Laws of the People's Republic of China

State Food and Drug Administration

Notice of the State Food and Drug Administration on the Issues concerning the Implementation of the Administrative Measures for the Import of Drugs

GuoShiYaoJianZhu [2003] No. 320

November 19th, 2003

All port administrations of food and drugs, all port drug inspection offices, the customs of Guangdong Province of the General Administration of Customs, the special offices of Tianjin and Shanghai, and all customs directly under the General Administration of Customs:

In accordance with Order No. 4 of the State Food and Drug Administration, the Administrative Measures for the Import of Drugs (hereinafter referred to as the Measures) shall be implemented as of January 1st, 2004. With a view to earnestly carrying out the implementation of the Measures, we hereby make the notice of the relevant issues as follows:

1.

Upon the approval of the State Council, imported drugs are allowed to enter China through 18 port cities, that is, Beijing, Tianjin, Shanghai, Dalian, Qingdao, Chengdu, Wuhan, Chongqing, Xiamen, Nanjing, Hangzhou, Ningbo, Fuzhou, Guangzhou, Shenzhen, Zhuhai, Haikou, and Xi'an.

With a view to strengthening the administration and enhancing the efficiency of customs clearance, the State Food and Drug Administration and the General Administration of Customs have further determined the name list of the specific ports permitting the entry of imported drugs (Annex1)

2.

In light of the Measures, the destinations of all the imported drugs (including narcotics and psychotropic drugs) shall fall within the specified ports of the above-mentioned 18 cities.

3.

In accordance with the need of import record keeping, the following 18 administrations of drugs are determined as port administrations of drugs by the State Food and Drug Administration, that is, the drug administrations of Beijing, Tianjin, Shanghai, Dalian, Qingdao, Chengdu, Wuhan, Chongqing, Xiamen, Nanjing, Hangzhou, Ningbo, Fuzhou, Guangzhou, Shenzhen, Zhuhai, Haikou and Xi'an. The addresses and telephone numbers of the port drug administrations are indicated in Annex 2.

4.

In accordance with the need of drug inspection, the State Food and Drug Administration shall authorize the National Institute for the Control of Pharmaceutical and Biological Products, the drug inspection offices of Beijing, Tianjin, Shanghai, Dalian, Qingdao, Chengdu, Wuhan, Chongqing, Xiamen and Guangzhou, and the drug inspection offices of Jiangsu Province, Zhejiang Province, Fujian Province, Hainan Province, Guangdong Province and Shaanxi Province as the port drug inspection offices. The addresses and telephone numbers of all port drug inspection offices are indicated in Annex 3.

5.

All port drug administrations and port drug inspection offices shall, in accordance with the respective actual circumstances, determine their respective jurisdictional scope and functions. Each of the port drug administrations shall, in accordance with the port within its jurisdiction, form a working relationship with only one port drug inspection office of import record keeping and port inspection. Their specific jurisdictional scope and functions shall be carried out in conformity with the Distribution Form of Drug Import Ports, the Drug Inspection Administrations and Drug Inspection Offices under Centralized Management as formulated by the State Food and Drug Administration. (Annex 4)

6.

The new Catalogue of Import Drugs shall be promulgated by the State Food and Drug Administration along with the General Administration of Customs. Before the new Catalogue is promulgated, the jurisdictional scope of import drugs shall be carried out in conformity with Annex 1, namely the Import Drug Management Catalogue - in the Notice on the Several Issues concerning Strengthening the Administration on Imported Drugs (GuoYaoGuoZhu [2002] No. 622).

The jurisdictional scope of narcotics and psychotropic drugs shall be still according to Annex 1, namely Catalogue of Narcotics under Control and Annex 2, namely Catalogue of Psychotropic Drugs under Control in the Notice on the Relevant Issues concerning Intensifying the Import and Export of Narcotics and Psychotropic Drugs (GuoYaoGuanZhu [2001] No. 585).

7.

A uniform seal shall be used in the record-keeping of drug import, the name of which is "The Special Seal for the Drug Import Record Keeping of Drug Administration". The "Special Seal" shall be made by carving and issued by the State Food and Drug Administration, which shall be used by a port drug administration in conducting the drug import record keeping. Among the special seals, "The Special Seal for the Drug Import Record Keeping of the State Food and Drug Administration" held by the State Food and Drug Administration shall be effective in all ports, through which drugs are permitted to import. The models of all seals are indicated in Annex 5.

8.

For the commodities listed in the scope of commodity codes in the Catalogue of Imported Drugs, the customs shall conduct the procedures for the customs declaration and clearance upon the strength of the Customs Clearance Permit for Imported Drugs sealed with the Special Seal for the Drug Import Record Keeping of Drug Administration issued by the department authorized by the State Food and Drug Administration and the relevant other instruments. The Customs Clearance Permit for Imported Drugs shall only be used by the port customs indicated in the Customs Clearance Permit for Imported Drugs. The system of one permit for one batch shall be adopted and any modification may not be made to the content in the permit. If it is necessary to modify the content of the permit, the permit shall be renewed and reissued. The customs shall still implement the relevant regulations concerning the supervision over and administration of narcotics and psychotropic drugs of the State Food and Drug Administration and the General Administration of Customs.

9.

