circular. - The National Institute of Drug Quality Control shall the drug quality inspection database for the Ministry of Health;
- Formulate plans to collect drug samples for testing and surveillance of drug/drug ingredient quality; reserve, receive and use the annual budget for sample collection and tests on drug/drug ingredient samples; - Collect drug/drug ingredient samples for quality inspection in accordance with the approved plans at establishments doing pharmacy business and using drugs; ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - Report the test results to the Ministry of Health (Drug Administration) and the Department of Health if the drug/drug ingredient samples do not meet the quality standards as specified in Clause 3, Article 7 of this Circular. Article 19. Implementation responsibilities The Director General of the Drug Administration, Chief of the Ministry Office, Chief Ministerial Inspector, heads of units affiliated with the Ministry of Health, provincial Departments of Health, pharmacy business establishments, other related authorities, organizations and individuals have the responsibility to implement this Circular. If any complication arises during implementation, the authorities, organizations and individuals are advised to notify the Ministry of Health (Drug Administration) for consideration and solution. ON BEHALF OF THE MINISTER DEPUTY MINISTER Truong Quoc Cuong APPENDIX I ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Sampling tools All sampling tools and implements should be made of inert and clean materials, which should be suitable for each sample type, ensure no effect on sample quality, prevent impurities that cause contamination of samples or cross-contamination and ensure safety of sampler (see Section III) 2. Quantity of sample taken 2.1. The quantity of sample taken for analytical and retention purposes should be calculated according to inspection requirements, pharmaceutical product quality standards, applied pharmaceutical starting materials and testing methods but should be sufficient to allow for at least three analyses or to perform tests to obtain accurate and reliable results. 2.2. Two samples are usually taken from each consignment (one for analytical purpose and one for retention purpose). Where necessary, the number of analytical samples and retention samples may be more than two to be sufficient for testing and retention at relevant organizations. 3. Sampling operations 3.1. Sampling principles: - Depending on the inspection purpose and each type of product, the sampler should decide to adopt an appropriate sampling method. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - The sampling procedure should be such that non-uniformity of pharmaceutical products in each sampling unit and entire consignment can be detected. Signs of non-uniformity include differences in shape, size or colour of particles in crystalline, granular or powdered solid substances; moist crusts on hygroscopic substances; deposits of solid pharmaceutical product in liquid or semi-liquid products; and stratification of liquid products. - Pooling of the samples from the different portions should be avoided, because this can mask contamination, low potency or other quality problems. Separate samples should be formed from these portions and containers. - For finished drug products, the sampling procedure should take account of the official and non-official tests required for the individual dosage form (e.g. tablets or parenteral preparations). Non-official tests could include testing for adulteration and counterfeiting. - It is not recommended to mix the pharmaceutical product removed from a container directly with the one left in that container. 3.2. Sampling procedures - Carry out physical inspection of the consignment: segregate containers by each type of product and consignment, segregate containers that show any signs of deterioration and do not ensure cleanliness for inspection or sampling. Reject unlabelled sampling units. - Take sampling units from the consignment of products, open containers to take original samples and reseal the containers from which the samples were taken. Ensure that the quantity of materials in the original samples is sufficient to prepare next samples. - Gently mix original samples into separate samples of each sampling unit. - Gently mix separate samples into a common sample. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 3.3. Analytical samples and retention samples should be placed in sealed and labeled containers. A sample container should be labeled with name of the pharmaceutical product, name of the manufacturer, lot number, expiry date, number of containers from which samples were taken, place of sampling, number of samples taken (if samples taken are pharmaceutical starting materials for manufacture of narcotic drugs and psychotropic drugs, precursors used as pharmaceutical products and starting materials for manufacture of radiopharmaceuticals), date of sampling and storage conditions in accordance with the sampling record. 3.4. After the sampling is done, analytical samples and retention samples should be separately sealed to ensure their safety during transportation. The seal should clearly specify the date of sampling and bear at least signatures of the sampler and the representative of the establishment where the sample was taken. Where necessary, the remainder of the sampling interval should be also sealed to prevent tampering of pharmaceutical products and pharmaceutical starting materials. 