1. Quarantine access

As required, animal derived traditional Chinese medicinal materials require overseas enterprise to register, however, the import of plant-based Chinese medicinal materials generally does not require the overseas enterprises to register (if the plant-based Chinese medicinal materials have traditional trade records before, the registration of overseas enterprises is not required. For newly applied varieties, registration shall be made by the overseas enterprises if it's needed according to the requirements of both parties' protocols.) For details, please check the List of Approved Imported Chinese Medicinal Materials and Exporting Countries and Regions in the customs website. From November 2022, the work including the quarantine access and registration of overseas enterprises for animal and plant derived Chinese medicinal materials with high quarantine risks shall be responsible by the new department of the General Administration of Customs. The “List of Countries and Regions That Export Food to China and Meet the Evaluation and Review Requirements and Have Traditional Tradition” shall not be referred. The Chinese medicinal materials module in this catalog has recently been offline, and new data must be used to determine the specific quarantine access status, enterprise registration conditions, procedures, and required information of the Chinese medicinal materials. It should be emphasized that this is a completely new change, and almost all fragmented information on the internet remains in the old mode. It is recommended to communicate and confirm with us before implementation to obtain direct and correct guidance to avoid being misled by complex information.

The risk assessment and review on the equivalence of the regulatory system for traditional Chinese medicinal materials in the country (region) of origin conducted by General Administration of Customs:

(1) Sort out the relevant laws and regulations on animal and plant epidemics, veterinary hygiene, public health, plant protection, enterprise registration management, etc. in the country or region of origin, as well as written materials on the establishment and personnel situation of the competent department in the country or region of origin, as well as the implementation of laws and regulations;

(2) Application. The intended exporting country (region) shall submit an application to the General Administration of Customs for export to China in written. The General Administration of Customs initiates the admission process and provides a risk assessment questionnaire to the intended exporting country;

(3) Organize evaluation. The intended exporting country will reply based on the questionnaire, provide relevant technical information, and the General Administration of Customs will conduct a risk assessment. As required, an expert team will be dispatched to visit overseas for investigation;

(4) The General Administration of Customs shall negotiate with the competent authorities of the exporting country or region to determine the quarantine requirements for exporting Chinese medicinal materials to China based on risk analysis and evaluation review results, sign relevant protocols, and determine quarantine certificates;

(5) Enterprises shall register in the General Administration of Customs according to the specific requirements of the protocol, and the General Administration of Customs shall publish a list of products of the countries or regions that meet the evaluation and review requirements;

2. Registration of overseas enterprises

According to the results of risk analysis, the General Administration of Customs shall determine the varieties list of medicinal materials that need overseas registration and implement dynamic adjustment. The General Administration of Customs shall implement registration for overseas manufacturers that export medicinal materials to China and need overseas registration, and the registration shall be valid for four years. If the access status of the plant derived Chinese medicinal materials is “normal”, the enterprises of this country do not need access registration; if the access status is “allowed to import from registered enterprises”, access registration is required (such as saffron of Greece and Afghan, tuckahoe and blood creeper from Laos, Licorice from Uzbekistan, which have obtained access in the past two years). If the country is not indicated, the General Administration of Customs shall carry out product risk analysis and evaluation of the supervision system on the countries or regions exporting Chinese medicinal materials to China for the first time. After the negotiation on the inspection and quarantine requirements of both parties, a protocol shall be signed. The registration of overseas production enterprises will be implemented according to the specific requirements of the protocol.

3. Quarantine approval

For the imported Chinese medicinal materials need to conduct quarantine approval for imported animals and plants, the owners or their agent should apply for the Quarantine Permit for Imported Animals and Plants through “Internet plus + Customs” in accordance with the provisions of Administrative Measures for the Quarantine Approval of Imported Animals and Plants before signing the trade contract. Animal derived Chinese medicinal materials need quarantine approval, while plant derived Chinese medicinal materials do not need quarantine approval.

