【CODEX】《特殊医学用途配方食品注册管理办法》-中英双语

《特殊医学用途配方食品注册管理办法》

（国家食品药品监督管理总局令第24号）

Provisions for Food for Special Medical Purpose Registration

(Decree No. 24 of China Food and Drug Administration)

　　第一条 为规范特殊医学用途配方食品注册行为，加强注册管理，保证特殊医学用途配方食品质量安全，根据《中华人民共和国食品安全法》等法律法规，制定本办法。

Article 1.     This Provisions is formulated in accordance with Food Safety Law of the People's Republic of China and other laws and regulations in order to regulate the registration of food for special medical purpose, strengthen registration administration and ensure the quality and safety of food for special medical purpose.

　　第二条 在中华人民共和国境内生产销售和进口的特殊医学用途配方食品的注册管理，适用本办法。

Article 2.     The Provisions applies to the registration administration of food for special medical purpose produced, sold and imported within the territory of People’s Republic of China.

　　第三条 特殊医学用途配方食品注册，是指国家食品药品监督管理总局根据申请，依照本办法规定的程序和要求，对特殊医学用途配方食品的产品配方、生产工艺、标签、说明书以及产品安全性、营养充足性和特殊医学用途临床效果进行审查，并决定是否准予注册的过程。

Article 3.     The registration of food for special medical purpose refers to the prescribed process conducted by China Food and Drug Administration upon application to decide whether the food for special medical purpose shall be approved for registration based on the review of the product formula, production process, labeling, instructions, safety, nutrient adequacy and clinical effect for special medical purpose in accordance with the procedures and requirements stipulated in this Provisions.

　　第四条 特殊医学用途配方食品注册管理，应当遵循科学、公开、公平、公正的原则。

Article 4.     Administration of food for special medical purpose registration shall follow the principles of scientificity, publicity, equity and justice.

　　第五条 国家食品药品监督管理总局负责特殊医学用途配方食品的注册管理工作。
Article 5.     China Food and Drug Administration shall be responsible for the administration of food for special medical purpose registration.

　　国家食品药品监督管理总局行政受理机构（以下简称受理机构）负责特殊医学用途配方食品注册申请的受理工作。

The administrative acceptance institution of China Food and Drug Administration (hereinafter referred to as the acceptance institution) shall be responsible for the acceptance of the application for the registration of food for special medical purpose.

　　国家食品药品监督管理总局食品审评机构（以下简称审评机构）负责特殊医学用途配方食品注册申请的审评工作。

The food evaluation institution of China Food and Drug Administration (hereinafter referred to as the evaluation institution) shall be responsible for the evaluation of food for special medical purpose.

　　国家食品药品监督管理总局审核查验机构（以下简称核查机构）负责特殊医学用途配方食品注册审评过程中的现场核查工作。

The review and verification institution of China Food and Drug Administration (hereinafter referred to as the verification institution) shall be responsible for the on-site verification during the review of food for special medical purpose registration.