Provisions for Crude Drugs Importation

Chapter III Filing

Article 18 The applicant of first importation of crude drugs shall, within 1 year after obtaining its approval document, organize the importation of crude drugs from the port of arrival indicated in the approval document for crude drugs importation.

Article 19 The importer shall file at the drug regulatory department of ports, fill out the Testing Application Form for Crude Drugs Importation through the information system and submit the following materials:

(I) Original Testing Application Form for Crude Drugs Importation;

(II) A copy of the certificate of the place of production;

(III) Crude drug standards and source of standards;

(IV) A copy of the packing list, bill of lading and shipping invoice;

(V) When a crude drug to be imported has been re-exported from other countries (regions), all of its purchase contracts, packing lists, bills of lading and shipping invoices of the place of production and of every transit country or region shall be submitted at the same time;

(VI) Where the importation of crude drugs involve the endangered species of wild fauna and flora that are restricted from export and import as specified in the Convention on International Trade in Endangered Species of Wild Fauna and Flora, a copy of the approval document for export and import issued by national authorities for the import and export management of endangered species shall also be provided.

For the filing of first importation of crude drugs, in addition to materials specified in the first paragraph, a copy of the approval document for importation of crude drugs and that for supplementary application for importation of crude drugs (if any) shall also be submitted.

For the filing of non-first importation of crude drugs, in addition to materials specified in the first paragraph, a copy of the Drug Manufacturing Certificate or Drug Distribution Certificate of the importers, a copy of the entity registration certificate of the exporters, and a copy of purchase contract and the notarial document thereof shall also be submitted. If the importer is the MAH of Chinese patent medicine, a copy of drug approval document shall be provided.

Article 20 Drug regulatory departments of ports shall conduct a preliminary review on the completeness and normalization of filing materials. For those meeting the requirements, drug regulatory departments of ports shall issue the Drug Import Note, take back the approval document for first importation of crude drugs, and simultaneously issue the Notice for Port Testing for Importation of Crude Drugs to the drug control institutions of ports with a copy of filing materials attached.

Article 21 Importers shall go through the formalities of Customs declaration, inspection and clearance at customs with the Drug Import Note.

Chapter IV Port Testing

Article 22 Drug control institutions of ports shall, within 2 days after receiving the notice for port testing for importation of crude drugs, negotiate with the importers on site sampling time, and carry out on-site sampling at the specified storage location on time. During on-site sampling, importers shall show the original certificate of the place of production.

Article 23 Drug control institutions of ports shall check the consistency of the original certificate of the place of production and actual arrival of crude drugs with the filing materials provided by drug regulatory departments of ports. For those meeting the requirements, the sampling shall be conducted, the sampling record for importation of crude drugs shall be filled out, and the original Drug Import Note held by the importers shall be marked with "Sampling Completed" and stamped with the official seal of the sampling unit; for those not meeting the requirements, the sampling will not be conducted and the information shall be reported to local drug regulatory departments of ports within 2 days.

Article 24 Drug control institutions of ports shall complete testing within 20 days after sampling, and issue the testing report of importation of crude drugs. Where the testing cannot be completed on time due to objective reasons, the extension time and reasons shall be notified to the importers and reported to drug regulatory departments of ports in written form.

Drug control institutions of ports shall submit the testing reports of importation of crude drugs to the drug regulatory departments of ports, and notify the importers.

The imported crude drugs can be sold and used only after passing the port testing.

Article 25 In case of any objection to the testing results, the importer may apply for re-testing in accordance with the Drug Administration Law. Drug control institutions shall, within 20 days upon the acceptance of the application for re-testing, draw an arbitration conclusion, report to drug regulatory departments of ports and notify the importers.

Chapter V Supervision and Administration

Article 26 After receiving the notice of disapproval for sampling of importation of crude drugs, drug regulatory departments of ports shall take compulsory administrative measures to seize or detain all the crude drugs which have been proved to be harmful to human health and have been cleared by the customs after inspection, and make a decision on the disposal thereof within 7 days.

Article 27 For imported crude drugs that fail to meet the requirements of testing standards and have been cleared by the customs, drug regulatory departments of ports shall take compulsory administrative measures in a timely manner to seize or detain all the crude drugs upon the receipt of the testing report, make the decision on the disposal thereof according to law, and report the relevant disposal to local provincial drug regulatory department at the same time.

Article 28 The NMPA may, when necessary, organize and carry out overseas inspection on the place of production or the production sites such as the site of primary processing of imported crude drugs. Importers of crude drugs shall coordinate with the exporters in the inspection.

Article 29 In case of purchasing imported crude drugs, MAHs of Chinese patent medicine, manufacturers and distributors shall check the copy of testing report of imported crude drugs issued by drug control institutions of ports, and the copy of the Drug Import Note marked with "Sampling Completed" and stamped with the official seal, and strictly implement the provisions related to drug traceability management.

Article 30 The packaging of imported crude drugs must be suitable for its quality requirements, so as to facilitate storage, transportation and import testing. On each package, the Chinese name of crude drugs, approval document number (except non-first importation for crude drugs), place of production, shipping marks and numbers, name of the importer, name of the exporter, port of arrival, weight, and date of processing and packing must be clearly marked.

Article 31 Regarding the importation of crude drugs, the application and acceptance, the results of review and approval, the circumstances of violations of laws and regulations, and the resulting penalties shall be disclosed on the website of NMPA.

Chapter VI Legal Liabilities

Article 32 Any importer providing false certificates, documents or samples, or adopting other deceptive means to obtain the approval document for the first importation of crude drugs shall be handled according to the Drug Administration Law and other laws and regulations.

Article 33 Any importer providing false certificates or documents, or adopting other deceptive means to file importation of crude drugs shall be warned, and fined not less than RMB 10,000 but not more than RMB 30,000.

Chapter VII Supplementary Provisions

Article 34 The numbering format of approval documents for importation of crude drugs is: (abbreviation of province, autonomous region or municipality directly under the Central Government)药材进字 + 4-digit year number + 4-digit serial number.

Article 35 The Provisions shall come into force as of January 1, 2020. The Provisions for Medicinal Material Import (Interim) promulgated by the former China Food and Drug Administration on November 24, 2005, shall be repealed simultaneously.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.