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(Courtesy Translation) Summary of the Application Procedures for the National Administrative Documents for Import Declaration of CEPA Goods To facilitate the Macao exporter or producer to have a fundamental understanding of the national administrative documents and the relevant application procedures for goods exported to the Mainland under the CEPA, in accordance with the provisions of the relevant regulations of the Mainland, this text gives an outline of the specific documents, apart from the usual documents, for import declaration. The information in this text is for reference only, the specific application procedures shall be enforced with reference to the provisions of the regulations of the regulatory and issuing entities of the Mainland. The national administrative documents are used for customs clearance, and is a measure by the Mainland for the administration of imports and exports trade. The customs clearance for the CEPA goods also needs to comply with the relevant regulations of the foreign trade policies of the Mainland. The China Customs implements this measure according to the laws and regulations of the foreign trade. Should the CEPA goods subject to the national administrative documents, the importers must obtain the relevant administrative documents for customs clearance. The major administrative documents of the CEPA goods are as follows : Drug Import Note Import Control for Psychotropic Drugs and Narcotic Drugs Import and Export License for Drugs Import License for the Import of Waste Certificate for China Compulsory Product Certification Import Permit for Endangered Species Notice of Customs Clearance for Imported Goods Automatic Import License Automatic Import License (New and Used Mechanical and Electrical Products) Import Permit Issued by the People's Bank of China Issuance Permit for Audio and Video Products Clearance Notification for Environmental Management on the Import of Toxic Chemicals Import of Agricultural Chemicals Registration Certificate Veterinary Drug Import Note Import License for Dual-Use Items and Technologies 1 Drug Import Note The State Food and Drug Administration and General Administration of Customs adopted the “Administrative Measures on Import of Pharmaceutical Products” for the administration of pharmaceutical imports with a view to regulate the record filing, customs declaration and inspection, and quality control of imported drugs. Under these measures, pharmaceuticals must be imported via designated ports. 1. The applicant must fulfill the following conditions: According to the provisions stipulated by Article 36 of the “Regulations for Implementation of the Drug Administration Law of the People’s Republic of China”, for importation of a drug, an application for registration shall be made according to provisions of the drug regulatory department under the State Council. A drug may only be imported after an “Import Drug License” is given if it is produced by a foreign manufacturer, or a “Pharmaceutical Product License” is given if it is produced by a manufacturer in Hong Kong, Macao or Taiwan of China. 2. The applicant must submit the following documents: After obtaining the “Import Drug License” or the “Pharmaceutical Product License”, the applicant is required to apply the “Drug Import Note” from the local drug regulatory department in the place where the port is located, specific requirements are as follows :The applicant has to fill in the “Declaration and Inspection Form for Pharmaceutical Imports”, and provide the original copy of the “Import Drug License”(or the “Pharmaceutical Product License”) (original or copy), to the local drug regulatory department in the place where the port is located together with the following documents, in duplicate: (1) Copy of the “Import Drug License” or the “Pharmaceutical Product License”(original or duplicate copy); (2) Copy of the “Drug Supply Certificate” and “Business License of Enterprise Legal Person” of the applicant; (3) Copy of the certificate of origin; (4) Copy of the purchase contract; (5) Copy of the packing list, bill of freight and shipping invoice; 2 (6) Copy of the certificate of analysis for the release of drugs by the manufacturer; (7) Inset sheet of the pharmaceutical products and samples of the packaging and labels (not applicable to pharmaceutical raw materials and intermediate preparations); (8) Copy of the latest “Drug Import Note”(not applicable for the first time of import); (9) For biological products regulated by the State Food and Drug Administration, original copies of the production certification docket and approval certificate issued by the regulatory agency for pharmaceutical products in the country or region of production. The official seal of the importer shall be affixed to the aforesaid copies. All purchase contracts, packing lists, bills of freight and shipping invoices from the place of origin to each place of transshipment shall be submitted simultaneously for pharmaceutical imports that are transshipped through other countries or regions. 