Entry And Exit Of Traditional Chinese Medicine And Quarantine Supervision And Administration

Original Language Title: 进出境中药材检疫监督管理办法

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  Chapter I General provisions article to strengthen entry and exit quarantine supervision and administration of Chinese herbal medicines, prevent the introduction of animal and plant disease outbreaks spread borders, protection of agricultural production and human health, forestry, animal husbandry, fisheries, protection of ecological security, according to the People's Republic of China Law on the entry and exit animal and plant quarantine and its implementing regulations, the provisions of laws and regulations, these measures are formulated.

Second Chinese herbal medicines in these measures refers to medicinal plants, animal medicinal part of later harvesting and primary processing of raw materials for the formation of medicinal herbs.

Article these measures shall apply to the Declaration for the entry and exit of traditional Chinese medicine of medical quarantine, and supervision and management.

Declaration of Chinese herbal medicines for the entry and exit of food inspection and quarantine and supervision in accordance with the circular of the State administration of quality supervision, inspection and quarantine (hereinafter referred to as AQSIQ) regulations about the import and export food.

Article fourth AQSIQ unified management over entry and exit of traditional Chinese medicine and quarantine and supervision work.

National quality watchdog based in local entry-exit inspection and quarantine Department (hereinafter referred to as the inspection and quarantine departments) responsible for the entry and exit quarantine and supervision of Chinese herbal medicines in the area of management. Fifth implementation taken by the AQSIQ to Chinese herbal medicines-use reporting system.

At the entry and exit of Chinese herbal medicines, businesses should be declared to the inspection and quarantine departments intended use clear "medicinal" or "food". Declared as "medicinal" of Chinese herbal medicines should be included in the People's Republic of China Pharmacopoeia drug list items.

Declared as "consumption" of Chinese herbal medicines should be a national law, administrative regulation, regulations, documents can be used for food items.

Sixth article national quality General on inbound and outbound Chinese herbal medicines implementation risk management; on to China territory output Chinese herbal medicines of outside production, and processing, and store units (following referred to outside production enterprise) implementation registered registration management; according to entered national or area of requirements on exit Chinese herbal medicines production, and processing, and store units (following referred to exit production enterprise) implementation registered registration management; on inbound and outbound Chinese herbal medicines production, and business enterprise implemented integrity management,. 

Seventh entry and exit of enterprises of Chinese herbal medicines should be in accordance with the laws and administrative regulations and related standards in the production, processing and marketing, bear the primary responsibility for prevention, social and public accountability, ensure the entry and exit of safety of Chinese herbal medicines, take the initiative to accept supervision and shoulder social responsibility.

Chapter II entry and quarantine supervision article eighth quarantine AQSIQ imported Chinese herbal medicines access system, including control systems for product risk analysis, assessment and review, identify and quarantine requirements, offshore production enterprise registration and entry quarantine, and so on.

Nineth AQSIQ on the export to China of Chinese herbal medicine for the first time countries or regions for control systems for product risk analysis, assessment, to trade countries and regions have conducted a retrospective review.

State General Administration of quality supervision based on risk analysis, review the results of the assessment, and the exporting country or regional authorities agreed to China's export of Chinese herbal medicine and quarantine requirements, signing the relevant protocols, and identify and quarantine certificates.

AQSIQ is responsible for formulating, adjusted and posted on the AQSIQ Web site allows entry of Chinese herbal medicines country or region list, and product categories. Tenth State quality inspection administration according to the results of the risk analysis, determine the need for offshore production, processing, storage units list of registered varieties of Chinese herbal medicines, and implement dynamic adjustments.

Registration procedures and technical requirements formulated and announced separately by the AQSIQ. AQSIQ on foreign manufacturing enterprises to implement registration of the Chinese herbal medicines listed in the catalog.

The registration is valid for 4 years.

11th overseas production enterprises shall comply with the exporting country or regional laws and regulatory requirements, and in accordance with the compulsory requirements of the technical norms of the State in China. 12th article output national or area competent sector in outside production enterprise application to China registered registration Shi, needed on its for review, meet this approach tenth article, and 11th article related provides Hou, to national quality General recommended, and submitted following Chinese or in the English control material: (a) where national or area related of flora and fauna outbreak, and veterinary health, and public health, and plant protection, and enterprise registered management, aspects of legal regulations, Where national or area competent sector institutions set and personnel situation and the legal regulations implementation, aspects of written information; (ii) application registered registration of outside production enterprise list; (three) where national or area competent sector on its recommended enterprise of epidemic prevention, and health control reality of assessment conclusion; (four) where national or area competent sector on its recommended of enterprise meet China legal regulations requirements of statement; (five) enterprise registered applications, factory, and workshop, and warehouse of plane figure, and process flowchart, and

Animal or plant quarantine control system, disinfection treatment facility photos, photos of harmless treatment of waste and packaging facilities; (vi) other necessary supporting documents.