After the Measures come into effect, any of the aforesaid commodities, for which a customs declaration for import has been filed, but the port drug administration refuses to offer Customs Clearance Permit for Imported Drugs, the customs may, upon the strength of the applications of the consignees or agents, directly handle the formalities for returning the commodities according to the relevant regulations.

10.

In light of Article 10 of the Measures, the destination shall be one of the ports specified as customs clearance ports in Beijing, Shanghai and Guangzhou.

Where the biological products as provided in Article 10 of the Measures are vaccines, blood products and diagnostic reagents used for blood screening (See Annex 6 for the catalogue), the State Food and Drug Administration shall, in accordance with the actual circumstances, modify this catalogue in time.

11.

Considering the special requirements for the storage of the drugs listed in Annex 6, before the special warehouse of the customs are determined, the temporary formalities for the import record keeping shall be carried out when these types of biological products are imported. A port drug administration shall, after it receives an Application for the Inspection on Imported Drugs and the relevant materials, conduct examination and inspection according to Article 16 of the Measures before issuing Customs Clearance Permit for Imported Drugs and the special Notice on Port Inspection on Imported Drugs (See Annex 7). After the port drug inspection office has taken samples, the port drug administration shall seal up all the drugs. The drugs may be unsealed and permitted to enter China to be sold and used after the drugs are deemed as qualified upon inspection.

12.

With regard to the human serum albumin among the six types of biological products listed in Annex 6, the Drug Inspection Offices of Beijing, Shanghai or Guangdong shall be responsible for taking samples and making port inspection in light of the different destinations of the product. Where the destination of the other types is Beijing, the National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for taking samples and making port inspection. The port drug administration shall issue a Notice on Port Inspection on Imported Drugs to the National Institute for the Control of Pharmaceutical and Biological Products. Where the destination is Shanghai or Guangzhou, Shanghai Drug Inspection Office or the Drug Inspection Office of Guangdong Province shall be responsible for taking samples, and the National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for the port inspection. The port drug administration shall issue a special Notice on Port Inspection on Imported Drugs to Shanghai Drug Inspection Office or the Drug Inspection Office of Guangdong Province, which shall, within 2 days after it has taken samples, send the samples to the National Institute for the Control of Pharmaceutical and Biological Products.

The State Food and Drug Administration shall, according to the port drug inspection offices' capacities to test the biological products, authorize them to undertake port inspection on other biological products. With regard to the biological products other than the circumstances as prescribed in Article 10 of the Measures, the destination port drug inspection offices shall strictly conduct port inspection in accordance with the registered standards of the imported drugs. In case a port drug inspection office lacks such inspection conditions or capacities, it may entrust the National Institute for the Control of Pharmaceutical and Biological Products to conduct the inspection.

13.

The port drug administrations shall exercise the functions as prescribed in the Measures as of January 1st, 2004, shall formally accept the applications for the drug import record keeping, and shall handle the relevant matters on the Customs Clearance Permit for Imported Drugs. At the same time, the port drug inspection offices shall stop their former function of accepting inspection applications. The import entities shall file applications to the port drug administrations for the drug import record keeping as of January 1st, 2004.

Where a Customs Clearance Permit for Imported Drugs issued prior to December 31st, 2003 is still within its valid period, it may be used continuously. Where the valid period expires and the party concerned fails to go through the formalities for customs declaration and clearance, the Customs Clearance Permit for Imported Drugs shall be replaced by a new one in the port drug administration.

14.

With a view to ensuring the quality and standardization of the work of drug import record keeping, the State Food and Drug Administration has formulated the Guidelines for Drug Import Record Keeping (Annex 8), all port drug administrations shall comply with them in doing the specific work of drug import record keeping.

15.

Drug import record keeping is a new task undertaken by all port drug administrations. All port drug administrations shall study the relevant laws, regulations and knowledge, and shall in time submit to the State Food and Drug Administration the problems found in handling import record keeping. The port drug administrations and the customs shall strengthen the communication, coordination and cooperation between them, and ensure that the work of import record keeping run smoothly.

16.

The provisions on the examination and approval of the import of preventive biological products and blood products as prescribed in the Administrative Measures for Imported Drugs shall be repealed as of January 1st, 2004.

17.

The Notice on Intensifying the Administration on the Import of Drugs (GuoYaoGuanZhu [2002] No. 622) and the Notice on Distributing the Notice of the State Food and Drug Administration on the Relevant Problems concerning Strengthening the Administration on the Import of Drugs (ShuFa [2001] No. 71) shall be repealed as of January 1st, 2004.

Please implement the above-mentioned provisions.

Annexes:

1.

The Name List of Drug Import Ports (Omitted)

2.

The Name List of the Port Drug Administrations (Omitted)

3.

The Name List of the Port Drug Inspection Offices (Omitted)

4.

The Distribution Form of Drug Import Ports, the Drug Inspection Administrations and Drug Inspection Offices under Centralized Management (Omitted)

5.

The Styles of the Special Seals for Drug Import Record Keeping (Omitted)

6.

The Catalogue of the Biological Products Proscribed by the State Food and Drug Administration (Omitted)

7.

Notices on Port Inspection on Imported Drugs (Omitted)

8.

Guidelines for the Drug Import Record Keeping (Omitted)