You are here

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 )

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 accord-ing 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 comple-ment is not met, the application shall be deemed to have not been filed.

Article 11.   The competent authorities for the production and distri-bution of pharmaceuticals under the State Council shall finish the exami-nation within six months from the date of receipt of the application doc-uments, or from the date of receipt of the complementary documents stipulated in Article 10(2) of these Regulations. If, under special circum-stances, the examination cannot be finished within six months, the com-petent authorities for the production and distribution of pharmaceuticals under the State Council shall promptly notify the applicant, inform the reason and properly prolong the examination time.

After examination, where the application is in conformity with the provisions of these Regulations, administrative protection shall be grant-ed; Where the application is not in conformity with the provisions of these Regulations, no administrative protection shall be granted and the reason shall be informed.

Article 12.   Where a pharmaceutical is granted with administrative protection, the competent authorities for the production and distribution of pharmaceuticals under the State Council shall issue the certificate for administrative protection and make an announcement.