Laws of the People's Republic of China

No.9

The Interim Measures for the Check and Ratification of Export Enterprises of Ephedrine Chemicals Liable to Producing Narcotic Drugs have been deliberated and adopted at the 5th ministerial meeting of the Ministry of Commerce on May 17, 2006. They are hereby promulgated upon approval of the Ministry of Public Security, General Administration of Customs and the State Food and Drug Administration, and shall come into force 30 days as of the promulgation date. Bo Xilai, Minister of Commerce

Zhou Yongkang, Minister of Public Security

Mou Xinsheng, Director of the General Administration of Customs

Shao Mingli, Director General of the State Food and Drug Administration

October 10, 2006

Interim Measures for the Check and Ratification of Export Enterprises of Ephedrine Chemicals Liable to Producing Narcotic Drugs

Article 1

With a view to strengthening the export administration over ephedrine chemicals liable to producing narcotic drugs, regulating the export business order of these chemicals and preventing them from flowing into illegal channels, the present Measures are constituted under the Regulations on the Administration of Chemicals Liable to Producing Narcotic Drugs.

Article 2

The term "ephedrine chemicals liable to producing narcotic drugs" as mentioned in the present Measures means the ephedrine materials and the saline chemicals (including pharmaceutical products and single preparations) listed at the attached list of the Regulation on the Administration of Chemicals Liable to Producing Narcotic Drugs, such as ephedrine, pseudo ephedrine, mesoephedrine, phenylpropanolamine, methylephedrine, ephedrine extractum, and ephedrine extractum powder.

Article 3

The ephedrine chemicals liable to producing narcotic drugs may be exported by the enterprises that have been checked and ratified by the Ministry of Commerce together with the State Food and Drug Administration under present Measures.

The list of export enterprises of ephedrine chemicals liable to producing narcotic drugs shall be checked and ratified once every two years, and shall be promulgated by the Ministry of Commerce in the form of public announcement.

Article 4

The Ministry of Commerce shall take charge of the administration on the check and ratification of export enterprises of ephedrine chemicals liable to producing narcotic drugs of the whole nation. The competent departments for commerce of all provinces, autonomous regions, municipalities directly under the Central Government and cities under separate state planning (hereinafter referred to as provincial competent departments for commerce) shall take charge of the administration and other related work of the check and ratification of export enterprises of ephedrine chemicals liable to producing narcotic drugs of their respective regions upon the entrustment of the Ministry of Commerce.

Article 5

The customs declaration of the export of ephedrine chemicals liable to producing narcotic drugs shall be limited at the ports of Beijing, Tianjin, Shanghai and Shenzhen, and the actual departure shall also be limited at the same port. The other customs shall reject the export declaration business of these products.

Article 6

To apply for the check and ratification qualification of export enterprise of ephedrine chemicals liable to producing narcotic drugs, an enterprise shall meet the following conditions:

(1)

having gone through the registration formalities for a foreign trade operator, or it is a foreign-funded enterprise established upon the approval under law;

(2)

having no record of criminal penalty or administrative penalty by the related departments because of illegal operation within the last three years;

(3)

having established and improved the special administration mechanism on the export of ephedrine chemicals liable to producing narcotic drugs, and having special management personnel;

(4)

the legal representative and the management personnel shall have related knowledge and management experience on chemicals liable to producing narcotic drugs; and

(5)

having relatively fixed channels for raw materials supply.

Article 7

The Ministry of Commerce shall produce a notice on qualification check and ratification three months before the expiration of the time limit of the check and ratification. And the enterprises shall submit the documentary evidences as prescribed in Article 6 to the provincial competent departments for commerce within the time limit as stipulated in the notice.

If an applicant enterprise is a foreign-funded enterprise, it shall also submit the certificate of approval of foreign-funded enterprise (photocopy) attached with the mark of passing the joint annual inspection, joint operation contract, report of assets examination and business license (photocopy).

