Circular 8/2006/tt-Byt: Guide To Import Vaccines, Medical Products; Chemicals, Preparations For Destroying Insects, Bactericide Used In Household Sector And Of Health And Medical Equipment

Original Language Title: Thông tư 08/2006/TT-BYT: Hướng dẫn nhập khẩu vắc xin, sinh phẩm y tế; hoá chất, chế phẩm diệt côn trùng, diệt khuẩn dùng trong lĩnh vực gia dụng và y tế và trang thiết bị y tế

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Circular imports vaccines, medical products; chemicals, preparations for destroying insects, bactericide used in household sector and of health and medical equipment _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Pharmacy pursuant to the law No. 34/2005/QH11 on June 14, 2005;
 
Pursuant to Decree No. 49/2003/ND-CP dated May 15, 2003 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
Pursuant to Decree No. 12/2006/ND-CP dated 23/01/2006 of Prime Minister detailing the trade Enforcement Act of purchase and sale of goods and international dealers buying, selling, processing and transiting goods with foreign countries, the Ministry of health guidelines the importation of vaccines , medical products; chemicals, preparations for destroying insects, bactericide used in household sector and of health and medical equipment as follows: i. GENERAL PROVISIONS 1. The scope of this circular adjustment adjust the import activities: 1.1. Vaccines, biological medical products, semi-finished products, raw materials, packaging, catering for the use, production, vaccine research, medical products.
1.2. Chemicals, preparations for destroying insects, bactericide used in household and medical fields.
1.3. medical equipment including: type of equipment, instruments, materials, specialized transportation service for medical activities.
2. Subjects of application this circular apply to traders, organizations active in fields related to imported vaccines, medical products; chemicals, preparations for destroying insects, bactericide used in household sector and of health and medical equipment.
3. list of vaccines, medical products; chemicals, insecticides, preparations used in sterilizing medical and household and medical equipment 3.1. List of vaccines, medical products and chemicals, insecticides, preparations used in sterilizing medical and household entered the needs include vaccines, medical products and chemicals, insecticides, preparations used in sterilizing medical and Health Ministry were registered license valid in circulation (for vaccines , medical products), certificate of registration (for chemicals, insecticides, preparations used in sterilizing medical and household).
3.2. The medical equipment not subject to the provisions in part IV of this circular and not in the directory import prohibition stipulated in Decree No. 12/2006/ND-CP dated 23/01/2006 of Prime Minister detailing the trade Enforcement Act of purchase and sale of international goods agent activities and purchasing , selling, processing and transiting goods with foreign countries shall be imported according to the needs.
4. Customs procedure 4.1. For vaccines, medical products, chemicals, insecticides, preparations used in sterilizing medical and household list import-on-demand: traders, import organization filed for customs registration licence copy circulating current (for vaccines, medical products) , The registration certificate (for chemicals, insecticides, preparations used in sterilizing medical and household) of imported products due to the head of the business sign, stamp, responsible before the law.
4.2. for vaccines, medical products and chemicals, insecticides, preparations used in sterilizing medical and not list import-on-demand: traders, import organization filed for customs import license by the Department of preventive medicine Vietnam-the Ministry of Health issued if importer 1 time or when importing many times and must process a key to compare.
4.3. for medical equipment import must apply for the license of the Ministry of health: import traders filed for customs import license issued by the Ministry of health if the import once or when importing many times and must submit a key to compare.
II. REGULATIONS On IMPORTED Vaccines, Health PRODUCTS 1. Vaccines, BIOLOGICAL medical IMPORT PERMIT NOT 1.1. 1.1.1 conditions. Traders, business organizations, vaccine medical products must be certified eligible by the agency business authorities. For businesses that are made of imported vaccines, medical products but does not yet have a certificate of eligibility, the business must complete the statutory procedures.
1.1.2. the foreign enterprise has license to operate in the field of vaccines, medical products and raw materials for production of vaccines, medical products with Vietnam are offering vaccines, medical products for enterprises to import vaccines, products of Vietnam according to the range of activities specified in the license.
