Create profile
EN
【CODEX】Provisions for Food for Special Medical Purpose Registration
Date:2022-02-17
¥961.65
Download

【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.


 




      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买


【CODEX】Provisions for Food for Special Medical Purpose Registration
Date:2022-02-17
¥961.65
Download

【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.


 




      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买


Our Advantages
Sixteen years of translation experience in medical and intellectual property fields
Sixteen years of translation experience in medical and intellectual property fields
Since the establishment, CODEX has been deeply engaged in medical translation. Quality translation and services are the driving force for our sustainable development.
Professional and Elite Team
Professional and Elite Team
The translation team consists of graduates returned from abroad, post-graduate students from the most prestigious universities, professional native-speaking translators and consultants in the medical industry.
Authoritative Quality Certification
Authoritative Quality Certification
We provide services for many world-renowned pharmaceutical companies with ISO9001:2015 and ISO17100:2015 Quality Management System Certification.
Strict Control Process
Strict Control Process
Codex has established a perfect translation quality assurance system and systematic operation process, strictly adopts the working procedure of  “firstly translation, secondly modification, thirdly proofreading and fourthly review”.
Excellent Staff Quality
Excellent Staff Quality
Being strictly examined and selected, every one of us is characterized with a strong sense of responsibility and proficiency in medical translation , and we strictly follow the confidential system.
Client Support
Client Support
“Pursue Excellence, Strive for Perfection”. Serve you with quality and confidentiality .
Contact Us
CODEX By Your Side

Beijing CODEX Translation Co.,LTD

400-136-8786

We Are Here For You 24/7
Who We Are
As one of the few medical translation suppliers in China that have been certified by ISO17100: 2015, we have been providing life sciences translation services, localization services and intellectual property translation services since our founding 16 years ago.
Open a membership
Send a verification code
Sign up
Already have an account? Sign in here
Use your account
Use your message
Login
Do not have an account? Sign up here
Send a verification code
Login
Do not have an account? Sign up here
Scan QR code
CODEX WeChat Public Platform
WeChat
CODEX customer service
Contact Us
400-136-8786
E-mail
Info@codex-trans.com