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Rules for Implementation of the Regulations on Administrative Protection of Pharmaceuticals (1992)

( Promulgated by the State Pharmaceutical Administration of
the People's Republic of China on December 30, 1992 )

General Provisions

Article 1.   These Rules are formulated in accordance with the provi-sions of Article 22 of the Regulations on Administrative Protection of Pharmaceuticals (hereinafter referred to as the Regulations).

Article 2.   The competent authorities for the production and distribu-tion of pharmaceuticals under the State Council, as mentioned in the Regulations, refers to the State Pharmaceutical Administration of the People's Republic of China (hereinafter referred to as the SPAC).

The SPAC shall establish the Office for Administrative Protection of Pharmaceuticals, which shall be in charge of the receiving and examina-tion of the applications for administrative protection of pharmaceuticals, the issuance of certificates, the registration and announcement of relevant matters of administrative protection and the settlement of infringement disputes.

The administrative department of health under the State Council, as mentioned in the Regulations, refers to the Ministry of Public Health of the People's Republic of China.

Article 3.   The pharmaceuticals, as mentioned in the Regulations, re-fer to substances intended for use in the prevention, treatment or diagnosis of human diseases, or intended to effect the purposive regula-tion of human physiological functions, for which indications, usage and dosage are prescribed.

Article 4.   An owner of the exclusive right of a pharmaceutical, as mentioned in the Regulations, refers to the person or legal entity that possesses the complete rights of manufacturing and using and selling of the pharmaceutical applied for administrative protection.

Article 5.   "Has not been marketed in China", as mentioned in Article 5 (3) of the Regulations, refers to the pharmaceutical applied for admini-strative protection had not been distributed through lawful commercial channels in the pharmaceutical markets within China's territory.

Article 6.   The agency, as mentioned in Article 7 of the Regulations, refers to Huake Pharmaceutical Intellectual Property Consultative Center.

Article 7.   Any application for administrative protection of pharmaceuticals filed with the Office for Administrative Protection of Pharmaceuticals and any other relevant proceedings shall be prepared in the form prescribed by the SPAC.

Article 8.   Where the documents concerning administrative protection of the Office for Administrative Protection of Pharmaceuticals need to be sent to an applicant, they shall be transmitted by the agency.

Article 9.   The first day of any time limit prescribed in the Regula-tions or these Rules shall not be counted. Where a time limit is counted by year or by month, it shall expire on the corresponding day of the last month; if there is no corresponding day in that month , the time limit shall expire in the last day of that month. If a time limit expires on an of-ficial holiday, the time limit shall expire on the first working day after that official holiday.