Pharmaceutical Affairs Act Article 42
The central competent health authority shall establish operational guidelines as standards for issuance, change, and extension of medicament licenses in regard to the manufacture or import of medicaments.The operational guidelines referred to in the preceding paragraph shall be established by the central competent health authority.
中文原文 藥事法第42條
中央衛生主管機關對於製造、輸入之藥物，應訂定作業準則，作為核發、變更及展延藥物許可證之基準。
前項作業準則，由中央衛生主管機關定之。
前項作業準則，由中央衛生主管機關定之。