Regulation for the Issuance and Management of Western Pharmaceuticals Distribution Licenses and Certificates Article 3
The western pharmaceuticals distribution license shall include registration of the following items:1.The registered name of the pharmaceutical firm, address, and name of the management pharmacists.2.The distribution operation items for which the license has been granted. 3.The pharmaceuticals storage warehouse location.4.The expiration date.5.The license number.If there is any change in the registration matters under Subparagraph 1 in the preceding paragraph, an application for amendment of registration shall be submit to the central competent health authority after submitting a photocopy of western pharmaceuticals distribution license, the amended photocopy of the pharmaceutical firm business permit license and pay the application fee within 30 days from the date of the occurrence of the change. If there is to be any change in the matter under Subparagraph 2 and Subparagraph 3 of Paragraph 1, the provisions of the preceding paragraph shall apply mutatis mutandis to its application and review procedure.
中文原文 西藥運銷許可及證明文件核發管理辦法第3條
西藥運銷許可之內容,應記載下列事項:
一、依本法及相關法規登記之藥商名稱與地址及管理藥師、藥劑生姓名。
二、運銷作業項目。
三、貯存藥品倉庫之場所。
四、有效期限。
五、許可編號。
前項第一款記載事項有變更者,應自事實發生之日起三十日內,檢附西藥運銷許可影本及已完成變更之藥商許可執照影本,並繳納費用後,向中央衛生主管機關申請變更。
第一項第二款及第三款之變更,其申請及審查程序,準用前條規定。
一、依本法及相關法規登記之藥商名稱與地址及管理藥師、藥劑生姓名。
二、運銷作業項目。
三、貯存藥品倉庫之場所。
四、有效期限。
五、許可編號。
前項第一款記載事項有變更者,應自事實發生之日起三十日內,檢附西藥運銷許可影本及已完成變更之藥商許可執照影本,並繳納費用後,向中央衛生主管機關申請變更。
第一項第二款及第三款之變更,其申請及審查程序,準用前條規定。