Received the AQSIQ 13th article references and after passing the written examination, after consultation with the competent Department of the export country or area can be sent to the exporting country or region to assess their regulatory system, check the application for registration of foreign manufacturing enterprises.

Meet the requirements upon examination of applicants, be registered. Article 14th registration needs continued outside production companies had been made, by the authorities in the exporting country or area in the 6 months before the expiry, as stipulated in the article 12th of this approach applied to the AQSIQ.

AQSIQ can be sent to the exporting country or a retrospective review of its regulatory system, and manufacturers outside of the application for examination.

Retrospective review meets the requirements of the country or region, and overseas manufacturers meet the requirements upon examination, registration, extension 4.

15th article advancement required approval for quarantine of entry of traditional Chinese medicine, the owner or his agent shall, before signing trade contracts, according to the quarantine of entry management approaches require the approval of the People's Republic of China entry quarantine permit.

16th AQSIQ can be based on actual needs, and national or regional government authorities agreed to output Chinese herbal medicines, sent to preflight the exporting country or region. 17th article Chinese herbal medicines entry Qian or entry Shi, owner or its agent should holding following material, to entry port test quarantine sector reported check: (a) output national or area official issued of meet national quality general requirements of quarantine certificate original; (ii) implementation flora and fauna quarantine approval of, should provides entry flora and fauna quarantine license; (three) State drug supervision management sector approved of drug production license or drug business license; (four) origin proved, and trade contract, and bills of lading, and

Packing lists, invoices and other relevant documents.

18th inspection and quarantine departments to owner or his agent to review the relevant documents, and meet the requirements of the receiving inspection.

Government of the exporting country or region-free effective quarantine certificate issued by the animal and plant quarantine agency, need to be registered without the required registration, or failing to go through quarantine examination and approval procedures, the inspection and quarantine departments depending on the circumstances, be returned or destroyed.

Article 19th imported Chinese herbs, inspection and quarantine departments in accordance with the provisions of Chinese laws and regulations and national standards, quarantine of entry set out in the permit requirement and Nineth identify and quarantine requirements implemented these measures and quarantine. 20th article entry port test quarantine sector should according to following provides implementation site quarantine: (a) query shipment time and port, and via national or area, and mount listing,, check single card whether real effective, single card and goods of name, and number (heavy) volume, and output national or area, and mark head, and mark, and outside production Enterprise name, and registered registration,, whether match; (ii) packaging whether intact, whether with flora and fauna sex packaging, and bedding material, and meet People's Republic of China inbound and outbound flora and fauna quarantine method

And its implementing regulations, quarantine supervision and administration of wooden packages of imported goods regulations and (iii) there is no deterioration phenomenon of Chinese herbal medicines, with or without carry harmful organisms, animal or other animal tissue, with or without carry dead animals, soil, and other prohibited objects. 21st article site identification has following case one of of, test quarantine sector issued quarantine processing notice, and for corresponding quarantine processing: (a) belongs to legal regulations ban entry of, and with ban entry real of, and goods card inconsistent of, and found serious corruption metamorphic of for returned or destroyed processing; (ii) on packaging damaged of, by owner or its agent is responsible for finishing intact, party can unloading away from transport tool.

Inspection and quarantine departments on contaminated sites, article, apparatus for quarantine treatment; (c) with a harmful biological, animal or other animal tissue, in accordance with the relevant provisions of the quarantine treatment; (iv) were contaminated with pests and diseases or suspected contaminated with pests, storage of the goods concerned, of contaminated goods, handling and disinfection tools, site.

22nd field found in the quarantine pests, pest damage symptom, or according to the working procedures for laboratories and quarantine, inspection and quarantine departments should be imported samples of Chinese herbal medicines, and sent to laboratories.

Article 23rd before the quarantine, Chinese herbal medicines prove, shall be deposited in a place approved by the inspection and quarantine departments, without permission of the inspection and quarantine departments, and no unit or individual may unlawfully transferred, marketing, processing. The quarantine of entry permit by stating that the product destination inspection and Quarantine Bureau quarantined, process monitoring, port inspection and quarantine Department to verify identification and packaging after disinfection, issue the transfer notice of entry of goods, the consignee or their agents to apply for quarantine inspection and quarantine departments of destination within the specified time limits.

Quarantine, not marketing, processing.

Need the approval of quarantine inspection of imported Chinese herbal medicines should be in a quarantine of entry approval set out in the permit specifies the enterprise storage and processing. 24th entry pass the quarantine inspection of Chinese herbal medicines, after inspection and quarantine Department proof of entry inspection and quarantine of goods, may be sold, used or stored in the specified enterprise, processing.

Entry of goods inspection certificate shall set out the name of the goods, the country of origin or region, the quantity/weight, lot number/date of production, use and so on.

25th not passed quarantine inspection, inspection and quarantine departments to issue notice of quarantine treatment, by the owner or his agent under the supervision of the inspection and quarantine departments, and disinfestation, returned or destroyed, pass the treatments allowed to enter.

Need to claim for certification by the inspection and quarantine departments, and quarantine certificates issued by the inspection and quarantine departments in accordance with the provisions of the relevant. Article 26th carry entry of Chinese medicinal materials transport and containers shall conform to the requirements of safety and health. Need to implement disinfection treatment, should be at the port of entry inspection and quarantine Department under the supervision of the implementation of disinfection treatment.

Without permission of the inspection and quarantine departments, and imported Chinese herbal medicines may not be unloaded from the means of transport, containers, or ship the parcels. 27th owner or his agent shall establish within Chinese herbal medicines import and sales records, processing systems, recorded and retained for at least 2 years.

Should also be equipped with traditional Chinese medicine immunization safety managers, establishment of traditional Chinese medicine and epidemic prevention management system.

Chapter III 28th exit exit quarantine regulation of Chinese herbal medicines should be consistent with the Chinese Government quarantine agreement with the importing country or region, protocols, memoranda and other provisions, as well as into national or regional standards or requirements of the contract.

29th exit production enterprise shall meet the importing country or area requirements of the relevant laws and regulations, and in accordance with relevant Chinese laws and regulations.

30th exit production enterprises should establish and improve the disease prevention system and traceability management system.

Outbound production enterprise shall set up procurement of raw materials, packaging materials, such as purchasing, receiving and inspection records, production records, inspection records, storage record, detailing the exit production process of traditional Chinese medicine prevention management and product traceability.

Such records shall be true to the retention period shall be not less than 2 years.

Outbound production enterprises shall quarantine management staff, clearly prevention responsible. 31st to enter country or region requires its own output of Chinese medicinal materials from production enterprise registration, inspection and quarantine departments to register.

The registration is valid for 4 years. 32nd article exit production enterprise application registered registration Shi, should submitted following material: (a) exit Chinese herbal medicines production enterprise quarantine registered registration application table (a type 2 copies); (ii) business license (copies); (three) epidemic prevention management system and the tracing management system; (four) involved environmental requirements of, must provides County or County above environmental sector issued of sewage license; (five) factory plane figure and the pictures information, including door, and factory, and library district panorama photos, about production processing facilities, and

Storage facilities, disinfection treatment facilities, waste, packaging and pictures of sewage treatment facilities (vi) product technology; (VII) other materials stipulated by Chinese laws and regulations. 33rd article location directly under the test quarantine Council (following referred to directly under the test quarantine Council) on exit production enterprise of application, should according to following situation respectively made processing: (a) application material complete, and meet statutory form or applicants according to requirements submitted all correction application material of, should accepted application; (ii) application material exists can spot corrections of errors of, should allows application people spot corrections; (three) application material not complete or not meet statutory form of,

Shall, on the spot or within 5 working days once inform all applicants need to correct the content, fails to inform the, shall be accepted as of the date of receipt of the application materials.

Inspection and Quarantine Bureau to accept or not to accept an application, it shall issue a dated and stamped with the Special seal of the Executive in written form.

34th entry inspection and Quarantine Bureau shall, within 10 working days after acceptance of the application review group, exit manufacturing enterprises to apply for site assessment.

35th review group shall after the end of the examination in the field review report to the Bureau of inspection and quarantine in a timely manner.

Article 36th inspection and quarantine upon receipt of the evaluation report, shall be made within 10 business days of the following decisions: (a) accredited qualified for registration, issuance of certificate of incorporation, (ii) failed to pass the review, issue a notice of registration has not been approved.

37th registered exit production enterprise changes its corporate name, legal representative, product type, storage, production and processing, and so on, should be changed in the 30th after written application to the Bureau of inspection and quarantine, fill in the quarantine of outbound Chinese herbal medicine production enterprises registration application form and submission of information relative to the change (in 2 copies).

Change of company name, legal representative, by the inspection and Quarantine Bureau of the information, direct handling of change procedures.

Change the type of product or production capacity, organized by the inspection and quarantine administrations under review relevant information and site assessment, after passing the review, go through the change procedures.

Relocation of enterprises, should be re-registration applications made to the inspection and Quarantine Bureau. 38th must recommend to overseas registration, inspection and Quarantine Bureau production enterprise list of short-listed and exit should be reported to the State administration of quality supervision.

AQSIQ organizational assessment, the unified recommended to enter the national or regional authorities and the relevant procedures.

39th article exit Chinese herbal medicines of owner or its agent should to Chinese herbal medicines production enterprise location test quarantine sector reported check, reported check Shi, needed truthfully declared products of expected uses, and submitted following material: (a) contract, and invoice, and boxing single; (ii) production enterprise issued of factory qualified proved; (three) products meet entry national or area flora and fauna quarantine requirements of written statement original.

40th inspection and quarantine departments shall, in accordance with the way article 28th of exit quarantine regulation of Chinese herbal medicines.

Exit pass the quarantine inspection of Chinese herbal medicines or treatments that pass the relevant quarantine certificates issued by the inspection and quarantine departments shall, in accordance with the provisions are allowed to exit.

Not passed quarantine inspection or disinfestation with effective methods, no exit.

41st authority may, according to the State administration of quality supervision inspection and quarantine requirements, combined with Chinese herbal medicines within the responsible areas and exit, the importing country or region required, production ability and level of enterprise management, enterprise credibility, as well as factors such as risk monitoring, risk analysis based on the classification of Chinese medicinal materials and production enterprises of the area and exit management.

Supervision and administration of the fourth chapter of 42nd Chinese herbal medicines taken by the inspection and quarantine departments to the production, processing, and storage implementation of quarantine and supervision.

43rd State quality inspection Administration imposed on entry and exit of Chinese herbal medicine plant and animal disease surveillance.

When a problem is found in the inspection and quarantine departments in monitoring, report on disposition and shall be in accordance with the regulations in a timely manner. 44th imported Chinese herbal medicines of the owner or his agent and outbound Chinese herbal medicine production enterprises shall establish information on the epidemic situation reporting and emergency response solutions.

Found the epidemic information should be promptly reported to the inspection and quarantine departments and cooperate with the inspection and quarantine departments to outbreak management.

45th article national quality General according to get of risk information, in risk analysis of based Shang, released risk warning information informed, and decided on related products take following control measures: (a) has conditions to limit entry or exit, including closely monitoring, and added strict quarantine,; (ii) ban entry or exit, local destroyed or for back shipped processing; (three) revoked production enterprise registered registration qualification; (four) started about emergency disposal plans.

Inspection and quarantine departments are responsible for organizing the implementation of risk warning and control measures. 46th State quality inspection Administration can refer to the international standards and practices, the uncertain risks of direct release alert notifications and control measures provided for in this article 45th.

And timely collection and add the relevant information and data for risk analysis.

47th article turnover boundary medicine this risk has been eliminated or reduced to an acceptable level, the AQSIQ shall promptly release risk early warning notification or alert notifications and control measures.

48th entry and exit inspection and quarantine departments to Chinese herbal medicines found in the quarantine of the outbreak, particularly major outbreaks should be disposed in accordance with entry and exit significant plant and animal disease emergency preparedness.

49th inspection and quarantine departments of the entry and exit of Chinese herbal medicines should be the owner or his agent, as well as domestic and foreign manufacturers into management.

Fifth chapter legal responsibility 50th article inbound and outbound Chinese herbal medicines owner or its agent, has following violations one of of, test quarantine sector should according to People's Republic of China flora and fauna quarantine method 40th article, People's Republic of China flora and fauna quarantine method implementation Ordinance 59th article of provides, be punishment: (a) not reported check or not law handle quarantine approval procedures or not by quarantine approval of provides implementation of; (ii) reported check of Chinese herbal medicines and actual inconsistent of.

51st has one of the following offences, the inspection and quarantine departments shall, in accordance with the People's Republic of China regulations on animal and plant quarantine law provisions of 60th, shall be punished as follows: (a) without permission of the inspection and quarantine departments without authorization from entering Chinese medicinal materials unloaded from the means of transport or ship the parcels, (ii) unauthorized opening, damaging quarantine seal or logo.

52nd article has following violations one of of, law held criminal; is not constitute crime or crime plot significantly minor law not need sentenced to penalty of, test quarantine sector should according to People's Republic of China flora and fauna quarantine method implementation Ordinance 62nd article of provides, be punishment: (a) caused major flora and fauna outbreak of; (ii) forged, and variable made test quarantine single card, and seal, and logo, and seal General of.

53rd Chinese herbal medicines taken by the staff in the inspection and quarantine departments to quarantine and oversight in the management of the abuse of power, deliberately making parties, favoritism and falsification of the results of inspection and quarantine, or neglects his duties, delays in inspection and quarantine certificate shall be given administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.

Sixth chapter supplementary articles the 54th article turnover boundary of Chinese herbal medicines involve wild or endangered animals and plants, should comply with the relevant legal and regulatory requirements or relevant country or region.

55th International Express, mail and passengers carried the means of Chinese herbal medicines, shall comply with the relevant regulations.

56th quarantine of Chinese herbal medicines in transit in accordance with the People's Republic of China entry and exit animal and plant quarantine Act and its implementing regulations.

57th this approach by the AQSIQ to interpret. 58th article this way come into force December 1, 2015.

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