Enterprise leave sample check conform to stipulate suspected of being involved in bad medicine destroy or seal up for safekeeping temporarily in situ?

Enterprise leave sample check, conform to, stipulate, suspected of being involved in bad medicine, destroy or seal up for safekeeping temporarily in situ?
I think according to the stipulations of law, these 5 boxes of medicines should be pulled away and destroyed! No, should seal up for safekeeping temporarily. Pursue /Zhu TianMing The topic is returned: First medicines that one medicines manufacturing enterprise produces can see foreign matter project not in accordance with regulation by test, the medicines supervision department has placed it on file and investigated and prosecuted according to producing and selling bad medicine. Through investigating, this batch of medicines is except that 5 boxes left a kind of medicines, the others have already been all sold. While handling the course in the case, the enforcer should confiscate and produce and have different views while leaving a kind of medicines to 5 boxes: Someone thinks according to the stipulations of article 75 of " law of medicine management ": "Ones that produce, sell bad medicine, confiscate medicines produced, sold illegally "Because has not left a kind of medicines and made special regulation to enterprises, should confiscate in accordance with the law. Someone thinks according to the stipulations of article 9 of " law of medicine management ": " medicines manufacturing enterprise must make " medicines standardard management of quality of production " organize producing " " according to law this according to department, pharmaceuticals administration of the State Council, ,And <>Leave a kind of products and should keep medicines for one year after validity at least according to registering the storage terms that are sanctioned in 225th regulation, if confiscate and destroy in accordance with the law, medicines already sold are imitated or the bad incident appears, will not contrast products than the right situation, should refuse to confiscate to leaving a kind of medicines in view of the above, continue being left kind and dealt with by enterprises. Somebody thinks that should confiscate in accordance with the law, is sealed up for safekeeping and leave one kind of rooms in enterprises by the medicines supervision department, destroy after leaving a kind of expiration. Because first medicines are suspected of being involved in bad medicine, do you think that how 5 boxes of medicines of kind are dealt with staying to enterprises? The view 1: Go on, destroy author, think, should stay a kind of medicines, go on confiscating to 5 box after leaving a kind of expiration, sealed up for safekeeping and leave one kind of rooms in enterprises by the medicines supervision department, destroy after leaving a kind of expiration. The reason is as follows: First of all, article 75 of " law of medicine management " stipulates: "Ones that produce, sell bad medicine, confiscate medicines produced, sold illegally "This enterprise has not determined the nature to appeal this medicines, there is no objection to result that medicines supervision department examines to prove it, this case has already entered and carried out stage, because the law does not have particular provisions in leaving a kind of medicines, so, leave a kind of medicines and should confiscate 5 boxes involved in accordance with the law. Secondly, the original intention that " law of medicine management " legislates, using medicine in order to guaranteeing the people is safe as the purpose. The medicines supervision department deals with the situations of various fields to consider synthetically while implementing administrative penalty, in order to fully implement the legislative original idea, but not quote out of context to the legal clause mechanically. The second paragraph of article 4 of " law of administrative penalty " stipulates: It must be based on fact to presume and implement administrative penalty, equal to fact, property, plot and social extent of injury of the illegal activities. Reach the actual conditions of this case specifically, medicines which flowed into the market have already been sold, the unlawful gains that the enforcer should sell first medicines to enterprises in accordance with the law are confiscated and fined correspondingly. Because these 5 boxes have left a kind of medicines already under the control of medicines supervision department and enterprise, it is impossible to continue circulating on the market, so will not cause the behavior of endangering the people's life and health. Third, false medicine to confiscating, supervision department generally destroy medicines after the expiration of time limit of the case lawsuit, but properties which leave a kind of medicines have their particularity, within term of validity, it is playing the function that is traced back to or investigates to the medicines quality of manufacturing enterprise. <>Article 225 stipulates: Should keep medicines for one year after validity at least according to registering the storage condition that is sanctioned while leaving a kind of products. If during this period, have already sold medicines and is imitated or the bad incident appears, leaving a kind of medicines can be regarded as and contrasted products to use, will otherwise have no awkward situation suitable for consulting of contrast product. To sum up, in should get up in the treatment course of the case, the medicines supervision department is while dealing with this enterprise in accordance with the law, because these 5 boxes leave the situation belonged to needing to retract and destroy immediately of a kind of medicines, as to this should confiscate, is sealed up for safekeeping and leaves one kind of rooms in enterprises by the supervision department, destroy after leaving a kind of expiration. The food medicines supervision bureau of Fengxiang county of Shaanxi Province is old first medicines which the dragon produces can see foreign matter project not in accordance with regulation by test dawn, the medicines supervision department produces and sells behavior of bad medicine to place to it on file and investigate and prosecute, should according to the 