3.5. Make a sampling record: The sampling record should contain the batch number, date and place of sampling, storage conditions, notes on possible abnormalities, any other relevant observations and at least the name and signature of the sampler and representative of the establishment where the sample was taken. In the cases where the quality inspectorate takes samples, the record is required to bear the signature of the inspectorate's head. In case the representative of the establishment where the sample was taken fails to sign the record, the record should bear the signatures of the sampler and witness. The record should be made into three copies, which are kept at the establishment where the sample was taken, testing authority and pharmaceutical product quality inspecting authority respectively. 4. Sampling of pharmaceutical starting materials 4.1. In case the material is placed in one container only: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 4.2. In case the consignment of material is placed in multiple containers: Depending on the sampling purpose, uniformity and quality of the consignment of material, adopt an appropriate sampling method according to Section Clause 9 of this Appendix. 5. Sampling of unpackaged semi-finished products These products include powdered pharmaceutical products, solutions, syrups, ointments, granules, tablets, injections, etc. that are transported in large containers to the packaging facility. Samples shall be taken from each consignment as follows: 1. If the consignment of products is contained in 1 - 2 containers, open the two containers. If the consignment of products is contained in more than 3 containers, open the three containers. Take at least 3 original samples in different locations of each container. 2. Mix original samples into a common sample, and then form final samples, including analytical and retention samples. 6. Sampling of packaging materials Samples of packaging materials shall be taken as prescribed in Section 1 Clause 9 of this Appendix. 7. Sampling of finished pharmaceutical products ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
7.2. Take samples to carry out visual inspection upon import of pharmaceutical products: the quantity of sample taken to carry out visual inspection is specified in Section IV of this Appendix. 8. Sampling of herbal pharmaceutical starting materials If herbal medicinal products or partially processed herbal medicinal products, including animals and plants (dried medicinal plants and parts thereof) and minerals are regarded as homogeneous, samples thereof shall be taken as prescribed in Section I Clause 9 “r plan” of this Appendix. 9. Sampling plans for pharmaceutical starting materials and packaging materials 9.1. Before sampling, the sampler should check the integrity and deterioration of the container, and uniformity of products in each sampling unit. 9.2. Sampling should be carried out according to one of the three sampling plans provided in Table 1 below. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Value of n, p, r Values of N n plan p plan r plan 2 up to 3 up to 25 up to 2 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 4 - 6 25 - 56 3 - 4 4 7 - 13 57 - 100 5 - 7 5 14 - 20 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 8 - 11 6 21 - 30 157 - 225 12 - 16 7 31 - 42 17 - 22 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 43 - 56 23 - 28 9 57 - 72 29 - 36 10 73 - 90 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 37 - 44
The “n plan” should be used only when the material to be sampled is considered uniform and is supplied from a recognized source. Samples can be withdrawn from any part of the container (usually from the top layer). The “n plan” is based on the formula n = 1 + , where N is the number of sampling units in the consignment. The value of n is obtained by simple rounding. Original samples are taken from n sampling units selected at random and these are subsequently placed in separate sample containers. These original samples are visually inspected and tested for identity. If the results are concordant, the original samples are combined into a final, common sample from which an analytical sample is prepared, the remainder being kept as a retention sample.
The “p plan” may be used when the material is uniform, is received from a recognized source and the main purpose is to test for identity. The p plan is based on the formula p = 0.4 , where N is the number of sampling units. The figures for p are obtained by rounding up to the next highest integer. Original samples are taken from each of the N sampling units of the consignment and placed in separate sample containers. These original samples are visually inspected and tested for identity. If the results are concordant, p common samples are formed by appropriate pooling of the original samples (if necessary).