3. Schedule of Approval Procedures After receiving the “Declaration and Inspection Form for Pharmaceutical Imports” and relevant documents from the applicant, the local drug regulatory department in the place where the port is located shall review the documents submitted. If there are not any irregularities, the local drug regulatory department shall complete all the record filing formalities on the same day, and issue the “Drug Import Note”. The drug importer shall, with the “Drug Import Note”, complete the formalities for customs declaration and clearance. Within two days from the completion of the declaration formalities in the Customs, the drug importer is required to arrange the sampling and testing formalities in the port drug testing institution, the local drug regulatory department in the place where the port is located shall seal the medicaments after samples obtained. If the samples pass the testing, the medicaments shall be unsealed and can be marketed. 3 Import Control for Psychotropic Drugs and Narcotic Drugs According to the provisions of the “Drug Administration Law of the People’s Republic of China”, the “Administrative Measures on Narcotic Drugs” and the “Administrative Measures on Psychotropic Drugs” of the State Council, licensing regime is adopted for the imports of narcotic and psychotropic drugs. Under the “Administrative Measures on Import of Pharmaceutical Products”, drugs must be imported via designated ports. 1. The applicant must fulfill the following conditions: For the imports of psychotropic and narcotic substances, regardless of the form of imports, and the purposes of use, the applicant is required to obtain the “import license” from the State Food and Drug Administration before arranging the import formalities with the Customs. The applicant is required to obtain the “Import Drug License” or “Pharmaceutical Product License” before applying for the “Import License” of psychotropic or narcotic substances. For the imports of psychotropic or narcotic substances, the applicant is required to fill in the application form together with the copy of the contract, for the approval of the regulatory department. 2. The applicant must submit the following documents: The applicant has to fill in the “Declaration and Inspection Form for Pharmaceutical Imports”, and provide the original copy of the “import license” for narcotic and psychotropic substances, to the local drug regulatory department in the place where the port is located together with the following documents, in duplicate: (1) Copy of the “Import Drug License” or the “Pharmaceutical Product License”(original or duplicate copy) and the “Import License” for narcotic and psychotropic substances; (2) Copy of the “Drug Supply Certificate” and “Business License of Enterprise Legal Person” of the applicant; (3) Copy of the certificate of origin; (4) Copy of the purchase contract; (5) Copy of the packing list, bill of freight and shipping invoice; (6) Copy of the certificate of analysis for the release of drugs by the manufacturer; 4 (7) Inset sheet of the pharmaceutical products and samples of the packaging and labels (not applicable to raw pharmaceuticals and pharmaceutical intermediate preparations); (8) Copy of the latest “Inspection Report for the Pharmaceutical Imports”. The official seal of the importer shall be affixed to the aforesaid copies. All purchase contracts, packing lists, bills of freight and shipping invoices from the place of origin to each place of transshipment shall be submitted simultaneously for pharmaceutical imports that are transshipped through other countries or regions. 3. Application and Approval Procedures For the imports of narcotic and psychotropic substances, the local drug regulatory department in the place where the port is located shall review all the documents submitted, if there are not any irregularities, shall issue a “Notice of Customs Inspection for Pharmaceutical Imports”, together with the copies of the aforesaid documents, to the port drug testing institution where the testing is conducted, but the “Drug Import Note” is not required. The port drug testing institution shall obtain samples at the location as specified in the “Notice of Customs Inspection for Pharmaceutical Imports”, the testing result shall be sent to the local drug regulatory department in the place where the port is located. If the samples pass the testing, the drugs can be imported. 5 Import and Export License for Drugs In order to regulate the management of the imports and exports of anabolic agents and peptide hormones, licensing regime is adopted for the imports and exports of anabolic agents and peptide hormones in accordance with laws and regulations such as “Drug Administration Law of the People’s Republic of China”, “Customs Law of the People’s Republic of China” and “Anti-Doping Regulation”. 1. The applicant must fulfill the following conditions: In accordance with the “Drug Administration Law” and its relevant implementation regulations, the drug importer has to apply for the “Import Drug License” (or the “Pharmaceutical Product License”) issued by the food and drug regulatory department under the State Council for the imports of anabolic agents and peptide hormones. The drug importer has to apply for the import and export license from the State Food and Drug Administration. 