02 NCAC 52G .0201. BIOLOGICS PRODUCTION LICENSE APPLICATION AND FEES

(a)  An application for an initial license to produce biologics shall be accompanied by an application fee of one hundred dollars ($100.00) and a license fee of one hundred dollars ($100.00).

(b)  Applications for a license to produce biologics shall contain all of the following:

(1)           the name and address of the person who owns the establishment proposed to produce biologics;

(2)           the name and address of the person in charge of biologics production;

(3)           the type(s) of biologics to be produced;

(4)           a full description of the building, including its location, facilities, equipment, and apparatus to be used in biologics production; and

(5)           such other information as may be required by the Commissioner.

 

History Note:        Authority G.S. 106‑710; 106‑712; 106‑713;

Eff. April 1, 1984.