It should be a health food production license.
I. Project Name
"Health food production license" issued.
Second, the legal basis
(1) Administrative Licensing Law of People's Republic of China (PRC);
(2) People's Republic of China (PRC) (China) Food Safety Law;
(3) Regulations for the Implementation of People's Republic of China (PRC) Food Safety Law;
(4) Measures for the administration of health food.
Third, the charging standard
No charge for the time being.
Four. Acceptance scope
(1) Health food production enterprises newly built, rebuilt or expanded within the administrative area of Henan Province;
(two) health food production enterprises to change the main equipment.
Verb (abbreviation of verb) application materials
(1) Application Form for Issuing Health Food Production License in Henan Province (download and print);
(2) A notice of pre-approval of enterprise name or a copy of enterprise business license issued by the administrative department for industry and commerce;
(three) a copy of the review opinions that meet the requirements of good manufacturing practices for health food;
(four) a copy of the registration approval of health food products (including attachments);
(5) Copies of the identity cards of the legal representative and the person in charge of the enterprise;
(6) Certificate of education or professional title (qualification) of quality manager, copy of ID card and resume;
(seven) health food product catalogue, product formula, production process flow chart and description;
(8) Sample labels and instructions of the minimum sales package of the product;
(9) Copies of three consecutive batches of self-inspection reports shall be provided for the products applied for production (products shall be produced after obtaining gmp review opinions, and relevant production records shall be checked on site, and a batch of samples shall be randomly selected for inspection);
(ten) a copy of the enterprise standard of each product;
(eleven) the key control points and control measures in the production process of each product;
(12) List of employee health examination certificates;
(13) List of training materials on health food hygiene knowledge for employees;
(14) list of laboratory settings and detectable items;
(15) If the production is commissioned, copies of the commissioned production contract, the business license of the entrusting party and other documents issued by the provincial US Food and Drug Administration shall be submitted;
(sixteen) if the agent is not the legal representative or the person in charge himself, it shall submit the power of attorney of the enterprise and a copy of the agent's ID card;
(seventeen) other relevant information.
Information requirements of intransitive verbs
(a) the application materials should be bound in the above order, and each part should be separated by a labeled separator. The content of the project is written on the next page, the project number is marked on the label, and the whole set of information is bound into a book.
(2) Print on a4 paper (each title is No.2, the content is No.4 in Chinese and No.0/2 in English, with a spacing of 25 pounds), with the left margin of 3cm and the page number marked in the center of the footer.
(three) the application materials should be stamped with the official seal of the enterprise page by page (except the original inspection report, notarized documents, official documents and third-party documents) and the riding seal. The submitted copy must be consistent with the original, and the applicant must indicate the words "consistent with the original" and the date of copying on the copy, and affix the official seal of the enterprise. (The applicant is an entrusted processing enterprise, and the materials provided by the entrusting party must be stamped with the official seal of the entrusting party at the same time). Verify the original during on-site inspection.
(four) the pictures and drawings attached to the application materials must be clear and easy to distinguish, and the drawings should indicate the area and size.
(five) the letter of guarantee in the application shall be signed by the legal representative and stamped with the official seal of the enterprise.
(6) The application materials are in duplicate.
(seven) the matter shall not be applied at the same time as other administrative licensing matters.
Seven. Licensing procedure
(1) acceptance. If the application materials are complete and meet the requirements of formal examination, fill in the acceptance notice and give it to the applicant as an acceptance certificate. If the application materials submitted by the applicant are incomplete or do not meet the requirements of formal examination, the accepting personnel shall inform the applicant of all the contents that need to be corrected on the spot or within 5 working days; Fails to inform, since the date of receipt of the application materials is accepted.
(2) examination and approval. From the date of acceptance, the application materials shall be examined and checked on the spot. On-site sampling shall be sent to the designated inspection organization for re-inspection. Those who pass the examination shall be issued with the original and duplicate of the health food production license. Unqualified, make a "decision not to grant administrative license", explain the reasons and inform them that they have the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
(3) Delivery: delivered by the administrative matter acceptance office.
Eight. Time limit for commitment
The time limit for examination and approval is 20 working days (excluding the re-inspection time of samples), and the time limit for issuing certificates is 10 working days.
Nine. actuating mechanism
Implementing agency: US Food and Drug Administration of Henan Province.
X. Duration and extension of license
The production license of health food is valid for three years and reviewed once a year. "Health food production license" expires 30 days before the original issuing authority to apply for extension, overdue application for extension, according to the new application for "health food production license".