重庆市基层医疗机构药品及无菌器械管理规定(试行)
重庆市人民政府
重庆市基层医疗机构药品及无菌器械管理规定（试行）
此规范性文件经市政府法制办审查，符合《重庆市行政机关规范性文件审查登记办法》的规定，决定予以登记。
渝文审〔2007〕25号
第一章 总则
第一条 为贯彻《中共中央、国务院关于进一步加强农村卫生工作的决定》，加强基层医疗机构药品管理，确保人民群众用药安全有效，根据《中华人民共和国药品管理法》等法律法规，结合我市实际，制定本规定。
第二条 本市基层医疗机构药品和无菌器械的采购、储存和使用，必须遵守本规定。
本规定所称基层医疗机构指一级及其以下医疗机构，包括乡镇卫生院、村卫生室、社区卫生服务中心（站）、医务室、门诊部、诊所等。
本规定所称无菌器械指一次性使用无菌医疗器械。
第三条 基层医疗机构实行规范药房管理制度。规范药房评审标准和评审办法由重庆市卫生局会同重庆市食品药品监督管理局另行制定。
第二章 药品管理
第四条 基层医疗机构应根据国家有关法律、法规和本规定，结合本单位实际，制定药品质量管理制度，并定期检查。
药品质量管理制度主要有：
（1）各级药品质量管理岗位职责；
（2）药品采购、验收、储存、养护、陈列、调配（包括拆零调配）管理制度；
（3）供货企业合法资质和所购药品合法性审核管理制度；
（4）进口药品管理制度；
（5）药品效期管理制度；
（6）不合格药品管理制度；
（7）特殊药品的购进、储存、使用制度；
（8）临床制剂管理制度；
（9）药品不良反应监测、报告制度；
（10）环境卫生和人员健康及教育、培训、考核管理制度。
第五条 基层医疗机构必须从具有药品生产、经营资格的企业采购药品。
第六条 基层医疗机构购进药品时，必须向供货单位索取、查验、保存以下资料，并保证其资料的真实性。
（一）加盖供货企业原印章的《药品生产许可证》、《药品经营许可证》和营业执照复印件；
（二）加盖供货企业原印章的购进药品的批准证明文件和药品出厂检验报告书复印件；
（三）购进进口药品的，按照国家有关规定提供相关证明文件；
（四）加盖供货企业原印章和企业法定代表人印章或签字的企业法定代表人委托授权书原件，授权书应载明授权销售的品种、地域和期限；
（五）药品销售人员身份证复印件。
第七条 基层医疗机构购进药品必须有合法票据，做到票、帐、物相符。
第八条 基层医疗机构购进药品，必须建立并执行进货验收制度，并建有真实完整的药品购进记录。药品购进记录必须注明药品通用名称、生产厂商（中药材标明产地）、剂型、规格、批号、生产日期、批准文号、有效期、供货单位、数量、价格、购进日期、质量状况、验收人签名等。
购进记录应保存至超过药品有效期一年，但不得少于三年。
第九条 基层医疗机构药品由区县统一组织询价采购，村卫生室药品可由乡镇卫生院代为采购。为村卫生室代购药品的乡镇卫生院必须建立分发单位目录、相对应的分发药品目录和分发单位档案。
第十条 乡镇卫生院为村卫生室代购药品不以营利为目的，不得向村卫生室收取任何形式的费用。
第十一条 乡镇卫生院为村卫生室代购药品，应保留完整的购药发票、购进记录和分发记录备查。分发记录应注明分发单位、药品名称、剂型、规格、批号、有效期、生产厂商、批准文号、数量、价格、分发日期、分发人签名。
在购进记录上注明分发单位、分发日期和分发人签名的，可视为分发记录。
分发记录应保存至超过药品有效期一年，但不得少于三年。
第十二条 基层医疗机构根据需要可设置药房、药柜或库房。储存药品应设立库房，实行药品代购的乡镇卫生院应设立独立的代购药品库房。
代购药品库房应设有待验区、合格品区、不合格品区、发货区和退货区，并有明显标识，面积与服务功能和规模相适应。
第十三条 基层医疗机构储存药品，应制定和执行药品保管制度，采取必要的防潮、防尘、防污染、防虫、防鼠、防霉变等措施，需冷藏的药品必须冷藏，保证药品质量。
中药材、中药饮片、化学药品、中成药应分开储存，分类存放。易燃、易爆、易腐蚀等危险性药品必须单独存放，并采取必要的安全措施。
第十四条 药房应环境整洁，有陈列药品的设施设备、完好的衡器及清洁卫生的药品调配工具和包装用品等。
第十五条 中药材应无伪劣掺杂使假，中药饮片应符合炮制规范。装斗前应做质量复核，不得错斗、串斗，防止混药。斗前应正名正字。
第十六条 严禁使用假劣药品。发现假劣药品或质量可疑药品，必须及时报告当地食品药品监督管理部门，不得自行退、换货。
第十七条 基层医疗机构必须凭本医疗机构医生的处方调配药品，严格执行《处方管理办法（试行）》，不得非法销售或变相销售药品。
第十八条 乡镇卫生院和村卫生室要分别按照卫生行政部门制定的乡村医疗机构基本用药目录配备和使用药品。
第十九条 调配口服药品需要拆零时，使用工具和包装物品应清洁卫生，不得对药品产生污染。拆零药品的外包装必须留存至原包装药品使用完毕，不得混批装放。发出药品的包装袋上应注明患者姓名、药品名称、用法、用量、发药日期和药品有效期。
第二十条 基层医疗机构可设置药品咨询台，为患者提供用药咨询。应按照有关规定，配合临床医师开展合理用药，做好药物不良反应监测工作。发现可能与药品有关的不良反应应及时分别向当地食品药品监管部门和卫生行政主管部门报告。
第二十一条 医疗机构配制制剂，必须符合《医疗机构制剂配制质量管理规范(试行)》的有关规定。
配制的制剂凭医师处方在本单位使用，不得在市场上销售或变相销售。
第二十二条 特殊药品必须严格按规定采购、保管和使用，并执行《重庆市特殊药品监控信息网络系统运行管理办法（试行）》。
第三章 人员与培训
第二十三条 基层医疗机构药品质量负责人应根据岗位需求，具有药学或相关专业大专、中专以上学历或取得药师以上专业技术职称。村级医疗机构药品质量管理人员可由医务人员兼任。
