保健食品批文变更流程

HEALTH FOOD APPROVAL CERTIFICATE CHANGE PROCESS

(1) Domestic product registration process:

If the company want to apply for “Change product’s name, expiry date, daily intake, or decrease the range of suitable group, increase the range of unsuitable group, notice or other functional contents”

APPLICATION PROVINCE FDA FORM EVALUATION & ACCEPT (5 DAYS) PROVINCE FDA PRESENT EVALUATION OPINIONS (10 DAYS) FDA EVALUATION AND MAKE DECISION (40 DAYS) ADMINISTRATIVE CENTER SEND OUT DECISION (10 DAYS)

If the company want to apply for “change specification, quality standards”,

APPLICATION PROVINCE FDA FORM EVALUATION & ACCEPT (5 DAYS) PROVINCE FDA PRESENT EVALUATION OPINIONS (10 DAYS) FDA EVALUATION AND MAKE DECISION (50 DAYS) ADMINISTRATIVE CENTER SEND OUT DECISION (10 DAYS) TESTING AGENCY, TIANJIANHUACHENG TESTING (30 DAYS)

(2) Abroad products registration process

If the company want the certificate “Change product’s name, expiry date, daily intake, or decrease the range of suitable group, increase the range of unsuitable group, notice or other functional contents”,

APPLICATION PROVINCE FDA FORM EVALUATION & ACCEPT (5 DAYS) FDA EVALUATION AND MAKE DECISION (40 DAYS) ADMINISTRATIVE CENTER SEND OUT DECISION (10 DAYS)

If the company want to apply for “change specification, quality standards and the manufacture place of the product in abroad”,

APPLICATION PROVINCE FDA FORM EVALUATION & ACCEPT (5 DAYS) FDA EVALUATION AND MAKE DECISION (40 DAYS) ADMINISTRATIVE CENTER SEND OUT DECISION (10 DAYS) ISSUE NOTIFICATION IN FIVE DAYS AND PROVIDE SAMPLES TESTING AGENCY, TIANJIANHUACHENG TESTING (30 DAYS)

NOTICE:

* As for changing the name and address of applicant, and change the responsible agency in China, in 20 days after this changing, the applicant should fill in the

“DOMESTIC HEALTH FOOD CHANGE APPLICATION FORM” OR “ABROAD HEALTH FOOD CHANGE APPLICATION FORM” and together with other documents submitted to CFDA for registration.

* When apply for decrease the range of suitable group, increase the range of unsuitable group, notice or other functional contents, change daily intake,

specification, expiry date and quality standards, and the health food must be the product on selling. The increased function must be the function qualified by CFDA.

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