2 N.C. Admin. Code 52G.0403

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

Section 52G .0403 - REGISTRATION

(a) Registration of a biologic shall be approved when the applicant provides such information concerning protocols, source of biologic agents, purity and safety as may be required by these Rules.

(b) Upon approval, a biologic shall be registered upon receipt of a fifty dollar ($50.00) fee.

(c) The registration of a biologic shall specify the conditions of use and period for which the registration is granted.

(d) No change in composition, protocol of production or labeling of a biologic registered by the Commissioner shall be made without prior approval of the Commissioner.

02 N.C. Admin. Code 52G .0403

Authority G.S. 106-709; 106-710; 106-712; 106-713; 106-715;
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. 106-709; 106-710; 106-712; 106-713; 106-715;
Eff. April 1, 1984.