Laws of the People's Republic of China

No.25 Provisions on Managing the Import and Export of Protein Assimilation Preparation and Peptide Hormone (For Trial Implementation) have been passed upon deliberation by the State Food and Drug Supervision Administration, the General Administration of Customs and the State General Administration of Sports and are hereby promulgated in line with the decree order of the State Food and Drug Supervision Administration and shall enter into force as of September 1, 2006. Commissioner of the State Food and Drug Supervision Administration Shao Mingli

Director of the General Administration of Customs Mu Xinsheng

Commissioner of the State General Administration of Sports Liu Peng

July 28, 2006

Provisions on Managing the Import and Export of Protein Assimilation Preparation and Peptide Hormone (For Trial Implementation)

Article 1

Pursuant to the stipulations in the Law of the People's Republic of China on Administering Pharmaceutical Products, the Customs Law of People's Republic of China, the Provisions on Anti-doping and other relevant laws and administrative regulations, these provisions are hereby formulated to strengthen management of import and export of protein assimilation preparation and peptide hormone.

Article 2

The State shall implement a license control management over the import and export of protein assimilation preparation and peptide hormone.

Article 3

Dealers engaging in the import of protein assimilation preparation and peptide hormone shall file application with State Food and Drug Supervision Administration.

Article 4

Dealers engaging in the import of protein assimilation preparation and peptide hormone for medical purpose shall submit materials as follows:

(1)

Application Form for Drug Import;

(2)

the duplicate of purchasing contract or purchasing order;

(3)

the duplicate of the Drug Import Registration Certificate (or the Pharmaceutical Product Registration Certificate) (original or copy);

(4)

the duplicates of License for Pharmaceutical Trading, Business License for Enterprises as Legal Persons, Certificate of Approval for Enterprises with Foreign Trade Rights (Registry Form for Foreign Trade Dealers), Certificate of Organization Code of the importers; pharmaceutical enterprises engaging in import of pharmaceutical raw materials and preparation intermediate (including domestic preparation for package use) for self-use purpose shall submit duplicates of License for Pharmaceutical Production, Business License for Enterprises as Legal Persons and Certificate of Organization Code;

(5)

Holders of the Drug Import Registration Certificate (or the Pharmaceutical Product Registration Certificate) who entrust other companies to export pharmaceuticals shall present entrustment letter of export.

All duplicates mentioned above should be covered with the seal of the importers.

Article 5

For importing protein assimilation preparation and peptide hormone for education, scientific and research purpose, the importers shall submit materials as follows:

(1)

Application Form for Drug Import;

(2)

the duplicate of purchasing contract or purchasing order;

(3)

the legal qualification certification of the user enterprises, the calculating basis of the pharmaceuticals usage and lawful letter of guarantee for legal use and management of the pharmaceuticals produced by the user enterprises;

(4)

documents of approval of relevant scientific projects or approval documents of the corresponding administrative department;

(5)

Importers who act as trustees of the end user enterprises shall present the duplicate of commission agreement and duplicates of Business License for Enterprises as Legal Persons, Certificate of Approval for Enterprises with Foreign Trade Rights (Registry Form for Foreign Trade Operators) and Certificate of Organization Code of the importers.

All duplicates mentioned above should be covered with the seal of the importers.

Article 6

Besides the materials as prescribed in Items 1, 3 and 5 of Paragraph 1 of Article 5 , domestic enterprises, who apply for the import of protein assimilation preparation and peptide hormone due to the need of conducting production on commission from enterprises abroad, shall submit the certification which shows that they have filed with the drug (food) supervision and administration department at provincial, autonomous regional and municipal level at their respective localities.

All duplicates mentioned above should be covered with the seal of the importers.

Article 7

The State Food and Drug Supervision Administration shall make decision whether to approve import or not within 15 working days as of the day on which they receive the import application and the relevant materials. Where the application is approved, the State Food and Drug Supervision Administration shall issue the License of Import for pharmaceuticals. Where the application is disapproved, the State Food and Drug Supervision Administration shall account for in written form.

