Product Compliance
filing/registration/consulting/training

Answer to the problem of filing domestic toothpaste in Guangdong Province eight
one Do all toothpaste products that have completed filing need to be reported annually,What specific requirements do you have
refer to Regulations on the Management of Registration and Filing Materials for Cosmetics Article 53: Provisions,The annual report of toothpaste should include the following information one Production of products Import Overview,And the shutdown situation of products during this period two The product complies with regulations Mandatory national standards Self inspection of technical specifications, etc.
two Toothpaste products that have completed registration,Can we adjust the amount of raw materials added to the formula or replace them with new quality specifications
answer refer to Regulations on the Management of Registration and Filing Materials for Cosmetics Article 42: Provisions,Registered toothpaste products are not allowed to change their formula arbitrarily,Except for minor changes in product formula due to changes in raw material sources or other reasons.
Manufacturers of raw materials used in registered toothpaste products Increase or change in raw material quality specifications,The content of the raw materials used in the formula and the specific types of ingredients in the raw materials The proportion has not changed,Raw material manufacturer information and raw material safety information should be updated and maintained through a filing information platform.Changes in product safety assessment data,Product safety assessment data should also be updated.
Manufacturers of raw materials used in registered toothpaste products Increase or change in raw material quality specifications,The content of raw materials in the formula and the main functional components and solvents in the raw materials have not changed,Trace stabilizers added to ensure the quality of raw materials antioxidant Changes in the type or content of preservatives and other ingredients,The following documents should be submitted
one Record Change Information Form
two formulation
three Explanation of the situation where changes have occurred,Including the reasons for the change,The purpose of using the changing components in the raw materials, etc
four Product safety assessment data for the proposed product change
five Changes in standards related to product execution,The standard for implementing the proposed product change should be submitted
six The proposed change involves the full ingredient labeling in the product label sample draft Changes in safety warning language, etc,A sample product label for the proposed product change should be submitted.
three Toothpaste products that have completed registration,Brief description of the standard production process for product execution Microbial and physicochemical indicators and quality control measures Usage Safety warning language Storage conditions Changes in usage period, etc,What documents should be submitted
answer refer to Regulations on the Management of Registration and Filing Materials for Cosmetics Article 43: Provisions,Brief description of production process in the standards for product execution Microbial and physicochemical indicators and quality control measures Usage Safety warning language Storage conditions Changes in usage period, etc,The following documents should be submitted
one Record Change Information Form
two Proposed changes to the standards for product execution
three Changes in production process description,An explanation of the changes that have occurred should be submitted,And submit the microbiological and physicochemical test reports for the proposed product change
four Involving changes in product usage methods,Product safety assessment materials for the proposed product change should be submitted
five Involving the extension of product usage period,Stability research materials for the proposed product change should be submitted
six Changes in the content of product safety assessment materials,Product safety assessment materials should be submitted
seven Involving changes in the original sales packaging and labeling of imported products,The original sales packaging of the product to be changed should be submitted Including instruction manual Chinese translation of foreign labels
eight Changes related to product label samples,Product label sample changes should also be made in accordance with relevant requirements.
four Can toothpaste products continue to be sold until the end of their shelf life after being deregistered
answer According to the National Medical Products Administration's release Frequently Asked Questions on Cosmetics Supervision and Management four Relevant regulations,No longer producing Imported products,The registrant can actively apply for cancellation on the filing platform.Products applying for active cancellation,If there is no violation of laws and regulations,Related products that have been listed before the cancellation of filing information,Can be sold until the end of the shelf life.