Registration of health food products improved

On 21 July, the State Food and Drug Administration issued the Administrative Licensing of Health Food Products Notice to regulate and strengthen the administrative licensing of health food products and to improve the health food registration process under the Health Food Registration Administrative Measures (Trial Implementation). The Notice came into effect on 1 September, and primarily covers the following:

Scope of application

• The process for submitting additional information for health food registration is improved. Under the Measures, if additional information is required during the health food registration process, the applicant should submit it within five months of receipt of a notice, or else the review of the application will be withdrawn. However, the Notice grants an exception to the five-month time limit, saying if the applicant fails to submit the additional information on time due to special circumstances, the time limit can be extended to one year. In such a case, the applicant must give an explanation when submitting the additional information.
• The health food re-registration process is improved. According to the Measures, a healthcare food approval certificate must be re-registered if it expires. But the Notice describes various different cases to further regulate the re-registration process: (1) if no production or sales occur within the five-year period of an approval certificate, the trial production of samples, on-site inspection, checking and technical review must be conducted in accordance with relevant regulations and procedures; (2) if production or sales are carried out within the five-year period of an approval certificate, a product quality inspection report issued by a registered inspection agency which is approved by the State Food and Drug Administration must be presented upon making a re-registration application.

Business Law Digest is compiled with the assistance of Haiwen & Partners. The authors can be emailed at baochen@haiwen-law.com. Readers should not act on this information without seeking professional legal advice.