"Health food registration and record management approach" to be made three major changes

Pharmaceutical Network November 6 hearing in order to implement the spirit of the State Council reform of the administrative examination and approval system, and further strengthen the registration of special food to effectively improve the efficiency of review and approval, the State Food and Drug Administration drafted the "State Food and Drug Administration on the revision <保健食品注册与备案管理办法>(Draft for Opinion) ", it is proposed to change the registration of the special food made by the State Food and Drug Administration and the renewal of the registration approval decision (including domestic and import), authorized by the State Food and Drug Administration Health Food Review Center to countries The State Food and Drug Administration made the name of the same time not to the validity of the certificate 6 months before the health food extension to provide a continuation of the application of relief measures to make it clear that the applicant may be extended before the expiry of the application for registration; At the expiration of the original registration certificate, the enterprise shall cease production until it can make a decision on the approval of the registration, and the food and drug supervision and administration department shall make a decision on whether to grant the renewal within 6 months from the date of acceptance.

The comment period is as of November 20, 2017.

National food drug Supervision and Administration decided to "Healthy food Registration and Record Management Measures "to make the following changes:

1. The first paragraph of Article 16 is amended as follows: 'The review agency shall organize the examination of the application materials and organize the inspection agency to carry out on-site inspection according to the actual needs and organize the inspection agency to carry out the review and verification within 60 working days Review work and submit the consolidated findings and recommendations to the State Food and Drug Administration.

2. The second paragraph of Article 32 is amended as follows: 'If the valid period for the registration of health food products already produced and sold needs to be extended, the registrant of health food products shall apply for renewal before the expiry of 6 months; If the application for renewal is made before the month of registration and the registration certificate is valid, the registrant of the health food product may apply for extension of registration. However, upon the extension of the registration application, upon the expiry of the validity of the original registration certificate, enterprise Should stop production, pending approval of the registration decision can be resumed production.

Due to law Regulations And food safety standard Changes, the product does not meet the new requirements, health food registrants shall promptly supplement and improve the relevant materials in line with the requirements of the new regulations.

Article 38 shall be amended as follows: 'The review organization shall review the application materials for alteration registration or extension of health food products and make the registration according to Article 36 and Article 37, 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 before the expiry of the validity period, the review institution shall make a decision on whether to grant a renewal before the expiry date of the health food registration certificate.

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.

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.