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Medicines Management Procedures (Trial Implementation)

Original Language Title: 药材管理办法(试行)

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(November 24, 2005 order of the State food and drug administration released 22nd, come into force on February 1, 2006) Chapter I General provisions article to strengthen the supervision and administration of imported medicinal materials, guarantee the quality of imported medicines, according to the People's Republic of China pharmaceutical administration law and the People's Republic of China pharmaceutical administration law implementing regulations (hereinafter referred to as the drug management law, the implementing Ordinance) and the provisions of relevant laws and regulations, these measures are formulated.     Article import medicinal application, examination and approval, registration, inspection and supervision management, these measures shall apply.     Imported medicinal materials application and approval, refers to the State food and Drug Administration request of the applicant, in accordance with legal procedures and requirements on foreign production using medicinal herbs sold in China for technical review and administrative review, and whether or not to approve of its import decision.     Imported medicines the applicant, shall be made in China the drug manufacturing license or the drug business of drug producing or trading companies.     Article responsible for medicines imported by the State food and Drug Administration approval and registration for supervision and management, inspection, etc.     Provinces, autonomous regions and municipalities (for food) and drug administration shall conduct supervision on imported medicines.     Allowing drug imports port location of a border or allow drug imports (food) Drug Administration (hereinafter referred to as ports or border crossings (food) and Drug Administration) is responsible for the registration of imported medicine, organizing inspection and supervision and management.     First import of pharmaceutical and biological products is responsible for drug samples tested, the quality standard of review, and so on.     Determined by the State food and drug administration and drug control agency responsible for customs inspection of imported medicine. Article fourth of medicines must be approved by the State Council to allow drug imports port or border ports allows drug imports.     Allows drug imports of border crossings, can import medicines produced by country or region around the port.     Chapter II application and approval section one General provisions article fifth in medicine imports shall be applied for the State food and Drug Administration accepted place public information projects and the application model.     Applicant drug imports should be in accordance with the provisions of article VI submitted complete material, reflect the true situation, and is responsible for the authenticity of the substance of the declared information.     Article submitted by the applicant to declare information on errors that can be corrected on the spot, shall permit the applicant to be corrected on the spot. Article information is not complete and does not meet the statutory declaration form, the State food and Drug Administration should make correction or inform the applicant of the need in the 5th all, fails to inform the, starting from the day of receipt of the application materials shall be accepted.     Inadmissible, shall state the reasons in writing. Nineth during the review process, the State food and drug administration requires additional information, should be submitted once. The applicant shall, within 4 months of receiving notice of additional information additional information received to meet the requirements of, on the basis of its review of the original examination time limit the time limit extended 20th; additional information was not submitted by the deadline, be returned. Due to force majeure, you cannot submit additional information within the prescribed must apply in writing to the State food and drug administration, and state the reasons.     The State food and Drug Administration should put forward opinions on 20th.     Tenth Article herbs imports application by law review, think meet requirements of, national food drug supervision authority should in provides time within made approved decided, and in 10th within to applicants served imports herbs approved proved file; think not meet requirements of, should in provides time within written told applicants, description reason, and told applicants enjoys law application review, and administrative reconsideration or filed administrative litigation of right. 11th state food and Drug Administration on drug imports found during the review of an application for the matter directly related to the vital interests of others, shall be notified to the interested parties.     Applicants and interested parties may submit written statements and pleadings, or legally required to hold a hearing.     12th national food and Drug Administration should be set up on the Government's website announcement medicine import applications, review the information about the process and has approved the import of medicines. Herbs section II import application, examination and approval article 13th first import of medicines imported applications including medicine applications and non-imported for medicinal applications.     Import medicinal applications, including for the first time have a statutory standard first import of medicinal applications and standards cannot be first import of medicinal applications.     Article 14th drug imports, the applicant shall fill in the application form for imported medicinal materials in accordance with regulations and State food and Drug Administration to submit relevant information.     15th after the State food and Drug Administration to declare information received, shall, within the 5th to normative, and completeness of information form review and notice of admissible or inadmissible.     16th imported medicines for the first time after the application is accepted, the applicant shall promptly examine samples and related information submitted to the pharmaceutical and biological products.     Article 17th of pharmaceutical and biological products after receiving test samples and related information, the existing legal standard first import of medicinal applications, should be finished in 30th sample inspection, standards cannot be first import of medicinal applications, quality standards review shall be completed within 60 days and sample inspection and examination and review comments on the report submitted to the State food and drug administration. 18th the State food and drug administration of pharmaceutical and biological products received the inspection report and review comments, technical review and administrative review shall be completed within 40 days.     To meet the requirements, issued the import of medicine documents; does not meet the requirements, the review notice will be issued, and explain the reasons. 19th first import of the State food and Drug Administration accepts non-drug applications, should be finished in 30th technical review and administrative review.     To meet the requirements, issued the import of medicine documents; does not meet the requirements, the review notice will be issued, and explain the reasons.     20th State food and drug administration, depending on your needs, you can visit the imported medicinal materials production site. Article 21st of the imported medicinal materials documents once effective documents and multiple use license.     Once valid license valid for 1 year, multiple use license is valid for 2 years.     