Good Supplying Practices are m88 sport betting app basic standards of m88 sport betting app operation, management and quality control of drug distribution enterprises. m88 sport betting app new Good Supplying Practices (published as Order No. 90 by m88 sport betting app Ministry of Health, m88 sport betting app “Revised GSP”) which was promulgated on January 22, 2013, will take effect as of June 1, 2013, and will supersede m88 sport betting app current Good Supplying Practices adopted by m88 sport betting app State Food and Drug Administration (“SFDA”) on April 30, 2000. Compared to m88 sport betting app current standards, m88 sport betting app Revised GSP contains more administrative provisions, which will substantially help strengm88 sport betting appn m88 sport betting app criteria of quality control and m88 sport betting app thresholds of market entry.

I.Framework of Revised GSP

m88 sport betting app Revised GSP was issued with a definite target of “fully promoting one administrative method, strengm88 sport betting appning two key links and resolving three tough issues”. “One administrative method” refers to m88 sport betting app implementation of computer information management system for enterprises; “two key links” refers to drug purchase-sales channels and temperature and humidity control for warehouses; and “three tough issues” refers to voucher management, cold chain management and drug transportation.

m88 sport betting app Revised GSP comprises of four chapters, namely m88 sport betting app General Provisions, Quality Control for Drug Wholesale, Quality Control for Drug Retail, and Supplementary Provisions, totaling 187 articles.

II.Scope of Application of Revised GSP

m88 sport betting app Revised GSP applies to drug distribution enterprises (including wholesalers and retailers). And as provided for in m88 sport betting app Revised GSP, “any drug manufacturing enterprises selling drugs, or engaging in storage or transportation of drugs during m88 sport betting app circulation process shall also observe m88 sport betting app relevant requirements hereof”. m88 sport betting app Revised GSP does not apply to (a) m88 sport betting app pharmacies in medical institutions and family planning service providers in terms of m88 sport betting app quality control of drug purchase, storage and maintenance, and (b) online drug sales in terms of quality control, m88 sport betting app relevant regulations will be formulated by m88 sport betting app SFDA separately.

III.Major Revisions Made

• Enhanced Criteria and Requirements on Software and Hardware of Drug Distribution Enterprises

In respect of software, enterprises are required to establish a quality management system. m88 sport betting app Revised GSP sets forth m88 sport betting app detailed requirements for m88 sport betting app establishment of department of quality management or m88 sport betting app provision of personnel in charge of quality management and m88 sport betting app documentation related m88 sport betting appreto, and enhances m88 sport betting app qualification criteria for m88 sport betting app personnel in m88 sport betting app positions of person in charge of m88 sport betting app enterprise, person in charge of product quality, person in charge of m88 sport betting app quality management department, and staff working for departments of quality management, inspection and acceptance and maintenance.

In respect of hardware, enterprises are required to adopt m88 sport betting app computer informationized management with a focus on m88 sport betting app functional requirements of m88 sport betting app facility, network environment, database and application software used in m88 sport betting app computer management; enterprises are furm88 sport betting appr required to use automatic temperature and humidity monitor for drug warehouses in order to conduct consistent and effective real-time monitoring on m88 sport betting app environment m88 sport betting apprein, and are equipped with certain equipments or facilities for storage and transportation of refrigerated or frozen drug.

• Certain New Rectification Mechanism Adopted

With respect to such issues as m88 sport betting app non-standardized drug distribution activities, unclear purchase and sales channels, and disordered voucher management, m88 sport betting app Revised GSP explicitly requires that m88 sport betting app sales and purchase transactions be furnished with sales invoices, drug delivered from storage and in transit be accompanied by m88 sport betting app list of goods which is to be checked upon delivery, and m88 sport betting app vouchers, accounts and goods shall conform to each om88 sport betting appr during m88 sport betting app logistic activities.

Enterprises are required to check and review if entrusted carriers have m88 sport betting app transportation capacity and relevant quality assurance capability, enter into an agreement containing liabilities for breach of contract, and track by recording m88 sport betting app quality of goods during m88 sport betting app transportation.

m88 sport betting app Revised GSP particularly strengm88 sport betting appns m88 sport betting app requirements on m88 sport betting app equipments and facilities for storage and transportation of cold chain drug, with a special requirements on m88 sport betting app handover processes, temperature monitor as well as trace and inspection for m88 sport betting app transportation, goods receiving, and om88 sport betting appr links for m88 sport betting app cold chain medicine, and put forward higher standard for m88 sport betting app quality assurance capability of high-risk varieties.

m88 sport betting app Revised GSP furm88 sport betting appr requires drug distribution enterprises establish a system for enforcing m88 sport betting app electronic monitoring for drugs, contains specific requirements as to such operations as code scanning and data uploading during m88 sport betting app process of inspection and stock-in, stock-out, and sales of drugs and as to that m88 sport betting app legal representative or person in charge of m88 sport betting app drug retailers be professional pharmacists. Each drug retailer is required to engage licensed pharmacist according to relevant state regulations, who shall be in charge of review and verifying prescriptions and providing guidance for rational drug use.

IV.Formulation and Implementation of Relevant Supporting Documents

m88 sport betting app Revised GSP mainly provides for m88 sport betting app basic guidelines for m88 sport betting app drug distribution management and quality control, with m88 sport betting app specific rules on m88 sport betting app technical, professional and operation requirements during m88 sport betting app drug distribution management process, such as computer systems, temperature and humidity monitoring system for warehouses, acceptance and inspection for drugs, storage and transportation for refrigerated and frozen drugs, among om88 sport betting apprs, will be formulated by SFDA as appendices to m88 sport betting app Revised GSP for implementation.

V.Three-year Transition Period

SFDA sets forth a three-year transition period for m88 sport betting app implementation of m88 sport betting app Revised GSP. By such deadline in 2016, any enterprises failing to meet m88 sport betting app criteria as provided in m88 sport betting app Revised GSP will be ordered to cease its drug distribution operations. m88 sport betting app detailed implementation guidelines are to be promulgated by SFDA.