02 NCAC 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.

 

History Note:        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.