The number formats of imported medicinal materials documents as: medicinal herbs into the word + 4 year + 4-bit sequence number.     22nd the State food and Drug Administration on endangered species medicines or imported import of medicinal applications, one-time effective documents.     Article 23rd change the imported medicinal herbs in the documents of the applicant name and port, the applicant shall apply in supplement to the State food and drug administration, and to submit the relevant information.     Supplementary application by the applicant should be the original drug import holders of the documents.     24th State food and drug administration after receiving a supplementary application, shall, within the 5th review normative and completeness of the information on the application form, and notice of admissible or inadmissible. 25th State food and Drug Administration should be complete in the 20th after supplementary applications for administrative review.     To meet the requirements, application documents for issuing import medicinal supplements; does not meet the requirements, review notifications will be issued, and explain the reasons.     26th of the imported medicines supplement documents relating to the term of validity of the original documents relating to the same.     27th applicants to the State food and Drug Administration approved decisions taken by objections, notifications can be received rejection within 10th of written applications for review to the State food and drug administration and the grounds for reexamination.     Review is limited to original applications and declarations. 28th the State food and drug administration after receipt of the application for review, and shall, in accordance with the original application review time frames and requirements for review and make a decision.     Decisions of the revocation shall not be approved, the applicants will be issued the corresponding import medicine documents or application documents for the imported medicinal supplements; upheld the decision, the State food and Drug Administration does not accept applications for review again.     29th reviewed the need for sample inspection or review of quality standards, shall, in accordance with the original sample inspection or review timelines and requirements for quality standards.     Chapter III registration article 30th after the applicant has obtained the import of medicine documents, from the imported medicinal materials documents indicate the port of organized medicine imports.     Organized medicine imports, the applicant shall provide the port or border crossings (food) and Drug Administration registration, fill out the inspection of imported medicinal materials form and submit relevant information. 31st ports or border crossings (food) and Drug Administration registration information should be the integrity of the review, normative and authenticity, and review decisions taken on the day. To meet the requirements of the published import drugs tongguan Dan to recover once effective documents and drug testing to determine the State food and Drug Administration issued the notification of imported medicinal materials inspection, and registration information.     Does not meet the requirements, the imported medicines not registered notice will be issued, and explain the reasons. Articles 32nd to not process the registration of imported medicines, the applicant shall be shipped back.     Unable to return from port or border crossings (food) and drug administration supervision and treatment in accordance with the relevant provisions. The fourth chapter port inspection and supervision article 33rd national food and drug inspection institutions determined by the authority upon receipt of the notification of imported medicinal materials inspection, shall be in accordance with the imported medicines in the 2nd sample regulations to the inventory provided for field sampling.     When sampling, the applicant shall provide medicine certificate of origin. Article 34th Determined by the State food and drug administration and drug control agencies should be based on port or border (food) Drug Administration to provide registration information for medicinal origin certificate and medicinal herbs to verify the actual delivery.     To meet the requirements, sampling, fill in the imported medicine sample record form, in drug importation on the Customs form marked "sample" words, and shall affix its official seal; do not meet the requirements, not sampled, and 2nd in the notice submitted to the location of the imported medicines are not sampling ports or border crossings (food) and drug administration.     Ports or border crossings (food) and drug administration after receipt of the notification of imported medicinal materials are not sampling should have imported all the herbs to take seizure, seizure of compulsory administrative measures, and to make a decision in the 7th.     35th State established by the food and drug administration and drug control institutions shall perform inspection in the 20th after sampling, the imported medicinal materials testing report issued by, submitted to the home ports or border crossings (food) and drug administration, and notify the applicant accordingly; not be able to meet the time limit on completion of the survey shall be made to the port or border crossings (food) and Drug Administration reports, and notify the applicant accordingly. 36th article of not meeting the standard of imported medicinal materials, ports or border crossings (food) drug immediately upon receipt of the inspection report, the administration shall take seizure, seizure of compulsory administrative measures, and to make a decision of administrative handling within 7th; to file an application for re-inspection, have to reinspect the conclusion date make a decision of administrative handling within 15th. And location of the report on the situation of provinces, autonomous regions and municipalities (food) and drug administration.     The applicant shall upon receipt of the inspection report is located in the 2nd ports or border crossings (food) all imports of drug administration in writing details of circulation and use medicinal plants. 37th the applicant disagrees with the results of testing, you can press the drug management law article 67th file an application for re-inspection.     Drug testing agencies to accept the re-inspection application, shall promptly report to the port or border crossings (food) Drug Administration, retesting and re-inspection conclusions on the 20th after filing, reporting ports or border crossings (food) and drug administration, and notify the applicant accordingly.     38th meeting the prescribed standards upon re-inspection of import medicinal herbs, ports or border crossings (food) and drug administration shall receive a re-inspection after the conclusion, the immediate lifting of the compulsory administrative measures of sealing up, distraining and report location of provinces, autonomous regions and municipalities directly under the (food) and drug administration.     39th on within the set time file an application for re-inspection or retest is still not meeting the prescribed standards of imported medicinal materials, ports or border crossings (food) and drug administration shall make a decision of administrative handling, take the appropriate measures, both the seat of provinces, autonomous regions and municipalities (food) and drug administration.     