Administrative Measures For The Import Of Drugs

Original Language Title: 药品进口管理办法

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(On August 18, 2003 national food drug supervision authority, and Customs makes 4th, announced) first chapter General first article for specification drug imports record, and customs and port test work, guarantee imports drug of quality, according to People's Republic of China drug management method, and People's Republic of China Customs method, and People's Republic of China drug management method implementation Ordinance (following referred to drug management method, and customs method, and drug management method implementation Ordinance) and the related legal regulations of provides, These measures are formulated. Second drug import record keeping, customs declaration and port inspection and import procedures apply. Article medicines must be imported through ports which are approved by the State Council to allow drug imports. Fourth filing mentioned in these measures refers to imported units to allow drug imports port local drug regulatory authorities (hereinafter referred to as the port Drug Administration) to apply to the process of customs clearance of imported drugs. Narcotic and psychotropic drugs for import record keeping, refers to the importer to the port Drug Administration to apply for the notification of inspection of imported drugs. Port inspection mentioned in these measures refers to countries identified by the food and drug administration and drug control agency (hereinafter referred to as the port drug inspection Institute) on arrival at the port of import drug law implementation inspection work. Fifth imported drugs shall be issued by the State food and Drug Administration made the imported drug registration certificate (or certificate of registered pharmaceutical products), or the imported drugs after approval, for import record keeping and port inspection procedures. Import of narcotic drugs, psychotropic drugs, must also be issued by the State food and drug administration of narcotic and psychotropic drugs of the import permit. Drug import holders a sixth importer customs form to the customs declaration, Customs port Drug Administration issued by the customs clearance of imported drugs, and go through the formalities of Customs Declaration and examination of imported drug. Import of narcotic drugs, psychotropic drugs, and Customs issued by the State food and drug administration of narcotic and psychotropic drugs go through the formalities of Customs Declaration and examination of the import permit. Seventh, the State food and drug administration in conjunction with the General Administration of customs develop, revise, publish list of imported drugs. Chapter II import record keeping article eighth port drug administration responsible for drug import record keeping work. Port drug supervision authority bear of imports record work by national food drug supervision authority of led, its specific duties including: (a) accepted imports record application, review imports record information; (ii) handle imports record or not imports record of about matters; (three) contact Customs handle and imports record about of matters; (four) notification port drug test by on imports drug implementation port test; (five) on imports record and port test in the found of problem for supervision processing; (Vi) other matters prescribed by the State food and drug administration. Nineth Inspection Unit should be holding the drug business of independent legal entities. Pharmaceutical manufacturers import raw materials required for drugs and intermediate preparations (including local preparations for package), you should hold the drug manufacturing license. Tenth following cases of imported drugs, must be approved by the port drug inspection offices inspection in accordance with standard requirements, formalities for import record keeping procedures. Not meeting the prescribed standards, the port drug administration no import record keeping: (a) biological products under the State food and drug administration, (ii) drugs sold in China for the first time, and (iii) other drugs prescribed by the State Council. The 11th article Import when you sign a purchase contract, to allow drug imports CIF cargo port of choice. Which medicines the tenth provisions of these measures must be approved by the national special ports that allow drug importation. 12th for import record keeping, should apply to the goods CIF port drug administration and port drug inspection Office responsible for the port drug inspection test. 13th article handle imports record, reported inspection units should fill in imports drug reported inspection single, holding imports drug registered card (or medicine products registered card) (original or copy) original, imports anesthesia drug, and spirit drug also should holding anesthesia drug, and spirit drug imports allowed card original, to location port drug supervision authority submitted by imports varieties of about information a type two copies: (a) imports drug registered card (or medicine products registered card) (original or copy) copies ; Anesthesia drug, and spirit drug of imports allowed card copies; (ii) reported inspection units of drug business license and enterprise corporate license copies; (three) origin proved copies; (four) purchased goods contract copies; (five) boxing single, and mention AWB and freight invoice copies; (six) factory test report book copies; (seven) drug manual and the packaging, and label of style (raw materials drug and preparations intermediate