A "Drug-handling Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be determined by the department of the State Council administering health.

第十一条开办药品经营企业必须具备以下条件：

[Article 11] The establishment of a drug-handling enterprise must satisfy the following conditions:

（一）具有与所经营药品相适应的药学技术人员。

(1) It must employ pharmaceutical technicians appropriate to the medicines handled.

经营中药的企业和兼营药品的企业没有药学技术人员.配备熟悉所经营药品的药性并经县级以上卫生行政部门审查登记的药工人员。

Where an enterprise engaged in the handling of Chinese medicines or partly engaged in handling drugs does not have a pharmaceutical technician it may use drug industry personnel with an intimate knowledge of the medicinal nature of the drugs handled who have been examined and registered by a department administering health at above county level.

（二）具有与所经营药品相适应的营业场所、设备、仓储设施和卫生环境。

(2) It must have business premises, equipment, storage facilities and a hygienic environment appropriate to the drugs handled.

第十二条收购药品，必须进行质量验收；不合格的，不得收购。

[Article 12] On purchasing drugs, quality examinations must be carried out; if the drugs do not come up to standard, they may not be purchased.

第十三条销售药品必须准确无误，并正确说明用法、用量和注意事项；

[Article 13] In selling drugs, it is necessary to be exact and accurate; the method of use, dosage and points to note must be explained precisely.

调配处方必须经过核对，对处方所列药品不得擅自更改或者代用。

In making up prescriptions, checks must be carried out; the drugs itemised in the prescription must not be altered or substituted without authorisation. 

对有配伍禁忌或者超剂量的处方应当拒绝调配；必要时经处方医生更正或者重新签字，方可调配。

Where a prescription contains ingredients that are incompatible or amounts of ingredients in excess of the proper dosage, a request to make up the prescription shall be refused; if necessary, after the prescribing doctor has corrected it and signed it again, it may be made up.

销售地道中药材，必须标明产地。

Where authentic Chinese medicines are sold, they shall be labelled to indicate the place of origin.

第十四条药品仓库必须制定和执行药品保管制度，采取必要的冷藏、防潮、防虫、防鼠等措施。

[Article 14] Drug warehouses shall lay down and implement a system of rules and regulations for the storage of drugs and take measures necessary in relation to cold storage, protection against damp, and protection from insects, rodents, etc.

药品入库出库必须执行检查制度。

An inspection system shall be put into effect in relation to drugs which are brought into or removed from the warehouse.

第十五条城乡集市贸易市场可以出售中药材，国家另有规定的除外。

[Article 15] Chinese medicinal materials may be sold in town and country trading markets except where otherwise stipulated by the State.

城乡集市贸易市场不得出售中药材以外的药品持有《药品经营企业许可证》的除外。

Drugs other than Chinese medicinal materials may not be sold in the trading markets of country towns, unless a "Drug-handling Enterprise Licence" is held.

第四章医疗单位的药剂管理

CHAPTER IV ADMINISTRATION OF DRUGS IN MEDICAL TREATMENT UNITS

第十六条医疗单位必须配备与其医疗任务相适应的药学技术人员，非药学技术人员不得直接从事药剂技术工作。

[Article 16] Medical treatment units must be staffed with the number of pharmaceutical technicians appropriate to their medical treatment responsibilities. Personnel who are not pharmaceutical technicians may not be engaged directly in pharmaceutical technical work.

第十七条医疗单位配制制剂必须经所在省、自治区、直辖市卫生行政部门审查批准，并发给《制剂许可证》。

[Article 17] The making up of drugs by medical treatment units must be examined and approved by the department in charge of health administration in the province, autonomous region or municipality under the direct control of the Central Government where the unit is situated, which will issue a "Dispensing Licence".

《制剂许可证》应当规定有效期，到期重新审查发证。具体办法由国务院卫生行政部门规定。

A "Dispensing Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be laid down by the department of the State Council administering health.

第十八条医疗单位配制制剂必须具有能够保证制剂质量的设施、检验仪器和卫生条件。

[Article 18] A medical treatment unit which makes up drugs must have adequate facilities, instruments for examination and hygienic conditions to ensure the quality of the drugs prepared.

第十九条医疗单位配制的制剂，必须根据临床需要并按照规定进行质量检验；合格的，凭医生处方使用。

[Article 19] The drugs made up by medical treatment units must comply with clinical requirements and, in accordance with regulations, quality examinations must be conducted. They are only to be used if up to quality and on a doctor's prescription.

医疗单位配制的制剂不得在市场销售。

Drugs made up by medical treatment units may not be sold on the market.

第二十条医疗单位购进药品，必须执行质量验收制度。

[Article 20] When a medical treatment unit purchases drugs, it must implement a system of checking the quality on delivery.

第五章药品的管理

CHAPTER V DRUG ADMINISTRATION

第二十一条国家鼓励研究、创制新药。

[Article 21] The State encourages research into and development of new drugs.

研制新药必须按照规定向国务院卫生行政部门或者省、自治区、直辖市卫生行政部门报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品。经批准后，方可进行临床试验或者临床验证。

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