40th imported medicinal materials on sale before using for the first time, must be determined by the State food and Drug Administration inspection institution of sampling inspection, examined and passed before the sale. 41st for not meeting the standards, but have been in circulation to the port or the location of the border provinces, autonomous regions and municipalities directly under the (food) import medicinal drug administration jurisdiction outside the region, the port or the location of the border provinces, autonomous regions and municipalities directly under the (food) Drug Administration shall inform the relevant situation medicinal herbs into the region's provinces, autonomous regions and municipalities (food) and drug administration.     Medicinal herbs into the area of the provinces, autonomous regions and municipalities (food) Drug Administration shall take appropriate measures according to law. The 42nd article import medicine packaging must meet the quality requirements of imported medicinal materials, convenient storage, transport and import inspection.     On each package, and must indicate the medicine name, license number, country of origin, shipping marks, number one, apply for a business name, the name of manufacturer, port, weight and the date of processing, packaging and so on.     The fifth chapter legal liability article 43rd circumstances as provided in the administrative licensing law article 69th, State food and drug administration, according to the request of the interested party or ex officio, you can remove the imported drug approval documents. 44th article in imports herbs approval, and registration record and port test process in the, has following case one of of, in accordance with administrative license method 72nd article, and 73rd article, and 74th article and 75th article provides processing: (a) on meet statutory conditions of herbs imports application not accepted of; (ii) is not accepted places publicity herbs imports declared information project of; (three) in accepted, and review process in the, not to applicants perform statutory told obligations of; (four) applicants submitted of declared information not complete, and     Not meet statutory form, not once told applicants must correction of all content of; (five) not law description not accepted or not approved reason of; (six) on not meet this approach provides of herbs imports application made approved decided or beyond statutory terms made approved decided of; (seven) on meet this approach provides of herbs imports application made not approved decided or is not this approach provides term within made approved decided of; (eight) unauthorized charges or not according to statutory project and standard charges of;     (I) the solicitation or acceptance of other people's property, or seeking other interests.     Article 45th applicants to hide relevant information or provides false materials and sample applications for medicine imports, the State food and Drug Administration not to grant the application as inadmissible or, give warning to applicants, within one year of the inadmissibility of the applicant's drug import application.     Article 46th applicants providing false testimony, documents, samples or other dishonest methods made the import of medicine documents, the State food and Drug Administration revoke the import of medicine documents, not accepting an application for its raw material imports for five years and a fine of between 10,000 yuan and 30,000 yuan.     The applicant obtained through bribery or other improper means the import of medicine documents, State food and Drug Administration revoke the import of medicine documents, not accepting an application for its raw material imports for three years.     47th State established by the food and drug administration and drug control agencies in the provision of port inspection work, issue a false inspection report or an offence of charging inspection fees, 87th, according to the pharmaceutical administration law article 96th.     Sixth chapter supplementary articles article 48th deadlines as provided herein are based on working days, excluding holidays.     First import of raw material for medicine, refers to the imports of medicines from foreign origin for the first time.     Statutory standard medicine, refers to national drug standards or medicinal herbs standards of provinces, autonomous regions and municipalities of medicinal herbs.     Standards cannot be medicine, refers to the national drug standard, or medicinal herbs standards of provinces, autonomous regions and municipalities, but approved the prescription of proprietary Chinese medicines containing herbs in our country.     49th article of the rules come into effect on February 1, 2006.       Implementation of these measures before the release of the provisions relating to imported medicines, are inconsistent with this approach, from the date of implementation of these measures to stop execution.     Annex 1: medicine import declaration information items and requirements, non-imported medicines for the first time declared information project and applicant is required to submit the following information in a request.     (A) the application form for the imported medicines.     (B) the applicant's drug business license or drug manufacturing license, business license (photocopy).     (C) legitimate supplier registration certificates (business license) (copy).     (D) the purchase contract (copies).     (E) quality criteria and their sources.     Second, the first declarations of imported medicinal materials items and requirements applicants are required to submit two copies of the following information, separately submitted to the State food and drug administration and pharmaceutical and biological products.     (A) the application form for the imported medicines.     (B) the applicant's drug business license or drug manufacturing license, business license (photocopy).     (C) legitimate supplier registration certificates (business license) (copy).     (D) the purchase contract (copies).     (E) quality criteria and their sources.     (F) the medicinal materials base sources of information (studies have shown that information should be made by China with animal and plant-based source identification of qualified agencies).     Which, as imports herbs of quality standard from province, and autonomous regions, and municipalities herbs standard, applicants except submitted above information outside, also should according to specific situation, on the standard for corresponding of improve work, and submitted about research information; as imports herbs cannot set standard, applicants except submitted above information outside, also should submitted following information: 1, and herbs ecological environment, and growth features, and form description, and cultivation or cultivated (foster) technology, and origin processing,.     Quality standards 2, drafting instructions.     3, summary of the Pharmacology and toxicology studies.     4, the main pharmacodynamic data and documents.     5, experimental data of general pharmacology studies and literature.     6, acute toxicity test data and documents.     7, approved the prescription of proprietary Chinese medicines containing the drug evidence.     Third, supplementary information projects and requirements for (a) change of applicant name of applicant is required to submit the following information in a.     1, the imported medicinal materials of the supplementary application form.     2, imported medicinal materials of the originals of the documents.     3, the applicant original operating licenses in the drug or the drug manufacturing license, business license (photocopy).     4, the applicant is now a pharmaceutical license or drug manufacturing license, business license (photocopy).     5, the applicant changed the drug trade license or the drug manufacturing license, proof of business license in the name of the project file (copy).     (B) change the port a copies of the applicant is required to submit the following information.     1, the imported medicinal materials of the supplementary application form.     2, imported medicinal materials of the originals of the documents.    