Regulations on the Administrative Protection for Drugs

Regulations on the Administrative Protection for Drugs

Order of the State Pharmaceutical Administration No. 12

December 12, 1992

(Adopted by The People's Republic of China State Council on December 12, 1992, and released by the Order of the State Pharmaceutical Administration No. 12 on December 19, 1992)

CHAPTER I General Provisions

Article 1 These Regulations are enacted with a view to expanding economic and technological cooperation and exchange with foreign countries, providing Administrative Protection to the lawful rights and interests of the owners of the exclusive right of foreign pharmaceuticals.

Article 2 The "pharmaceuticals", as mentioned in these Regulations, refers to medicines for human beings.

Article 3 Enterprises and other organizations and individuals from the country or the region, which has concluded bilateral treaty or agreement with the People's Republic of China on administrative protection for pharmaceuticals, may apply for Administrative Protection for Pharmaceuticals in accordance with these Regulations.

Article 4 The competent authorities for the production and distribution of pharmaceuticals under the State Council receives and examines applications for Administrative Protection for Pharmaceuticals, grants Administrative Protection to the pharmaceuticals which conform with the provisions of these Regulations, and issues the Certificate for Administrative Protection for Pharmaceuticals to the applicants.

CHAPTER II 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, using or selling it in the country to which the applicant belongs, which was granted after January 1, 1986 and before January 1, 1993;
3.
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