Chapter III Control over Drug Distributors

Article 11For the establishment of a drug wholesaler, the applicant shall submit an application to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, where the projected drug wholesaler is to be located. The drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the date it receives the application, make a decision on approval or disapproval according to the standards for establishment set forth by the drug regulatory department under the State Council. After completion of establishment of the planned wholesaler, the applicant shall apply to the original approving department for acceptance inspection. The original approving department shall, within 30 working days from the date it receives the application, organize an acceptance inspection according to the requirements for establishment of drug distributors set forth in Article 15 of the Drug Administration Law and issue the Drug Supply Certificate to the applicant if the inspection is passed. The applicant shall, with the Certificate, register with the administrative department for industry and commerce in accordance with law.

Article 12For the establishment of a drug retailer, the applicant shall submit an application to the drug regulatory institution of the municipality divided into districts, or to the drug regulatory institution at the county level which is directly set up by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, where the projected retailer is to be located. The drug regulatory institution accepting the application shall, within 30 working days from the date it receives the application, make a decision on approval or disapproval after the review according to the regulations of the drug regulatory department under the State Council, taking into consideration the number of permanent residents, territory, transportation and practical needs in the place. After completion of establishment of the planned retailer, the applicant shall apply to the original approving department for acceptance inspection. The original approving department shall, within 15 working days from the date it receives the application, organize an acceptance inspection according to the requirements for establishment of drug distributors set forth in Article 15 of the Drug Administration Law and issue a Drug Supply Certificate if the inspection is passed. The applicant shall, with the Certificate, register with the administrative department for industry and commerce in accordance with law.

Article 13Drug regulatory departments of the people's government of the provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the certification of drug distributors. A drug distributor shall, according to the implementing measures and schedule formulated by the drug regulatory department under the State Council, undergo the Good Supply Practice for Pharmaceutical Products (GSP) inspection organized by the local drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government and obtain a GSP certificate. The format of GSP certificate shall be uniformly provided for by the drug regulatory department under the State Council.

All newly-established drug wholesalers and retailers shall, within 30 days from the date they obtain the Drug Supply Certificate, apply for the GSP certification to the drug regulatory departments or institutions which have issued them the Drug Supply Certificate. The drug regulatory institutions accepting drug retailers' applications for certification shall, within seven working days from the date they receive the applications, transfer the applications to the drug regulatory departments of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government that are responsible for organizing inspection of drug distributors. The drug regulatory departments of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government shall, within three months from the date they receive the applications, organize inspection of the drug wholesalers or retailers as to their compliance with the GSP according to provisions of the drug regulatory department under the State Council and issue GSP certificates to those passing the inspection.

Article 14A database of GSP inspectors shall be set up by each of the drug regulatory department of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government. A GSP inspector shall be qualified as required by the drug regulatory department under the State Council. A GSP inspection shall be conducted by a team of inspectors randomly selected from the said database according to the provisions of the drug regulatory department under the State Council.

Article 15The State adopts a classification system for prescription drugs and non-prescription drugs. The State subdivides the non-prescription drugs into Class A drugs and Class B drugs according to the level of safety.

Any drug retailer distributing prescription drugs or Class A non-prescription drugs shall have licensed pharmacists or other pharmaceutical technicians whose qualifications are legally recognized. Any retailer distributing Class B non-prescription drugs shall have pharmacy staff members who have passed the examination organized by the local drug regulatory institution of the municipality divided into districts or by the local drug regulatory institution at the county level which is directly set up by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government.

Article 16Any drug distributor that intends to alter the approved items in the Drug Supply Certificate shall, 30 days prior to the alteration of any approved items, apply to the original certificating-issuing authority for registration of alteration; no approved items may be altered without approval. The original certificate-issuing authority shall make a decision within 15 working days from the date it receives the application. The applicant shall, by holding Drug Supply Certificate with the altered items, register the alteration with the administrative department for industry and commerce in accordance with law.

Article 17The valid term of a Drug Supply Certificate is five years. To continue its drug distribution, the Certificate holder shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Drug Supply Certificate according to the provisions of the drug regulatory department under the State Council.

Where a drug distributor terminates its drug distribution or is closed down, its Drug Supply Certificate shall be withdrawn by the original certificate-issuing authority.

Article 18Where there is no drug retailers at town or country fairs in remote areas with poor communications, the local drug retailers may, after obtaining approval from the local drug regulatory departments of the counties (or municipalities) and being registered with the administrative departments for industry and commerce, set up stores at the fairs to sell non-prescription drugs within the approved scope for drug distribution.

Article 19Drug manufactures, drug distributors and medical institutions engaged in on-line drug transaction through the Internet and the drugs so transacted shall be in conformity with the provisions of the Drug Administration Law and in the Regulations. The administrative measures for on-line drug distribution services shall be formulated by the drug regulatory department under the State Council together with the other relevant departments under the State Council.

Chapter IV Control over Pharmaceuticals in Medical Institutions

Article 20To establish a pharmaceutical preparation unit in a medical institution, an application shall be submitted to the local administrative department for health of the people's government of the province, autonomous region or municipality directly under the Central Government, and, after being consented upon examination, be reported to the drug regulatory department of the people's government at the same level for review and approval. Approval shall be given to the medical institution if it passes the review by the said drug regulatory department and a Pharmaceutical Preparation Certificate for Medical Institution shall be issued.

The administrative department for health and the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the dates they receive the application respectively, make their own decisions whether or not to consent or approve the application accordingly.

Article 21Any medical institution that intends to alter the approved items in the Pharmaceutical Preparation Certificate for Medical Institution shall, 30 days prior to the alteration of any approved items, apply to the original reviewing and approving authorities for registration of alteration according to the provisions in Article 20 of the Regulations; no approved items may be altered without approval. The original reviewing and approving authorities shall make their own decisions within 15 working days from the dates they receive the application respectively.

Any medical institution which intends to add new dosage forms or change dispensing sites shall, after passing the acceptance inspection by the local drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, go through the registration of alteration of the Pharmaceutical Preparation Certificate for Medical Institution according to the provisions in the preceding paragraph.

Article 22The valid term of a Pharmaceutical Preparation Certificate for Medical Institution is five years. To continue dispensing pharmaceutical preparation, the medical institution shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Pharmaceutical Preparation Certificate for Medical Institution according to the provisions of the drug regulatory department under the State Council.

Where a medical institution terminates dispensing Pharmaceutical preparations or is closed down, its Pharmaceutical Preparation Certificate for Medical Institution shall be withdrawn by the original certificate-issuing authority.

Article 23To dispense pharmaceutical preparation, the medical institution shall submit the dossier and samples according to the provisions of the drug regulatory department under the State Council, and the pharmaceutical preparation may only be dispensed after being approved by the local drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government and being issued a pharmaceutical preparation approval number.