第二十四条 从事药品管理的药学技术人员每年应参加继续教育培训；从事药品管理的非药学技术人员应经培训考核合格后上岗，并每年参加继续教育培训。
第二十五条 直接接触药品的人员，应每年进行健康体检并建立健康档案。患有精神病、传染病或其他可能污染药品疾病的人员，不得从事直接接触药品的工作。
第四章 无菌器械管理
第二十六条 基层医疗机构必须从具有《医疗器械生产企业许可证》或《医疗器械经营企业许可证》的企业采购无菌器械。
第二十七条 基层医疗机构购进无菌器械时，必须向供货单位索取、查验、保存以下资料，并保证其资料的真实性。
（一）加盖供货企业原印章的《医疗器械生产许可证》、《医疗器械经营许可证》和营业执照复印件；
（二）《医疗器械产品注册证》复印件及产品合格证；
（三）加盖供货企业原印章和企业法定代表人印章或签字的企业法定代表人委托授权书原件，授权书应载明授权销售的品种、地域和期限；
（四）药品销售人员身份证复印件等。
第二十八条 基层医疗机构应建立无菌器械采购、验收制度，严格执行并做好记录。采购记录应包括：供货单位、产品名称、型号规格、产品数量、生产批号、灭菌批号、产品有效期等。按照记录应能追查到每批无菌器械的进货来源。
第二十九条 基层医疗机构应建立无菌器械使用后销毁制度。使用过的无菌器械必须按规定销毁，使其零部件不再具有使用功能，经消毒无害化处理，并做好记录。
基层医疗机构不得重复使用无菌器械。
第五章 法律责任
第三十条 基层医疗机构从事药品经营活动的，乡镇卫生院在代购中进行营利性药品购销活动的，由当地食品药品监管部门给予警告并责令改正；责令不改的，依照《药品管理法》第七十三条的规定予以处罚，并由当地卫生行政主管部门对单位负责人和药品质量管理负责人给予行政处分。
第三十一条 基层医疗机构从非法渠道购进药品的，使用假劣药及其他违法行为的，由当地食品药品监管部门按有关法律法规的规定予以处罚，并由当地卫生行政主管部门对单位负责人和药品质量管理负责人给予行政处分。
第三十二条 基层医疗机构重复使用无菌器械的，由当地卫生行政主管部门按照《传染病防治法》第六十九条的规定予以处罚。
第六章 附则
第三十三条 积极推行规范药房管理制度的基层医疗机构由当地卫生行政主管部门对该医疗机构及单位负责人和质量管理负责人予以表彰。
第三十四条 本规定由重庆市食品药品监督管理局会同重庆市卫生局负责解释。
第三十五条 本规定自2007年8月1日起施行。
LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON FOREIGN-CAPITAL ENTER-PRISES ——附加英文版
The National People's Congress
LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON FOREIGN-CAPITAL ENTER-PRISES
(Adopted at the Fourth Session of the Sixth National People's
Congress, promulgated by Order No. 39 of the President of the People's
Republic of China and effective as of April 12, 1986)
Article 1
With a view to expanding economic cooperation and technical exchange with
foreign countries and promoting the development of China's national
economy, the People's Republic of China permits foreign enterprises, other
foreign economic organizations and individuals (hereinafter collectively
referred to as "foreign investors") to set up enterprises with foreign
capital in China and protects the lawful rights and interests of such
enterprises.
Article 2
As mentioned in this Law, "enterprises with foreign capital" refers to
those enterprises established in China by foreign investors, exclusively
with their own capital, in accordance with relevant Chinese laws. The term
does not include branches set up in China by foreign enterprises and other
foreign economic organizations.
Article 3
Enterprises with foreign capital shall be established in such a manner as
