Our country implements the dual licensing licensing of medical device management with caution
Our country implements the dual licensing system for registration of medical device management, license and license of registered varieties Yaoxie production varieties. The relevant regulatory authorities should understand the licensing laws and regulations, in order to perform their duties in the process of consciously to prevent the risk of dereliction of duty.
Don't allow the license.
In accordance with the drug administration law, medical equipment supervision and management regulations and other laws and regulations, if the applicant does not meet the conditions for approval of the administrative license, there may be suspected of dereliction of duty, there are mainly the following two cases:
1 does not meet the conditions permit. Mainly refers to the variety of registration and production, operating access does not meet the conditions of the license. From the "on administrative licensing," "does not conform to the statutory conditions of the applicant to grant an administrative license" to "Drug Administration Law", "medical equipment supervision and management regulations" does not meet the requirements for certification certificate issued, production, business license approval, approval of imports, clinical trials, drug registration, approved drug advertising publishing other do not meet the conditions of the licensing act, the provisions of the "constitutes a crime, shall be investigated for criminal responsibility". There are strict and complete the prescribed conditions such as drug registration of clinical trial data, production processes on-site verification, pharmaceutical production license of the hardware facilities, quality management system, pharmaceutical trading license storage conditions, pharmacists on-the-job and the, any relaxation or conditions be granted permission to give up may form the risk of dereliction of duty.
To national level of drugs and medical devices registration approval, small counties level retail pharmacy business license and a kind of medical apparatus and instruments for the record registration, once the harmful consequences, the risk of dereliction of duty may evolve into the crime of dereliction of duty. The bottom line here constitute a crime should be understood as the Supreme People's court and the Supreme People's Procuratorate "on Several Issues concerning the application of law in the handling of criminal cases of dereliction of duty to interpretation" (hereinafter referred to as dereliction of duty, our solution) the first article on "great loss" and if the circumstances are especially serious "set of quantitative bottom value. Whether it is knowing that do not meet the conditions, or the negligence of the relaxation of the conditions to grant permission to set value will escape the abuse of authority, dereliction of duty of accountability.
2 over the scope of authority permits. According to different varieties and scope of production and operation, existing laws and regulations and professional regulations will be varieties of registration approval and production and operation of access permissions granted to the pharmaceutical supervisory and administrative departments of different levels, beyond the legal authority scope of authorization license, intentional is the abuse of power, unintentional is a dereliction of duty, if it involves the interests to plus or engages in malpractice for personal gain.
"On administrative licensing", "Drug Administration Law", the administrative measures for the registration of drugs, the drug is easy to precursor chemicals management approach "and other laws and regulations to the" beyond the statutory authority to make a decision to grant administrative license ", to make the provisions of the" constitutes a crime, shall be investigated for criminal responsibility ". It is understood that super powers license occurred in below the provincial drug administration departments, in varieties of registration approval, cross breed license, shall be borne by the State Bureau of examination and approval of the drug, in some basic bureau is according to medical device registration and approval; the second is cross license category, class II medical devices shall be borne by the Provincial Bureau for examination and approval, in some of the Municipal Bureau but its registration as a kind of medical apparatus and instruments.
License should not be allowed to leak
To comply with the statutory conditions shall be granted made decision not to license, or beyond the statutory time limit, make a decision of approval, which in general is not easy to arouse the attention of regulators, more not easy and dereliction of duty crime linked.
1 decided not to permit. Professional regulations of the law of administrative licensing and the drug, medical device registration approval and access permission to applicants who meet the statutory conditions to make a decision on disapproval of administrative licensing, "constitutes a crime, shall be investigated for criminal responsibility" provisions. The harm of the crime of dereliction of duty is more to the specific population - the application of artificial into a major economic loss. Once the applicant has the burden of proof, the license without permission, resulting in the loss of the company to achieve the Secretary of the Department of dereliction of duty to solve the major losses and serious cases of the bottom line, the crime of dereliction of duty will constitute. Such as some varieties of application for registration, in line with the statutory conditions has made decided not to grant the approval, the applicant can not be reconciled into early research and clinical trials of huge funds causes losses, in accordance with the law to safeguard their own rights and interests.
2 term license. To make a decision to grant an administrative license, but not within the statutory time limit, "which constitutes a crime, shall be investigated for criminal responsibility in accordance with the law". Here constitute the crime of dereliction of duty of risk in addition to may cause the applicant huge economic losses, is more important, the varieties registered in May for the approval of the delay time, the original should be is the first variety, by others of the same species replacement for non new varieties; originally should is the patented product has lost the opportunity to apply, so that the applicant shall enjoy the many legal, policy and market priorities right no longer has. Once the applicant by legal means, dereliction of duty which must be accountable.
Permission not to violate the rules of procedure
License in accordance with the law, in addition to must be in accordance with the statutory conditions permit, must also be in accordance with the statutory licensing procedures, or may be caused by dereliction of duty and jailed.
1 violation of the procedures permit. Varieties of registration approval, production, business access permission although is a behavior of using administrative power, but due to the medicines, medical apparatus and instruments relating to people's health and life safety, and itself has the technical content, especially in the registration and approval varieties, more is a technical review and approval.