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Notice of the State Food and Drug Administration on the implementation of the new revision of the newly revised "Specifications for the Management of Drug Operations"
Release time: 2013-07-25 & nbsp & nbsp & nbsp Source: Anonymous

Each province、Autonomous Region、Food and Drug Administration (Drug Supervision Administration),Xinjiang Production and Construction Corps Food and Drug Administration:

Newly revised "Specifications for the Management of Drug Business" (hereinafter referred to as Drug GSP) has been released。According to the relevant provisions of the Drug Management Law of the People's Republic of China and the overall requirements of the "National Drug Safety & LDQUO; Twelve Five -Year Plan",Requirements for the State Food and Drug Administration,Complete the implementation of the new revised drug GSP by the end of 2015。To promote this work smoothly,The relevant matters are notified as follows:

1、Improve ideological understanding,Do a good job of learning, propaganda and implementation

Implementation of new revised drugs GSP,It is a standardized order of drug circulation,Improve the level of drug management and service,Important measures to maintain public health rights。Food and drug supervision departments at all levels must fully Stake Sports Bettingunderstand stake betting appthe importance and urgency of implementing the new revised drug GSP,Effectively strengthen organizational leadership、Clear work responsibility、Implementation implementation plan,Promote the orderly development of work。To organize relevant regulatory personnel to carefully study the newly revised drug GSP,Master content,Grasp the key,Grasp the main points。We must use a variety of forms to actively promote the society,Make the public understand that the newly revised drug GSP is to ensure the safety of drugs、Standardize the significance of the order of drug circulation; let the enterprise realize that the newly revised drug GSP is adjusted to promote industry structure、The important role of promoting industrial upgrading,Create a good atmosphere of implementation work。To strengthen investigation and research,Find out the status and problems of drug business enterprises in the area,Take a targeted measure,Promote enterprises to transform in accordance with the requirements of the newly revised drug GSP,Complete implementation work within the prescribed time limit。

2. Adjust work ideas and do a good job of functional conversion

According to the "Notice of the General Office of the State Council on Printing and Distributing the Regulations on the Compilation of the State Administration of Food and Drug Administration in the main responsibilities of the State Food and Drug Administration" (State of the Statement and Personnel Preparation of the State Administration,The administrative licensing of administrative licenses and drug management quality management standards for drug operation will gradually integrate into an administrative license。The implementation of the newly revised drug GSP is a good opportunity to promote the transformation of function,The requirements for functional changes also provide strong support for the successful implementation of newly revised drugs GSP。Make full use of this opportunity,Do a good job of integrating two stake online sports bettingMy stake betting appadministrative licenses。From now on,"Drug Operation License" or "Drug Operation Quality Management Certification Certificate" of drug business enterprises,All take the newly revised drug GSP as the standard,Wholesale Enterprise、Retail Enterprise Organization Inspection,Meeting the requirements,Replacement "Drug Operation License",Putting "Certificate of Quality Management Specifications for Drug Operation"。 Before December 31, 2013,The certificate expires but it cannot complete the transformation,You can apply for,The validity period of the certificate will not exceed the continuation of June 30, 2014。

3. Clear time limit requirements, do a good job of implementing step by step

Active、Promoting the implementation of the new revised drug GSP steadily,The integration of two licenses in various places should be combined with two licenses and in accordance with the following time limit requirements,Develop a specific work plan,Implementation step by step。

(1) From July 1, 2013,Newly opened drug business enterprises,and drug business enterprises apply for new creation (change、Expansion) Business places and warehouses shall meet the requirements of the newly revised drug GSP, Eligible issuance of "Drug Operation License" and "Drug Operation Quality Management Certificate Certificate"。

(2) Before December 31, 2014,Operating vaccine、Anesthesiologically and psychotropic drugs, and wholesale companies of protein assimilation preparations and peptide hormones、Wholesale enterprises that can accept the storage and distribution of drugs through approval,It should meet the requirements of the newly revised drug GSP,Eligible renewal "Drug Business License" and "Drug Operation Quality Management Certificate Certificate";,Nuclear reduction in its corresponding business scope or cancel its entrustment。

(3) Before December 31, 2015,All drug business enterprises regardless,It must meet the requirements of the newly revised drug GSP。From January 1, 2016,The GSP requirements of the newly revised drug are not met,Do not continue Stake Sports Bettingstake online sports bettingto engage in drug business activities。

4、Coordinated planning deployment,For the implementation of the implementation work to achieve effectiveness

Provincial food and drug regulatory authorities should take the implementation of the newly revised drug GSP as a key task of regulatory work at the present and in the future.,Put an important position,Intellectual schedule。To conduct in -depth investigations and research,Find the contradictions and problems that affect work development,Formulate a specific work plan in combination with the actual area of ​​the jurisdiction,Take practical measures,Coordinated planning arrangements。To effectively strengthen the construction of the inspector team,Vigorously carry out the training of inspectors and relevant regulators,Efforts to improve the quality of the drug GSP inspection。We must do a good job of publicity of drug business enterprises in the jurisdiction、Education and training,Classified guidance of enterprises,Create a good working environment。Strictly implement the standard,Carry out certification and inspection in accordance with the law,Poor business conditions,Irregular management,Drug business enterprises that disrupt market order,To resolutely clear out the market。Strive of work discipline,Do not perform their duties seriously,Caused that the implementation of new revised drugs GSP is not effective,To resolutely correct,and seriously investigate the responsibility of relevant departments and personnel。

To ensure the smooth development of the new revised drug GSP work,The General Administration will strengthen policy research and guidance,Coordinating relevant departments,In the distribution of basic drugs、Undertaking national pharmaceutical reserves、Selecting a medical insurance designated pharmacy and other aspects to introduce corresponding encouragement policies; explore the establishment of a classification management system for the establishment of a stake betting appstake betting appdrug business enterprise,Improve the Pharmaceutical Pharmacist system; speed up the introduction of supporting documents for the implementation of new revised drugs GSP; actively do a good job of training。The General Administration will strengthen the urging of the implementation of the work in various places、Check and guide。Please report to the General Administration in time。

 


State Food and Drug Administration
June 24, 2013