to help the development of China's national economy; they shall use
advanced technology and equipment or market all or most of their products
outside China. Provisions shall be made by the State Council regarding
the lines of business which the state forbids enterprises with foreign
capital to engage in or on which it places certain restrictions.
Article 4
The investments of a foreign investor in China, the profits it earns and
its other lawful rights and interests are protected by Chinese law.
Enterprises with foreign capital must abide by Chinese laws and
regulations and must not engage in any activities detrimental to China's
public interest.
Article 5
The state shall not nationalize or requisition any enterprise with foreign
capital. Under special circumstances, when public interest requires,
enterprises with foreign capital may be requisitioned by legal procedures
and appropriate compensation shall be made.
Article 6
The application to establish an enterprise with foreign capital shall be
submitted for examination and approval to the department under the State
Council which is in charge of foreign economic relations and trade, or to
another agency authorized by the State Council. The authorities in charge
of examination and approval shall, within 90 days from the date they
receive such application, decide whether or not to grant approval.
Article 7
After an application for the establishment of an enterprise with foreign
capital has been approved, the foreign investor shall, within 30 days from
the date of receiving a certificate of approval, apply to the industry and
commerce administration authorities for registration and obtain a business
licence. The date of issue of the business licence shall be the date of
the establishment of the enterprise.
Article 8
An enterprise with foreign capital which meets the conditions for being
considered a legal person under Chinese law shall acquire the status of a
Chinese legal person, in accordance with the law.
Article 9
An enterprise with foreign capital shall make investments in China within
the period approved by the authorities in charge of examination and
approval. If it fails to do so, the industry and commerce administration
authorities may cancel its business licence. The industry and commerce
administration authorities shall inspect and supervise the investment
situation of an enterprise with foreign capital.