Article 8

Upon the strength of the License of Import for pharmaceuticals, the importers shall declare to customs in the ports which are authorized with the right to import pharmaceuticals. The customs shall examine and handle customs formalities in accordance with the License of Import for pharmaceuticals. There is no need to fill in the form of import of pharmaceuticals going through customs formalities when applying for import of protein assimilation preparation and peptide hormone.

Article 9

For importing protein assimilation preparation and peptide hormone (including products available in China for the first time) for medical purpose, the importers shall fill in the Inspection Form of Drug Import timely after going through the import formalities. Then with the Drug Import Registration Certificate (or the Pharmaceutical Product Registration Certificate) (original or copy) and the License of Import for pharmaceuticals (original), the importers shall submit two copies of the following materials to the drug (food) supervision and administration department of the import port to apply for the Port Inspection Advice of Drug Import:

(1)

duplicates of Drug Import Registration Certificate (Pharmaceutical Product Registration Certificate) (original or copy) and License of Import for pharmaceuticals;

(2)

duplicates of License for Pharmaceutical Trading or License for Pharmaceutical Production, and Business License for Enterprises as Legal Persons of the importers;

(3)

the duplicate of certificate of original;

(4)

the duplicate of the purchasing contract;

(5)

duplicates of packing list, bill of lading and freight invoice;

(6)

the duplicate of the quality inspection report produced by the manufacture;

(7)

the instruction, package and label pattern of pharmaceuticals (excluding pharmaceutical raw materials and intermediate);

All duplicates above should be covered with the seal of the importers.

Article 10

The drug (food) supervision and administration department, when receive the Inspection Form of Drug Import and other relevant materials, shall return the original Drug Import Registration Certificate (or Pharmaceutical Product Registration Certificate) (original or copy) and License of Import for pharmaceuticals to the importers after examination and issue the Port Inspection Advice of Drug Import to the port drug inspection institute in charge of the inspection the day on which they receive the materials and attach the materials as prescribed in Article 9 of these Provisions.

Port drug inspection institute shall contact with the importers to draw samples in the storage spot within 2 working days since they receive the Port Inspection Advice of Drug Import. Then they shall mark "sampled" on the back of the first page of the Drug Import Check and Examination of Port and cover the seal of the inspection institute.

Article 11

The import of protein assimilation preparation and peptide hormone for teaching and research purposes and for meeting the need of production of domestic enterprises entrusted by foreign enterprises is exempted from inspection.

Article 12

Port drug (food) supervision and management departments shall report to the State Food and Drug Supervision Administration under any of the following conditions:

(1)

Port drug (food) supervision and management department refuses to issue the Port Inspection Advice of Drug Import in accordance with stipulations in Article 17 of the Provisions on Management of Drug Import (Decree No.4of the State Food and Drug Supervision Administration and General Administration of Customs)

(2)

Port drug inspection institutes refuses to draw samples in accordance with the stipulations in Article 25 of the Provisions on Management of Drug Import.

Port drug (food) supervision and management department shall take other mandatory administrative measures of detaining and sealing up towards the imported pharmaceuticals that conform to the stipulations in the previous article. They shall make decisions of approval of return within 7 days since the pharmaceuticals are detained and sealed up and inform the importers to handle the License of Import pharmaceuticals according to procedures of exporting protein assimilation preparation and peptide hormone as stipulated in these Provisions and sent all the imported pharmaceuticals back to the exporting country.

Port drug (food) supervision and administration department is authorized to destroy the detained and sealed up pharmaceuticals under the condition that importers fail to response or express the wish of returning the pharmaceuticals to the exporting country in a clear and definite way.

Article 13

Under the condition that the imported protein assimilation preparation and peptide hormone are proved to fail to reach the quality standard by the port drug (food) supervision and administration department after inspection, the importers shall report all detailed information about the circulation and use of all imported pharmaceuticals to the port drug (food) supervision and administration department within 2 days since they receive the Port Inspection Advice of Drug Import.

Port drug (food) supervision and administration department shall take mandatory administrative measures of detaining and sealing up all pharmaceuticals immediately when receive the Port Inspection Advice of Drug Import and decide whether or not file a suit within 7 days.