The “r plan” may be used when the material is suspected to be non-uniform and/or is received from a source that is not well known, herbal medicinal products or partially processed herbal medicinal products. This plan is based on the formula r = 1.5 , where N is the number of sampling units. The figures for r are obtained by rounding up to the next highest integer.Original samples are taken from each of the N sampling units of the consignment and placed in separate sample containers. These original samples are visually inspected and tested for identity. If the results are concordant, r samples are randomly selected and individually subjected to testing. If these results are concordant, the r samples are combined for the retention sample. 9.3. The abovementioned sampling plans are not recommended for sampling of starting materials for identification tests. The GMP-WHO rules shall apply instead. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 1. Bulk liquid products The steps to be considered when sampling bulk liquid products are as follows: - Read and understand the precautions to be observed for the safe handling of the material. - Gather together the required sampling equipment (sampling tube or weighted sampling can, sample bottles and labels) and check that all the required items are clean. - Locate the batch. - Examine the container(s) for signs of contamination of the batch. Record any faults. - Examine the labels for obvious differences and signs of changes including obliterations and mislabelling.Record any faults. - Investigate and clarify the sources of and reasons for any faults before proceeding. - Choose a liquid-sampling tube of size and orifice suitable for the viscosity of the liquid being sampled. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - Seal the tube, withdraw it from the bulk liquid, and allow liquid adhering to the outside of the tube to drain. Transfer all the contents of the tube to a clean, labelled sample bottle. - Repeat steps 8 and 9 until sufficient samples for analytical and retention purposes have been obtained. - Seal the sample bottle. - Reseal the container from which the samples were taken and label as “sampled”. - Clean and dry the sampling tube, observing the relevant safety precautions. - Sample other required containers in the same manner following steps 8–12 above. - Clean the sampling tube using the recommended cleaning procedure. - Deliver the analytical samples to the laboratory and the reserve samples to the retention sample store. Report any aspects of the sampling that should be brought to the attention of the analyst or the inspector. - Check supplier certificate versus the specifications, if applicable. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 The steps to be considered in sampling a powdered starting material are as follows: - Read and understand the precautions to be observed for the safe handling of the material. - Gather together the required sampling equipment (sampling spear, sample bottles and labels) and check that all items are clean. - Locate the consignment and count the number of containers. - Examine all the containers for obvious differences and signs of damage. Record any faults. - Examine all the labels for obvious differences and signs of changes, including obliterations and mislabelling. Record any faults. - Segregate any damaged containers and those with suspected spoiled contents for separate examination. These should then be referred or rejected and dealt with accordingly. - Segregate any containers with different batch numbers and treat these separately. - Number the remaining containers. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - Choose the containers to be sampled in accordance with the requirements of the chosen plan (by the use of random number tables, by drawing lots or by the use of a random number generator if applicable). - Open the containers one at a time and inspect the contents. Record any differences. - Choose a suitable, clean sampling spear and plunge this (gates closed) into the powder so that the point of the spear reaches the bottom of the container. - Open the gates to allow the powder to enter the spear cavities, then reclose them. - Withdraw the spear from the container and transfer the spear contents to a labelled sample bottle. - Repeat steps 12–14 until sufficient material has been collected for analytical and retention requirements. - Seal the sample bottle. - Reseal the container from which the samples were withdrawn and label as “sampled”. - Wipe clean the sampling spear if required, observing the safety precautions, before sampling the other chosen containers. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - Clean the sampling spear using the recommended cleaning procedure. - Deliver the analytical samples to the laboratory and the reserve samples to the retention sample store. Report any aspects of the sampling that should be brought to the attention of the analyst or the inspector. - Check supplier certificate versus the specifications, if applicable. 3. Packaging materials The steps to be considered in sampling packaging materials are as follows: - Check the consignment against any associated documentation. - Check transit containers for the following and report any deviations as necessary: + Correct identification; + integrity of seal, if appropriate; and ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - Obtain the required sample from the required number of containers, bearing in mind the special considerations for sampling packaging materials noted in Section I Clause 9 of this Appendix. - Place the sample units into identified appropriate sample containers. - Identify the consignment containers that have been sampled. - Note any special situations found during the sampling process (e.g. rogue items or component damage). Report any such observations as necessary. - Remove all sampled material pallets or containers from the sampling area together with all documentation. - Check supplier certificate versus the specifications, if applicable. 