Pharmaceuticals; PHARMACEUTICAL PRODUCTS (HS 30)

The Amendment to the "Regulation on Designation, and Approval Procedure and Method of Pharmaceutical Products for National Lot Release" (25 page(s), in Korean)

The Amendment to the Regulation on Designation, and Approval Procedure and Method of Pharmaceutical Products for National Lot Release:

1.    Clarifies details, including quantity of samples, period for the procedure, etc., of SARS-CoV-2 viral vector vaccines and other newly authorized pharmaceutical products subject to national lot release;

2.    Clarifies products subject to be classified as carrying risk level 3 (subject to summary protocol review and test on entire items) as products (A) which have received national lot release inappropriately, (B) of which master formula is not provided during on-site inspection, or (C) for which false test results were submitted; and 

3.    Modifies quantity for samples of items including anti-tetanus immunoglobulin.