According to the Reply of the US Food and Drug Administration on Relevant Issues Concerning the Applicable Laws for the Sale of Non-drug Counters in Packaging Gift Boxes with Nourishing Chinese Herbal Medicines as the Contents (Guo Fa Fa [2006] No.78), ordinary commercial enterprises do not need to obtain a Pharmaceutical Business License for the sale of nourishing and health-care Chinese herbal medicines, regardless of whether they are packaged or not.

Official Reply of the State Council on the Legal Issues Applicable to the Sales of Non-pharmaceutical Counters of Packaging Gift Boxes with Nourishing and Health-care Chinese Herbal Medicines as the Content

(US Food and Drug Administration [2006] No.78)

Beijing Drug Administration:

Your request for instructions on the legal issues applicable to the sale of boxed Chinese herbal pieces in non-pharmaceutical counters with nourishing and health care as the content (Beijing Drug Administration [2005]193) has been received. After study, the answers to the relevant questions are as follows:

According to the provisions of Articles 21, 31 and 34 of the Drug Administration Law of People's Republic of China (PRC), and the Report of the Legal Affairs Office of the Beijing Municipal People's Government on the Sales of OTC Counter by the Legislative Affairs Office of the State Council.

Reply to the Request for Instructions on Applicable Legal Issues Concerning the Sale of Nourishing and Health-care Chinese Herbal Medicines (Guo Fa [2005] No.59), we believe that non-pharmaceutical business units sell nourishing and health-care Chinese herbal medicines without approval.

No matter whether these nourishing and health-care Chinese herbal medicines are packaged (gift box packaging), it is not necessary to obtain a drug business license.

This reply

SFDA

February 27(th), 2006