I. Division of responsibilities
1. China Food and Drug Administration is responsible for formulating the examination standards and procedures for health food production licenses, and guiding the provincial food and drug supervision and administration departments to carry out the examination of health food production licenses.
2. The provincial food and drug supervision and administration department is responsible for formulating the examination process of health food production license within its administrative area and organizing the implementation of the examination of health food production license.
3. The department responsible for technical review is responsible for organizing the written review and on-site verification of the health food production license, the selection, training, selection and management of examiners, and is specifically responsible for the written review of the health food production license.
4. The review team is specifically responsible for the on-site verification of the production license of health food.
Two. accept
1. The applicant for the health food production license shall be a legal person who has obtained a business license and meets the corresponding conditions required by the Measures for the Administration of Food Production License.
The applicant shall, in accordance with the requirements of the Catalogue of Application Materials for Health Food Production License (Annex 1), fill in the application form for food production license and submit the application materials to the local provincial food and drug supervision and administration department.
2. To apply for a health food production license, the applicant shall refer to the requirements of the Catalogue of Health Food Production Licenses (Annex 2) and fill in the list of health food varieties applied for production.
If the applicant newly establishes a health food production enterprise or a new dosage form, it may entrust the production, submit the health food registration certificate of the entrusting party, or obtain the health food production license qualification with the "varieties to be filed".
3. When applying for the production license of raw material extracts and compound nutrients of health food, the applicant shall submit the health food registration certificate or filing certificate, as well as the production technology and quality standards of raw material extracts specified in the registration certificate or filing certificate, and the product formula, production technology and quality standards of compound nutrients specified in the registration certificate or filing certificate.
Legal basis: Detailed Rules for the Examination of Health Food Production License 1.2 Scope of Application These Rules are applicable to the examination of health food production license in China, including technical examination, written examination and on-site verification.