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.