2. The applicant must submit the following documents: For the imports of anabolic agents and peptide hormones, the drug importer is required to submit the following documents: (1) Application form for the import of drugs; (2) Copy of the purchase contract; (3) Copy of the “Import Drug License” (or the “Pharmaceutical Product License”) (original or duplicate copy); (4) Copy of the “Drug Supply Certificate”, “Business License of Enterprise Legal Person”, “License for Imports and Exports of the Enterprise” (or “Registration form for External Trade Operator”), and copy of the “Organization Code Certificate”. When drug manufacturer imports raw pharmaceuticals and pharmaceutical intermediate preparations for its own production (including repackaging), copy of the “Drug Manufacturing Certificate”, “Business License of Enterprise Legal Person” and the “Organization Code Certificate” are required. (5) If the holder of the “Import Drug License” (or the “Pharmaceutical Product License”) appoints another company to export its pharmaceutical products, letter of authorization is required. The official seal of the importer shall be affixed to the aforesaid copies. 6 For the imports of anabolic agents and peptide hormones for educational and scientific research, the drug importer is required to submit the following documents: (1) Application form for the import of drugs; (2) Copy of the purchase contract; (3) Permit of the unit qualified for engaging in use of drugs, the basis for calculating the quantity needed, and a letter from the unit engaging in use of drugs guaranteeing the proper use and management of the drugs; (4) the approval document for the relevant scientific research project or the approval document from the relevant regulatory department; (5) If the unit engaging in use of drugs appoints another importer to import the drugs, copy of the appointment contract, copy of the “Business License of Enterprise Legal Person”, “License for Imports and Exports of the Enterprise” (or “Registration form for External Trade Operator”), and the “Organization Code Certificate” of the importer are also required. The official seal of the importer shall be affixed to the aforesaid copies. 3. Application and Approval Procedures The State Food and Drug Administration shall make a decision about the drug import application within fifteen working days after receiving it. If approved, the “import license” for the drugs shall be issued, otherwise, written explanation for the rejection shall be provided. The importer shall present the “import license” issued by the State Food and Drug Administration to the customs port where the drugs are allowed for import to arrange customs declaration, and the customs shall release the goods. For the imports of anabolic agents and peptide hormones, the “Drug Import Note” is not required. 7 Import License for the Import of Waste 1. The applicant must fulfill the following conditions: (1) The waste for imports must be listed in the “Catalogue of Imports of Waste under State Control”. (2) The imports of waste and its manufacturing processes must be in compliance with the relevant laws and regulations. (3) The unit for exploitation of the waste must comply with the approved business scope and environmental protection requirement as set out in its business license, and must obtain the “Authorization in relation to Environmental Protection for Construction Project”, and possess the capacity to process and transform the imported waste and ability to take preventive measures against infection. (4) The waste importer must conform to the importing business scope as per its business license and authorization given by the foreign trade department. 2. The applicant must submit the following documents: (1) The qualification certificate of imports of the waste importer; (2) Copy of the business license of the importer and the unit of exploiting the waste; (3) Copy of the valid tax registration certificate; (4) Copy of the purchase contract; (5) “Environmental Risk Evaluation Report of Waste Imports” prepared by a competent institute which is certified by the State Environmental Protection Administration to conduct environmental risk evaluation; (6) Duly completed “Application Form for Waste Imports”. 8 3. Schedule of Approval Procedures (1) The enterprise requesting the imports of waste has to submit the application to the environmental protection department where the enterprise is established. The environmental protection department shall conduct the data verification and site survey, and produce the preliminary evaluation opinion, and this procedure usually takes ten working days. (2) After the preliminary evaluation, the enterprise requesting the imports of waste is required to present the “Environmental Risk Evaluation Report of Waste Imports” and the “Application Form for Waste Imports” endorsed with preliminary opinion by the environmental protection department at the level of a city, to provincial environmental protection department. The provincial environmental protection department shall review the application materials, endorse the evaluation opinion and send the materials to the State Environmental Protection Administration, within ten working days (for Guangdong Province). (3) The provincial environmental protection department shall collect unitarily all the “Import License for the Import of Waste” approved by the State Environmental Protection Administration, archive the duplicates and notify the applicants to collect the import licenses. 