except); (eight) national food drug supervision authority provides batch issued of biological products, Summary needs to provide verification and the producer or the lot release certificate issued by regulatory authorities, (IX) the tenth provided drugs other than these measures, recent drug import inspection report shall be submitted with a copy of the customs clearance of imported drugs. Pharmaceutical producing enterprises can import produce the necessary APIs and pharmaceutical intermediates for import record keeping, (b) information should be submitted to the drug manufacturing license with a copy of the business license. Imported drugs going through other countries or regions, need to submit both from the point of origin to the re-export to all purchase contracts, packing lists, tracking and shipping invoice. Copies of these types of seals shall be affixed to imported units. 14th article port drug supervision authority received imports drug reported inspection single and the related information Hou, according to following program of requirements be review: (a) itemized verification by reported information whether full, and real; (ii) identification imports drug registered card (or medicine products registered card) (original or copy) original, or anesthesia drug, and spirit drug of imports allowed card original authenticity; (three) review correct Hou, will imports drug registered card (or medicine products registered card ) (Original or copy) original or narcotic drugs, psychotropic drugs in the original import permit, returned to the inspection and related procedures completed in time for import record keeping on that day. 15th article tenth of the drugs in these measures, the port drug administration review after all the information is correct, it shall inspect the port drug inspection Office has issued the notice of inspection of imported drugs, 13th provided a copy of these measures and to issue the notification of the sampling of imported drugs. Sites sampled on the port drug inspection offices enter the customs supervision regulations formulated by the State food and drug administration and the General Administration of customs. Port drug inspection Office in accordance with the provisions of the notice of inspection of imported drugs sampling locations, taking test samples, inspection and the inspection result to the local port drug administration. Inspection in accordance with prescribed standards, granted for import record keeping, issued by the port drug administration import drugs tongguan Dan; do not meet the requirements of the standard, no import record keeping by the port Drug Administration issued no notice of filing in the drug. 16th article tenth drugs other than herein, the port drug administration review after all the information is correct, granted for import record keeping, issued of the customs clearance of imported drugs. And to inspect the port drug inspection Office has issued the notice of inspection of imported drugs, 13th provided a copy of these measures. For narcotic drugs, psychotropic substances, the port drug administration review after all the information is correct should be only to inspect the port drug inspection Office has issued the notice of inspection of imported drugs, 13th provided a copy of these measures, without the customs clearance of imported drugs. Port drug inspection Office shall be provided for in the notice of inspection of imported drugs sampling site sampling, quality control and the inspection result to the local port drug administration. For not meeting the standards of drugs, by the port drug administration in accordance with the drug administration law and relevant regulations. 17th article following case one of of imports drug, not imports record, by port drug supervision authority issued drug not imports record notice; on anesthesia drug, and spirit drug, port drug supervision authority not issued imports drug port test notice: (a) cannot provides imports drug registered card (or medicine products registered card) (original or copy), and imports drug documents or anesthesia drug, and spirit drug of imports allowed card original of; (ii) handle imports record Shi , The imported drug registration certificate (or certificate of registered pharmaceutical products), or narcotic, psychotropic drugs of the import permit has expired, (iii) when the formalities for import record keeping, drug the validity period is less than 12 months. (For drug itself validity insufficient 12 months of, imports record Shi, its effective term should not below 6 months); (four) origin proved by marked of actual production to and imports drug registered card (or medicine products registered card) provides of origin inconsistent of, or regional international organization issued of origin proved not marked imports drug registered card (or medicine products registered card) provides origin of; (five) imports units not made drug business license (production enterprise should made Drug production license) and enterprise corporate license of; (six) to Bank varieties of packaging, and label and national food drug supervision authority of provides inconsistent of; (seven) drug preparations no Chinese manual or Chinese manual and approved of manual inconsistent of; (eight) not in State approved of allows drug imports of port organization imports of, or goods to Bank to not belongs to location port drug supervision authority jurisdiction range of; (Nine) national food drug supervision authority provides batch issued of biological products not provides effective of producer or area drug management institutions issued of biological products batch issued proved file of; (ten) forged, and variable made about file and notes of; (11) imports drug registered card (or medicine products registered card) has was revoked of; (12) this approach tenth article provides case of drug, port drug test by according to this approach 25th article of provides not sampling of; (13) article tenth of the drugs in these measures, port inspection does not meet the requirements of the standard, (14) other not in conformity with relevant provisions of China's drug administration. 