2 N.C. Admin. Code 52G.0201

Current through Register Vol. 39, No. 11, December 2, 2024

Section 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.

02 N.C. Admin. Code 52G .0201

Authority G.S. 106-710; 106-712; 106-713;
Eff. April 1, 1984;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 26, 2017.

Authority G.S. 106-710; 106-712; 106-713;
Eff. April 1, 1984.