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GSP新规刚发布时,许多药包印刷企业表现出些许恐慌,以为药品追溯不再采用电子监管码,而是采取其他替代方案。实际上,GSP新规只是去除了有关电子监管码的描述,增加了建立药品追溯体系的相关表达,落实了制药企业的追溯管理责任,更加强调企业的主体意识。换句话说,之前国家要求制药企业必须采用电子监管码对药品进行监管,但现在只是规定制药企业必须达到药品监管的目的,具体实现方式及过程可自行选择。
When the GSP regulations were just released, many drug packaging printing companies showed some panic that they would no longer adopt the electronic regulatory code for drug traceability, but instead adopted other alternatives. In fact, the new GSP just removed the description of the electronic regulatory code, increased the establishment of drug traceability system related expressions, the implementation of the retrospective management responsibility of pharmaceutical companies, more emphasis on the main part of the enterprise awareness. In other words, in the past, the state required pharmaceutical companies to adopt electronic regulatory codes to regulate drugs. However, it only stipulates that pharmaceutical companies must achieve the goal of drug regulation. The specific methods and procedures for their implementation can be chosen at their own discretion.