4. Finished products The following steps should be considered when sampling finished products: - Determine the number of pallets per batch in the consignment. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 + Check condition of pallet and packaging for integrity of outer packaging material. + Check outside of goods on the pallets for general cleanliness. + Check that the overall labelling of the pallets matches the packing list. + Count, categorize and record the number of defects. - Count the total number of transport packs on the number of pallets present and verify the total against the packing list. - From the number of pallets, work out the number of transport packs to be sampled: + Check condition of boxes for integrity of packaging material. + Check for cleanliness of boxes. + Check the labelling of the boxes for damage. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 + Check the labels for spelling mistakes. + Check the labels for manufacturing and expiry dates. + Count, categorize and record the number of defects. - From the number of boxes selected, work out the number of unit packs to examined visually: + Check condition of the containers for integrity of packaging material. + Check for cleanliness of containers. + Check condition of containers for shape and colour. + Check the labelling of containers for damage. + Check the containers for overall damage. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 + Check the labels for manufacturing and expiry dates. + Count, categorize and record the number of defects. - From the number of containers selected, determine the number of containers to be taken for physical and chemical testing and for retention. - Check the supplier certificate against the specifications, if applicable. III. Types of sampling tools Figure 1. Sampling scoops for solids Figure 2. Typical dip tube ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Figure 3. Typical sample thieves (i) The plug thief (Figure 3.i) typically consists of a hollow tube with an inner rod that has a tip on the end to allow the thief to enter the powder bed in the closed position. Pointed tips distort the powder bed less than blunt-tipped probes. Some thieves have a locking device that allows the sample volume to be set to the required sample weight, thereby reducing the weight variation in the sample population. (ii) A chamber thief (Figure 3.ii) generally consists of two concentric tubes; the inner tube is solid except for the chambers in which the sample is collected. The outer tube is hollow with openings that can be aligned with the chambers in the inner tube. A well-designed thief will have a sharp end to minimize disruption to the powder bed. Note: When it is inserted into a static powder blend a thief will distort the bed by carrying pharmaceutical product from the upper layers of the blend to the lower layers. The magnitude of this distortion can depend on whether the thief is inserted into the blend with a smooth, jerky or twisting action. Therefore, staff should be trained in using the appropriate technique. The angle at which the thief enters the powder bed can also influence sampling error. If a thief is inserted into the powder bed vertically, it can extract samples of different particle size from those that would be obtained using the same thief inserted at an acute angle. In addition, the orientation of a chamber thief in relation to the powder bed (i.e. whether the chamber is at the top, the bottom or in the middle of the thief) may also influence the sampling error. Sampling error can also be affected by bed depth, as the static pressure of the bulk blend forces the material into the sample chamber(s). This pressure is far greater at the bottom of a large container than it is in the middle or at the top. It is quite possible that the same thief could extract samples of different particle size from the top or bottom of a static powder blend. Figure 4. Weighted container For taking samples from large tanks and storage vessels, a container in a weighted carrier can be used. The container is designed such that it can be opened at the required depth. Marks on the cord used for lowering the container can be used to determine when the correct ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Figure 5. Typical sampling spears A: Closed spear for sampling large grains such as maize B: Closed spear for sampling small grains such as wheat C: Open spear D: Double-tube spear Sampling spears generally have a maximum external diameter of about 12 mm, but can be up to 25 mm in diameter and should be 40–45 cm in length. IV. Number of sampling units from batches of finished pharmaceutical products to be taken for visual inspection (ISO 2859-1) Lot size Number of sampling units from batches/lots Number of sampling units from batches of finished pharmaceutical products to be taken for visual inspection ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 2 9 - 15 3 16 - 25 5 26 - 50 8 51 – 90 13 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 