Environmental Agents Control Act Article 18
The mixing and packaging of environmental agents may be performed only after receiving central competent authority approval.The central competent authority shall determine regulations governing application conditions, review, approval, and other binding matters with regard to the commissioning or being commissioned in the foregoing paragraph.“Mixing”, as mentioned in the first paragraph, means the mixture of different components or environmental agent products to create environmental agents; separate packaging means to change for the purpose of sale the package capacity of an environmental agent that has been issued a permit.The packaging of environmental agents in the first paragraph may be performed only in environmental agents factories possessing unitary dosage form equipment.
中文原文 環境用藥管理法第18條
環境用藥之調配或分裝，應經中央主管機關核准後，始得為之。
前項申請條件、審查、核准及其他應遵行事項之準則，由中央主管機關定之。
第一項所稱調配，指以販賣為目的，將不同成分或環境用藥產品調合配藥；所稱分裝，指以販賣為目的，將已核發許可證之環境用藥改變包裝內容量。
第一項環境用藥之分裝以具有同一劑型設備之環境用藥工廠，始得為之。
前項申請條件、審查、核准及其他應遵行事項之準則，由中央主管機關定之。
第一項所稱調配，指以販賣為目的，將不同成分或環境用藥產品調合配藥；所稱分裝，指以販賣為目的，將已核發許可證之環境用藥改變包裝內容量。
第一項環境用藥之分裝以具有同一劑型設備之環境用藥工廠，始得為之。