(a) Biological equivalence test of biological equivalence test (hereinafter referred to as “biological equivalence test”) refers to a biological body test that shows that the biological equivalence test of two preparations containing the same major components is statistically equivalent to that of the same major components;

A person who intends to engage in the business of manufacturing medicines shall obtain permission from the Commissioner of the Korea Food and Drug Administration (hereinafter referred to as the "Administrator of the Korea Food and Drug Administration") under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare, obtain permission for items by item, or report items by item, and where he/she intends to modify permitted or reported matters, he/she shall obtain permission for modification or report changes [Article 26 of the Pharmaceutical Affairs Act (amended by Act No. 8365 of Apr. 11, 2007)]. Where items he/she intends to obtain such permission are the same as new drugs that have obtained manufacturing approval (import approval) after January 1, 1989, where items he/she intends to obtain such permission are identical to those of the drugs for which he/she has obtained manufacturing approval after he/she has obtained such permission, he/she shall attach data on the bio-sex test plan, comparative clinical trial plan or comparative clinical trial report [Article 23 (1) 1 (f) of the Pharmaceutical Affairs Act (amended by Ordinance of the Ministry of the Korea Food and Drug Administration).

(Article 24(2) of the Enforcement Rule of the above Act. After the enforcement of a pharmaceutical medicine from July 1, 200, pursuant to Article 23-2 of the Pharmaceutical Affairs Act amended by Act No. 6511, Aug. 14, 2001, a pharmacist, in principle, contains, content, and content of a pharmaceutical product in a prescription given by a doctor or a dentist.