18th article of no import record keeping imported drugs, the import entity shall be shipped back. Unable to return, the port drug administration supervision by the customs. Article 19th clinical urgent need of drugs, donations of medicines, drug research and drug samples or controlled drugs required for registration, must be approved by the State food and Drug Administration approved and issued by the State food and Drug Administration's drug import documents, in accordance with the provisions of the present article 16th, formalities for import record keeping procedures. Chapter III inspection 20th port drug inspection by the State food and Drug Administration on import customs inspection of medicine needs to be determined. Port drug test by of duties including: (a) on to Bank goods implementation site nuclear inspection; (ii) verification factory test report book and origin proved original; (three) according to provides for sampling; (four) on imports drug implementation port test; (five) on has objections of test results for complex inspection; (six) national food drug supervision authority provides of other matters. Article 21st of pharmaceutical and biological products are responsible for the inspection of imported drugs of guidance and coordination. Required for customs inspection standards and the control of pharmaceutical and biological products is responsible for auditing, calibration. 22nd the port drug inspection Office shall in accordance with the imported drug registration certificate (or certificate of pharmaceutical product registration) shall record the registration standards test on imported drugs. 23rd port drug inspection Office after receipt of the notice of the inspection of imported drugs, shall, within the 2nd contact importer, to provide stock location in accordance with the sampling provisions for on-site sampling of imported drugs. Importers shall, before sampling, provide the factory inspection report and the original certificate of origin. Need access to the customs surveillance zone for sampling, the port drug inspection Office shall at the same time to contact Customs sampling, with the consent of the customs agreement. When sampling, importers and customs officers should be present. 24th the port drug inspection and sampling at the scene, it should be noted that verification of the actual delivery of the imported varieties, well sampling records and fill out the sampling of imported drugs record keeping form. The tenth provided drugs other than these measures, after the sampling is completed, the port drug inspection offices shall be held by the importer of the original import drugs tongguan Dan indicated on the "sample" words, and shall affix its official seal. On narcotic drugs, psychotropic drugs, after the sampling is completed, it should be indicated in the import permit, the original "sample" words, and shall affix its official seal. 25th article on has following case one of of imports drug, port drug test by not sampling: (a) not provides factory test report book and origin proved original, or by provides of original and declared imports record Shi of copies inconsistent of; (ii) shipment mark head and single card inconsistent of; (three) imports drug batch or number and single card inconsistent of; (four) imports drug packaging and the label and single card inconsistent of; (five) other not meet national drug supervision management legal, and regulations and regulations provides of. For drugs that are not sampled, the port drug inspection Office shall, within the 2nd, to record the sampling of imported drugs to the local port drug administration. 26th the port drug inspection Office shall promptly on the extraction of the samples tested and sampled in the 20th, perform inspection, issued the report on inspection of imported drugs. Can't finish the examination in special variety or special situations, you can extend the testing period and notify the importer and the port drug administration. The report on inspection of imported drugs should be clearly marked "meeting the prescribed standards" or "does not meet the standards" test results. Lot release of biological products under the State food and drug administration, port inspection in accordance with the standard requirements, audit compliance, and shall at the same time granting Biologics lot release certificate. 27th test meeting the prescribed standards of imported drugs, the port drug inspection Office shall send a report of the inspection of imported drugs to seat the port drug administration and imported units. To test imported drugs not meeting the prescribed standards, the port drug inspection Office shall timely report of the inspection of imported drugs send port drug administrations and other port drug inspection Office, and submitted to the State food and drug administration and pharmaceutical and biological products. 28th article import drug test samples shall be kept until the expiration date. Easy storage of samples, according to the actual situation grasp to save time. Claim or return of seized goods samples shall be preserved until at the end of the case. Over shelf life samples, be dealt with by the port drug inspection offices and records. 