20 151 - 280 32 281 - 500 50 501 - 1200 80 1201 - 3200 125 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 200 10001 - 35000 315 35001 - 150000 500 150001 - 500000 600 Over 500001 1250 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Number of samples of pharmaceutical products and pharmaceutical starting materials taken for quality inspection (excluding samples taken for retention purpose): No. Dosage form Type, specifications Number 1 Tablets, capsules, film coated tablets 1 active ingredient 80 tablets/capsules ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 120 tablets/capsules 2 Solutions ≥ 100 ml 20 bottles (vials) 10 - 100 ml 30 bottles (vials) 5ml - 10ml 50 bottles (vials) ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 100 bottles (vials) 3 Granules, powders Packaged in single-dose or multiple-dose ~ 100 gram Hard pills, soft pills \> 0,5 g/pill 120 pills 0,1 - 0,5 g/pill ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 < 0,1 g/pill 500 pills 4 Medicinal liquor ≤ 650 ml 7 bottles \> 650 ml 5 bottles 5 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ≥ 250 ml 20 bottles 100 ml - 250 ml 25 bottles < 100 ml 50 bottles Syringes 1ml 150 syringes ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 120 syringes Distilled water for injection 2 ml 250 ampoules 5 ml 100 ampoules 10 ml 80 ampoules 6 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ≤ 2ml/100mg 100 vials (tubes) \> 2ml/100mg 80 vials (tubes) 7 Topical ointments, creams, gels ≤ 100mg 30 vials (tubes) \> 100mg ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 8 Powders for injection < 100 mg 150 vials 100 - 450 mg 120 vials \> 450 mg 100 vials 9 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 1 - 2 ml 30 vials ≥ 5 ml 20 vials 10 Various forms ~100g 11 Herbal medicinal materials ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 250 g Not containing oil 100 g 12 Oil Various forms 150 ml 13 Vaccines, biologicals ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 In accordance with the manufacturer's regulations 14 Materials Precious materials 20 g Antibiotic materials 50 g Materials for manufacture of narcotic drugs and psychotropic drugs, precursors 10 g ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 100 g Plastic beads 200 g 15 Infusion sets Various forms 30 sets 16 Hollow glass tubes ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 500 tubes ≥ 5 ml 300 tubes 17 Bottles for intravenous fluids Various forms 10 bottles APPENDIX II ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. The pharmaceutical product is counterfeit, illegally imported and of unknown origins; 2. The pharmaceutical product contains substances banned from use in manufacture of pharmaceutical products; 3. The finished pharmaceutical product is manufactured from a material not intended for human use or material not yet granted licenses for use in manufacture of pharmaceutical products or food intended for human use; 4. The pharmaceutical product is manufactured at a facility not yet granted the certificate of eligibility for pharmacy business; 5. There is no evidence that the injection or parenteral pharmaceutical product has undergone quality inspection during the manufacture process and before release; 6. A foreign competent authority notifies a recall of the pharmaceutical product; 7. A competent authority concludes that the pharmaceutical product is not safe; 8. The pharmaceutical product contains wrong active ingredients; ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 10. The parenteral pharmaceutical product fails the sterility, pyrogen or endotoxin test; 11. The injection is not sterile; 12. The content, route of administration or dose on the label of the pharmaceutical product that contains a strong active ingredient and has low safety threshold is incorrect. II. Second-degree violation means a violation where there is evidence that the pharmaceutical product does not guarantee effective treatment or is unsafe for users but does not cause harm to the users’ health or life in one of the following cases: 1. A competent authority concludes that the pharmaceutical product does not guarantee effective treatment; 2. The pharmaceutical product is manufactured from materials that fail to meet specifications; 3. There is no evidence that the pharmaceutical product has undergone quality inspection during the manufacture process and before release (except for the case specified in Clause 5 of Section II); 4. The pharmaceutical product is not granted the certificate of pharmaceutical product registration or the import license; 5. A competent authority concludes that the pharmaceutical product is granted the certificate of pharmaceutical product registration according to counterfeit documents; ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 7. The pharmaceutical product is manufactured at a manufacturing facility while it is being suspended or while the certificate of eligibility for pharmacy business is suspended; 8. The active ingredient content of the pharmaceutical product deviates by more than 5%; 9. The pharmaceutical product contains wrong active ingredients (except for the case in which the first-degree violation is committed); 10. The pharmaceutical product fails to meet specifications in terms of bacterial contamination (except for the cases specified in Clauses 10 and 11 Section II); 11. The