The third batch of collection came 86 rules to start information collection.
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Last Update: 2020-07-28
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Source: Internet
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Author: User
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On the second of month, Shanghai Sunshine Pharmaceutical Procurement Network issued a "notice on the implementation of some drug-related basic information collection work" announcementDrug-related enterprises: In order to do a good job in the centralized procurement of drugs related work optimization work is to carry out part of the drug basic information collection work related matters as follows: First, drug requirements belong to the scope of information collection (see annex) and obtain the domestic effective registration of the approved drugs and meet one of the following requirements: the original research drug and the State Drug Administration issued the quality and consistency of the efficacy of generic drugs evaluation reference preparationsA generic drug that is evaluated for the quality and efficacy of generic drugs by the State Drug AdministrationIn accordance with the "Announcement of the State Administration of Food and Drug Administration on the Work Programme for the Implementation of the Work Programme for the Classification of Chemical Registrations" (No1) of generic drugs approved according to the new registration classification of chemical sinesDrugs included in the China Listed Drug List2The scope of enterprises that fall within the scope of this information collection and meet the requirements of pharmaceuticals include: the representative institution or enterprise legal person that provides drugs and accompanying services for domestic pharmaceutical production enterprises whose drug listing license holders are foreign manufacturers who are appointed or designated in Chinese mainland and can bear the corresponding legal liabilities3Collection Content The representative institution or legal person of the enterprise (including the name of the enterprise, unified social credit code, contact person, authorization, etc.) established or designated by the overseas production enterprise in Chinese mainland and can bear the corresponding legal liabilitySupporting materials that meet the requirements of the drug (including the approval of the drug registration, the supplementary registration approval, the specification, etc.)Production capacity and raw materials self-production instructions4Other matters This information collection work is only used for related work of the groping and research not as a centralized pharmaceutical procurement enterprise declaration according to the specific declaration of enterprise qualification and declaration of variety qualifications to the procurement documents as the basis of the annex: information collection scope.
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