Will launch in Shanxi from now on - the medicines will be renovated one hundred days safely will take action-
In order to prevent and control the emergence of the safe incident of great medicines effectively, further promote Shanxi medicines' security level, centralized time, gathering, concentrating on solving the outstanding problem that the domain of medicines exists, it is determined that the province eats Bureau of Drugs Supervision: From July 20, the food pharmaceuticals administration department of the whole province launches " Medicines are renovated safely to take action in one hundred days " . Renovate and regard influencing safe key link of medicines as the emphasis point this time, arrange checking as the foundation big with the potential safety hazard, put forth effort to solve the problem that not according to standardizing the production and management, attack and produce and sell serious illegal activities such as medicines of imitation and poor quality, unlicensed business activity,etc. sternly, strict Cong is heavy to investigate and prosecute a batch of main points case quickly, forms the high-pressure situation of the new round of fright unlawful practice in accordance with the law. In renovating the medicines production ink, regard implementing medicines GMP as and check the basis, launch risky enterprise, risky variety, special medicines and arrange and check the activity big for all medicines quality potential safety hazards of manufacturing enterprise of the focal point, check enterprise's supplies buying, production process control, quality inspection, prescription and production technology implementation especially. Strengthen badly to personnel's quality, the management level is low, inspect the disqualification rate by random samples to supervise and inspect more than the high risky medicines manufacturing enterprise, strengthen and arrange checking to risky assortment hidden dangers such as blood product, injectable preparation medicines, special medicines,etc.. Strengthen special medicines to produce and supervise, strict special medicines raw materials medicine are examined and approved, check special medicines severely and include the sale of compound preparation medicines of special medicine to flow into. In renovating the links of circulating of medicines, regard changing the card as the opportunity, strengthen the market to renovate in an all-round way, stress that renovates the serious behavior that upsets illegality of the management order, check medicines and manage enterprises and buy contents such as channel, condition of the storage, note management, business scope,etc. especially, investigate and prosecute sternly and is affiliated to, crossed the ticket to manage, retail and hire out the counter, the waybill is separated, ultra way, out-of-range operation, promote the medicines management order to further standardize. Strengthen the supervision of special medicine of link to circulating, check the storage conditions and marketing channels of narcotics, a kind of psychotropic substances especially, standardize albumen and assimilate preparations, peptide type hormone ' Including including rough preparation) Operation. Strengthen the supervision to that the medical organization used medicines, check under the county especially medical organization and individual clinic, clinic medicines buy the channel, attack and buy medicines, use the medicines illegal activities of imitation and poor quality from the illegal channel sternly. In the medical equipment is renovated, check contents such as the quality management system, raw material sources, production technology, delivery inspection of manufacturing enterprise,etc. especially. In managing and using links, strengthen the risky medical equipment to supervise and inspect, plant dept. of orthopedics into the thing especially, artificial heart and lungs apparatus, the blood dialyses and strains the apparatus with the blood, products such as the conduit, support,etc. buy channel, products qualification, record of acceptance of purchase, whole management system to check in pacemaker, blood vessel, investigate and prosecute illegal production, unlicensed business activity, out-of-range to manage and buy the illegal activities of the medical equipment from the illegal channel sternly. The focal point that renovate, for being thorough to check large case of taking, units at various levels eat medicines supervise the department to check through strengthening medicines, concentrate strength on investigating and dealing with a batch of influential illegal cases of medicines according to law, attack and investigate and prosecute and produce and sell medicines of imitation and poor quality, violate the standardard management of quality, illegal channel and purchase and sell illegal activities such as medicines,etc. seriously especially, to that the production, management, user of the illegal activities take place seriously and many times in the illegal activities, strictly according to " Two is high " " about handling and producing, selling false medicine, the explanations of several questions of concrete application law of criminal case of bad medicine ", transfer the eligible case to the public security organ in time, punish severely in accordance with the law. (Wen YuXing)
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