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Service specification pharmaceutical commerce enterprises of medical institutions
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SB/T 11037-2013
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Basic data | Standard_ID | SB/T 11037-2013 (SB/T11037-2013) | | Description (Translated English) | Service specification pharmaceutical commerce enterprises of medical institutions | | Sector / Industry | Domestic Trade Industry Standard (Recommended) | | Classification of Chinese Standard | C00 | | Classification of International Standard | 03.080.20 | | Word Count Estimation | 13,141 | | Date of Issue | 2013-12-04 | | Date of Implementation | 2014-06-01 | | Quoted Standard | GB/T 28842-2012; SB/T 10767-2012 | | Drafting Organization | China Pharmaceutical Business Association | | Administrative Organization | People's Republic of China Ministry of Commerce | | Regulation (derived from) | No. 8 of 2014 (No. 176) China Industry Standards Record Announcement | | Proposing organization | PRC Ministry of Commerce | | Issuing agency(ies) | PRC Ministry of Commerce | | Summary | This standard stipulates the service items of medical commercial enterprises to medical institutions and their contents, as well as the standards that should be met by the service and the supervision and evaluation of service quality, and proposes the organizations, facilities and personnel that pharmaceutical commercial enterprises should have in order to do a good job. Requirements. This standard applies to pharmaceutical commercial enterprises within the territory of the People's Republic of China and to pharmaceutical manufacturers that sell pharmaceutical products directly to hospitals. | SB/T 11037-2013: Service specification pharmaceutical commerce enterprises of medical institutions
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Service specification pharmaceutical commerce enterprises of medical institutions
ICS 03.080.20
C00
Record number. 46957-2014
People's Republic of China domestic trade industry standard
Service specification of medical commercial enterprises to medical institutions
Released on.2013-12-04
2014-06-01 implementation
Published by the Ministry of Commerce
Foreword
This standard is a recommended industry standard, based on the "Contract Law of the People's Republic of China", "The Drug Administration Law of the People's Republic of China"
Quality Management Regulations, based on the development status of the domestic pharmaceutical circulation industry, with reference to the development level of the pharmaceutical circulation industry in developed countries, comprehensive above
The factors are formulated; the purpose is to promote the standardization and standardization of medical business enterprises' services to medical institutions, and to comprehensively improve the sales of medical products.
Distribution and supply service work quality.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is proposed and managed by the Ministry of Commerce of the People's Republic of China.
This standard was drafted. China Pharmaceutical Business Association, Sinopharm Holding Co., Ltd., China Resources Pharmaceutical Commercial Group Co., Ltd., Guangzhou Medical
Pharmaceutical Co., Ltd., Chongqing Pharmaceutical (Group) Co., Ltd., Zhejiang Yingte Pharmaceutical Co., Ltd., Huadong Pharmaceutical Co., Ltd., Yunnan
Provincial Pharmaceutical Co., Ltd.
Service specification of medical commercial enterprises to medical institutions
1 Scope
This standard stipulates the service items of medical commercial enterprises to medical institutions and their contents, as well as the standards and standards for services.
The supervision and evaluation of service quality puts forward the requirements of the organizations, facilities and personnel that pharmaceutical commercial enterprises should have in order to do a good job.
This standard applies to pharmaceutical commercial enterprises within the territory of the People's Republic of China and to pharmaceutical manufacturers that sell pharmaceutical products directly to hospitals.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 28842-2012 Pharmaceutical cold chain logistics operation specification
SB/T 10767-2012 Evaluation index of logistics service capacity of pharmaceutical wholesale enterprises
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Medical commodity themedicinecommodity
Special commodities for preventing and treating various diseases, ensuring good health and conducting scientific experiments are to save lives, save lives, and analyze and test.
Necessities, including drugs (referring to chemicals), medical devices, chemical reagents, glass instruments, proprietary Chinese medicines, and Chinese herbal medicines.
3.2
Drug drug
For the prevention, treatment, diagnosis of human diseases, purposefully regulate the physiological functions of the human body and provide indications or indications for function, use and use
Amount of substances, including Chinese herbal medicines, Chinese herbal medicines, Chinese patent medicines, chemical raw materials and their preparations, antibiotics, biochemical drugs, radioactive drugs, serum,
Vaccines, blood products and diagnostic drugs.
[Drug Administration Law, Article 102]
3.3
Specially managed drug drugunderspecialmanagement
Including narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs.
3.4
Refrigerated drug coldstoragedrug
For the storage and transportation of drugs with cold, freezing and other temperature requirements.
[GB/T 28842-2012, definition 3.1]
3.5
Pharmaceutical business enterprise pharmaceuticalcommerceenterprises
Enterprises engaged in the operation of pharmaceutical commodities; among them, those engaged in the operation of pharmaceuticals and medical devices refer to the "pharmaceutical business license" and "drugs".
Management Quality Management Standard Certificate "Medical Device Business Enterprise License" (limited to second-class and third-class medical device enterprises)
The Legal Person Business License, which sells pharmaceutical products such as medicines and medical devices purchased to pharmaceutical commodity manufacturers, business enterprises and medical institutions.
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