9 Certificate for China Compulsory Product Certification The certification for China compulsory products is a regime of quality evaluation in accordance with the regulations, with a view to protect the safety of the consumers and animals and plants, and to protect the environment and national security. Under this regime, the products must comply with the state standards and the technological regulations. The certification for compulsory products, which requires products listed in the “Catalogue of Products Subject to Compulsory Product Certification System” to be duly certified. For product listed in the catalogue, without the certificate issued by authorized certification agency and without the compulsory certification mark applied properly, is not allowed for imports and uses for commercial purposes. 1. The applicant must fulfill the following conditions: In accordance with the provisions of article 13 of the “Administrative Rules on Compulsory Product Certification”, producer, vendor and importer can apply for the certificate from the China Quality Certificate Centre. 2. The applicant must submit the following documents: (1) The identification document of the applicant; (2) The assembly diagram, the electrical schematic diagram, the circuit diagram; (3) List of major components and/or major raw materials; (4) Other necessary explanatory documents; (5) If the applicant is the vendor or importer, copy of the contract between the producer and the vendor or between the producer and the importer is required; (6) If the applicant appoints an agent to handle the application of product certification, the applicant has to conclude a contract with the agent regarding matters such as certification, examination, inspection and follow-up, etc. The agent is required to submit copies of the letter of authorization, contract of authorization, and other relevant contracts to the designated certification agency. Interested parties can consult the “Rules for the implementation of Compulsory Product Certification” for the specific documents required for a particular product. 10 3. Schedule of Approval Procedures In accordance with the provisions of article 15 of the “Administrative Rules on Compulsory Product Certification”, the certification agency is responsible for the reception of applications. According to the provisions of the regulations, the agency has to arrange testing, factory inspection and samples examination, etc. If there are not any irregularities, the agency shall issue the certificate. Under normal circumstances, the certification agency shall make a decision of approval or disapproval of the application and notify the applicant within ninety days after receiving it. 11 Import Permit for Endangered Species In accordance with the provisions of the “Law of the People’s Republic of China on the Protection of Wildlife” and relevant regulations, import permit must be obtained from the Endangered Species Import and Export Management Office or its delegation for the import of species of wildlife and the products thereof under first and second class protection listed in the “List of Wildlife under Special State Protection”, and for the import of animals, animal products, plants and plants products listed in appendices I, II and III of the “Convention on International Trade in Endangered Species of Wild Fauna and Flora”. 1. The applicant must fulfill the following conditions: (1) In case of imports for commercial purposes, the unit must be authorized for imports; (2) In case of imports for non-commercial purposes, the unit must possess qualification approved by relevant department to engage in domesticating and breeding (cultivating), scientific research, culture exchange and educational promotions of Species of Wild Fauna and Flora; (3) Unit or person not authorized for imports can appoint another unit, which is authorized for imports, to apply for the import permit, and authorization agreement duly signed by both parties must be attached. 2. The applicant must submit the following documents: (1) Application report for the imports of wild animals and plants (submit written application detailing the importing country or region, species, quantity, origin, purposes of use, etc., to the Forestry Administration of Guangdong); (2) Application form of wild animals, plants and products thereof of the People’s Republic of China (unit or individual has to submit application form for imports of wild animals, plants and their products thereof, the information must be true, without any omission and must be typed.); (3) Contract or agreement of imports; (4) The importer must submit the export (re-export) license issued by the competent government department of the exporting country, certificate of origin, or any other documents indicating the approval for exports (re-exports) issued by the competent government department of the exporting country; 12 (5) Documents issued by the Customs; (6) Ingredients table of the Chinese-style medicaments, and the packaging materials containing explanations. 