Announcement of the National Medical Products Administration on Issuing and Implementing the Work Practices on the Registration and Filing Inspection of Cosmetics
Announcement of the National Medical Products Administration on Issuing and Implementing the Work Practices on the Registration and Filing Inspection of Cosmetics
Announcement of the National Medical Products Administration on Issuing and Implementing the Work Practices on the Registration and Filing Inspection of Cosmetics
Announcement of the National Medical Products Administration [2019] No. 72
September 3, 2019
With a view to regulating the registration and filing inspection of cosmetics, and ensuring the openness, fairness, impartiality and scientificity of the registration and filing inspection of cosmetics, the National Medical Products Administration (hereinafter referred to as the "NMPA") has formulated the Work Practices on the Registration and Filing Inspection of Cosmetics (hereinafter referred to as the "Practices"), which are hereby issued with relevant issues concerning the implementation thereof announced as follows:
I. As of the issuance date of this Announcement, inspection and testing institutions that comply with the requirements of the Practices may undertake cosmetics registration and filing inspection work after submitting their relevant information via the cosmetics registration and filing inspection information management system.
II. As of the issuance date of this Announcement, cosmetics that are newly registered or filed but have not been inspected shall respectively be subject to an inspection as required by the Practices with an inspection report issued; with respect to those that have been inspected or for which the relevant sunscreen inspection has been completed by an overseas laboratory with an inspection report issued, such inspection report may continue to be used for the relevant cosmetic registration or filing. Where a product has been registered or filed, if there is any discrepancy between the original inspection items and those specified in the Practices, the inspection of corresponding inspection items to be supplemented shall, after the issuance of this Announcement, be completed within one year in accordance with the requirements for inspection items as specified in the Practices (excluding human safety inspection items). The supplementarily completed inspection report shall be submitted at the time of application for renewal of the validity period of the administrative licensing for such product, or be provided for future reference when the product is confirmed as filed for continued production.
III. As of November 1, 2019, relevant qualifications of cosmetics-related administrative licensing inspection institutions or domestically-made non-special-purpose cosmetics filing inspection institutions that have obtained qualification accreditation or designation from former food and drug product administrations previously shall be terminated automatically, and relevant inspection institutions may not continue to accept cosmetics registration or filing inspection in the name of qualifications formerly accredited or designated.
The Announcement is hereby given.
Work Practices on the Registration and Filing Inspection of Cosmetics
Article 1 The Practices are formulated in accordance with relevant regulations on cosmetics with a view to regulating the registration and filing inspection of cosmetics and ensuring the openness, fairness, impartiality and scientificity of the registration and filing inspection of cosmetics.
Article 2 The Practices shall apply to whoever engages in cosmetics registration and filing-related inspection and testing work such as microbial as well as physical and chemical inspection, toxicological testing and human safety and efficacy evaluation inspection within the territory of the People's Republic of China.
Article 3 Cosmetics enterprises shall, in accordance with the requirements of laws and regulations, mandatory national standards and practices, select inspection and testing institutions with corresponding inspection capacity to inspect their cosmetics under application for registration or submission for filing and be responsible for the authenticity and completeness of the inspection samples and related materials provided by them.
Inspection and testing institutions engaging in cosmetics registration and filing inspection work (hereinafter referred to as "inspection and testing institutions") shall carry out such inspection and testing work in accordance with the requirements of laws and regulations, mandatory national standards and practices, follow the principles of independence, objectivity, fairness, openness and good faith and be responsible for the authenticity and reliability of inspection reports issued by them.
Article 4 The NMPA shall organize the establishment of a cosmetics registration and filing inspection information management system (hereinafter referred to as the "inspection information system") for the administration of cosmetics registration and filing inspection work and the management of inspection and testing institution information.
Article 5 An inspection and testing institution shall generally have an independent legal person qualification.
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Announcement of the National Medical Products Administration [2019] No. 72
September 3, 2019
With a view to regulating the registration and filing inspection of cosmetics, and ensuring the openness, fairness, impartiality and scientificity of the registration and filing inspection of cosmetics, the National Medical Products Administration (hereinafter referred to as the "NMPA") has formulated the Work Practices on the Registration and Filing Inspection of Cosmetics (hereinafter referred to as the "Practices"), which are hereby issued with relevant issues concerning the implementation thereof announced as follows:
I. As of the issuance date of this Announcement, inspection and testing institutions that comply with the requirements of the Practices may undertake cosmetics registration and filing inspection work after submitting their relevant information via the cosmetics registration and filing inspection information management system.
II. As of the issuance date of this Announcement, cosmetics that are newly registered or filed but have not been inspected shall respectively be subject to an inspection as required by the Practices with an inspection report issued; with respect to those that have been inspected or for which the relevant sunscreen inspection has been completed by an overseas laboratory with an inspection report issued, such inspection report may continue to be used for the relevant cosmetic registration or filing. Where a product has been registered or filed, if there is any discrepancy between the original inspection items and those specified in the Practices, the inspection of corresponding inspection items to be supplemented shall, after the issuance of this Announcement, be completed within one year in accordance with the requirements for inspection items as specified in the Practices (excluding human safety inspection items). The supplementarily completed inspection report shall be submitted at the time of application for renewal of the validity period of the administrative licensing for such product, or be provided for future reference when the product is confirmed as filed for continued production.
III. As of November 1, 2019, relevant qualifications of cosmetics-related administrative licensing inspection institutions or domestically-made non-special-purpose cosmetics filing inspection institutions that have obtained qualification accreditation or designation from former food and drug product administrations previously shall be terminated automatically, and relevant inspection institutions may not continue to accept cosmetics registration or filing inspection in the name of qualifications formerly accredited or designated.
The Announcement is hereby given.
Work Practices on the Registration and Filing Inspection of Cosmetics
Article 1 The Practices are formulated in accordance with relevant regulations on cosmetics with a view to regulating the registration and filing inspection of cosmetics and ensuring the openness, fairness, impartiality and scientificity of the registration and filing inspection of cosmetics.
Article 2 The Practices shall apply to whoever engages in cosmetics registration and filing-related inspection and testing work such as microbial as well as physical and chemical inspection, toxicological testing and human safety and efficacy evaluation inspection within the territory of the People's Republic of China.
Article 3 Cosmetics enterprises shall, in accordance with the requirements of laws and regulations, mandatory national standards and practices, select inspection and testing institutions with corresponding inspection capacity to inspect their cosmetics under application for registration or submission for filing and be responsible for the authenticity and completeness of the inspection samples and related materials provided by them.
Inspection and testing institutions engaging in cosmetics registration and filing inspection work (hereinafter referred to as "inspection and testing institutions") shall carry out such inspection and testing work in accordance with the requirements of laws and regulations, mandatory national standards and practices, follow the principles of independence, objectivity, fairness, openness and good faith and be responsible for the authenticity and reliability of inspection reports issued by them.
Article 4 The NMPA shall organize the establishment of a cosmetics registration and filing inspection information management system (hereinafter referred to as the "inspection information system") for the administration of cosmetics registration and filing inspection work and the management of inspection and testing institution information.
Article 5 An inspection and testing institution shall generally have an independent legal person qualification.
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