75th regulation of " law of medicine management " " Confiscate medicines and unlawful gains produced, sold illegally " . Remaining 5 box leave kinds of medicines, belong to medicines that produce obviously, except the intersection of string and regulation this especially explain and leave samples, so, so long as bad medicine, no matter leave samples, should all confiscate in accordance with the law. But because of particularity of this case, only remaining 5 box medicines to stay samples, within validity of this medicines, leave sample bear to this enterprise the intersection of batch and the intersection of products and " quality is traced back to or investigates " this Important task. Combine with the complexity of the market of medicines, this batch of medicines can not be all retrieved on the market because of investigation of a case and destroyed, pass non- medicines off as medicines or pass a kind of medicines of his off as the illegal activities of this kind of medicines to happen repeatedly, the quality of medicine of imitation and poor quality is inquired about inevitably. So, weigh the advantage and disadvantages, these 5 boxes leave samples and should keep and leave one kind of rooms in the manufacturing enterprise temporarily, let it continue playing a due role. What merits attention is, the medicines supervision department is unsuitable to confiscate and keep and will leave samples. According to the stipulations of new GMP, leave kind and should keep until one year after the validity of medicines at least according to registering the storage condition that is sanctioned. But the medicines supervision department does not have " Register the storage condition sanctioned " ,If after this medicines are confiscated and kept to the medicines supervision department, because store the condition to change or store in a wrong way, it is extremely apt to cause the other indexes of medicines to change or lose and damage. In addition, once meet quality of inquiring of manufacturing enterprise this batch of medicines of other supervision departments, enterprises are unable to reply. Propose defining this kind of situation clearly when " law of medicine management " is revised, in order to solve this kind of dispute. Gansu Province the intersection of Qingyang and municipal the intersection of food and the intersection of medicines and supervision bureau stock medicines stay management of kind refer to the intersection of medicines and manufacturing enterprise leave kind to product that have merchandize already slowly, leave kind and observe it with serial activities such as examining regularly, analysis of the stability data variation tendency, in order to guarantee the inherent quality of the products accords with the demands for regulation all the time. The products stay kind has two purposes: First, in order to analyze that tests that offers samples ' Contrast samples) ; Second, as finished real kind, for the demonstration of product, distinguish that packs, sticks signing, shape characteristic of the products, lot number, term of validity,etc.. " the medicines manufacturing enterprise leaves kind and seals and signs the management system " stipulates, the medicines supervision department is on the premise of a voluntary one of enterprise, to the intersection of medicines and medicines that manufacturing enterprise produce ' Excluding raw materials medicine and traditional Chinese medicine are drunk Slice) Leave kind and seal and sign and manage. The topic? School �� ���'s large bamboo or straw hat with a conical crown and broad brim flies to wash gruels and consult Xi �? Box medicines will not cause danger to the society for sale. " the law has not expressed regulations not excessive " ,Since the laws and regulations do not carry on the regulation in leaving the treatment of a kind of medicines at present, propose the medicines supervision department seals it up for safekeeping in enterprises to leave one kind of rooms, destroys after leaving a kind of expiration. The Tai County food medicines supervision bureau of provincial governor of Fujian has Duan JianMin of the municipal food medicines supervision bureau of Hubei Wuhan to forgive agricultural readers who hold this kind of view of will, the intersection of Fujian Province and the intersection of gloss and the intersection of county and the intersection of food and ZhengFang Ling, medicines of supervision bureau, the intersection of Fujian Province and the intersection of clear stream and the intersection of county and the intersection of food and the intersection of medicines and forest dawn of supervision bureau, the king of the food medicines supervision bureau of Yuexi county of Anhui Province is three springs, Zhou Feng of the municipal food medicines supervision bureau of Jiujiang of Jiangxi Province, Chen YiTing of the medicines supervision bureau of food of Yunxiao County of Fujian Province,etc.. The view 2: Confiscate and deal with it according to the stipulations of article 75 of " law of medicine management " in accordance with the law: "Ones that produce, sell bad medicine, confiscate medicines and unlawful gains produced, sold illegally, and produce, sell the penalty of more than one but less than three times amount of money of the medicines goods value illegally in the place "It is obvious, should confiscate leaving samples of manufacturing enterprise too. The 2005 version " pharmacopoeia " stipulates, use the standard product and contrast products in test of medicines, it is the standard material used for being distinguished, checked, the content is determined. In this case, this medicines have already been judged and does not possess the function of contrasting product as bad medicine, can't regard as, contrast product go on than right again. Moreover, medicines of this batch already sold have already been judged as bad medicine, should deal with, must not let medicines not up to standard flow into the market, endanger public health. The municipal food medicines supervision bureau of Gongyi of Henan Province lets some gorgeous medicines manufacturing enterprises should leave medicines which are suspected of being involved in bad medicine of kind according to the regulation of article 75 of " law of medicine management ": "Ones that produce, sell bad medicine, confiscate medicines produced, sold illegally ",Confiscate, can't retain or seal up for safekeeping and leave one kind of rooms in the manufacturing enterprise. Though <>Article 225 stipulates: " leave a kind of products and should keep medicines for one year after validity at least according to registering the storage condition that is sanctioned " ,But it is the next compared with " law of medicine management " in its law,according to at there last principles of law the next is location law, when there are conflicts in the next law and regulation of the law of location of going, the location law of using going preferably, namely use " law of medicine management " preferably. In addition, if bad incident imitated has appeared after this bad medicine, the medicines supervision department can well manage the regulations of the laws and regulations according to medicines, sources such as the medicines sales figure, buying the record of acceptance through enterprises,etc. flow into the irrigation ditch to investigate and verify the true and false. And supervision department can seal medicines up for safekeeping and examine the relevant storehouses of the organization in the medicines storehouse or medicines which accords with this organ that stores the condition of it after confiscating this bad medicine, use in order to contrast investigating and verifying. Totally unnecessary to retain or seal it up for safekeeping, leave kinds of room on enterprise, there are no laws to abide by and future trouble sows in order to this measure of preventing from. Supervision bureau Lin Hong's big view 3 of food medicines of Suiping county of Henan Province: The key that should confiscate lies in recalling in accordance with the law, confiscating and staying to enterprises 5 boxes of medicines of kind, whether need it when this batch of medicines is imitated or appeared situations such as the bad incident,etc., by leaving samples and going on than to verifying. Medicines this can see test foreign matter project not in accordance with regulation, until bad medicine determine the nature conclusive fact and according to abundant. Since characterize as bad medicine, must have potential safety hazards, accord with the regulation of article 4 (potential safety hazard in these procedures that " medicines recall management ", it is unreasonable and dangerous that the ones that mean because the reason of researching and developing, producing etc. may make medicines have threaten the security of health and life) . The 5th regulation that " medicines recall management " at the same time, the medicines manufacturing enterprise recalls the obligation of the medicines with potential safety hazard. So, medicines supervision department should regulation of article 25 order manufacturing enterprise this sell already until " whether medicines recall management " but these batch of medicines in market circulation Recall. Then stay 5 box these medicines of kind confiscate according to the 75th regulation of " law of medicine management " together with medicines recalled. In this way, can prevent the medicines from need, carry on than right contradiction in cases imitated or bad incident,etc. appears. Readers who holds this kind of view of supervision bureau Li Ming of medicines of Nanshi food of Wei of Shaanxi Province have Henan Guo ZongHai of the food medicines supervision bureau of township county inside the province, Hu YanLing of the food medicines supervision bureau of Qihe River county of Shandong, knowing the army high of huge rock municipal food medicines supervision bureau of Jilin Province, Jilin Province the intersection of Tonghua and the intersection of county and the intersection of food and the intersection of medicines and supervision bureau embroider gentle, etc slowly. The view 4: Enterprises deal with the medicines supervisor in enforcing the law and handling a case according to leaving the sample regulation, should go on according to procedure of rules and regulations and requirement strictly, but not act according to its will. First of all, it is not the goods that manufacturing enterprise of the traditional Chinese medicine product of this case leaves samples, do not have legal attribute of circulation of commodities, so should not confiscate these 5 boxes and leave a kind of medicines in accordance with the regulation of article 75 of " law of medicine management ". Secondly, " seal up for safekeeping and leaves one kind of rooms in enterprises after confiscating in accordance with the law by the medicines supervision department, destroy after leaving a kind of expiration " Statement there are no laws to abide by. Once medicines of imitation and poor quality are confiscated, the ownership of medicines is shifted promptly, the obligation which enterprises keep on having medicines that are confiscated, there are no enterprises to confiscating the mandatory clause that articles are paid and kept in law. So, should not confiscate to leaving a kind of medicines, but should be dealt with according to leaving the sample regulation by the manufacturing enterprise. Third, <>Already medicines of kind have been regulated specifically to staying in article 225, " law of medicine management " and " implementing regulations of the law of medicine management " do not have clear provision in leaving a kind of medicines, since the rule has regulations, the enforcer should understand and carry out this regulation correctly, administer the state according to law. Will stipulate clearly: "Should keep medicines for one year after validity at least according to registering the storage condition that is sanctioned while leaving a kind of products. " I think, it should be that manufacturing enterprises produce the behavior after the finished product to store and leave a kind of medicines, but not the medicines supervision department hands over to enterprises to store after confiscating. So, as to this leave a kind of medicines and should continue being dealt with by this manufacturing enterprise. Henan Province the intersection of Hebi and municipal the intersection of food and medicines supervision bureau often will duckweed

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