3. Schedule of Approval Procedures The authority shall make a decision of approval or disapproval of the application within fifteen working days after receiving it. If approved, to submit the application for examination and approval to the State Forestry Administration and Endangered Species Import and Export Management Office. 13 Notice of Customs Clearance for Imported Goods In accordance with the provisions of the “Law of the People’s Republic of China on Import and Export Commodity Inspection”, “Law of the People’s Republic of China on Animal and Plant Quarantine” and “Law of the People’s Republic of China on Food Hygiene” and relevant laws and regulations, the authority of quality supervision, inspection and quarantine shall issue “Customs Clearance for Imports Certificate” for import commodity listed in “List of Import and Export Commodities Subject to Inspection by the Commodity Inspection Authorities”. The Customs will inspect and release the goods against the “Notice of Customs Clearance for Imported Goods” issued by the entry-exit inspection and quarantine authority at the port of entry. 1. The applicant must fulfill the following conditions: The consignee or the consigner can apply for inspection, or can appoint an agent to arrange. If the imports and exports of goods require express treatment, the consignee or the consigner must appoint an agent with express entry-exit services to arrange the formalities. 2. The applicant must submit the following documents: (1) Declaration of inspection for imports certificate; (2) Contracts of imports; (3) Commercial invoice; (4) Bill of lading / bill of freight; (5) Packing list; (6) Other documents as required by relevant regulations 14 Automatic Import License With a view to effectively monitor the import of specific types of goods and to regulate the management of automatic import licensing, the Ministry of Commerce has authorized the Quota & License Administrative Bureau, the cabinets of the commissioners of the Ministry of Commerce, the administrations of foreign trade at the level of a province, autonomous region or municipality directly under the Central Government, to be responsible for the management of goods under the automatic import licensing and to issue the “Automatic Import License”. 1. The applicant must fulfill the following conditions: For goods subject to automatic import licensing administration, the consignee (including the importer and user) is required to apply for automatic import license from the local or respective issuing authorities, and to arrange customs declaration formalities with automatic import license. 2. The applicant must submit the following documents: (1) Qualification certificate of the consignee to engage in import and export of goods, registration documents foreign-invested enterprise; or the approval certificate of (2) Application form for the automatic import license; (3) Contract of goods imports; (4) If the goods are imported through an agent, it is required to submit the agreement of authorization (original); (5) If the goods imported are subject to special provisions of the uses and final users, it is required to submit documents specifying that the uses and final users are in compliance with the national regulations; (6) Other documents required to be submitted as listed in the “Catalogue”; (7) Other documents required to be submitted by the Ministry of Commerce 3. Schedule of Approval Procedures The issuing authority has to issue the “Automatic Import License” within ten working days after receiving the correct and completed application. 15 Automatic Import License (New and Used Mechanical and Electrical Products) In accordance with the decree n° 10, 2001 “Administrative Measures on the Import of Mechanical and Electrical Products” of the Ministry of Foreign Trade and Economic Cooperation, the General Administration of Customs and the General Administration of Quality Supervision, Inspection and Quarantine, and the “Rules for the Implementation of Automatic Import Licensing Administration of Mechanical and Electrical Products”, with regard to the import of mechanical and electrical products subject to automatic import licensing administration, the importer must, prior to handling customs declaration formalities with customs, apply from the Ministry of Commerce or the local responsible department for foreign trade and economics or the departmental mechanical and electrical products office for an “Automatic Import License”. 1. The applicants must fulfill the following conditions: The Legal Person of the Peoples’ Republic of China or the importer who plans to import the mechanical and electrical products into the Mainland. 2. The applicant must submit the following documents: (1) Application form for the import of mechanical and electrical products; (2) Copy of the legal document issued by the competent administrative unit specifying the approved business scope of the importer; (3) Other supplementary documents. Under the following circumstances, relevant documents mentioned below are required: (1) For the imported mechanical and electrical products under investment projects, is required to provide the project approval document issued by the competent investment project management authority, or registration document; (2) For the imported mechanical and electrical products which are purchased by the way of international competitive bidding, is required to provide the “Notification of the Evaluation Result of the International Bidding” issued by competent international bidding management authority. 