4. Customs clearance form for imported medicinal materials or Permission of imported medicinal materials

The medicinal materials imported for the first time shall be registered in the drug regulatory department at the port after obtaining the permission for import of medicinal materials in accordance with the provisions; The medicinal materials imported for the first time refer to the imported medicinal materials of different countries (regions), different applicants and different origins. For the Chinese medicinal materials in the List of non-First Imported Medicinal Materials, online registration from the port drug supervision and administration department can be made directly obtain Customs clearance form for imported medicinal materials without the permission of imported medicinal materials. If the Chinese medicinal material is listed as an endangered species (Appendix to the Convention on International Trade in Endangered Species of Wild Fauna and Flora), it also needs the National Forestry and Grassland Administration to issue an “administrative licensing decision allowing the import of wildlife products”. For the first time of importing medicinal materials, the applicant shall fill in the application form for import of medicinal materials through the information system of the State Drug Administration, and submit the following information to the local provincial drug regulatory department:

(1) Application form for import of medicinal materials;

(2) Copies of drug production license or license for pharmaceutical trading of the applicant, and if the applicant is the holder of the marketing authorization for Chinese patent medicines, copies of relevant drug approval documents shall be provided;

(3) Copies of the exporter’s principal registration certificate;

(4) Copies of the purchase contract and its notarial documents;

(5) Ecological environment, resource reserves, wild or cultivated situation, information on harvesting and primary processing of origin in the place of origin of medicinal materials;

(6) Standards and standard sources of medicinal materials;

(7) The original copy of the medicinal materials identification of origin, recording identification conclusion, sample picture, authenticator, authenticate organization and its seal, issued by the institution with the qualification of plant base identification in China.

5. Domestic consignee recordation

The domestic consignee shall apply to the customs where its industrial and commercial registration locates for the recordation. The importer of medicinal materials shall be the holder of the marketing approval for Chinese patent medicines, traditional Chinese medicine manufacturer, as well as pharmaceutical trading enterprises with the business of Chinese medicinal materials or Chinese herbal slices in China. The consignee shall fill in the relevant information through the standard “Enterprise Qualification” subsystem of “China International Trade Singlewindow” or “Enterprise management” subsystem of “Internet + Customs” of General Administration of Customs, and submit the application materials to the customs where industrial and commercial registration locates.

6. Regulations for processing and storage enterprises (only applicable to animal derived Chinese medicinal materials)

Imported animal derived Chinese medicinal materials must be processed and manufactured by designated qualified processing enterprises, and can only go on sale after the qualification assessment procedure completed. For details, please refer to the List of Designated Enterprises for the Storage and Processing of Imported Animal Derived Traditional Chinese Medicine on the customs website. Processing enterprises log on to the “Internet plus + Customs” integrated online service platform（ http://online.customs.gov.cn ）and enter the “Recordation for the Designated Storage and Processing Enterprise of Imported Traditional Chinese Medicine” section under the column “Enterprise Management and Inspection” to fill in and submit the online application and scanned copies of the above-mentioned paper materials. After accepting the application, competent customs will review the paper recordation application materials submitted by the enterprise, organize a review team to review, and issue a review report. The competent customs shall record, number, and publish enterprises that are qualified after the evaluation. From the date of publication, the validity period is 4 years.

7. Designated import customs clearance port

Heilongjiang Province: Heihe, Dongning

Jilin Province: Ji’an, Changbai, Tumen, Sanhe

Inner Mongolia: Erenhot, Manzhouli

Guangxi: Pingxiang, Dongxing, Longbang, Aidian

Yunnan Province: Ruili, Tianbao, Jinghong, Hekou

Xinjiang Uygur Autonomous Region: Dzungarian Gate, Khorgos, Torugart, Khunjerab

Tibet Autonomous Region: Zhangmu, Jilong, Pulan

Customs declaration prompt after meeting the supervision requirements above:

1. Submit declaration materials for customs clearance

Bill of lading, packing list, invoice, trade contract, certificate of origin, plant quarantine certificate, China customs clearance form for imported medicinal materials or the permission of imported medicinal materials, health certificate (requirements for enterprises have ever processed and different port customs are different), ingredient testing report, label and translation documents, declaration elements, etc.