3, the purchase contract (copies). The above copy shall be stamped with the seal of the applicant.     Annex 2: registration and information items and requirements applicants are required to submit two copies of the following information.     First, the copies of the import of medicine documents (with a copy of the imported medicinal materials supplementary application documents).     Second, the applicant's drug business license or copy of the pharmaceuticals production license.     Third, the copy of the certificate of origin.     Four, purchase a copy of the contract.     Five copies of invoices, packing lists, tracking and freight.     Six, imported medicinal materials going through other countries or regions, from their place of origin shall be submitted simultaneously to the re-export of all purchase contracts, packing lists, tracking and shipping invoice.     Seven, on endangered species of medicinal herbs, should provide proof of import and export both national endangered species import and export Management Agency copy.       These copies shall bear the seal of the applicant.                                                                  Annex 3: State food and Drug Administration import medicinal application form application number: XXXXXXXXX ┏━━━━━━━┳━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┓┃ application ┃                                                      ┃┣━━━━━━━┛┃┃ 1. application category: 0 first imported medicinal materials: 0 statutory standards standard medicinal 0 cannot have been first import of medicines ┃ ┃ 0 non-medicinal herbs                                                                  ┃ ┃2.批件分类:○一次性有效批件  ○多次使用批件                                      ┃ ┣━━━━━━━┳━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┫ ┃进口药材情况  ┃                                                                      ┃ ┣━━━━━━━┛                                                                  ┃ ┃3.中文名:                                                                        ┃ ┃4.拉丁学名:                                                                          ┃ ┃5.英文名:                                                                        ┃ ┃6.别名:                                                          ┃ ┃7.产地(国家):                                                                  ┃ ┃8.出口地(国家):                                                                ┃ ┃9.申请进口数量(公斤):                                                                       ┃ ┃10.包装材料:                                                                     ┃ ┃11.包装规格:                                                                     ┃ ┃12.合同号:                           ┃ ┃13.检验标准:  ○中国药典____________版                                           ┃ ┃               ○进口药材质量标准,标准来源____________                     ┃ ┃ 0 Ministerial medicine standards, standards source _____________ ┃ ┃ 0 medicine standards of provinces, autonomous regions and municipalities, standard source ______________________ ┃ ┃ 0 self-quality standard (only for standards cannot be imported medicinal materials)                                               ┃ ┃14.到货口岸:                                                                     ┃ ┃15.口岸或边境口岸(食品)药品监督管理局:                                         ┃ ┃16.是否属濒危物种        ○是  ○否                                                                                  ┃ ┃ 17. enterprises imported whether 0 is 0 for the first time, has imported times: total imports (kg): ┃ ┃ original approval number: ┃ ┃                                                                                  ┃ ┠─────────────────────────────────────────┨ ┃18.申请进口理由:                                                                 ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                      ┃ ┗━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┛                                                                           XXXXXX ┏━━━━━┳━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┓ ┃申请人    ┃   ┃ ┣━━━━━┛                                                                      ┃ ┃19.机构:                              □本机构负责缴费                           ┃ ┃名                                                    称:                                                                         ┃ ┃组织机构代码:                                                                    ┃ ┃相关证件:1.《营业执照》编号:                                      ┃ ┃          2.○《药品生产许可证》编号:                                            ┃ ┃            ○《药品经营许可证》编号:                                            ┃ ┃法定代表人:                          职位:                      ┃ ┃注册地址:                                        邮政编码:                      ┃ ┃生产地址:                                        邮政编码:                      ┃ ┃注册申请负责人: 签名:      职位:                          ┃ ┃电话(含区号及分机号):                          传真:                          ┃ ┃电子信箱:                                                                        ┃ ┃联系人:                              电话:                                      ┃ ┣━━━━━━━┳━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┫ ┃其他           相关情况  ┃                                                                  ┃ ┣━━━━━━━┛                                                                  ┃ ┃20.机构(出口商或出口企业):                          □本机构负责缴费                                             ┃ ┃名   称:                                                                         ┃ ┃组织机构代码:                                                                    ┃ ┃相关证件:《营业执照》         编号:                                        ┃ ┃法定代表人:                                      职位:                          ┃ ┃注册地址:                                        邮政编码:                      ┃ ┃生产地址:                                                                                  邮政编码:                      ┃ ┃联系人:                              电话:                                      ┃ ┃                                                                    ┃ ┃21.机构(国外加工企业):                          □本机构负责缴费               ┃ ┃名   称:                                                                         ┃ ┃组织机构代码:                                        ┃ ┃相关证件:《营业执照》         编号:                                             ┃ ┃法定代表人:                                      职位:                          ┃ ┃注册地址:                                                                                  邮政编码:                      ┃ ┃生产地址:                                        邮政编码:                      ┃ ┃联系人:                              电话:                                      ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                           ┃ ┃                                                                                  ┃ ┗━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┛                                                                          XXXXXX ┏━━━┳━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┓ ┃申  明┃                                                                          ┃ ┣━━━┛ ┃ ┃ 22. We guarantee: ① this application comply with People's Republic of China drug management method, and People's Republic of China drug management method ┃ ┃ implementation Ordinance and imports herbs management approach, legal, and regulations and regulations of provides; II application table content and the by submitted information ┃ ┃, and samples are real, and source legal, not violations others of interests, which test research of method and data are for this drug by used ┃ ┃ of method and by this drug get of test data      C submit electronic file exactly the same content as the print.                               ┃ ┃ If false, we accept the resulting legal consequences.                                                                                  ┃ ┃23.其他特别申明事项:                                                             ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃24.申请人机构名称  公章  法定代表人签名  签名日期:                               ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                           ┃ ┃                                                                                  ┃ ┗━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┛    XXXXXX instruction, application category: according to the measures for the management of imported medicinal materials (on trial) relevant provisions of the 13th, 48th to fill in. Second, the documents relating to category: according to the measures for the management of imported medicinal materials (on trial) at its 21st, 22nd, fill in the relevant provisions. Third, Chinese name, English name, Latin name, alias names, country of origin (country), export (country), applications for imports quantity (kg), packaging material, packaging specifications, contract number: according to the specific relevant information to fill in.     "Chinese name" must be the national drug standard, or provinces, autonomous regions and municipalities in medicine standard name with each other. Four, and test standard: where has imports herbs quality standard of varieties, its test standard implementation imports herbs quality standard; imports herbs quality standard not containing of varieties, its test standard implementation China Pharmacopoeia standard; China Pharmacopoeia not containing of varieties, its test standard implementation Department awarded herbs standard; Department awarded herbs standard not containing of varieties, its test standard implementation province, and autonomous regions, and municipalities herbs standard; above standard must indicate standard source, as China Pharmacopoeia release, and standard number and released time.     Beyond the standards of imported medicinal materials, self-quality standard.     Five, port: according to the measures for the management of imported medicinal materials (on trial) the relevant provisions of the fourth complete.     Six, ports or border crossings (food) and Drug Administration: under the imported medicines regulations (trial) relevant provisions of article filled out.     Seven, whether endangered species: according to the specific situation to fill out.     Eight, whether for the first time the company imported varieties: the varieties according to the specific import conditions to fill out.     Nine, application for reason: briefly imports imports cause, purpose, and so on. Ten, applicant, the other relevant circumstances, stated: according to the specific circumstances of the applicant to fill in.       "Exporters or export-oriented enterprises" means the purchase contract with the applicant enterprise; "foreign enterprises" means imported medicinal materials production and processing enterprises in foreign countries; "exporters or export-oriented enterprises" and "foreign enterprises" could be the same company.                                                                      Annex 4: State food and Drug Administration import medicinal supplementary application form application number: XXXXXXXXX ┏━━━━━┳━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┓┃ application ┃ ┃ ┣━━━━━┛                                                                      ┃ ┃1.申请分类:□变更申请人名称    □变更到货口岸    □其他                          ┃ ┣━━━━━━━┳━━━━━━━━━━━━━━━━━                                                                        ━━━━━━━━━━━━━━━━┫ ┃进口药材情况  ┃                                                                  ┃ ┣━━━━━━━┛                                                                  ┃ ┃2.中文名:                                                                        ┃ ┃3.拉丁学名:                                                                      ┃ ┃4.英文名:                                                                ┃ ┃5.别名:                                                                          ┃ ┃6.产地(国家):                                                                  ┃ ┃7.出口地(国家):                                                                   ┃ ┃8.包装材料:                                                                      ┃ ┃9.包装规格:                                                                      ┃ ┃10.原批件编号:                                                                     ┃ ┃11.原批件有效期至:    年  月  日                                                 ┃ ┣━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┫ ┃12.申请内容:                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┣━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┫ ┃13.原批准的相应内容:                                                             ┃ ┃                                                                     ┃ ┃                                                                                  ┃ ┣━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┫ ┃14.申请理由:                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                   ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃ ┃ ┗━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┛                                                                           XXXXX X ┏━━━━┳━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┓ ┃申请人  ┃                                                                        ┃ ┣━━━━┛                                                                        ┃                                                                    ┃15.机构(申请人):                            □本机构负责缴费                   ┃ ┃名   称:                                                                         ┃ ┃组织机构代码:                                 ┃ ┃          相关证件:1.《营业执照》      编号:                                    ┃ ┃                    2.○《药品生产许可证》编号:                                  ┃ ┃                       ○《药品经营许可证》编号:                                          ┃ ┃                                                                                  ┃ ┃法定代表人:                          职位:                                      ┃ ┃注册地址: 邮政编码:                    ┃ ┃生产地址:                                          邮政编码:                    ┃ ┃注册申请负责人:                      签名:        职位:                        ┃ ┃电话(含区号及分机号):                            传真: ┃ ┃电子信箱:                                                                        ┃ ┃联系人:                              电话:                                      ┃ ┣━━━━┳━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ━━━━┫ ┃ 申  明 ┃                                                                        ┃ ┣━━━━┛                                                                        ┃ ┃16.我们保证:①本申请遵守《中华人民共和国药品管理法》、《中华人民共和国      Drug management method ┃ ┃ implementation Ordinance and imports herbs management approach, legal, and regulations and regulations of provides; II application table content and the by submitted information ┃ ┃, and samples are real, and source legal, not violations others of interests, which test research of method and data are for this drug by used ┃ ┃ of method and by this drug get of test data; ③ together submitted of electronic file and print file content completely consistent.                              ┃ ┃ If false, we accept the resulting legal consequences.                                                                                  ┃ ┃17.其他特别申明事项:                                                             ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃18.