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Regulatory Guide - Drugs - Regulations on Administrative Protection for Pharmaceuticals
Regulations on Administrative Protection for Pharmaceuticals
 
2011/7/4 9:11:03Source: Hits:

REGULATIONS ON ADMINISTRATIVE PROTECTION FOR PHARMACEUTICALS

Approved by the State Council on December 12, 1992 and promulgated by the State Pharmaceutical Administration 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 Peoples 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 Chinas 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) Has not been marketed in China prior to the date of filing the application for administrative protection.

Article 6. The right of applying for Administrative Protection for 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 appoint an agency designated by the competent authorities for the production 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 for Pharmaceuticals;
(2) A copy of the certificate issued by the compete

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