A: If the product is being supplemented and corrected, the basic information (enterprise name, legal representative) of the applicant's product formula registration application (including substantive changes) has changed during the review process, the relevant explanatory documents and correction materials can be submitted together; If the product has been supplemented and corrected, the official document can be submitted and the information will be revised after the receipt of the document by the Centre.
Q82. What application materials can be simplified when applying for registration according to the new national standard?
A: (1) In the application materials of the same applicant with different formulas, if the following materials are the same and meet the relevant requirements, the complete content can be provided in the application materials of a particular formulation, and the consistency statement can be provided in other formulations.
1. Text of quality standards for food additive preparations: the same food additive preparations are used for each formulation, including those with the same composition and its dosage, the same specifications and the same quality standards.
2. Control plan for contaminants, micro-organisms, mycotoxins and other hazardous substances. Test reports on risk indicators for each formulation raw material and finished product should be provided separately.
3. Relevant materials such as strain traceability, contamination prevention and control of miscellaneous bacteria and other related materials: indicate that the strain of bacteria used in each formula are the same, the composition of raw materials is the same, and the suppliers are the same.
4. Methodological texts and methodological studies without national standard methods, and related validation materials.
(2) If the same raw material involves multiple suppliers or multiple specifications, only the relevant information of the raw materials used in the commercial trial production shall be submitted.
(3) If the label involves more than one specification, submit a sample of one specification and a description of the consistency of multiple specifications.
(4) If a reference is involved, an index or abstract is sufficient and the full text need not be submitted.
Q83. What issues should applicants pay attention to when submitting application materials for registration of infant formula milk powder products?
A: Applicants should submit application materials in strict accordance with the relevant provisions of the State Food and Drug Administration Announcement No. 65 in 2017 "Application Materials Items and Requirements of Infant and Young Children Formula Milk Powder Formula Registration (trial) (2017 Revision)", and pay attention to the following issues:
(1) The entire set of application materials should be bound into a booklet, and each material should have a cover page. The product name and the applicant's name should be indicated on the cover page, and the name of the material should be indicated in the upper right corner. The materials should be clearly distinguished from each other (e.g. pagination stickers or dividers) with the name of each material or the serial number of the catalogue in which the material is located.
(2) The entire set of application materials should provide a detailed catalog of materials and serve as the first page of the application materials.
(3) The original and photocopies of the entire set of application materials shall be complete and clear, and shall not be altered.
(4) In addition to the registration application and the inspection report issued by the inspection agency, the application materials should be stamped with a complete and clear official seal or seal of the applicant page by page or stitched, and stamped at the text. The official seal or seal should be consistent. If the overseas applicant does not have the official seal or seal, the official seal or seal of the representative office in China or the domestic agency should be affixed.
(5) The applicant's name, address, legal representative, etc. filled in the application materials should be consistent with the relevant information in the applicant's subject qualification certificate. The same content in the application materials (such as applicant's name, address, product name, etc.) shall be consistent.
(6) The applicant shall provide the original copy of the application materials such as the guarantee letter that the patent obtained by others does not constitute infringement, the guarantee letter that the product name does not constitute infringement, and the inspection report and other application materials.
(7) When uploading electronic materials on the enterprise side, the applicant shall select the original scanned documents to ensure that the text of the electronic version of the documents is clear and legible and that the electronic documents in the uploading system are complete.
(8) The applicant should keep the original, photocopy and scanned materials consistent.