申请人机构名称  公章  法定代表人签名  签名日期:                               ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃                                                                                  ┃ ┃ ┃ ┗━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┛                                                                           XXXXXX     填表说明     一、申请分类:根据《进口药材管理办法》(试行     23rd) section fill in the relevant provisions. Second, Chinese name, English name, Latin name, alias names, country of origin (country), export (country), packaging material, packaging specifications: according to the specific relevant information to fill in.     "Chinese name" must be the national drug standard, or provinces, autonomous regions and municipalities in medicine standard name with each other.     Third, the validity of the original license number, the original documents: according to the indicate the relevant information on the original documents of the applicant.     Four, application contents: brief description of changes.     Five, the original approval of the corresponding contents: according to the information indicated on the original documents.     Six, the grounds of the application: brief description of the reason for the change.       VII, applicant, stated: according to the specific circumstances of the applicant to fill in. 附件5:                           进口药材申请受理通知单                                                          No:_____________ _______________:       你单位申报的下列进口药材申请: 药材名称:__________________________________________ ______________________ Origin: ________________________________ imports: ______________________________________________________ reviewed, the application meets the requirements of drug import regulations for review, decide to accept.             Admissible number: notice is hereby given that. Note: this technology only as this application is accepted by the State food and drug administration documents, results no necessary link with the approval of this application.                                                             Approval progress available to the query, URL: www.SFDA.gov. ─────── cn。                         ─     受理注明:                                         受理机关:国家食品药品监督管理局(盖章)                                   经办人:                                   受理日期:      年    月    日       附件6: 进口药材申请不予受理通知单                                                          No:_____________ _______________:       你单位申报的下列进口药材申请: 药材名称:________________________________________________ 产地:______________       ____________________ Imports: ____________________________________________________________ subject to review, the application does not comply with the measures for the management of imported medicinal materials (on trial) the provisions relating to requests for review, decide not to accept.     Notice is hereby given that.     ─────────────────────────────────────     理由:                                                    受理机关:国家食品药品监督管理局(盖章)                                  经办人:                                  受理日期:            年    月    日       附件7:                           国家食品药品监督管理局                                进口药材批件  受理号:                                                 批件号: ┌──────┬─────┬────────┬─────┬───────┐ │ │  中文名  │                │   别名   │              │ │            ├─────┼────────┴─────┴───────┤ │  药材名称  │ 拉丁学名 │                                            │ │            ├─────┼────────────────── ────┤ │            │  英文名  │                                            │ ├──────┼─────┴────────┬─────┬───────┤ │    产地    │                            │  出口地  │              │ ├──────┼──────────────┼───── ┼───────┤ │进口数量(kg)│                            │ 包装规格 │              │ ├──────┼──────────────┼─────┼───────┤ │  包装材料  │                            │  合同号  │              │ ├──────┼──────────────┴─────┴─── ────┤ │  检验标准  │                                                        │ ├──────┼────────────┬───────┬───────┤ │  到货口岸  │                        │ 登记备案单位 │              │ ├──────┼───────┬────┼───────┴───────┤ │  批件类型  │              │批件效期│ 本批件有效期至    年  月  日 │ ├──────┼─────┬─┴            ────┴───────────────┤ │            │   名称   │                                            │ │            ├─────┼──────────────────────┤ │   申请人   │   地址   │                                            │ │                                            ├─────┼────────┬─────┬───────┤ │            │ 电话传真 │                │  联系人  │              │ ├──────┼─────┼────────┴─────┴───────┤ │            │   名称   │              │ │            ├─────┼──────────────────────┤ │出口商或出口│   地址   │                                            │ │    企业    ├─────┼────────┬─────┬───────┤ │            │ 电话传真 │                │  联系人  │                                            │ ├──────┼─────┼────────┴─────┴───────┤ │            │   名称   │                                            │ │            ├─────┼──────────────────────┤ │国外加工企业│   地址   │                                                                │ │            ├─────┼────────┬─────┬───────┤ │            │ 电话传真 │                │  联系人  │              │ ├──────┴─────┴────────┴─────┴───────┤ │备注: │ │                                                                      │ │                                                                      │ └────────────────────────────────                                                 -┘ Date of State food and Drug Administration Annex 8: State food and Drug Administration import medicinal supplements apply for an approval number: 批件号: ┌──────┬─────┬──────┬───────────────┐ │            │  中文名  │            │别名                          │ │            ├─────┼──────┴───────────────┤ │  药材名称  │ 拉丁学名     │                                            │ │            ├─────┼──────────────────────┤ │            │  英文名  │                                            │ ├──────┼─────┴──────┬───────┬───────┤ │    产地  │                        │    出口地    │              │ ├──────┼────────────┼───────┼───────┤ │进口数量(kg)│                        │   包装规格   │              │ ├──────┼────────────┼───────┼───────┤ │  包装材料   │                        │    合同号    │              │ ├──────┼────────────┴───────┴───────┤ │  检验标准  │                                                        │ ├──────┼────────────┬───────┬───────┤ │  到货口岸 │                        │ 通关备案单位 │              │ ├──────┼────────────┴───────┴───────┤ │  审批结论  │经审核,同意由……                          Changed to ... ....                                                        │ │            │                                                        │ │            │                                                        │ │            │                                                        │ │            │                                                        │ │            │                                                        │ │            │ │ │            │                                                        │ ├──────┼────────────┬───────┬───────┤ │  原批件号  │                        │本批件有效期至│  年  月  日  │ ├──────┼─────┬───            ───┴───────┴───────┤ │   申请人   │   名称   │                                            │ │            ├─────┼──────────────────────┤ │            │   地址   │                                            │ │                                                                ├─────┼──────┬───────┬───────┤ │            │ 电话传真 │            │    联系人    │              │ ├──────┴─────┴──────┴───────┴───────┤ │备注:                                                                      │ │                                                                      │ │                                                                      │ │                       │ └───────────────────────────────────┘                                                  国家食品药品监督管理局                                                       年    月    日       附件9:                                                                      国家食品药品监督管理局审查意见通知件  受理号: ┌───────────────────────────────────┐ │_____________________:                                               │ │ │ │ You declare imported medicinal materials of the following applies: │ │                                                                      │ │药材名称:________________                                            │ │                        │ │产地:______________________                                          │ │                                                                      │ │进口数量:____________________________________                  │ │                                                                      │ │    经审查,存在下列问题,不予颁发《进口药材批件》。                                                        │ │                                                                      │ │    特此通知。                                                                      │ │                                                                      │ ├───────────────────────────────────┤ │理由:                                                                │ │                                                                      │ │                                                                      │ │                                                                      │ │                                                                      │ │                                                                      │ │                                                                      │ │                                                                      │ ├───────────────────────────────────┤ │备注:根据《进口药材管理办法》(试行)第十条规定,你单位享有依法申请复│ │                                  │ │ Right to audit, administrative reconsideration or bring an administrative suit.                              │ └───────────────────────────────────┘                                                  国家食品药品监督管理局                                                      年    月    日     附件10:                进 口 药 材 报 验 单  HS商品编码: ┌──────┬──────────┬───────────────────┐ │            │中文                │英文名                                │ │  药材名称  ├──────────┼───────────────────┤ │            │别名        │拉丁学名                              │ ├──────┼──────────┴───────────────────┤ │  包装规格  │                                                            │ ├──────┼────┬───┬───┬──┬─────┬────┬───┤ │   批件号   │       │合同号│      │检验│          │ 索赔期 │      │ │            │        │/唛头│      │标准│          │        │      │ ├──────┼────┼───┼───┴──┴─────┼────┼───┤ │  货物数量  │        │ 货值 │                        │提运单号│  │ ├──────┼────┼───┼───┬────┬───┼────┼───┤ │   发货港   │        │发  货│      │运输工具│      │        │      │ │            │        │      │      │(航/班│      │负责海关│      │ │   (地)   │        │日  期│      │ 次)  │      │        │      │ ├──────┼────┼───┼───┼────┼───┴────┴───┤ │   到岸港   │        │到  岸│      │存货地点│                        │ │   (地)   │        │日  期│      │        │                        │ ├─────                ─┼────┴───┴───┼────┴───┬────────┤ │   出口商   │                        │      国家      │                │ ├──────┼────────────┼────────┼────────┤ │  发货单位  │                        │      国家      │              │ ├──────┼────┬───────┼────────┼────────┤ │            │        │              │药品经营或生产许│                │ │            │ 名  称 │              │                │                │ │            │        │                                │    可证证号    │                │ │            ├────┼───────┴────────┼────────┤ │   申请人   │        │                                │                │ │            │ 地  址 │    │                │ │(报验单位)│        │                                │                │ │            ├────┼─────┬──┬───────┤                │ │            │        │          │    │              │                                                            (公章)    │ │            │ 联系人 │          │电话│              │                │ │            │        │          │    │              │   年  月  日   │ ├──────┼────┴─────┴──┴───────┴────────┤ │            │                                                            │ │            │                                                            │ │     所     │                                                            │ │     附     │                                                            │ │     资     │                                                            │ │     料     │ │ │            │                                                            │ │            │                                                            │ └──────┴────────────────────────    ------┘ (Note the back "notes"), the State food and Drug Administration notes 1. this form filled out by the applicant, a duplicate. A port or border crossings (food) and Drug Administration archive, an Institute for drug control.     The applicant shall specify "official seal" seals.     2. imported medicinal materials going through other countries or regions, should report to both from the point of origin to the re-export of all purchase contracts, packing lists, tracking and shipping invoice.     3. "test" means the import of medicine enshrined in the documents relating to the quality of standards and their numbers.     4. "the quantity of the goods" means the import of medicine documents set forth the amount of packing specifications as the basic unit of the goods, such as number of bottles, boxes, kilograms, etc.     5. inventory location for completes the customs formalities of goods the proposed storage of specific locations, indicate the name and address.     6. "the attached information" should be by reference to the number of imported medicinal materials documents provided information.       7. If this verification certificate there is not enough space, attach a separate sheet.                                                                      附件11:                            进 口 药 品 通 关 单                                                      编号: ┌───────────────────────────────────┐ │                                                                      │ │___________________海关:                                             │ │                                                                      │ │    根据《进口药材管理办法》(试行)的有关规定,下列药材已予登记备案,│ │                                                │ │ Please go through the formalities of Customs Declaration and examination. │ │                                                                      │ │                                                                      │ │药材名称(中/英):_______________________________________________                                                                      __ │ │                                                                      │ │别       名:____________________拉丁学名:__________________________ │ │ │ │收 货 单 位:________________________________________________________ │ │                                                                      │ │申请人(报 验 单 位):_________________________________________                                                                      _____ │ │                                                                      │ │HS 商品 编码:______________________ 提运单号:______________________ │ │ │ │......................................................................                                                                      │ │                                                                      │ │合同号/唛头:___________________ 进口口岸:_________________________ │ │ │ │进口商:_________________________ 产地:_____________________________ │ │                                                                      │ │批件号:_________________________ 包装种类:_________________________ │                                                                      │                                                                      │ │包装规格:_______________________ 件数:_____________________________ │ │ │ │进口数量:_______________________ 进口货值:_________________________ │ │                                                                      │ │抽样单位:___________________________________________________________ │ │                                                                      │ │......................................................................                                                                      │ │                                                                      │ │以下由抽样单位填写并盖章:                                            │ │                                                                      │ │是否已抽样:                       抽样单位盖章:                     │ │                                                                      │ │                  │ │: Customs clearance form from the date of issuance of this valid for a 15th late handling has to be replaced.                                                                      │ │                                                                      │ │                                                                      │ │                             口岸或边境口岸(食品)药品监督管理局     │ │ │ │                                    药品登记备案专用章                │ │                                                                      │ │                                        年    月    日                │ └───────────────────────────────────┘ (说明:本单由国家食品药品监督管理局统一印制,一式四联。 The first archive, the second customs, the third applicant, the fourth Stock Exchange Institute.                                                                      )       附件12:                           进口药材口岸检验通知书                                                      编号: ┌───────────────────────────────────┐ │                                                                      │ │_____________药品检验所:                                             │ │                                                                      │ │    下列进口药材已到岸,根据《进口药材管理办法》(试行)的有关规定,请│ │                  │ │ To stock the site inspection sampling to this batch of medicine, and quality control. │ │                                                                      │ │                                                                      │ │药材名称(中/英):_______________________________________________                                                                      __ │ │                                                                      │ │别       名:____________________拉丁学名:__________________________ │ │ │ │收 货 单 位:________________________________________________________ │ │                                                                      │ │申请人(报 验 单 位):_________________________________________ _____ │ │                                                                      │ │HS 商品 编码:____________________提运单号:_________________________ │ │                                                                      │ │合同号/唛头:___________________ 进口口岸:_________________________ │ │                                                                      │                                                                       │进口商:_________________________ 产地:_____________________________ │ │                                                                      │ │批件号:_________________________ 包装种类:_________________________ │ │                                                                      │ │包装规格:_______________________ 件数:_____________________________ │ │                                                                      │ │进口数量:_______________________ 进口货值:_________________________ │ │                                                                      │ │存货地名称/地址:___________________________________________________ │ │                                                                      │ │联系人:_________________________ 电话:_____________________________ │ │                                     │ │                                                                      │ │                           口岸或边境口岸(食品)药品监督管理局       │ │                                                                      │ │ 药品登记备案专用章                │ │                                                                      │ │                                      年    月    日                  │ └----------------------------------------------┘ (Note: the uniformly printed by the State food and drug administration, one in three. The first archive, the second applicant, the third stock exchange to take tests for drug testing.                                                                      )       附件13:                         进口药材不予登记备案通知书                                                      编号: ┌───────────────────────────────────┐ │                                                                      │ │___________________海关:                                             │ │                                                                      │ │    下列进口药材不符合《进口药材管理办法》(试行)关于登记备案的要求,│ │                                                    │ │ List according to the relevant regulations. │ │                                                                      │ │                                                                      │ │药材名称(中/英):_______________________________________________                                                                      __ │ │                                                                      │ │别       名:____________________拉丁学名:__________________________ │ │ │ │收 货 单 位:________________________________________________________ │ │                                                                      │ │申请人(报 验 单 位):_________________________________________                                                                      _____ │ │                                                                      │ │HS 商品 编码:_____________________提运单号:________________________ │ │ │ │合同号/唛头:____________________ 进口口岸:________________________ │ │                                                                      │ │进口商:__________________________ 产地:__________________________                                                                      __ │ │                                                                      │ │批件号:__________________________ 包装种类:________________________ │ │ │ │包装规格:________________________ 件数:____________________________ │ │                                                                      │ │进口数量:_______________________  进口货值:_______________________                                                                      _ │ │                                                                      │ │理由:_______________________________________________________________ │ │ │ │_____________________________________________________________________ │ │                                                                      │ │_____________________________________________ ________________________ │ │                                                                      │ │                                                                      │ │                             口岸或                                                                      边境口岸(食品)药品监督管理局     │ │                                                                      │ │                                     药品登记备案专用章               │ │ │ │                                       年    月    日                 │ │                                                                      │ └───────────────────────────────────┘ (Note: the uniformly printed by the State food and drug administration, a four. The first archive, the second customs, the third applicant, the fourth drug test. )