injection or parenteral pharmaceutical product fails to meet specifications in terms of clarity, impurity, particles visible or invisible to the naked eye; 12. The tablet fails to meet specifications in terms of disintegration while it disintegrates in the acidic environment for more than 02 (two) hours (except for enteric-coated tablets); 13. The enteric-coated tablet containing active ingredients that are unstable or irritate stomach fails to meet specifications in terms of the disintegration or dissolution in the acidic environment; 14. The liquid injection has a volume smaller than 75% of that written on the label; 15. The powdered injection has a weight smaller than 75% of that written on the label; ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 17. The pharmaceutical product fails to meet specifications in terms of relevant impurities; 18. The injection or parenteral pharmaceutical product fails to meet specifications in terms of pH; 19. The prolonged-release tablet and modified-release tablet fail to meet specifications in terms of dissolution; 20. The pharmaceutical product fails to meet specifications in terms of sedimentation of blend and emulsion for injection; 21. The pharmaceutical product is recalled by a foreign competent authority, except in the case it is urgently recalled, and is found to be imported into Vietnam through inspection; 22. The pharmaceutical product is incorrect due to mistakes during manufacture or labeling; the label of the pharmaceutical product specifies wrong route of administration, dosage, content, concentration of active ingredients and use (except for the case specified in Section I); 23. The pharmaceutical product is not manufactured and imported according to the application for pharmaceutical product registration or import license; 24. The pharmaceutical product contains content or concentration exceeding the permissible limits. II. Third-degree violation means violations other than those specified in Sections I and II that do not affect the treatment ability and safety of the drug in one of the following cases: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 2. The pharmaceutical product fails to meet specifications in terms of density; 3. The tablet fails to meet specifications in terms of weight variation tolerance (average weight of a tablet); 4. The ointment or cream fails to meet specifications in terms of weight variation tolerance; 5. The powdered injection has a weight greater than 75% of that written on the label but smaller than the registered limit; 6. The enteric-coated tablet fails to meet specifications in terms of disintegration but disintegrates for less than 02 (two) hours; 7. The sugar coated tablet and hard pill fail to disintegrate completely; 8. The tablet fails to meet specifications in terms of dissolution (except for the case specified in Clause 17 Section II); 9. The tablet fails to meet specifications in terms of content of active ingredients but the deviation of active ingredient content in the tablet is less than 5%; 10. The herbal tablet fails to meet specifications in terms of impurity and humidity; ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 12. The liquid pharmaceutical product fails to meet specifications in terms of pH (except for the case specified in Section II); 13. The oral solution fails to meet specifications in terms of sedimentation; 14. The oral solution and lotion fail to meet specifications in terms of volume; 15. The injection fails to meet specifications in terms of volume but its volume is not smaller than 75% of that written on the label; 16. The injection or parenteral pharmaceutical product fails to meet specifications in terms of pH; 17. The pharmaceutical product fails to satisfy all labeling requirements, except for the cases specified in Section I and II; 18. The pharmaceutical product packaging material and method fail to satisfy storage requirements; 19. The pharmaceutical product fails to satisfy average weight criterion, the pharmaceutical product is not manufactured according to the application for pharmaceutical product registration: change of weight of a tablet, excipient ratio and type of excipients. IV. Other violations: The Drug Administration of Vietnam shall conclude the degree of violations after the certification advisory council of the Ministry of Health comments. Counsel of the council shall be given by assessing effects of the pharmaceutical product committing violations on users’ health. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 APPENDIX III: FORMS (Enclosed with the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Minister of Health) Form No. 01: Sample collection form Name of the supervisory authority Name of the establishment --- THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness --- (Place name), date (dd/mm/yyyy) …. FORM OF SAMPLE COLLECTION FOR QUALITY VERIFICATION ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Full names, position and workplace of people who took samples: 1 ................................................................................................................................ 2 ................................................................................................................................ 