PDF《2018》

第1条?? Section

1 Pharmacy and Poisons (Amendment) (No.

5) Regulation

2018 《2018 年药剂业及毒药 ( 修订 ) ( 第5号)规例》

2018 年第

191 号法律公告 B4896 L.N.

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2018 B4897

2018 年第

191 号法律公告 《2018 年药剂业及毒药 ( 修订 ) ( 第5号)规例》 ( 由药剂业及毒药管理局根 《药剂业及毒药条例》 ( 第138 章)第29(1B) 条在食物及o生局局长批准下订立 ) 1. 修订 《药剂业及毒药规例》 《药剂业及毒药规例》 ( 第138 章,附属法例 A) 现予修订,修 订方式列於第

2、3 及4条. 2. 修订附表

1 ( 关於销售、供应、标签及贮存的限制根

3、

5、

6、22 及24 条而适用的物质 ) (1) 附表 1,A 分部,在 布比卡因;

其盐类 项目之后―― 加入 布立西坦;

其盐类 . (2) 附表 1,A 分部,在 钆塞酸;

其盐类 项目之后―― 加入 胞磷胆碱;

其盐类;

但限於包含在拟用於治疗脑血管 病或脑损伤 ( 或脑血管病兼脑损伤 ) 相关的认知及神 经失调的药剂制品内者 . (3) 附表 1,A 分部,在 度他雄胺 项目之后―― L.N.

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2018 Pharmacy and Poisons (Amendment) (No. 5) Regulation

2018 (Made by the Pharmacy and Poisons Board under section 29(1B) of the Pharmacy and Poisons Ordinance (Cap. 138) subject to the approval of the Secretary for Food and Health) 1. Pharmacy and Poisons Regulations amended The Pharmacy and Poisons Regulations (Cap.

138 sub. leg. A) are amended as set out in sections 2,

3 and 4. 2. Schedule

1 amended (substances to which certain restrictions with respect to the sale, supply, labelling and storage apply under regulations 3, 5, 6,

22 and 24) (1) Schedule 1, Division A, after item Brinzolamide;

its salts ― Add Brivaracetam;

its salts . (2) Schedule 1, Division A, after item Citalopram;

its salts ― Add Citicoline;

its salts;

when contained in pharmaceutical products intended to be used for the treatment of cognitive and neurological disorders associated with cerebrovascular disease or brain injury, or both . (3) Schedule 1, Division A, after item Duloxetine;

its salts ― 第2条?? Section

2 Pharmacy and Poisons (Amendment) (No. 5) Regulation

2018 《2018 年药剂业及毒药 ( 修订 ) ( 第5号)规例》

2018 年第

191 号法律公告 B4898 L.N.

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2018 B4899 Add Durvalumab . (4) Schedule 1, Division A, after item Embutramide ― Add Emicizumab . (5) Schedule 1, Division A, after item relating to Guanidines ― Add Guselkumab . (6) Schedule 1, Division A, after item Inosine pranobex ― Add Inotuzumab ozogamicin . (7) Schedule 1, Division A, after item Lidoflazine ― Add Lignocaine;

its salts;

when in mixture with prilocaine or in mixture with the salts of prilocaine, and intended to be used for the treatment of premature ejaculation . (8) Schedule 1, Division A― Repeal item Lignocaine;

its salts in mixture with tetracaine or in mixture with the salts of tetracaine Substitute Lignocaine;

its salts;

when in mixture with tetracaine (being an amino alcohol esterified with a derivative of benzoic acid) or in mixture with the salts of tetracaine . (9) Schedule 1, Division A, after item Methoxsalen ― