Measures for the supervision and administration of quarantine of Chinese herbal medicines entering and leaving the country

Chapter I General Provisions Article 1 In order to strengthen the supervision and administration of quarantine of Chinese herbal medicines, prevent the entry and exit of animal and plant epidemics, protect the production of agriculture, forestry, animal husbandry and fishery and human health, and protect ecological safety, these Measures are formulated in accordance with the Law of People's Republic of China (PRC) on Entry and Exit Animal and Plant Quarantine and its implementing regulations and other laws and regulations. Article 2 The term "Chinese herbal medicines" as mentioned in these Measures refers to the medicinal parts of medicinal plants and medicinal animals, and refers to the raw materials formed by preliminary processing after harvesting. Article 3 These Measures shall apply to the quarantine, supervision and administration of Chinese herbal medicines declared for medicinal purposes.

The inspection, quarantine, supervision and management of the imported and exported Chinese herbal medicines declared for consumption shall be carried out in accordance with the provisions of the General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as AQSIQ) on the import and export of food. Article 4 The General Administration of Quality Supervision, Inspection and Quarantine shall uniformly administer the quarantine, supervision and administration of Chinese herbal medicines entering and leaving the country.

The entry-exit inspection and quarantine department established by the General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the inspection and quarantine department) is responsible for the quarantine, supervision and management of Chinese herbal medicines entering and leaving the territory under its jurisdiction. Article 5 The General Administration of Quality Supervision, Inspection and Quarantine shall implement an application and declaration system for Chinese herbal medicines entering and leaving the country. When Chinese medicinal materials enter or leave the country, the enterprise shall declare the intended use to the inspection and quarantine department, indicating "medicinal" or "edible".

Chinese herbal medicines declared as "medicinal" should be included in the Catalogue of Medicinal Materials in People's Republic of China (PRC) and China Pharmacopoeia. Chinese medicinal materials declared as "edible" shall be articles that can be used as food as stipulated by national laws, administrative regulations, rules and documents. Article 6 The General Administration of Quality Supervision, Inspection and Quarantine shall carry out risk management on Chinese herbal medicines entering and leaving the country; To register and manage overseas production, processing and storage units (hereinafter referred to as overseas production enterprises) that export Chinese herbal medicines to China; According to the requirements of the importing country or region, the production, processing and storage units of outbound Chinese herbal medicines (hereinafter referred to as outbound production enterprises) shall be registered and managed; Integrity management shall be implemented for enterprises engaged in the production and operation of inbound and outbound Chinese herbal medicines. Article 7 Chinese herbal medicine enterprises entering and leaving the country shall engage in production, processing and business activities in accordance with laws, administrative regulations and relevant standards, assume the main responsibility for epidemic prevention, be responsible to the society and the public, ensure the safety of Chinese herbal medicines entering and leaving the country, take the initiative to accept supervision and assume social responsibilities. Chapter II Supervision on Entry Quarantine Article 8 AQSIQ shall implement a quarantine access system for imported Chinese herbal medicines, including product risk analysis, evaluation and review of supervision system, determination of quarantine requirements, registration of overseas production enterprises and entry quarantine. Article 9 The General Administration of Quality Supervision, Inspection and Quarantine shall conduct product risk analysis and supervision system evaluation on countries or regions that export Chinese herbal medicines to China for the first time, and conduct retrospective review on countries or regions that have already traded.

According to the results of risk analysis, evaluation and review, AQSIQ shall negotiate with the competent authorities of exporting countries or regions to determine the quarantine requirements for exporting Chinese herbal medicines to China, negotiate relevant protocols and determine the quarantine certificate.

The General Administration of Quality Supervision, Inspection and Quarantine is responsible for formulating, adjusting and publishing on the website of the General Administration of Quality Supervision, Inspection and Quarantine the list of countries or regions that allow Chinese herbal medicines to enter the country and product types. Article 10 The General Administration of Quality Supervision, Inspection and Quarantine shall, according to the results of risk analysis, determine the catalogue of Chinese herbal medicines that need to be registered by overseas production, processing and storage units, and make dynamic adjustments. The registration review procedures and technical requirements shall be separately formulated and promulgated by the AQSIQ.

The General Administration of Quality Supervision, Inspection and Quarantine shall register the overseas production enterprises of Chinese herbal medicines listed in the catalogue. Registration is valid for 4 years. Article 11 An overseas production enterprise shall meet the requirements of the laws and regulations of the exporting country or region and the mandatory requirements of China's national technical specifications. Article 12 When an overseas production enterprise applies for registration in China, the competent department of the exporting country or region shall review it, recommend it to the AQSIQ after it meets the relevant provisions of Articles 10 and 11 of these Measures, and submit the following materials in Chinese or English:

(1) Laws and regulations related to animal and plant epidemic situation, veterinary hygiene, public health, plant protection, enterprise registration management, etc. Written information on the establishment of the relevant competent department, personnel situation and the implementation of laws and regulations in the country or region where it is located;

(2) A list of overseas production enterprises applying for registration;

(three) the evaluation conclusion of the competent department of the country or region where it is located on the actual situation of epidemic prevention and health control of the recommended enterprise;

(4) A statement by the relevant competent department of the country or region where it is located that the enterprise recommended by it meets the requirements of China laws and regulations;

(5) Application for enterprise registration, plans of factories, workshops and warehouses, process flow charts, documents of animal and plant quarantine prevention and control system, photos of epidemic prevention and disinfection treatment facilities, photos of harmless treatment facilities for wastes and packages, etc. ;

(6) Other necessary documents. Article 13 After receiving the recommended materials and passing the written examination, the General Administration of Quality Supervision, Inspection and Quarantine, after consulting with the competent authorities of the exporting country or region, may send personnel to the exporting country or region to evaluate its supervision system and inspect the overseas production enterprises applying for registration.

Those who meet the requirements after examination shall be registered. Article 14 Where a registered overseas production enterprise needs to renew its registration, the competent department of the exporting country or region shall, six months before the expiration of the validity period, apply to the AQSIQ in accordance with the provisions of Article 12 of these Measures. The General Administration of Quality Supervision, Inspection and Quarantine may send personnel to the exporting country or region to conduct a retrospective review of its supervision system and inspect the overseas production enterprises applying for it.

For countries or regions that meet the requirements after retrospective review, overseas production enterprises that meet the requirements after inspection shall be registered, and the validity period shall be extended for 4 years.