3 ................................................................................................................................ Name of the establishment where sample(s) was taken: ……………………………… Classification of the establishment where sample(s) was taken: …………………………….. Address:…………………………….. Telephone: …………………………….. No. Pharmaceutical product name, concentration, content, registration number ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Smallest pack Quantity of sample taken Name and address of manufacturer Name of importer (in case of imported pharmaceutical product), distributor Status of batch of pharmaceutical product prior to sampling ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Storage condition upon sampling: …………………. This form is made into 03 copies: 01 copy is kept at the establishment where sample(s) was taken, 01 copy is kept at the testing authority, 01 copy is kept at ……….(authority in charge of quality inspection and management). Person(s) taking samples (signature and full name) Representative of the establishment where sample(s) was taken (signature and full name) ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Name of the supervisory authority Name of the testing authority --- THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness --- TEST REPORT No. Sample to be tested: Manufacturer: Importer (in case of foreign pharmaceutical product): Batch number: Date of manufacture: Expiry date: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Place where sample was taken (sending sample): Person taking sample (sending sample): Testing requirements (specify contents, number and date of sample collection form or enclosed documents) Date of receiving sample: Test registration number: Person delivering sample: Person receiving sample: Standard applied: Status of sample upon receipt and opening of seal for testing: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Quality requirements Results and conclusions 1. 2. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 3… Conclusion: (Specify whether the batch meets specifications; in case of failure to meet, specify reasons thereof). (Place name), date (dd/mm/yyyy) …. Head of the testing authority (signature and seal) ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Name of the supervisory authority Name of the testing authority --- THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness --- ANALYSIS REPORT No. Sample to be analyzed: Manufacturer: Importer (in case of foreign pharmaceutical product): Batch number: Date of manufacture: Expiry date: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Place of sending sample: Person sending sample: Analysis requirements (specify contents, number and date of sample collection form or enclosed documents) Date of receiving sample: Analysis registration number: Person delivering sample: Person receiving sample: Standard applied: Status of sample upon receipt and opening of seal for analysis: Quality characteristics ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Results 1. 2. 3... ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 (Place name), date (dd/mm/yyyy) …. Head of the testing authority (signature and seal) Form No. 04: Pharmaceutical product recall form Name of the supervisory authority Name of the establishment --- THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness --- (Place name), date (dd/mm/yyyy) …. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 PHARMACEUTICAL PRODUCT RECALL FORM We are: (specify name and position of each member): 1/................................................................................................................................ 2/................................................................................................................................ 3/ ............................................................................................................................... from ........................................................................................................................... were assigned to recall pharmaceutical products that fail to meet specifications according to the Official Dispatch No. …………...... dated (date/month/year) .... of We recalled the following pharmaceutical products at ……………………: No. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Unit Quantity of pharmaceutical products recalled Batch number Manufacturer Notes ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Representative of the establishment where pharmaceutical products were recalled Members Head of recall department Form No. 05: Pharmaceutical product recall report Name of the supervisory authority Name of the establishment --- THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness --- ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 PHARMACEUTICAL PRODUCT RECALL REPORT To:... Implementing the Official Dispatch No. …………...... dated (date/month/year) .... of .... on recall of the pharmaceutical product..., registration number..., batch number..., date of manufacture..., expiry date... manufactured by... and imported by... (in case of imported pharmaceutical product),...