Administrative Measures for the Registration of Formula Food for Special Medical Purposes.

These Measures are developed in accordance with the Administrative Licensing Law, the Food Safety Law, the Regulation on the Implementation of the Food Safety Law, and other applicable laws and regulations for the purposes of regulating the registration of formula food for special medical purposes and ensuring the quality and safety of formula food for special medical purposes.
The Measures consist of 64 Articles divided into 7 Chapters: General provisions (I); Registration (II); Clinical trials (III); Labels and instructions (IV); Supervision and inspection (V); Legal liabilities (VII); Supplementary provisions (VII).
The registration of formula food for special medical purposes means the activities in which the State Administration for Market Regulation (SAMR), according to the procedures and requirements as prescribed in these Measures, examines the applications for the registration of formula food for special medical purposes and decides whether to approve registration.
Chapter 2 provides for the conditions, procedures and requirements to be satisfied for the application, acceptance, examination and renewal of the registration. These Measures shall apply to the administration of registration of formula food for special medical purposes produced and sold within and imported to the territory of the People's Republic of China.