1.1.3. Import business units use research unit, responsible before the law on the quality and safety of imported products and its activities.
1.1.4. Vaccines, medical products in the catalogue are imported according to the demand must remain at least 2/3 of the term in use since coming to Vietnam. In special cases the Ministry of health to consider allowing imports of the vaccine, medical products, shorter term is also regulation.
1.1.5. Vaccines, biological medical products import is provided only for the base functions and the eligible production of vaccines, health products for the purposes of production.
1.1.6. Vaccines, biological medical products after blending, packaging ... the finished products have to be the Ministry of health license registered in circulation prior to use on the market and must perform the procedure launched as each batch of products manufactured in the country.
1.2. procedure for submitting resumes, sample test

1.2.1. the importer must submit the export profile xưởngvà sample of shipments for national testing of vaccines and medical products including: 1.2.1.1. Of samples calibrated (number of samples as specified for each type of vaccine, medical products).
1.2.1.2. Votes sent the audit sample.
1.2.1.3. summary records of production and testing of vaccine batches, imported products (stamped copies certified by the manufacturer).
1.2.1.4. The licence issued by the competent bodies of water in or other equivalent body attached to each shipment type (stamped copies certified by the Director of import business).
1.2.1.5. Evidence of the cold chain during transportation of imports.
1.2.2. once adopted, vaccines, biological medical transportation to the enterprise repository for preservation under the rules and are only allowed out once to have the text of the national testing of vaccines and medical products confirm the batch of vaccine, medical products import safety standards on laboratory animals (for vaccines , medical products used to treat the form of finished products) or the text confirm got enough samples and profiles (for biological products used for medical diagnosis and the sale of finished products).
1.2.3. for vaccines, medical products used to treat form of finished goods, within 7 working days from receipt of sufficient samples and records as defined in item 1.2.1 above, national testing of vaccines and medical products must have text answers about safety of vaccines , medical products on animals the experiment sent the business. For biological products used for medical diagnosis and the sale of finished goods, within 3 working days from receipt of sufficient samples and profiles according to the regulations, national testing of vaccines and medical products must have a confirmation text got enough samples and record business.
1.2.4. Within 10 days after import, import business sent the Ministry of health (the Department of preventive medicine Vietnam) reported imports including categories, the number of vaccines, products imported for each of the shipments.
2. Medical PRODUCTS, VACCINE IMPORTERS MUST APPLY for the LICENSE 2.1. 2.1.1 condition. Traders, business organizations, vaccine medical products must have the certificate of the eligible business. For businesses that are made of imported vaccines, medical products but does not yet have a certificate of eligibility, the business must complete the statutory procedures.
2.1.2. The functional organization of vaccine research, medical products are imported vaccines, medical products to cater to the research work of the chứcđó.
2.1.3. A representative office, branch of the foreign enterprises in Vietnam only imported vaccine, medical products to do the registration procedure.
2.1.4. Traders, held responsible before the law on the quality and safety of imported products and its activities.
2.2. Record and licensing procedure 2.2.1. Vaccines, medical products imported for use in special cases (for the prevention, treatment and use for a particular audience group, expat living and working in Vietnam, the Vietnam travel, study and work in the country has the disease circulating).
2.2.1.1. Profile:-application for permit to import vaccines, medical products – demands on the number, types of health products, vaccines and vaccination of subjects vaccinated establishments.
-A commitment of vaccination on basis of use, conservation, vaccination, medical products for your purposes, the right audience, the right and responsibility for the use of vaccines, health products (Appendix 1).
-A commitment by the distribution company and manufacturer of the vaccine quality assurance, medical products provided to Vietnam (Appendix 2).
-A commitment by the company to import about the import, storage and transportation of vaccines, medical products according to the regulations (Appendix 3).
-The accompanying documentation (if any) including: certificates of manufacturing GMP standard country, circulating licenses vaccines, country products, the license in some other countries where the vaccine, medical products that have been registered and released.
2.2.1.2. procedure:-traders, organizations for permission to import the sent records of the Ministry of health (the Department of preventive medicine Vietnam).