The provincial competent department for commerce shall, within 20 days as of the receipt of the related prescribed materials submitted by the enterprise, complete the primary examination, where the applicant enterprise is determined as qualified in the primary examination. And the department shall submit the opinions of primary examination and the related materials to the Ministry of Commerce for check and ratification.

The Ministry of Commerce shall, within 20 days as of the receipt of the opinions of primary examination and the related materials, in collaboration with the State Food and Drug Administration and the related experts, undertake comprehensive appraisal in light of the basic conditions of enterprises, domestic and overseas drug prohibition situation, market status and the foreign trade order, and may conduct first-hand investigation and check and ratify the export enterprises and publish the list thereof.

Article 8

An enterprise, which has obtained the qualification of an export enterprise of ephedrine chemicals liable to producing narcotic drugs upon check and ratification (hereinafter referred to as ratified enterprise), shall apply for the export license of ephedrine chemicals liable to producing narcotic drugs under the Regulation on the Administration of Chemicals Liable to Producing Narcotic Drugs and the Regulation on the Administration of the Export and Import of Chemicals Liable to Producing Narcotic Drugs.

Article 9

The manufacture enterprises among the ratified enterprises may only export the self-produced ephedrine chemicals liable to producing narcotic drugs; the circulating enterprises among the ratified enterprises may only purchase ephedrine chemicals liable to producing narcotic drugs of the enterprises that have the permit to manufacture and manage ephedrine chemicals liable to producing narcotic drugs to export.

Article 10

Ratified enterprises must establish special machine accounts for the export of ephedrine chemicals liable to producing narcotic drugs to make detailed record of related export business activities, and keep the related records for two years for future reference.

Article 11

Ratified enterprises shall report the export situation of ephedrine chemicals liable to producing narcotic drugs of the previous year to the provincial competent departments of commerce, public security departments and the food and drug supervision departments prior to March 31 each year.

Article 12

Ratified enterprises shall be subject to the supervision and management of the competent departments of commerce and the food and drug supervision departments.

Article 13

For the purpose of protecting ephedra herbal resources and the natural environment, the state shall prohibit the export of natural ephedra herbal.

Article 14

In case an enterprise obtains the qualification of ratified enterprise by deceiving or other illegitimate means, the Ministry of Commerce shall cancel its qualification of ratified enterprise under law, and may give a warning or impose a fine not more than 30,000 Yuan; the enterprise violating laws may not apply for the qualification of ratified enterprise again within three years thereafter.

Article 15

In case an enterprise violates Article 9 to Article 12 of the present Measures, the Ministry of Commerce shall order it to make corrections within a certain time limit, and may give it a warning or impose a fine not more than 30,000 Yuan; if the enterprise fails to do so within the time limit, the Ministry of Commerce may cancel its qualification of ratified enterprise.

Article 16

In case an enterprise exports chemicals liable to producing narcotic drugs by violating the Regulation on the Administration of Chemicals Liable to Producing Narcotic Drugs, the Regulation on the Administration of the Export and Import of Chemicals Liable to Producing Narcotic Drugs and the present Measures, it shall be handled under the related provisions of the Regulation on the Administration of Chemicals Liable to Producing Narcotic Drugs and the Regulation on the Administration of the Export and Import of Chemicals Liable to Producing Narcotic Drugs; the Ministry of Commerce may cancel its qualification of ratified enterprise according to the seriousness of the circumstance.

Article 17

The original ratified export enterprises of ephedrine chemicals liable to producing narcotic drugs shall, within 60 days as of the promulgation of the present Measures, apply for the ratification of qualification under the present Measures. In case an enterprise fails to go through the related formalities within the prescribed time limit, its qualification ratified previously shall be cancelled.

Article 18

The present Measures shall come into force 30 days as of the promulgation date. The Circular on the Related Issues concerning the Intensifying of the Administration on the Export of Ephedrine Products (Wai Jing Mao Guan Fa [1998] No. 573) shall be repealed concurrently.