Our city will launch GSP certification for drug handling enterprises

If it fails to pass the certification within the time limit, it is not allowed to continue to engage in drug trading activities On February 20, the Municipal Food and Drug Administration issued a notice, starting from February 24, it will launch the new GSP certification of the city's drug wholesale enterprises and drug retail chain enterprises (i.e the newly revised "drug trading quality management specification") It is reported that those who fail to pass the certification within the time limit will not be allowed to continue to engage in drug trading activities, so some enterprises may be eliminated It is understood that there are more than 500 drug wholesale enterprises and 13000 drug retail enterprises in our city at present, but most of them are "making small noises" "The new GSP comprehensively improves the standards and requirements of business operation." The Municipal Food and Drug Administration explained that while ensuring the quality of drugs, the market access threshold was raised For example, in terms of software, the new regulations clearly require enterprises to establish a quality management system In terms of hardware, the enterprise shall adopt the automatic monitoring system of temperature and humidity for the drug warehouse, and implement continuous and effective real-time monitoring for the storage environment; it is required to equip specific facilities and equipment for the storage, transportation, refrigeration and freezing of drugs Some of the enterprises or the eliminated SFDA set out a schedule for drug distributors If a drug wholesale enterprise applying for establishment before May 31, 2013 has obtained a drug trade license but has not yet applied for GSP certification, it shall apply for a new revision of GSP certification before March 17, 2014; Before June 30, 2014, any drug wholesale enterprise or drug retail chain enterprise whose drug trade license or drug trade quality management specification certificate expires shall apply for a new license and pass the newly revised GSP certification before June 30, 2014; From July 1, 2014, any drug wholesale enterprise or drug retail chain enterprise whose drug trade license or drug trade quality management standard certificate expires shall apply for a new license before the expiration of the certificate and pass the newly revised GSP certification; Before December 31, 2015, all drug wholesalers and drug retail chain enterprises must apply for a new license and pass the newly revised GSP certification, regardless of whether their "drug trade license" and "drug trade quality management standard certification certificate" expire Those who fail to pass the certification within the time limit shall not continue to engage in drug trading activities "Due to the high requirements of the new GSP, it is undoubtedly a reshuffle for drug wholesale and retail enterprises." Some enterprises may be eliminated, the person in charge said For the public, the most direct benefit of banning pharmacies without licensed pharmacists is that there will be guidance from licensed pharmacists when buying drugs in pharmacies "The new GSP has a rigid regulation on the licensed pharmacist system, and it is forbidden to open pharmacies without licensed pharmacists." According to the new GSP regulations, the legal representative or person in charge of a retail pharmaceutical enterprise shall have the qualification of a licensed pharmacist, and the enterprise shall also have a licensed pharmacist in accordance with the regulations, who shall be responsible for the prescription review and guide the rational use of drugs.