29th importer disagrees with the results of testing, can be since the date of receiving the test results apply to the port drug inspection offices in the 7th reinspection or directly file an application for re-inspection to the pharmaceutical and biological products. Biological products directly to the reinspection of pharmaceutical and biological products applied for. The port drug inspection Office after accepting an application for re-inspection shall promptly notify the port drug administrations, and acceptance within 10th of the reinspection, to retest conclusion, notify the port drug administration and other port drug inspection Office, reported that the State food and drug administration and pharmaceutical and biological products. Supervision and administration of the fourth chapter 30th port drug inspection Office under the provisions of the present article 25th no sampling drugs completes the customs clearance procedures, the port drug administration shall have to import all drugs seizure, seizure of compulsory administrative measures. 31st article tenth drugs other than herein, the port drug inspection offices inspection does not meet the prescribed standards, the import entity shall upon receipt of the report of the inspection of imported drugs in the 2nd, all imported drugs, using the details, reports local port drug administration. Local port drug administration after receiving a report of the inspection of imported drugs, shall take all the drugs in time to seal up or seize administrative coercive measures, and make a decision of administrative handling within the 7th. To file an application for re-inspection, must be from the date of inspection reports issued 15th make a decision of administrative handling within. The situation shall promptly report to the State food and drug administration, and notify each province, autonomous region, municipality directly under the food and drug administration and other port drug administrations. 32nd article is not within the time stipulated in the proposed retest or retest is still not meeting the prescribed standards, the port drug administration shall, according to the pharmaceutical administration law and relevant provisions of decision of administrative handling. The situation shall promptly report to the State food and drug administration, and notify each province, autonomous region, municipality directly under the food and drug administration and other port drug administrations. Meeting the prescribed standards upon re-inspection, the port drug administration shall lift the seizure, seizure of compulsory administrative measures and will report to the State food and drug administration, and notify each province, autonomous region, municipality directly under the food and drug administration and other port drug administrations. Article 33rd other problems found in import record keeping, by the port drug administration in accordance with the drug administration law and relevant provisions to deal with it. 34th article domestic drug production enterprise, and business enterprise and medical institutions procurement imports drug Shi, supply units should while provides following information: (a) imports drug registered card (or medicine products registered card) copies, and imports drug documents copies; (ii) imports drug test report book copies or indicate "has sampling" and stamped seal of imports drug clearance single copies; national food drug supervision authority provides batch issued of biological products, Also required to provide copy of the batch certificate issued by the port drug inspection Office. Import of narcotic drugs, psychotropic drugs, should be also presented the imported drug registration certificate (or certificate of pharmaceutical product registration) of the copy of the import permit copies and copies of the report on inspection of imported drugs. These copies must be stamped with the supply unit. 35th port drug administration and port drug inspection Office shall establish a strict import record keeping materials and port inspection information management system, and the importer reported information confidential. Article 36th in violation of these regulations for import record keeping and port inspection provisions of the port drug administration and port drug inspection Office, the State food and drug administration, according to circumstances, criticism, criticism, serious to stop the import record keeping and port inspection qualification. 37th in violation of the relevant provisions concerning the customs, the customs in accordance with the Customs Act and the People's Republic of China administrative penalty provisions of the rules for the implementation of the Customs Act. The fifth chapter supplementary articles article 38th importers in these measures, including business unit, receiving and inspection units. Entity is a foreign import and export trade contracts signed and implemented by domestic enterprises or units. Receiving unit, refers to the purchase contract and shipping invoice the consignee or consignor set forth in. Inspection Unit refers to the territory of the actual owner or distributor of imported drugs, and specifically responsible for the formalities for import record keeping and port inspection procedures. Receiving and inspection units for the same unit. The 39th from abroad into the bonded warehouse, bonded areas, export processing zone, medicines, exempted from import procedures such as formalities for import record keeping and port inspection, in accordance with the relevant provisions of regulation from the bonded warehouse, export supervised warehouse, bonded areas, export processing zone or area into the country's drugs, according to the relevant provisions of the measures for import record keeping and port inspection procedures. Approved processing trade imports of raw materials, raw material for medicine, exempt from formalities for import record keeping and port inspection, import procedures, prohibited to sell its raw materials and manufactured goods. Unable to export due to special circumstances, transfer of local drug supervision and management departments in accordance with the regulations, the customs are cancelled. Inbound and outbound personnel carry personal use of small amounts of drugs, shall be limited to reasonable quantities for personal use and subject to customs control. 40th article import provisional API that are not included in the list of imported drugs shall be in compliance with the regulations, to the port drug administration formalities for import record keeping procedures. 41st medicine import record keeping and port inspection provisions, shall be separately formulated by the State food and drug administration. The 42nd article import of narcotic drugs, psychotropic drugs with the imported drug registration certificate (or certificate of registered pharmaceutical products), according to the State Department narcotics, psychotropic drug management and the related regulations of the import permit. 43rd article of the regulation of narcotic drugs, psychotropic drugs refers to clinical use, research, teaching, veterinary import of narcotic, psychotropic drugs, narcotic and psychotropic drugs under the State Council management and the related regulations. The 44th article of the way interpreted by the State food and drug administration and the General Administration of customs. 45th these measures shall come into effect on January 1, 2004. On May 1, 1999 implemented drug import regulation repealed simultaneously. 1: inspection of imported drugs note 1. this form filled in by the inspection unit, a duplicate. A report by the port drug administration archive, a port drug inspection Office. Inspection and receiving units should be designated "seal" seals. 2. the "initial variety" refers to the tenth article of the administrative measures for the import of drugs under the circumstance of the drug. 3. import drugs 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. 4. "test" means the registration of imported medicine or pharmaceutical product registration certificate shall record the quality of standards and their numbers. 5. "goods" refers to imported drugs registration certificate or the certificate of pharmaceutical product registration shall record the amount of packing specifications as the basic unit of the goods, such as number of bottles, boxes, kilograms, etc. 6. the pharmaceutical administration law stipulated in the 41st of variety, "inventory" for the exact location of the customs bonded warehouse; other inventory location for completes the customs formalities of goods the proposed storage of specific locations. Should indicate the name and address. 7. "the attached information" should be by reference to the number of drug information on import regulations. 8. If this verification certificate there is not enough space, attach a separate sheet. 2: import drugs tongguan Dan 3: inspection of imported drugs report of 4 of the notice: notice of the sampling of imported drugs 5: drug is not notice of filing a report 6: the sampling of imported drugs form considerations 1. This record single in four original copies, by the port drug inspection offices to fill out. A port drug administration in charge of clearance for the record, a copy of the inspection unit, by leaving a copy of the document. Need access to the variety of customs supervision zone sampling, sampling is completed, a copy thereof shall be responsible for customs. 2. the note in the table "-" should be based on the actual on-site inspection, is the "√" mark, not the "x" mark. 3. the on-site inspection is completed, the port drug inspection Office shall "sample conclusion" section clearly marked "compliance, has been sampling" or "does not meet the requirements will not be sampling" message so that port drug administration properly handled matters of customs clearance for the record. 4. this completed, the port drug inspection and inspection after its contents verified, both sides come into effect upon signature by sponsor. 7: pursuant to point 1, this piece is dedicated to pharmaceutical research sample, donations of medicines and other varieties of import approval. The applicant shall, within the validity of the provisions of this part, will approve import quantities imported finished; this shall be repeated using overdue void. 2, inspection entities shall take the original and the "Note" provides information in accordance with the provisions of the administrative measures for the import of drugs, responsible to the specified port drug administrations go through customs inspection procedures. 3, responsible for the inspection of the port drug inspection Office checked, recorded after the arrival of actual number of varieties, should inspection unit holding of this original location marked "cancelled" special to be cancelled. 4, the provisions of this part-free varieties, can be cleared without examination. 5, two copies of this piece. A copy of the application, a file. 6, this piece please keep, lost or damaged will not be re-issued. 