-Within 15 working days of receipt of a valid application, the Ministry of health (the Department of preventive medicine Vietnam) conducting review and respond in writing about agree or not agree to license to import and send requests, submit form for national testing of vaccines and medical products in case of need as defined in section II. 1.2 of this circular.
2.2.2. medical products, vaccine importers to test, try, as the registration form (to be used only for the purpose of registration of circulation, not used for any other purpose) 2.2.2.1. Profile:-dispatch please enter model test, try, save template-requirements of the auditing Agency, address 2.2.2.2 writing test. Procedure:-traders, organizations for permission to import the sent records of the Ministry of health (the Department of preventive medicine Vietnam)-within 15 working days of receipt of a valid application, the Ministry of health (the Department of preventive medicine Vietnam) conducting review and answer in writing on the agree or disagree on the import permit.

2.2.3. Vaccines, medical products used for research, use for programs, projects (just type to use for research purposes in the base functions of research, project implementation, not used for other purposes) 2.2.3.1. Profile:-dispatch import proposal.
-The text approved by the competent authority allowing the implementation of research projects and research outline was approved (for the research/project approval).
2.2.3.2. procedure:-traders, organizations for permission to import the sent records of the Ministry of health (the Department of preventive medicine Vietnam)-within 15 working days of receipt of a valid application, the Ministry of health (the Department of preventive medicine Vietnam) conducting review and answer in writing on the agree or disagree on the import permit.
2.2.4. Vaccines, imported medical products intended for the national program or aid (must list the World Health Organization recommends using) 2.2.4.1. Profile:-certificate of competent authority country allows circulation or export vaccines, medical products.
-Certificate of production base of GMP standards.
-Slip the standard test the quality of vaccines, the medical products of national auditing agency country or other competent authority for shipments (certified copies of import business).
2.2.4.2. procedure:-the profile is sent to the national testing of vaccines and medical products.
-Upon receipt of the prescribed documents, national testing of vaccines and medical products cold chain checked, proceed to sample and evaluate vaccines, medical products according to requirements: a) safety testing in the laboratory with the conclusion of prescribed standards.
b) safety tests on people in the field to conclude the prescribed standard.
Particularly for vaccines, medical products not yet having the registration number issued by the international organization has frequently collaborated with Vietnam in the medical field such as WHO, UNICEF, ... aid in emergency cases for Vietnam, depending on the particular case, national testing of vaccines and medical products to cold chain , conducted sampling to save and secure testing in the laboratory.
-After reviewing the documents mentioned above and with the audit results, quality testing as prescribed, national testing of vaccines and medical products with the Ministry of health, suggested (Department of preventive medicine Vietnam) to allow the unit to receive foreign aid importation and use of vaccines , medical aid products.
-Within 15 working days from the date of the proposed national testing of vaccines and medical products, the Ministry of health (the Department of preventive medicine Vietnam) will have text answers to agree or not agree to license.
-After the import, the import unit to print or paste the words "vaccines (medical products) aid, not sold" or "vaccine (medical products) in the national program, not sold" on the packaging of the product.
2.2.5. Raw material, packaging material, to produce vaccines, medical products (only to be imported to give the basis of eligible vaccine production, medical products to produce) 2.2.5.1. Profile:-dispatch import proposal.
-The requirements of the production facility in writing.
2.2.5.2. procedure:-traders, organizations for permission to import the sent records of the Ministry of health (the Department of preventive medicine Vietnam).
-Within 15 working days of receipt of a valid application, the Ministry of health (the Department of preventive medicine Vietnam) conducting review and answer in writing on the agree or disagree on the import permit.
III. REGULATIONS REGARDING the IMPORT of chemicals, INSECTICIDES, PREPARATIONS USED in STERILIZING medical and HOUSEHOLD SECTOR (hereinafter referred to as chemicals, products) 1. Chemicals, IMPORTED PRODUCTS DO NOT HAVE to APPLY for PERMITS to import products, chemicals have the registration certificate issued by the Directorate of preventive medicine Vietnam-Ministry of health validity level are allowed to import-on-demand, unlimited quantity, value, procedures at customs, not through the Ministry of health for approval. Import business responsibility before the law about his activities.
