Cosmetic Hygiene and Safety Act Article 5
Manufacturers or importers of specific purpose cosmetics designated by the public announcement of central competent authority, an application for registration shall be filed with the central competent authority. No manufacturing or import shall be allowed until a license is approved and issued.Licensed cosmetics of the preceding paragraph shall not modify any of the originally registered particulars without approval of the central competent authority. However, this restriction does not apply to particulars that may be voluntarily modified per public announcement by the central competent authority.The import of specific purpose cosmetics shall be exempted from application for registration of Paragraph 1 if one of the following conditions applies. Furthermore, the supply, sale, public display, consumer trial offer, or transfer to other uses of said cosmetics shall be forbidden:1. Import for personal use, the quantity of which complies with public announcement of the central competent authority;2. Import for the application for registration of Paragraph 1 or for use in research and trial, through special permission of the central competent authority.For the import of specific purpose cosmetics for personal use of the preceding Subparagraph 1 that exceed the quantity specified in public announcement, their excess portion shall be ordered a return or destruction within a specified time limit by the customs.Prior to the enforcement of this Act as amended on April 10, 2018, for the manufacturing or import with a license of cosmetics containing medical or poisonous drugs whose license validity term expires within five years following the enforcement of this Act as amended on April 10, 2018, and where it is necessary to continue the manufacturing or import, an application for extension may be filed within three months before the expiration of validity term and an application for registration in accordance with Paragraph 1 may be exempted.Regulations governing the issuance, modifications, revocation, and rescission of licenses with regard to Paragraph 1 and Paragraph 2, the application procedure for special permission with regard to Subparagraph 2 of Paragraph 3, the license extension with regard to Paragraph 5, and other matters to be observed shall be prescribed by the central competent authority.The provisions of Paragraph 1 and Paragraph 2 shall cease to apply starting five years after the date of enforcement of this Act as amended on April 10, 2018.
中文原文 化粧品衛生安全管理法第5條
製造或輸入經中央主管機關指定公告之特定用途化粧品者，應向中央主管機關申請查驗登記，經核准並發給許可證後，始得製造或輸入。
前項取得許可證之化粧品，非經中央主管機關核准，不得變更原登記事項。
但經中央主管機關公告得自行變更之事項，不在此限。
輸入特定用途化粧品有下列情形之一者，得免申請第一項之查驗登記，並不得供應、販賣、公開陳列、提供消費者試用或轉供他用：
一、供個人自用，其數量符合中央主管機關公告。
二、供申請第一項之查驗登記或供研究試驗之用，經中央主管機關專案核准。
前項第一款個人自用之特定用途化粧品超過公告數量者，其超量部分，由海關責令限期退運或銷毀。
本法中華民國一百零七年四月十日修正之條文施行前，製造或輸入化粧品含有醫療或毒劇藥品，領有許可證者，其許可證有效期間於一百零七年四月十日修正之條文施行之日起五年內屆滿，仍須製造或輸入者，得於效期屆滿前三個月內申請展延，免依第一項申請查驗登記。
第一項與第二項之許可證核發、變更、廢止、撤銷、第三項第二款之專案核准、第五項之許可證展延之申請程序及其他應遵行事項之辦法，由中央主管機關定之。
第一項及第二項規定，於本法中華民國一百零七年四月十日修正之條文施行之日起五年後，停止適用。
前項取得許可證之化粧品，非經中央主管機關核准，不得變更原登記事項。
但經中央主管機關公告得自行變更之事項，不在此限。
輸入特定用途化粧品有下列情形之一者，得免申請第一項之查驗登記，並不得供應、販賣、公開陳列、提供消費者試用或轉供他用：
一、供個人自用，其數量符合中央主管機關公告。
二、供申請第一項之查驗登記或供研究試驗之用，經中央主管機關專案核准。
前項第一款個人自用之特定用途化粧品超過公告數量者，其超量部分，由海關責令限期退運或銷毀。
本法中華民國一百零七年四月十日修正之條文施行前，製造或輸入化粧品含有醫療或毒劇藥品，領有許可證者，其許可證有效期間於一百零七年四月十日修正之條文施行之日起五年內屆滿，仍須製造或輸入者，得於效期屆滿前三個月內申請展延，免依第一項申請查驗登記。
第一項與第二項之許可證核發、變更、廢止、撤銷、第三項第二款之專案核准、第五項之許可證展延之申請程序及其他應遵行事項之辦法，由中央主管機關定之。
第一項及第二項規定，於本法中華民國一百零七年四月十日修正之條文施行之日起五年後，停止適用。