3. Schedule of Approval Procedures When the local foreign trade and economics department or the office in charge of mechanical and electrical products receives the complete application form for the import of mechanical and electrical products, automatic import license must be issued within ten working days. 16 Import Permit Issued by the People's Bank of China With a view to regulate the import of gold and the products thereof, to maintain the market stability and to prevent the loss of foreign exchange, the import of gold and silver is managed unitarily by the People’s Bank of China. Without exception, units cannot import gold and silver without permission by the People’s Bank of China, and infringement will be penalized according to the provisions of article 11 of the “Rules of Administrative Penalties for the Implementation of the Customs Law of the People’s Republic of China”, a penalty of less than the value of the goods will be imposed, and the duties should be paid. 17 Issuance Permit for Audio and Video Products The audio and video product import entities shall apply to the General Administration of Press and Publication for content examination when importing finished audio and video products, audio and video products used for publication and information network dissemination and for other purposes from aboard, from the Special Administrative Region of Hong Kong, the Special Administrative Region of Macao and the Taiwan area of China. The General Administration of Press and Publication shall be responsible for the supervision and administration of the import of audio and video products of the whole country. 1. The applicant must fulfill the following conditions: In accordance with the “Regulations on the Administration of Audio and Video Products”, the import of audio and video products shall be managed by the audio and video product operating entities designated by the General Administration of Press and Publication, no entity or individual may engage in the imports of audio and video products without the designation of the General Administration of Press and Publication. 2. The applicant must submit the following documents: 1) One who wishes to import the audio and video products used for publication or for information network dissemination shall file an application with the General Administration of Press and Publication and submit the following documents and materials: (1) Application form for examination of the imported audio (video) products; (2) Draft of the copyright trade agreement (versions in Chinese and foreign languages), certificate of the original copyright, authorization letter of copyright and the certification of registration issued by the copyright certification agencies of the State; (3) Sample of the program (the media can be CD, VCD or DVD); (4) Other materials needed for the content examination. 2) One who wishes to import finished audio and video products shall file an application with the General Administration of Press and Publication and submit the following documents and materials: (1) Application form for examination of the imported audio (video) products; (2) Draft of the import agreement; 18 (3) Sample of the program, lyrics in Chinese and foreign languages; (4) Other materials needed for the content examination. The above materials and sample of the program, in duplicate, need to be submitted to the Division of audio and video and electronic publications of the Publishing Management Department of the General Administration of Press and Publication. 3. Schedule of Approval Procedures The General Administration of Press and Publication has set up an evaluation committee, composed of several experts, to be responsible for content examination of the import of audio and video products. Under this evaluation committee, an office was set up to handle the submission of application documents and samples by the importing unit, and to coordinate content examination by the experts. The General Administration of Press and Publication, based on the opinions of the experts, shall make the decision on whether to approve or not within 30 days from receiving the application. For those approved, “Issuance permit for audio and video products” shall be granted; for those not approved, “Notification of examination for audio and video products” shall be granted and the reasons shall be explained. 