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Laws & Regulations - Drugs - Regulations on Administrative Protection for Pharmaceuticals
Regulations on Administrative Protection for Pharmaceuticals
 
2011/7/13 9:44:41Source: 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 competent authorities of 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 - foreign joint venture enterprises, or Chinese - foreign cooperative enterprises), which has obtained approval for manufacture or marketing of pharmaceuticals in accordance with the relevant Chinese laws and regulations , 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 manufacturing or marketing of the pharmaceutical in China, in accordance with the provisions of the Pharmaceutical Administration Law of the Peoples Republic of China.


CHAPTER III  EXAMINATION AND APPROVAL OF
APPLICATION FOR ADMINISTRATIVE PROTECTION
Article 10.  Within 15 days from the date of receipt of the application documents for Administrative Protection, the competent authorities for the production and distribution of pharmaceuticals of the State Council, upon preliminary examination, shall make the following decisions according to different conditions:
(1) Where the application documents are in conformity with the pro-visions of Article 8 of these Regulations, issue the notice of acceptance and announce it;
(2) Where the application documents are not in conformity with the provisions of Article 8 of these Regulations, request the applicant to complement within a definite time; if the time limit for making complement is not met, the application shall be deemed to have not been filed.

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