(Name of the establishment) would like to submit a pharmaceutical product recall report. To be specific: 1. Information about the batch of recalled pharmaceutical product: - Name of the pharmaceutical product, number of registration certificate or import license, name of active ingredient, concentration/content, dosage form, batch number, expiry date, manufacturer, importer; - Time of release/import; 2. Recall results: 2.1. Result of recall of the pharmaceutical product from pharmacy business establishments: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Name of the trader purchasing pharmaceutical product Unit Quantity of pharmaceutical products purchased Quantity of pharmaceutical products sold Quantity of pharmaceutical products recalled Notes 1 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 2 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 3... Total ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 2.2. Consolidation of recall results - Quantity of pharmaceutical products manufactured/imported; - Quantity of pharmaceutical products sold on the market; - Quantity of pharmaceutical products recalled. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Form No. 06: Pharmaceutical product destruction form Name of the supervisory authority Name of the establishment --- THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness --- No. (Place name), date (dd/mm/yyyy) …. PHARMACEUTICAL PRODUCT DESTRUCTION FORM Implementing the Decision No. …….. dated (date/month/year) … of ……… on destruction of pharmaceutical products that fail to meet specifications and expire. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 The pharmaceutical product destruction council established according to the Decision No. …….. dated (date/month/year) … of ……… is composed of: 1 ................................................................................................................................ 2 ................................................................................................................................ 3 ................................................................................................................................ ................................................................................................................................... and have witnessed and carry out destruction of the following pharmaceutical products: No. Pharmaceutical product name, concentration, content Batch number ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Planned quantity of pharmaceutical products destroyed Actual quantity of pharmaceutical products destroyed Difference (*) Notes ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ((*) If there is difference between the actual and planned quantity of pharmaceutical products destroyed, explanation thereof must be provided) Destruction method: ................................................................................................................................... ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 The pharmaceutical product destruction form is sent to ................................................. This form is made into ….. copies, each of which is kept by a party and ……. copies are sent. Members destroying pharmaceutical products (signature, full name and title) President of the pharmaceutical product destruction council (signature and full name) Form No. 07: Report on sampling of pharmaceutical products for quality inspection Name of the supervisory authority Name of the establishment --- THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness --- ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 (Place name), date (dd/mm/yyyy) …. REPORT ON SAMPLING OF PHARMACEUTICAL PRODUCTS FOR QUALITY INSPECTION To: The Drug Administration of Vietnam - The Ministry of Health Name and address of manufacturer Name of manufacturing country Name of pharmaceutical product (dosage form), active ingredients, content Registration number or import license number Batch number, date of manufacture (if any), expiry date ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Quantity of pharmaceutical products imported (*) Name and telephone of the applicant (*) Name and telephone of the importer (*) Name and telephone of the establishment entrusted to import (*) Name and telephone of Class I distributor (if any) (*) Date of import (*) Name and telephone of sampling facility and testing facility Date of sampling Date of issuing test report ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 (*) The sampling facility and testing facility are not required to report these contents. ...,(Place name), date (dd/mm/yyyy) …. Head of the establishment (signature and seal) Form No. 08: Certificate of vaccine/biological quality Name of the supervisory authority Name of the establishment --- THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness --- CERTIFICATE OF VACCINE/BIOLOGICAL QUALITY ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Commercial name: Common name: Number of Certificate of registration or import license: Quantity sample of the testing facility: Batch No. (on the vial/syringe/phial): Batch No. (on the box): Date of manufacture: Expiry date: Packaging method: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Expiry date: Manufacturer: Importer: Date of manufacture/ import: Quantity vaccines/biologicals manufactured/imported: Conclusion: (Specify whether the batch satisfies specifications approved by the Ministry of Health or whether the batch satisfies requirements for document inspection and storage conditions in the cold chain during the import. In case of failure to satisfy, specify reasons thereof). |