Under the condition that importers fail to propose a reconsideration or the pharmaceuticals still do not reach the standard upon reconsideration, the port drug (food) supervision and management departments shall make decision to approve of the return of the pharmaceuticals and inform the importers to obtain the License of Import for pharmaceuticals according to procedures for importing protein assimilation preparation and peptide hormone as stipulated by these Provisions and sent back all the imported pharmaceuticals to the original exporting countries. The port drug (food) supervision and administration department shall destroy all the imported pharmaceuticals under the condition that the importers fail to respond or express the wish of returning the pharmaceuticals in a clear and definite way within 10 days since the decision of approval of returning is made.

As for pharmaceuticals that reach the standard upon the reconsideration, the port drug (food) supervision and administration department shall remove the mandatory administrative measures of detaining and sealing up.

Port drug (food) supervision and administration department shall, in line with the stipulations in Items 2, 3 and 4 of this article, immediately report to the State Food and Drug Supervision Administration. In the meantime, drug (food) supervision and administration departments at the provincial, autonomous regional and municipal levels as well as other port drug (food) supervision and administration departments shall also be informed.

Article 14

When domestic pharmaceutical production enterprises, pharmaceutical trading enterprise and medical organizations purchase imported protein assimilate n preparation and peptide hormone, the suppliers shall provide the purchasers with the duplicate of the Drug Import Registration Certificate (or the Pharmaceutical Product Registration Certificate), the duplicate of License of Import for pharmaceuticals and the duplicate of the Port Inspection Advice of Drug Import and cover the seal of the suppliers on all these materials.

Article 15

For exporting protein assimilation preparation and peptide hormone, the exporters shall file application to the local drug (food) supervision and administration department at levels of provinces, autonomous regions and municipals directly under the central government and submit materials as follows:

(1)

Application Form of Drug Export;

(2)

the license of import original (or the duplicate and notarial certification) produced by the drug administrative department of the importing countries or regions;

As regards countries and regions which do not adopt the licensing system in the import of protein assimilation preparation and peptide hormone, the exporters shall present certification (original) which proves that the import of pharmaceuticals of this type is exempted from license as well as one of the following document:

a. the certification (or the duplicate and notarial certification) which shows the approval of import of pharmaceuticals of this type produced by the drug administrative department of the importing countries or regions;

b. the legal qualification certification original and legal certificate original of the usage of the pharmaceuticals (or the duplicate and notarial certification);

(3)

the duplicate of purchasing contract or order(excluding enterprises which export their own products);

(4)

the duplicate of export contract or order;

(5)

As regards the pharmaceuticals which are approved of being produced by domestic pharmaceutical enterprises, exporters must provide the duplicate of License for Pharmaceutical Production, Business License for Enterprises as Legal Persons and certification of the approval the pharmaceuticals; as regards the export of pharmaceuticals which are produced by domestic enterprises upon entrustment by foreign enterprises, exporters must submit the duplicate of certification which shows that they have filed the record to the drug supervision and administration department at the provincial autonomous regional and municipal level at their respective regions;

(6)

duplicates of Business License for Enterprises as Legal Persons, Certificate of Approval for Enterprises with Foreign Trade Rights (Registry Form for Foreign Trade Dealers), Certificate of Organization Code of the exporters;

All duplicates above should be covered with the seal of the exporters.

Article 16

As regards the return of the imported pharmaceuticals in line with the Article 12 and Article 13 of these Provisions, importers shall submit materials as follows when applying for License of Import for pharmaceuticals:

(1)

the certification of application for the return of the pharmaceutical produced by the original exporters of the exporting country;

(2)

License of Import pharmaceuticals.

Article 17

The drug supervision and administration departments at the provincial autonomous regional and municipal level shall make decisions on whether to approve export or not with 15 working days since they receive the application for export and the relevant materials. Where the application is approved, they shall issue License of Export for pharmaceuticals. Where the application is disapproved, the drug supervision administrative departments shall inform the exporters in writing and account for the disapproval.

As regards the application for License of Export for pharmaceuticals in line with the stipulations in Article16 of these Provisions, the license issuing department shall mark "commodities returned" on the License of Export for pharmaceuticals

Article 18

In line with License of Export for pharmaceuticals issued by the drug supervision and administration department at the provincial, autonomous regional and municipal level, the exporters shall declare to customs and submit export. The customs shall go through customs formalities, examination and clearance based on the License of Export for pharmaceuticals.

