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Regulations on Administrative Protection of Pharmaceuticals (1992)

( Approved by the State Council on December 12, 1992 and
promulgated by the State Pharmaceutical Administration on December 19, 1992 )

Application for Administrative Protection

Article 5.   A pharmaceutical which can be applied for administrative protection shall meet the following requirements:

(1) was not subject to protection by exclusive rights in accordance with the provisions of the China's Patent Law prior to January 1, 1993;

(2) is subject to an exclusive right to prohibit others from making, us-ing or selling it in the country to which the applicant belongs, which was granted after January 1, 1986 and before January 1, 1993;

(3) has not been marketed in China prior to the date of filing the ap-plication for administrative protection.

Article 6.   The right of applying for administrative protection of pharmaceuticals belongs to the owner of the exclusive right of the pharmaceutical.

Article 7.   Where an owner of the exclusive right of a foreign pharmaceutical applies for administrative protection, he or it shall ap-point an agency designated by the competent authorities for the produc-tion and distribution of pharmaceuticals under the State Council to act as his or its agent.

Article 8.   An applicant shall provide the following documents both in Chinese and the original:

(1) an application for administrative protection of the pharmaceutical;

(2) a copy of the certificate issued by the competent authorities of the country to which the applicant belongs granting such exclusive right;

(3) a copy of the document issued by the competent authorities of the country to which the applicant belongs for the approval for manufacture or marketing of such pharmaceutical;

(4) a copy of a contract for the manufacture and / or marketing formally entered into between the applicant and a Chinese enterprise as legal person (including wholly foreign capital enterprises, Chinese-for-eign joint venture enterprises, or Chinese-foreign cooperative enter-prises), which has obtained approval for manufacture or marketing of pharmaceuticals in accordance with the relevant Chinese laws and regula-tions, with respect to the manufacture and / or marketing of the pharmaceutical in China.

Article 9.   Prior to or after applying for the administrative protection, the owner of the exclusive right of a foreign pharmaceutical shall apply to the administrative department of health under the State Council for going through the procedures of approval for manufacture or marketing of the pharmaceutical in China, in accordance with the provisions of The Pharmaceutical Administration Law of the People's Republic of China.