19 Clearance Notification for Environmental Management on the Import of Toxic Chemicals In accordance with the “Regulations for Environmental Management on the First Import of Chemicals and the Import and Export of Toxic Chemicals”, the Ministry of Environmental Protection shall implement unified environmental supervision and management on the import and export of toxic chemicals included in the "List of Toxic Chemicals Banned or Severely Restricted in the People's Republic of China" 1. The applicant must fulfill the following conditions: Whenever foreign business concerns or their agents export to China, or domestic businesses import from abroad, industrial chemicals included in the "List of Toxic Chemicals Banned or Severely Restricted in the People's Republic of China", they must apply in advance to the Ministry of Environmental Protection for registration of environmental management on import of toxic chemicals. The “Registration Certificate for Environmental Management on the Import of Chemicals” and the “Clearance Notification for Environmental Management on the Import of Toxic Chemicals” shall be issued to them upon approval. The clearance notification is issued each time for each import/export of chemicals in the List. Each Clearance Notification can only be used for Customs declaration once within it's valid date. 2. The applicant must submit the following documents: 1) For the approval of the “Registration Certificate for Environmental Management on the Import of Toxic Chemicals” The applicant has to submit the following documents to the Chemical Registration Centre of Ministry of Environmental Protection: (1) Application form (including: name of the unit for application, address, chemical name in Chinese and English, the American Chemical (2) Abstracts No., customs code, importing quantity, exporting country (region), purpose of import, etc.); Original contract. The Chemical Registration Centre of Ministry of Environmental Protection, after receiving the application, will conduct preliminary evaluation whether the applicant complies with relevant environmental protection standard or not, and for chemicals that are in the list of international convention whether comply 20 with the provisions of the conventions. The Chemical Registration Centre will forward the documents that passed through the preliminary evaluation to the Ministry of Environmental Protection. The Ministry shall make the decision on whether to approve or not, and shall inform the Chemical Registration Centre of the decision. The Chemical Registration Centre shall inform the applicant of the decision in writing. 2) For the approval of the “Clearance Notification for Environmental Management on the Import of Toxic Chemicals” The applicant has to submit the following documents to the Chemical Registration Centre of Ministry of Environmental Protection: (1) Application form (including: name of the unit for application, address, chemical name in Chinese and English, the American Chemical Abstracts No., customs code, importing quantity, exporting country (2) (3) (4) (5) (region), purpose of import, method of supply, mode of domestic transport, port of discharge, etc.); Copy of the import registration of the foreign trader Qualification certificate; Contract of import; Details of the flow of import. The Chemical Registration Centre of the Ministry of Environmental Protection will conduct preliminary evaluation whether the applicant, the quantity of import and the unit that utilizes the chemicals comply with relevant environmental protection standard or not, and for chemicals that are in the list of international conventions whether comply with the provisions of the conventions. The Chemical Registration Centre will forward the documents that passed through the preliminary evaluation to the Ministry of Environmental Protection. The Ministry shall make the decision on whether to approve or not, and shall inform the Chemical Registration Centre of the decision. The Chemical Registration Centre shall inform the applicant of the decision in writing. 3. Schedule of Approval Procedures The period of approval for the “Registration Certificate for Environmental Management on the Import of Toxic Chemicals” is 30 working days, and for the “Clearance Notification for Environmental Management on the Import of Toxic Chemicals” is 20 working days. 21 Import of Agricultural Chemicals Registration Certificate In accordance with the “Regulations on the Control of Agricultural Chemicals” and to implement the “Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade” by the Food and Agriculture Organization of the United Nations and United Nations Environment Program, the Ministry of Agriculture and the General Administration of Customs decided to implement registration certificate management for the import and export of agricultural chemicals into and out the Mainland. The Agricultural Chemicals Import/Export Registration Certificate will be issued by the appraisal institution of agricultural chemicals under the Ministry of Agriculture. 1. The applicant must fulfill the following conditions: Prior to the application of the Agricultural Chemicals Import/Export Registration Certificate and in accordance with the “Administrative Measures of Registration Certificate for Import/Export of Agricultural Chemicals (Interim)”, the enterprise has to submit the “Registration Form for Agricultural Chemicals Import/Export Enterprise” to the appraisal institution of agricultural chemicals for filing. And the relevant agricultural chemicals should have the registration certificate. 2. The applicant must submit the following documents: Enterprise has to submit the application to the appraisal institution of agricultural chemicals, filing materials and application materials are needed for the first time of application, and only application materials are needed for every subsequent application. 