Article 10
In the event of a separation, merger or other major change, an enterprise
with foreign capital shall report to and seek approval from the
authorities in charge of examination and approval, and register the change
with the industry and commerce administration authorities.
Article 11
The production and operating plans of enterprises with foreign capital
shall be reported to the competent authorities for the record.
Enterprises with foreign capital shall conduct their operations and
management in accordance with the approved articles of association, and
shall be free from any interference.
Article 12
When employing Chinese workers and staff, an enterprise with foreign
capital shall conclude contracts with them according to law, in which
matters concerning employment, dismissal, remuneration, welfare benefits,
labour protection and labour insurance shall be clearly prescribed.
Article 13
Workers and staff of enterprises with foreign capital may organize trade
unions in accordance with the law, in order to conduct trade union
activities and protect their lawful rights and interests.
The enterprises shall provide the necessary conditions for the activities
of the trade unions in their respective enterprises.
Article 14
An enterprise with foreign capital must set up account books in China,
conduct independent accounting, submit the fiscal reports and statements
as required and accept supervision by the financial and tax authorities.
If an enterprise with foreign capital refuses to maintain account books in
China, the financial and tax authorities may impose a fine on it, and the
industry and commerce administration authorities may order it to suspend
operations or may revoke its business licence.
Article 15
Within the scope of the operations approved, enterprises with foreign
capital may purchase, either in China or from the world market, raw and
semi-processed materials, fuels and other materials they need. When these
materials are available from both sources on similar terms, first priority
should be given to purchases in China.
Article 16
Enterprises with foreign capital shall apply to insurance companies in
China for such kinds of insurance coverage as are needed.
Article 17
Enterprises with foreign capital shall pay taxes in accordance with
relevant state provisions for tax payment, and may enjoy preferential
treatment for reduction of or exemption from taxes.
An enterprise that reinvests its profits in China after paying the income
tax, may, in accordance with relevant state provisions, apply for refund
of a part of the income tax already paid on the reinvested amount.
Article 18
Enterprises with foreign capital shall handle their foreign exchange
transactions in accordance with the state provisions for foreign exchange
control. Enterprises with foreign capital shall open an account with the
Bank of China or with a bank designated by the state agency exercising
foreign exchange control. Enterprises with foreign capital shall manage
to balance their own foreign exchange receipts and payments. If, with the
approval of the competent authorities, the enterprises market their
products in China and consequently experience an imbalance in foreign
exchange, the said authorities shall help them correct the imbalance.
Article 19
The foreign investor may remit abroad profits that are lawfully earned
from an enterprise with foreign capital, as well as other lawful earnings
and any funds remaining after the enterprise is liquidated.
Wages, salaries and other legitimate income earned by foreign employees in
an enterprise with foreign capital may be remitted abroad after the
payment of individual income tax in accordance with the law.
Article 20
With respect to the period of operations of an enterprise with foreign
capital, the foreign investor shall report to and secure approval from the
authorities in charge of examination and approval. For an extension of the
period of operations, an application shall be submitted to the said
authorities 180 days before the expiration of the period. The authorities
in charge of examination and approval shall, within 30 days from the date
such application is received, decide whether or not to grant the
extension.
Article 21
When terminating its operations, an enterprise with foreign capital shall
promptly issue a public notice and proceed with liquidation in accordance
with legal procedure. Pending the completion of liquidation, a foreign
investor may not dispose of the assets of the enterprise except for the
purpose of liquidation.
Article 22
At the termination of operations, the enterprise with foreign capital
shall nullify its registration with the industry and commerce
administration authorities and hand in its business licence for
cancellation.
Article 23
The department under the State Council which is in charge of foreign
economic relations and trade shall, in accordance with this Law, formulate
rules for its implementation, which shall go into effect after being
submitted to and approved by the State Council.
Article 24
This Law shall go into effect on the day of its promulgation.
Important Notice:
This English document is coming from "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.
