EN Quality Audit Manual For Healthcare Manufacturers And Their Suppliers, Fifth Edition, Software Pa

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Jul 9, 2024, 2:35:54 AM7/9/24

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Article 1 These Provisions are formulated in accordance with the Regulations on Supervision and Administration of Cosmetics for the purpose of regulating manufacturing and marketing of cosmetics, strengthening supervision and administration of cosmetics, and ensuring quality and safety of cosmetics.

Article 2 These Provisions shall apply to manufacturing and marketing of cosmetics, supervision and administration in this respect within the territory of the People's Republic of China.

EN Quality Audit Manual For Healthcare Manufacturers and Their Suppliers, Fifth Edition, Software Pa

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The department in charge of drug supervision and administration of local people's governments at or above the county level shall be responsible for supervision and administration of cosmetics within their administrative areas.

Article 4 The registrant and the filing entity of cosmetics shall establish a quality management system for cosmetics manufacturing according to law, perform obligations related to product including adverse reaction monitoring, risk control, recall etc, and shall be responsible for their quality, safety and efficacy claims of cosmetics. Manufacturers and marketers of cosmetics shall comply with laws, regulations, provisions, mandatory national standards and technical specifications in engaging in manufacturing and marketing activities and conduct vigorous management, maintain integrity and practice self-discipline, thus to ensure the quality and safety of cosmetics.

Article 5 The state exercises licensing management for the manufacturing of cosmetics. To engage in manufacturing of cosmetics, the Cosmetics Manufacturing License shall be obtained in accordance with the law.

Article 6 Manufacturers and marketers of cosmetics shall establish, in accordance with the law, documentation system for the check and test of purchases, and product sales record, and other systems, to ensure traceability of the products.

Manufacturers and marketers of cosmetics are encouraged to adopt information technology to collect and store information on manufacturing and marketing, and establish a traceability system for quality and safety of cosmetics.

The department in charge of drug supervision and administration shall, in accordance with the law, promptly publish regulatory information on cosmetics manufacturing license, supervision and inspection, and administrative penalty, etc.

Article 8 The department in charge of drug supervision and administration shall give full play to the role of the associations of cosmetics industry, the associations of consumers and other consumer organizations, news media, etc., promote the construction of industry integrity system, and advance social co-governance for cosmetics safety.

(2) having the manufacturing premises that are appropriate to the varieties, quantity and manufacturing licensed items, etc. of the cosmetics produced, and being kept prescribed distance from toxic and hazardous premises and other sources of pollution;

(3) having the manufacturing facilities and equipment that are appropriate to the varieties, quantity and manufacturing licensed items, etc. of the cosmetics produced, and having a reasonable layout thereof, and the air purification, water treatment facilities and equipment, etc. that meet the specified requirements;

Article 10 The applicants for cosmetics manufacturing license shall submit an application to the drug regulatory department of the province, autonomous region or municipality directly under the central government, where it is located, submit the documents proving that they meet the requirements as specified in Article 9 of these Provisions, and shall be accountable for the authenticity of the documents.

Article 11 Regarding the application submitted by applicants for cosmetics manufacturing license, the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall handle respectively according to the following circumstances:

(2) If the application items are not within the scope of authority of drug regulatory department in accordance with the law, the relevant department shall make a decision of non-acceptance, issue a notification of non-acceptance, and inform the applicant to resubmit the application to the applicable administrative authority

(3) If the application documents contain errors that can be corrected on site, the applicant shall be allowed to make corrections on site, affix signature or seal to the correction, and indicate the date of correction thereon;

(4) If the application documents are incomplete or do not conform to statutory form, the applicant shall be notified of all contents ought to be supplemented and corrected on site or within 5 working days one-off. If no notification is made within the prescribed time limit, the application shall be deemed to have been accepted upon receipt of the application documents;

(5) The application for cosmetics manufacturing license shall be accepted if the documents are complete and conforming to statutory form, or if the applicant has submitted all the supplementary and corrected documents as required.

For acceptance or non-acceptance of the application for cosmetics manufacturing license, the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall issue an acceptance or non-acceptance notice. If non-acceptance is determined, the reason for non-acceptance shall be given, and the applicants shall be informed of being entitled to apply for administrative reconsideration or file an administrative litigation according to law.

Article 12 The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall review the application documents submitted by the applicant, and conduct on-site inspection on manufacturing premises of the applicant, and make a decision within 30 working days beginning from the date of acceptance of the application for cosmetics manufacturing license.

Article 13 The drug regulatory department of the province, autonomous region or municipality directly under the central government shall, according to review of the application documents and on-site inspection, grant approval for application if the specified requirements are met, and issue cosmetic manufacturing license to the applicant within 5 working days upon making the decision; if the specified requirements are not met, it shall not grant approval and shall give the reasons in writing in a timely manner, and in the meantime inform the applicant of being entitled to apply for administrative reconsideration or file an administrative litigation according to law.

The NMPA shall be responsible for making template of the Cosmetics Manufacturing License. The drug regulatory department of the province, autonomous region or municipality directly under the central government shall be responsible for printing, issuing and other management work of the cosmetics manufacturing license.

Article 16 The manufacturing licensed items for cosmetics shall be classified into general liquid unit, cream emulsion unit, powder unit, aerosol and organic solvent unit, wax-based unit, toothpaste unit, soap-based unit and other units according to manufacturing process, status and use of finished products, etc. of the cosmetics. The NMPA may adjust the unit classification of the manufacturing licensed items in accordance with practical needs for supervision and administration of quality and safety of cosmetics.

Article 17 If the licensing conditions of applicants, or the items specified in the license need to be changed within validity period of the Cosmetics Manufacturing License, the applicant shall apply to the drug regulatory department issued former license for change.

Article 18 In case of changes in the manufacturing licensed items, or changes in the manufacturing facilities and equipment that may affect the product quality and safety, or workshops are newly built, rebuilt or expanded on the original cosmetic manufacturing premises, cosmetics manufacturers shall apply to the drug regulatory department issued former license for change before manufacturing, and submit documents related to the change as specified in Article 10 of these Provisions. The drug regulatory department issued former license shall conduct the review, and make a decision on whether granting approval for change or not within 30 workings days upon acceptance of the application for change, and keep record on duplicate of the Cosmetics Manufacturing License. If it needs to make on-site inspection, it shall be handled as specified in Article 12 of these Provisions.

Where a comprehensive on-site inspection is required due to changes in manufacturing licensed items, etc., if the manufacturer conforms to requirements upon on-site inspection by the drug regulatory department of the province, autonomous region or municipality directly under the central government, a new Cosmetics Manufacturing License shall be issued with the license number unchanged, and the validity period thereof will be recalculated from the date of issuance.

Where the same cosmetics manufacturer applies for adding the manufacturing address of cosmetics in the same province, autonomous region or municipality directly under the central government, it may handle the procedures for change in accordance with provisions in these Provisions.

Article 19 Where the name, domicile, legal representative or responsible person, etc., of manufacturer change, the cosmetics manufacturer shall apply to the drug regulatory department issued former license for change within 30 working days from date of change, and submit documents related to the change. The drug regulatory department issued former license shall handle the procedures for change within 3 working days upon acceptance of the application.