2. Declaration of intended use

For the Chinese medicinal materials declared as “medicinal”, they shall be quarantined and supervised by the customs according to the Provisions for the Supervision and Management of Entry and Exit Quarantine of Chinese Medicinal Materials, and the drug supervision and management department shall be responsible for the inspection.

For the Chinese medicinal materials declared as “edible”, that is, “homology of medicine and food, items that are both drugs and food,” they shall be quarantined and supervised according to the regulations of the General Administration of Customs on import and export food.

3. Conformity assessment for drug administration and quarantine

(1) The general process of the drug administration department: after the port drug supervision and administration department receives the declaration information – information verification - issue the Port Clearance for Import Drug - sampling - Provincial Drug Inspection Research Center inspect and issue the inspection report for imported medicinal materials. (Applicable to Chinese medicinal materials declared as “medicinal”)

1. How to access botanical Chinese herbal medicines in the catalog?

Answer: If the access status of plant-derived Chinese medicinal materials is "normal", the overseas enterprises in the country do not need access application; those whose access status is "allowed to import from registered enterprises" need access registration (such as access in the past two years Greece and Afghanistan exported safflower to China). If the country and access status are not listed, the General Administration of Chinese Customs (GACC) will conduct product risk analysis and regulatory system assessment for the country or region that exports Chinese medicinal materials to China for the first time, whether the overseas manufacturers need to be registered is decided by the specific requirements of the protocol.
 

2. How to access Chinese herbal medicines of animal origin in the catalog?

For animal-originated Chinese herbal medicines, if the access status is "allowed to import, and registration is gradually completed", the overseas enterprises in the country do not need access application procedure; if the access status is "allowed to import from registered enterprises", access application is required. If the country is not listed, the General Administration of Chinese Customs (GACC) will conduct product risk analysis and assessment of the supervision system for the country or region that exports Chinese medicinal materials to China for the first time, whether the overseas manufacturers need to be registered is decided by the specific requirements of the protocol.

3. Does the domestic consignee of imported Chinese medicinal materials need to record?

Answer: yes, fill in the relevant information through the standard "Enterprise Qualification" subsystem of the "China International Trade Single Window" or the "Internet + Customs" and "Enterprise Management" subsystem of the General Administration of Chinese Customs, and submit paper application materials to the customs at the place where the industry and commerce are registered. .

4. Do all Chinese medicinal materials imported for "medicinal use" need to be approved for import of medicinal materials?

Answer: No, if the country of origin and product access conditions are met, if the Chinese medicinal material is listed in the "Catalogue of Non-First-Time Imported Medicinal Materials", it does not need to be processed.

5. What are the application channels and conditions for the approval of imported medicinal materials?

Answer: When importing medicinal materials for the first time, the applicant should fill in the application form for importing medicinal materials through the information system of the State Drug Administration, and submit the following materials to the local provincial drug administration:

(1) Application form for imported medicinal materials;

(2) A photocopy of the applicant's drug production license or drug business license. If the applicant is the holder of the marketing license for proprietary Chinese medicines, a photocopy of the relevant drug approval documents shall be provided;

(3) A copy of the main body registration certificate of the exporter;

(4) A copy of the purchase contract and its notarized documents;

(5) Information on the ecological environment, resource reserves, wild or planting and breeding conditions, harvesting and primary processing in the origin of medicinal materials;

(6) Standards and sources of medicinal materials;

(7) The original identification certificate of medicinal material origin issued by an institution with the qualification for identification of animal and plant origins in China, which contains the identification basis, identification conclusion, sample pictures, appraiser, identification agency and its official seal and other information.

6. What is the sample of permission of imported medicinal materials?


7. What is the sample of customs clearance form for non-first imported medicinal materials?

8. What are the specific contents of the catalogue of non-first-time imported medicinal materials?