1) Filing materials (for the first time of application) (1) Registration Form for Import/Export Enterprise; (2) Copy, with enterprise’s official seal, of the “Qualification Certificate of the Import/Export Enterprise of the PRC” or “Approval Certificate for Foreign-invested Commercial Enterprise” or “Filing and Registration (3) (4) Form of Foreign Trade Operators”; Copy, with enterprise’s official seal, of the Business License; Company profile, with enterprise’s official seal. 22 2) Application Materials (1) (2) 3. Application form for Import of Agricultural Chemicals Registration Certificate; Copy of the import contract, and the registration certificate of the agricultural chemical. Schedule of Approval Procedures The appraisal institution of agricultural chemicals shall complete the evaluation and issue the certificate within 3 working days from the date it receives all the application materials. 23 Veterinary Drug Import Note For the purpose of strengthening the administration of veterinary drugs, ensuring the quality of such drugs, preventing and controlling animal diseases, promoting the development of relevant industry, the Mainland China has implemented supervision and administration for the import and export of veterinary drugs. 1. The applicant must fulfill the following conditions: Where a veterinary drug is to be exported to China for the first time, the representative office established by the exporter within the territory of China or the agency within the territory of China authorized by it shall apply to the administrative department for veterinary medicine of the State Council (Ministry of Agriculture) for registration. To import a veterinary drug that has obtained the Registration Certificate of Veterinary Drugs in China, the agency within the territory of China shall apply to the administrative department for veterinary medicine of the State Council (Ministry of Agriculture at provincial level) where the port of entry is located for a “Veterinary Drug Import Note”. 2. The applicant must submit the following documents: (1) Application form for import of veterinary drug; (2) Copy of the “Veterinary Drug Distribution License” of the applicant; (3) Copy of the “Registration Certificate of Import Veterinary Drugs” of the import product; (4) Copy of the “Business License” of the importing unit. 3. Schedule of Approval Procedures For Guangdong Province, 20 working days. 24 Import License for Dual-Use Items and Technologies For the supervision and management of the trade of sensitive items and technologies, such as nuclear, missile, precursors and chemicals used in production of narcotic drugs and psychotropic substances and biological products, the import and export examination and approval mechanism has been formulated for dual-use items and technologies (i.e. sensitive items and technologies, precursor chemicals). In accordance with the relevant import and export control regulations, enterprises should obtain approval before engaging in the import and export operations of dual-use items and technologies. 1. The applicant must fulfill the following conditions: Currently under the import and export examination and approval mechanism for dual-use items and technologies, items that require import license are precursor chemicals. Prior to applying for the import license for precursor chemicals, enterprises should complete the formalities of filing and registration of foreign trade operators, and for Foreign-invested Commercial Enterprise established and permitted in accordance with relevant regulations, should complete the approval or registration formalities for production, purchase and distribution of precursor chemicals. 2. The applicant must submit the following documents: (1) “Application Form for the Import of Precursor Chemicals” with authorized signature and official seal (original); (2) Copy of the “Filing and Registration Form of Foreign Trade Operators”; (3) Copy of the Business License; (4) Certificates of approval or registration for production, distribution and purchase of precursor chemicals; (5) Copy of the import contract or agreement; (6) Copy of the identification document of the applicant. Enterprise can submit the electronic application form through the “administration platform of import and export of dual-use items and technologies” of the website of Ministry of Commerce, after verification by the provincial competent departments of commerce where the enterprise is located that the documents are correct, the enterprise can submit the paper documents. The provincial competent departments of commerce is in charge of the verification of the paper documents submitted, the verified documents will be forwarded to the Ministry of 25 Commerce. Upon receiving the application, the Ministry of Commerce will conduct the examination and approval, the approval import note of dual-use items and technologies will be issued for those approved. Upon presentation of the approval import note to the local issuing authority, the enterprise can obtain the “Import License for Dual-Use Items and Technologies” for customs formalities. 3. Schedule of Approval Procedures Committed time schedule is 20 working days. 26