Article 19

The importers and exporters shall submit one more custom declaration and apply to customs to sign it off when going through the formalities. The customs, in accordance with the License of Export for pharmaceuticals and License of Import for pharmaceuticals, shall cover the seal of "checked off" on this custom declaration and return it to the importers and exporters. The customs shall charge a certain amount of production cost.

Within 1 month since the import and export is implemented, the importers and exporters shall return the first page of the License of Export and License of Import for pharmaceuticals and the customs declaration with the seal covered by the customs to the license issuing department.

As regards the enterprises that obtain the license of import and export but do not engage in foreign trade, the license shall be returned to the license issuing department within 1 month since the license reaches its validity

Article 20

Validity period of License of Import is one year; validity period of License of Export for pharmaceuticals does not exceed 3 months (validity period may not go beyond the same year)

License of Export and License of Import for pharmaceuticals are one-off licenses which can be used only once within the validity period. The contents of the licenses may not be altered. The importers and exporters with License of Export and License of Import originals are permitted to apply for license alternation once under the condition that a postponement of import and export is unavoidable.

Article 21

For the loss of License of Export and License of Import for pharmaceuticals, the importers and exporters shall report the loss immediately to the license issuing department. The license issuing department shall inform the customs and reissue the licenses under the condition that no harmful consequence occurs.

Article 22

License of Export for pharmaceuticals and License of Import for pharmaceuticals shall be uniformly printed by the State Food and Drug Supervision Administration.

Article 23

For the import and export of protein assimilation preparation and peptide hormone in the form of processing trade, customs shall, in line with License of Export for pharmaceuticals and License of Import for pharmaceuticals, implement inspection and clearance of the pharmaceuticals and carry out supervision. Where the export of pharmaceuticals might not be conducted due to special reasons, the customs shall hand over the pharmaceuticals to the drug (food) supervision and administration department at the locality of the pharmaceuticals and handle write-off formalities in light of relevant certification materials.

Article 24

As regards the import and export of protein assimilation preparation and peptide hormone between the bounded zones, export processing zones, other special areas supervised by the customs, bounded supervision areas and the special areas supervised by the customs, bounded supervision areas abroad under the supervision of the customs, License of Export for pharmaceuticals and License of Import for pharmaceuticals shall be exempted and the customs' supervision shall be conducted.

The protein assimilation preparation and peptide hormone's entry into the outside areas in China from the bounded zones, export processing zones, other special areas supervised by the customs and bounded supervision areas should apply for License of Import for pharmaceuticals.

The protein assimilation preparation and peptide hormone's entry into the bounded zones, export processing zones, other special areas supervised by the customs and bounded supervision areas from outside areas in China should apply for License of Export for pharmaceuticals.

Article 25

The customs shall, in accordance with the relevant regulations on the prescriptions issued by health care authorities and the prescriptions of health care organization, inspect and clear on the protein assimilation preparation and peptide hormone which are carried or delivered by post for the individual medical self-use purpose within a reasonable amount limit.

Article 26

Unless it is otherwise provided in these Provisions, the import, port inspection and supervision on the protein assimilation preparation and peptide hormone for medical purpose shall refer to the relevant stipulations on import of pharmaceuticals in the Provisions of Management on Drug Import.

Article 27

The protein assimilation preparation and peptide hormone imported for medical purpose in these Provisions refer to the protein assimilation preparation and peptide hormone that are proposed to be used as production preparation or be sold in the market within China.

Importers refer to those importers that are marked on the License of Import for Pharmaceuticals obtain in line with these Provisions.

Exporters those exporters that are marked on the License of Export for Pharmaceuticals obtain in line with these Provisions.

Article 28

These Provisions shall enter into force as of September 1, 2006. Announcement on the Management of Import and Export of Protein Assimilation Preparation and Peptide Hormone (Guo Shi Yao Jian An [2004] No.474) promulgated by the State Food and Drug Supervision Administration on September 30, 2004 shall be concurrently repealed.