8: Appendix: sampling of imported drugs provision, for the good management of the sampling of imported drugs, ensure the port sampling representativeness and validity test, ensuring the accuracy of test results, especially the development of these regulations. Second, the sampling of imported drugs to undertake the inspection of the port drug inspection offices responsible for carrying out. Sampling inspection unit shall be responsible for the necessary tools and site preparation, and sampling of handle, stack transfer, opening and recovery of packaging and so on. Third, the same contract, drug name, manufacturer, production country, package, batch number, dosage form, specifications, mark and contract number will be the same, and can be used as sampling the same batch of drugs; the same contract to import the drugs arrive at different times, sampled at different times. Four, the sampling of imported drugs for domestic packages, import entity shall provide packaged the imported drug registration certificate and import drug-loaded documents, according to the repackaged specifications and quantity, sampling provisions referring to the relevant preparation. Five, the number of sampling in addition to special provisions and requirements, usually test three times. After testing the remaining sample addition to retention samples for future reference, should be returned to the inspection. Six, and sampling method (a) raw materials drug 1. drug packaging for 10 kg above of 10 pieces within, sampling 1 pieces; 11 pieces-50 pieces, each increased 10 pieces added pumping 1 pieces, insufficient 10 pieces who to 10 pieces meter; 51 pieces-100 pieces, each increased 20 pieces added pumping 1 pieces, insufficient 20 pieces who to 20 pieces meter; 101 pieces above, each increased 50 pieces added pumping 1 pieces, insufficient 50 pieces who to 50 pieces meter; 1001 pieces above, each increased 100 pieces added pumping 1 pieces, insufficient 100 pieces who to 100 pieces meter; 2. Drug packaging for 5-10 kg of (containing 5 kg), each 100 kg sampling 1 pieces, insufficient 100 kg who to 100 kg meter; 3. drug packaging for 1-5 kg of (containing 1 kg), each 50 kg sampling 1 pieces, insufficient 50 kg who to 50 kg meter; 4.1 kg following of, each 20 kg sampling 1 pieces, insufficient 20 kg who to 20 kg meter (original sampling). (Ii) injection agent 1. small capacity injection agent 20,000 support (bottle) following (containing 20,000 support), sampling 1 pieces; 50,000 support (bottle) following (containing 50,000 support), sampling 2 pieces; 100,000 support (bottle) following (containing 100,000 support), sampling 3 pieces; 100,000 support (bottle) above, each increased 100,000 support (bottle) added pumping 1 pieces, insufficient 100,000 support (bottle) to 100,000 support (bottle) meter. 2. large volume injection 100-1000 ml (1000 ml) injection, sample 1 per 10,000 bottles, less than 10,000 bottles of 10,000 dollars. More than 1000 ml injection (dialysate), each of 5000 bottles (bags) sample 1, less than 5000 bottles (bags) by 5000 meters. (C) other types of preparations for every 20,000 boxes (bottle), sampling a piece of less than 20,000 boxes (bottles) of 20,000 boxes (bottle). Seven, sampling requirements (a) the sampling before the unsealing, should check and inspection information packaging, label number or contract number and name, quantity, and so on. After unsealing shall be checking small packages, such as name, company name and lot number, and pay attention to check package integrity and cleanliness and there is no trace of water, mildew, or other substances. As part of the package modification, testing should be sampled separately. (B) raw materials packaging opened, in different parts of their respective sampling total sample number directly into the sample bottle, shake well. (C) sampled, opened package should be sealed, and the sampled quantity and date indicated on the packaging. Eight, sampling considerations (a) the sampling environment shall be clean and sampling tools must be clean, dry, and meets the requirements of drug. (B) the sampling should prevent pharmaceutical pollution when moisture absorption, weathering, oxidation and spoilage. Taking test samples should be rapidly put into airtight container (plastic bags, tin cans, or grinding glass bottles). (C) the need to shake the liquid samples after sampling. Containing crystalline, without affecting the quality of cases, should make it dissolves after extraction. (D) toxic, corrosive and explosive substances, sampling should have appropriate protective measures and careful handling, no vibration when sampling and sample bottles marked with "dangerous goods" logo. (E) corrosive drug to avoid using metal sampling sampling tool. (Vi) in case of perishable drug, samples should be protected from light, with colored bottles of samples, if necessary, to add black paper. (G) require sterile, pyrogen testing, microbial limit test APIs or vacuum, nitrogen, should press the aseptic technique or the special requirements. (H) the sampling should be undertaken by trained professionals (two or more), which sampled units concerned must be present. (I) according to the quality of the goods and the abnormal circumstance in the packages, it is necessary to change the sampling methods and quantity, the port drug inspection Office shall jointly agreed with the inspection unit change method, in order to extract representative samples. To change the sampling methods shall be recorded in the sampling of imported drugs record.

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