State Food and Drug Administration issued the "food production license review general rules"

In order to implement the relevant provisions of People's Republic of China "food safety law" and "food production license management approach", strengthen the supervision and management of food production, food production license review activities, in August 10, 2016, the State Food and Drug Administration issued the "notice on the food and Drug Administration of food production license issued by the general review" (food and Drug Administration Food Supervisor 2016 No. 103), officially released the "general food production license review" (hereinafter referred to as the "general"), will take effect on October 1, 2016.

With the "food safety law" and the implementation of a new round of food safety supervision system to start and promote the reform of food production in the field of supervision and management work has been strengthened. In particular, "food production license management approach" (the State Food and drug administration order No. sixteenth) after the implementation of its supporting technical documents issued is imminent. The "general" is the requirement of enterprises to obtain a food production license must be technology, to guide the food production enterprises to improve production conditions, strict process control, strengthen the control and inspection of raw materials, which plays an important role in food safety. On 2010 announced the "food production license review rules" has played an important role in food production license work over the past few years, but the existing laws and regulations, food safety standards and food safety supervision system has some differences exist in the actual work can not intersect. The "general rules" and the current "food production license review general rules" compared to the "two links one simple" three major changes: first, the realization of the "general" of the general. Food (including health food, formula foods for special medical purposes, infant formula food, food additives) general a "general", for the production of different categories of food the same enterprise, the basic requirements of unified examination, and the principle of "one card" to achieve effective convergence. Two is to achieve licensing and supervision of China unicom. Strengthen the production license and the daily supervision of the convergence, strengthen the supervision of the principle of things in the post. Will be found in the field of the rectification of the problem by the enterprise in a month after the license is completed within three months of supervision and inspection, not only to shorten the time limit for business, but also to enable the licensing and regulatory activities closely connected. Three is to simplify the licensing requirements, requirements and content. First, simplify the continuation of changes to submit materials and review requirements; second simplified qualified report on the trial product inspection requirements; third simplified external warehouse verification requirements; fourth simplified licensing documents.

"General rules" a total of 5 chapters 56, the main content of the scope of application, application materials review, on-site verification, verification results reporting and inspection requirements, etc..

First, the strict division of the way the license review. The "general rules" will be divided into two types of production license review and on-site verification of the application materials review. Provisions of the continuation of the license, the production of food varieties, legal representative personnel changes, you can only apply for a review of the material to decide whether to grant approval. At the same time, for the strict production conditions, to ensure food quality and safety, "general rules", the process, the main production equipment and facilities, food categories, the need for on-site verification.

Two is to optimize the on-site verification requirements. "Rules" provides both must conduct on-site verification of the situation, and provides a comprehensive on-site inspection personnel, check the contents, procedures, work time verification requirements, inspection record, verification results confirm etc.. Especially in the on-site verification of the requirements of the observers to participate in on-site verification, optimization of the verification score table, attendance table, improve the operability of the site verification.

Three is to improve the licensing review mechanism. Give the applicant the opportunity to check the rectification, the determination result is through on-site verification but there are some flaws in the management, to allow the applicant to carry out rectification within 1 months, the production license issued by the implementation of the food safety, responsible for the daily supervision and management of the food and drug supervision and management departments or their agencies in the license within 3 months after the certified enterprises to carry out an inspection, if found to focus on examination of on-site verification problems in the rectification.

Four is to put forward the administrative licensing convenient service mechanism. First, the decentralization of licensing decision power, as much as possible so that the applicant to the location of the city county licensing authority for licensing matters, improve administrative efficiency and convenience of the applicant; second, to allow the applicant entrusts an agent to apply for production licenses; third, on examination can not check the check now try not to conduct on-site inspection; to be made on the spot license the field should be decided, subject to immediately be concluded, to seize the handle immediately; fourth, improve licensing work, and actively promote the use of e-government, information networks and other means of modern technology, simplify procedures, reduce the links, improve the management level, strengthen the service, the convenience of the masses.

The State Food and drug administration requires all levels of the local food and drug supervision and management departments in strict accordance with the "food production license management measures", "rules" of the provisions of the procedures and requirements, and further optimize the approval process, improve the efficiency of licensing, strengthen supervision and management, and continuously improve the ability and level of food safety management, effective prevention and control of food safety risk, public security food safety.