Chemicals, insecticides, preparations used in sterilizing medical and household list import demand is also at least 2/3 of the term in use since coming to Vietnam. In special cases the Ministry of health to consider allowing imports of chemicals, insecticides, preparations used in sterilizing medical and shorter term is also regulation.
2. chemical, IMPORTED PRODUCTS MUST APPLY for the LICENSE 2.1. Chemicals, preparations have not been issued a certificate of registration issued to import as raw materials production 2.1.1. Profile:-the importing application (Appendix 4)-certified copy of business registration certificate.
-A commitment to quality assurance, safety, effect of chemicals (annex 5).
-A copy of the certificate of registration of chemical substances, preparations are manufactured from chemicals import, please.
-The planned use of chemical products, please enter the password.
2.1.2. procedure:-traders, held please submit import records of the Ministry of health (the Department of preventive medicine Vietnam).
-Within 15 working days of receipt of a valid application, the Ministry of health (the Department of preventive medicine Vietnam) would have written answer allow or not allow imports.

2.2. chemical, imported products to make assay, tested (after the Health Ministry allowed the assay in Vietnam) 2.2.1. Profile:-the importing application (Appendix 6).
2.2.2. procedure:-traders, held please submit import records of the Ministry of health (the Department of preventive medicine Vietnam).
-Within 15 working days of receipt of a valid application, the Ministry of health (the Department of preventive medicine Vietnam) would have written answer allow or not allow imports.
2.3. chemical preparations, not containing the registration number issued to research, aid, used for other specific purposes in 2.3.1. Profile:-application for import permits (annex 6).
-Notarized copy of the business registration certificate or other documents proving legal personality of the unit please enter password.
-A commitment to quality assurance, safety, effect of chemical substances (annex 5).
-The technical documentation of chemicals, products-research outline (for imported products, chemicals for research) or document explanation of purpose of use of imported products, chemicals (for the chemical, imported products for a particular purpose).
-The accompanying document (if available) include: certificate of GMP, ISO of the factory, chemical circulation license, country products, the license in some other country that the chemical, which products have to be registered and sold.
2.3.2. procedure:-traders, held please submit import records of the Ministry of health (the Department of preventive medicine Vietnam).
-Within 15 working days of receipt of a valid application, Department of preventive medicine Vietnam will have text answer allow or not allow imports.
IV. REGULATIONS On IMPORTED Medical EQUIPMENT 1. Medical equipment in Appendix 7 of this circular 1.1. Conditions: traders want to import medical equipment belonging to the category of Appendix 7 to ensure the following conditions: 1.1.1. Enough legal records of traders under the enterprise law or law of cooperatives, the law on investment in Vietnam.
1.1.2. Has a team of technical staff of medical equipment and facilities to meet the requirements of:-The main responsibility of the technique must have one of the following qualifications: Diploma of specialized university biomedical electronics; University diploma of engineering systems; Graduate College of medicine, pharmacy and have specialized training in medical equipment due to the legal training of technical medical equipment or foreign equivalent certification level, the duration of training for at least a month.
-For those who have the aforesaid qualifications and the time has a direct impact on the techniques of medical devices or medical device management in medical institutions from 3 years upwards are the heads of the unit where the work confirms the need not to have a certificate of specialized training of medical equipment.
-Officials, technical personnel qualified installation instructions, warranty, maintenance of the medical equipment that traders business (which is the manufacturer of the device for continuous training every year).
-About technical facilities: Headquarters, treasure match, qualified for preserving good medical equipment, are full of tools, equipment and techniques to accomplish the work of installation, maintenance, medical equipment maintenance; the media are full of explosions and to ensure environmental safety as provided by the law.
1.2. Profile:-application for import of medical equipment (annex 8).
-The documents referred to in Point 1.1, paragraph 1, section IV.
