Notice of the General Administration on printing and distributing the general rules for the examination of food production license

The food and Drug Administration of all provinces, autonomous regions and municipalities directly under the central government, and the food and Drug Administration of Xinjiang production and construction corps:

According to the "People's Republic of China food safety law" and its implementing regulations, "food production license management approach" and other relevant provisions of the State Food and drug administration organizations to develop a "food production license review rules", which are hereby issued since October 1, 2016 implementation.

The local food and drug supervision and management departments should strictly follow the "food production license management approach", "food production license review general" provisions of the procedures and requirements, and further optimize the approval process, improve the efficiency of licensing, strengthen supervision and management. Problems encountered during the implementation of the general principles for the examination of food production license, please report to the General Administration of.

Food and Drug Administration

August 9, 2016

General rules for the examination of food production license

Chapter I General Provisions

Article 1 in order to strengthen the administration of food production license, regulate food production license review, according to the "People's Republic of China food safety law" and its implementing regulations, "food production license management approach" and other relevant laws and regulations, regulations and national food safety standards, these general rules are formulated.

Article second this general rule applies to food and drug supervision and management departments to organize the applicant's food, food additives (hereinafter referred to as food) production license and license change, extension, etc..

Food production license review, including application materials review and on-site inspection.

Article third the general rules shall be in accordance with the relevant provisions of the food production license examination (hereinafter referred to as the examination rules) in combination with the use of. The use of local food production license review rules to carry out the review of production license, it should be in line with the "food production license management approach" provisions of the eighth.

Fourth review of the application materials, should be complete, the written application materials specification and conformance to the main contents of the inspection; on site verification, should be consistent with the actual situation of the application materials, the compliance review as the main content.

Fifth laws and regulations, rules and standards for the examination of food production license has special provisions, but also should comply with its provisions.

The second chapter material review

Sixth applicants should have the subject qualification of food production license. The applicant shall, according to the provisions of the food production license to the provincial food and drug supervision and management departments to accept authority, proposed food production license application to the local food and drug supervision and administration department at or above the county level.

Seventh application materials should be complete in variety, complete in content, in line with the statutory form and fill in requirements. The applicant shall be responsible for the authenticity of the application materials. The number of copies of the application materials determined by the provincial food and drug supervision and administration department according to the regulatory requirements, to ensure that the food and drug supervision and management departments responsible for the implementation of food safety supervision and management of the daily on the applicant's grasp the applicant to apply for permission.

Where the applicant is authorized to apply for the food production license, the agent shall submit the identity certificate of the authorized attorney and agent.

Eighth of the applicants for the food production permit, shall be submitted to the food production license application form and other materials specified copy of business license, food production and processing places and the surrounding environment plan, food production and processing places of the functional interval layout, major equipment and facilities equipment layout, food production, food production process flow chart, list directory of food safety management system and laws and regulations.

For health food, special medicinal formula, infant formula food production license, it shall also submit the document production quality management system suitable for the production of food and the corresponding product registration and filing.

Food additive production license application materials, in accordance with the "food production license management approach," the provisions of the implementation of the sixteenth.

Ninth apply for change, food production license shall submit an application for change, food production license (original and copy) and other materials to change the food production license matters related materials and provisions of laws and regulations.

Changes in food production license copy items specified in the same food categories in the change process, the applicant declares the equipment layout and process flow, main production facilities and other matters, shall submit the relevant materials in accordance with the provisions of the first paragraph of this article.

Where the applicant declares that the other production conditions are changed and the food safety may be affected, the relevant materials shall be submitted in accordance with the provisions of the first paragraph of this article.

Health food, formula foods for special medical purposes, the production of infant formula food enterprises to apply for change, the applicant shall also submit documents change matters of production quality management system suitable for the production of food, as well as the corresponding product registration and filing.

Tenth application for extension, shall be submitted to the food production license renewal applications, food production license (original and copy) and other materials to the applicants production conditions whether the change statement, the continuation of food production license matters related materials and provisions of laws and regulations.

Health food, formula foods for special medical purposes, the production of infant formula food enterprises to apply for the continuation of a food production license, shall also be provided and adapted to the production of food production operation of the quality management system the applicant change matters self-examination report, as well as the corresponding product registration and filing.

Eleventh licensing authority or