Amendment "health food registration and record management approach" decision
Pharmaceutical Network January 3 hearing the State Food and Drug Administration decided to "health food registration and filing management approach" to make the following changes:
1. The second paragraph of Article 7 is amended as follows: 'Applicants or record fillers of health food registrations shall be responsible for the truthfulness, completeness and traceability of the materials submitted and will voluntarily disclose the scientific documents and test basis related to product functions And bear legal responsibility for the authenticity of the submitted materials.
2. The first paragraph of Article 16 is amended as follows: 'The review agency shall organize the examination of the application materials and organize inspection agencies to carry out on-site inspections according to actual needs and organize the inspection agencies to carry out review and verification within 60 working days Review work, and to national food drug General Administration of Supervision submits consolidated findings and recommendations.
Third, the first paragraph of Article 32 amended as: 'Has been produced and sold Healthy food If the expiry of the registration certificate needs to be renewed, the registrant of the health food product shall apply for extension 6 months before the expiry of the validity period; if it fails to apply for renewal within 6 months before the expiry of the validity period and within the validity period of the registration certificate, the registrant of the health food product may apply for extension of registration , But extended registration application accepted, the expiry of the original registration certificate, enterprise Should stop production, pending approval of the registration decision can be resumed production.
Add a paragraph as the second paragraph of Article 32: due to law Regulations And food safety standard Changes, the product does not meet the new requirements, health food registrants should apply for changes in a timely manner, and supplement and improve the compliance with the requirements of the new laws and relevant materials.
Article 38 is amended as follows: 'The review organization shall review the application for alteration registration or renewal of the registration of the health food products and, in accordance with the provisions of Articles 36 and 37, make the registration or not Registration decision, and shall, within 10 working days from the date of making the decision, the accepting institution shall issue the health food registration certificate or the non-registration decision to the registered applicant.
Where a health food registrant makes a renewal application for registration 6 months prior to the expiry of the validity period, the review agency shall make a decision on whether to grant renewal before the expiry date of the health food registration certificate, and if no decision is overdue, it shall be deemed as continuation of the registration.
Where the health food registrant fails to apply for renewal within 6 months before the expiry of the validity period but applies for renewal within the valid period of the registration certificate, the review agency shall make a decision on whether or not to grant renewal within 6 months from the date of acceptance.
Fifth, the Article 55 is amended as follows: health food labeling, the main content of the manual shall not be involved in disease prevention and treatment functions, and declare 'This product can not replace the disease prevention and treatment of drugs'.
Without the edible evaluation of the population, the qualifying term of the health care function shall be increased. 'This product is only evaluated by animal experiments.' 'After the food consumption rating of the population, the qualifying term of the health care function shall be increased.
Sixth, add an article after Article 74 as Article 75: 'The registration certificate of health food products made by the food and drug regulatory department has the same legal effect as the printed health food registration certificate.'
This decision will come into effect on the same day.
"Health food registration and filing management approach" according to this decision to make the appropriate changes and the article serial number adjusted accordingly, redistribution.