-Documents, paperwork attached include: Catalogue (original) of each type of equipment; Certificate of quality management ISO 9001-manufacturer ISO 14,000, or equivalent; The license product circulation in the country of origin (annex 9).
1.3. procedure:-application for import of medical equipment to be sent to the Ministry of health (Service equipment and health-is a permanent unit) to sum up, the Board reviewed and licensed within 15 working days of receipt of a valid application.
-Licensed traders submit import fees are prescribed in decision No. 44/2005/QD-BTC dated 12 July 2005 of the Ministry of finance.
2. medical equipment in addition to the list in annex 7 of this circular The medical equipment in addition to the above mentioned categories in annex 7 but that device the application methods of diagnosis, new treatments and first imported to Vietnam must apply for import license of the Ministry of health. In addition to these conditions, record, import permit procedures as prescribed in clause 1, section IV of this circular, a medical equipment import must have pleased the results of clinical trials and evaluation by the Council of science and technology of the Ministry of health, the evaluation allows the new imported.
V. IMPLEMENTATION 1. The Ministry of health published the directory of health products, vaccines and insecticides, chemicals bactericide used in domestic and imported medical needs. Every year, the Ministry of health review, Supplement, adjust the equipment list in Appendix 7 to match the actual situation.

2. The Department of preventive medicine Vietnam within the authority receiving records and import license for vaccines, medical products and chemicals, insecticides, preparations used in sterilizing medical and household. Service equipment and medical works as a permanent unit of the Ministry of health is responsible, the Board reviewed and licensed to import medical equipment.
3. Inspection of the Ministry of health in collaboration with the Service, the Bureau of the Ministry of health functions perform checks, inspections on the scope of business activities in the country, imported vaccines, medical products; chemicals that kill insects, bactericide used in appliances and health and medical equipment.
4. the Department of health, the central cities perform testing, inspection of the operations, imported vaccines, medical products; chemicals that kill insects, bactericide used in appliances and health and medical equipment at local 5. National testing of vaccines and medical products-the Health Ministry to base the documentation sent enclosed with the shipment, import templates store, registered quality standards make functional testing, monitoring the quality of vaccines, the circulation of medical products on the market.
6. The base using vaccines, medical products is responsible for the use of vaccines, biological and periodic reporting, the use of vaccines: side effects, complications due to the use of vaccines and other extraordinary cases during use.
7. Traders, import, business organizations, vaccine research, medical and chemical products, insecticides, preparations used in sterilizing medical and household responsibility to seriously implement the rule of law and the accountability of its activities.
8. Quarterly Traders importing organizations, reported the Ministry of health (the Department of preventive medicine Vietnam) the situation of imported vaccines, medical products, chemical insecticides, bactericide used in appliances and health; Report Service equipment and health situation of importing medical equipment.
VI. ENFORCEMENT Of TERMS 1. This circular effect after 15 days from the date The report. Abolish circular No. 09/2001/TT-BYT on 21/05/2001 the Ministry of health guidelines implementation of the export and import vaccines, born immune products for the period 2001-2005; Circular No. 10/2003/TT-BYT on 15/05/2003 the Ministry of health guidelines on the management and use of vaccines, medical products not yet registered number in circulation are of aid in case of emergency or imported into Vietnam for use in special cases; Circular No. 13/2001/TT-BYT on 18/06/2001 directions Health Ministry's import-export of chemicals, insecticides, preparations used in sterilizing medical and household sectors to the period 2001-2005 and circular No. 14/2002/TT-BYT on 30/05/2002 of the Ministry of health "Guide to export-import of medical equipment management in the period 2002-2005".
2. The Department of preventive medicine Vietnam, Service equipment and medical works, Inspector of the Ministry of health, national testing of vaccines and medical products, the Health Department of the province, central cities, which use vaccines, biological health, the traders, the Organization imported vaccines , medical products; chemicals, insecticides, preparations used in sterilizing medical and household and medical equipment are responsible for the correct implementation of the provisions of this circular.
3. in the implementation process if there are difficulties, obstacles and suggest to contact the Service, the Bureau of the Ministry of health to consider resolution./.

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