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    【CODEX翻譯】《特殊醫學用途配方食品注冊管理辦法》-中英雙語
    發布日期:2022-02-17
    ¥961.65
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    【CODEX翻譯】《特殊醫學用途配方食品注冊管理辦法》-中英雙語


    《特殊醫學用途配方食品注冊管理辦法》

    (國家食品藥品監督管理總局令第24號)

    Provisions for Food for Special Medical Purpose Registration

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

     

      第一條 為規范特殊醫學用途配方食品注冊行為,加強注冊管理,保證特殊醫學用途配方食品質量安全,根據《中華人民共和國食品安全法》等法律法規,制定本辦法。

    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.

     

      第二條 在中華人民共和國境內生產銷售和進口的特殊醫學用途配方食品的注冊管理,適用本辦法。

    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.

     

      第三條 特殊醫學用途配方食品注冊,是指國家食品藥品監督管理總局根據申請,依照本辦法規定的程序和要求,對特殊醫學用途配方食品的產品配方、生產工藝、標簽、說明書以及產品安全性、營養充足性和特殊醫學用途臨床效果進行審查,并決定是否準予注冊的過程。

    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.

     

      第四條 特殊醫學用途配方食品注冊管理,應當遵循科學、公開、公平、公正的原則。


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

     

      第五條 國家食品藥品監督管理總局負責特殊醫學用途配方食品的注冊管理工作。
    Article 5.     China Food and Drug Administration shall be responsible for the administration of food for special medical purpose registration.

     

      國家食品藥品監督管理總局行政受理機構(以下簡稱受理機構)負責特殊醫學用途配方食品注冊申請的受理工作。

    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.

     

      國家食品藥品監督管理總局食品審評機構(以下簡稱審評機構)負責特殊醫學用途配方食品注冊申請的審評工作。

    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.


      國家食品藥品監督管理總局審核查驗機構(以下簡稱核查機構)負責特殊醫學用途配方食品注冊審評過程中的現場核查工作。

    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北京科譯翻譯有限公司是一家專業提供生命科學翻譯和本地化服務的公司,作為中國專業的生命科學翻譯公司之一以及國內為數不多的通過國際ISO17100: 2015認證的醫學翻譯提供商,CODEX科譯擁有更多的醫學資深語言專家,能實現40多種語言對的互譯,接受更高難度的醫學領域的項目挑戰,并在最短時間內適應以給出最合理的解決方案。保證最高質量,100%按時交付,高效、完善的售后保障是CODEX科譯給客戶的用心承諾。

    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.


          以上是免費內容,查看更多可立即購買

    【CODEX翻譯】《特殊醫學用途配方食品注冊管理辦法》-中英雙語


    《特殊醫學用途配方食品注冊管理辦法》

    (國家食品藥品監督管理總局令第24號)

    Provisions for Food for Special Medical Purpose Registration

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

     

      第一條 為規范特殊醫學用途配方食品注冊行為,加強注冊管理,保證特殊醫學用途配方食品質量安全,根據《中華人民共和國食品安全法》等法律法規,制定本辦法。

    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.

     

      第二條 在中華人民共和國境內生產銷售和進口的特殊醫學用途配方食品的注冊管理,適用本辦法。

    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.

     

      第三條 特殊醫學用途配方食品注冊,是指國家食品藥品監督管理總局根據申請,依照本辦法規定的程序和要求,對特殊醫學用途配方食品的產品配方、生產工藝、標簽、說明書以及產品安全性、營養充足性和特殊醫學用途臨床效果進行審查,并決定是否準予注冊的過程。

    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.

     

      第四條 特殊醫學用途配方食品注冊管理,應當遵循科學、公開、公平、公正的原則。


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

     

      第五條 國家食品藥品監督管理總局負責特殊醫學用途配方食品的注冊管理工作。
    Article 5.     China Food and Drug Administration shall be responsible for the administration of food for special medical purpose registration.

     

      國家食品藥品監督管理總局行政受理機構(以下簡稱受理機構)負責特殊醫學用途配方食品注冊申請的受理工作。

    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.

     

      國家食品藥品監督管理總局食品審評機構(以下簡稱審評機構)負責特殊醫學用途配方食品注冊申請的審評工作。

    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.


      國家食品藥品監督管理總局審核查驗機構(以下簡稱核查機構)負責特殊醫學用途配方食品注冊審評過程中的現場核查工作。

    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北京科譯翻譯有限公司是一家專業提供生命科學翻譯和本地化服務的公司,作為中國專業的生命科學翻譯公司之一以及國內為數不多的通過國際ISO17100: 2015認證的醫學翻譯提供商,CODEX科譯擁有更多的醫學資深語言專家,能實現40多種語言對的互譯,接受更高難度的醫學領域的項目挑戰,并在最短時間內適應以給出最合理的解決方案。保證最高質量,100%按時交付,高效、完善的售后保障是CODEX科譯給客戶的用心承諾。

    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.


          以上是免費內容,查看更多可立即購買
    發布日期:2022-02-17
    ¥961.65
    立即購買
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