On Key Legal Aspects of Drug Import in China

—  Explanations on Drug Import Management Methods in China

Dr. Michael Liu, Dr. jur. (Münster), LL.M. (Münster), M. A. in English, Attorney-at-Law, Partner, BBAC Vice President & Vice Director for German Law Institute of Harbin University of Technology

I. Background Introduction and Main Relevant Laws on Drug Import

The experience of Bright & Right in serving international pharmaceutical clients confirms that international pharmaceutical companies that are interested in exporting their pharmaceutical products to China have got to be duly informed of the relevant legal provisions on drug import in China.  The drug import in China falls under the strict state control, which is the same as in every other country in the world.  In general, the State Food and Drug Supervision and Administration Bureau as well as the General Agency of the Customs of the People’s Republic of China, together with their local organizations around China, are directly responsible for the administration of drug import in China.

There are many laws and regulations governing the drug import in China, such as the Law of the People’s Republic of China on the Drug Administration, the Law of the People’s Republic of China on the Customs, the Implementation Rules for the Law of the People’s Republic of China on Drug Administration, as well as the Administration Methods on Drug Import (hereinafter shortened as “Drug Import Administration Methods”) made by the State Food and Drug Supervision and Administration Bureau together with the General Customs Agency of the People’s Republic of China on August 18, 2003, among which the Drug Import Administration Methods are essential to the practice of drug import in China, as the relevant legal formalities for drug import, including the key legal aspects of drug import, are clearly stipulated therein.

II. Key Legal Aspects of Drug Import

The relevant legal formalities for drug import include the registration of drug import, the customs clearance of drug import, the port inspection of the drug imported and the like, among which the drug import registration and the port inspection of the drug imported are the two key legal aspects in the whole process of drug import in China.

The drug import registration and port inspection of the drug imported are closely related to each other, while, exactly speaking, the port inspection of the drug imported is the essential part of the drug import registration, and only when the port inspection is finished, then, the drug import registration comes to its official end.

1. Drug Import Registration

The drug import registration refers to the process in which the applicant/the importer makes the application to the local Drug Supervision and Administration Bureau in the relevant port cities designated for drug import, and gets the Customs Approval for Drug Import (Art. 4 section I of Drug Import Administration Methods), with which the importer finishes the formalities of customs clearance for the drug import.  There are eighteen (18) port cities designated by the State Council for drug import, including Beijing, Shanghai, Tianjin, Dalian, Qingdao and so on.  And the drug import must go through one of these designated port cities (So Art. 2 of Drug Import Administration Methods).

The preconditions for the drug import registration and port inspection are that the importer/applicant has obtained either the Registration Certificate for Drug Import or the Registration Certificate for Medical Products or the Approval Notice for Drug Import, as well as the Import Permit for narcotics and/or psychotropic drugs issued by the State Food and Drug Supervision and Administration Bureau (Art. 5 of Drug Import Administration Methods).  Further, the applicant/importer, as an independent business entity with business license, shall possess the License for Drug Management or the License for Drug Production (Art. 9 of Drug Import Administration Methods). 

The following documents shall be submitted to the local Drug Supervision and Administration Bureau for import registration (Art. 13 of Drug Import Administration Methods):

(1)   copy of the Registration Certificate for Drug Import, or copy of the Registration Certificate for Medical Products, or copy of the Import Permit for narcotics and/or psychotropic drugs;

(2)   copy of applicant’s/importer’s License for Drug Management and Business License for Enterprise Legal Person;

(3)   copy of certificate of product origin;

(4)   copy of sales contract;

(5)   copy of packing list, B/L, waybill and invoice;

(6)   copy of Plant Inspection Report;

(7)   drug instruction as well as packaging and labeling design;

(8)   original of Inspection and Determination Extract of Production and Approval Certificate issued by the Drug Administration Department in the country of production when importing the biological products approved by the State Food and Drug Supervision and Administration Bureau; and

(9)   copy of the latest Inspection Report for Drug Import and the latest Customs Approval for Drug Import.

In particular, the drug import registration shall not be carried upon when one of the following circumstances occurs (Art. 17 of Drug Import Administration Methods):

(1)   Either the Registration Certificate for Drug Import, or the Registration Certificate for Medical Products or the Import Permit is not available;

(2)   At the time of import registration, either the Registration Certificate for Drug Import, or the Registration Certificate for Medical Products or the Import Permit is no longer valid;

(3)   At the time of import registration, the shelf life/the expiry period is less than twelve (12) months or less than six (6) months when the shelf life/the expiry period of the drug itself is less than twelve (12) months;

(4)   The actual origin of the product indicated on the Certificate of Product Origin is not consistent with that indicated on the Registration Certificate for Drug Import or the Registration Certificate for Medical Products, or the origin of the product indicated on the Registration Certificate for Drug Import or the Registration Certificate for Medical Products is not shown on the Certificate of Product Origin issued by the regional international organization;

(5)   The License for Drug Management or the License for Drug Production or the Business License for Enterprise Legal Person is not available with the importer;

(6)   The packaging and labeling of the products arrived in port are not consistent with the requirements by the State Food and Drug Supervision and Administration Bureau;

(7)   The Drug products have no instruction in Chinese or its instruction in Chinese is not consistent with the instruction approved;

(8)   The drug import has not been carried on in one of the port cities designated for drug import, or the relevant port city does not belong to the jurisdiction of the relevant local Drug Administration Bureau;

(9)   No effective Approval documents by the country or region of production for the biological products approved by the State Food and Drug Supervision and Administration Bureau;

(10)   The relevant documents and/or bills have been falsified or forged; or

(11)   The Registration Certificate for Drug Import or the Registration Certificate for Medical Products has been revoked, and so on.

2. Port Inspection of Drug Imported

The port inspection of the drug imported refers to the inspection activities on the imported drugs arrived in a port by the Drug Inspection Institute determined by the State Food and Drug Supervision and Administration Bureau (Art. 4 section II of Drug Import Administration Methods).

The State Inspection and Determination Institute for Pharmaceutical and Biological Products is responsible for guiding and coordinating the port inspection of the drug imported, as well as examining and approving the standard products and the comparison products (Art. 21 of Drug Import Administration Methods).  The Port Inspection Institute determined by the State Food and Drug Supervision and Administration Bureau is responsible for the following (Art. 20 of Drug Import Administration Methods):

(1)   on-site inspection on cargos arrived in port;

(2)   checking the Plant Inspection Report and the original of the Certificate of Product Origin;

(3)   conducting sampling according to the regulations;

(4)   conducting the port inspection on the drugs imported; and

(5)   reviewing the inspection result to which the objection is put forward and so on.

In the process of conducting the port inspection, the sampling of drugs imported for inspection will not be conducted, if one of the following circumstances occurs (Art. 25 of Drug Import Administration Methods):

(1)   the Plant Inspection Report and/or the Certificate of Product Origin has not been provided, or the originals of the aforesaid are not consistent with the copy for import registration;

(2)   the exterior shipping indications are not consistent with the shipping documents; or

(3)   the packaging and labeling of the drug imported are not consistent with the shipping documents, and the like.

When the applicant/the importer does not agree upon the inspection result and puts forward the objection thereto, then within seven (7) days after the receipt of the inspection result, he can make the application to the original port Inspection Institute or to the State Inspection and Determination Institute for Pharmaceutical and Biological Products for re-inspection.  And the result of the re-inspection shall be done within ten (10) days after accepting the application for re-inspection (Art. 29 of Drug Import Administration Methods).