全屏显示专题章节

Article 14 The establishment of a drug wholesaler shall be subject to approval of the local drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Supply Certificate; the establishment of a drug retailer shall be subject to approval and be granted the said certificate by the local drug regulatory department at or above the county level.With the certificate, the wholesaler and the retailer shall be registered with the administrative department for industry and commerce.No one may distribute drugs without the certificate.

The valid term and the scope of business shall be indicated in the Drug Supply Certificate.For renewal of the certificate upon expiration, reexamination is required.

When giving approval to the establishment of a new distributor, the drug regulatory department shall see to it that, apart from the requirements specified in Article 15 of this Law that should be met, the principles of appropriate location and convenient purchase of drugs by the people are adhered to.

Article 15 A drug distributor to be established shall meet the following requirements:

(1)having legally qualified pharmaceutical professionals;

(2)having the business operation premises, equipment, warehouses and hygienic environment required for drug distribution;

(3)having the units or personnel for quality control over the drugs to be distributed; and

(4)having rules and regulations to ensure the quality of the drugs to be distributed.

Article 16 Drug distributors shall conduct business according to the Good Supply Practice for Pharmaceutical Products (GSP)formulated by the drug regulatory department under the State Council on the basis of this Law.The drug regulatory department shall inspect a drug distributor as to its compliance with the GSP requirements, and issue a certificate to the distributor passing the inspection.

The specific measures and schedule for implementing the GSP shall be formulated by the drug regulatory department under the State Council.

Article 17 For purchasing drugs, drug distributors shall establish and apply an examination and acceptance system, and check the certificate of drug quality, labels and other marks; no drugs that do not meet the requirements may be purchased.

Article 18 Drug distributors shall keep authentic and complete records when purchasing and selling drugs.In the record shall be indicated the adopted name in China, dosage form, strength or size, batch number, date of expiry, manufacturer, purchase (or sale)unit, amount of the drug purchased (or sold), purchase or sale price, date of purchase (or sale), and other items specified by the drug regulatory department under the State Council.

Article 19 Drug distributors shall sell drugs properly and make correct description of usage, dosage and cautions; prescription for dispensing shall be checked, and no drugs listed in the prescription may be changed or substituted without authorization.They shall refuse to dispense incompatible or over-dose prescriptions; when necessary, they may do the dispensing only after corrections or re-signing is made by the prescribing physician.

Drug distributors shall indicate the origin of the Chinese crude drugs to be sold.

Article 20 A drug distributor shall establish and apply a system for drug storage, and take necessary measures to ensure quality, such as cold storage, protection against freeze and humidity and avoidance of insects and rodents.

An examination system shall be applied for placing drugs in and releasing them from storage.

Article 21 Chinese crude drugs may be sold at town and country fairs, except those otherwise specified by the State Council.

No drugs other than the Chinese crude drugs may be sold at town and country fairs, but drug retailers holding the Drug Supply Certificate may, within the specified business scope, sell such drugs at stores they set up at the fairs.Specific measures shall be formulated by the State Council.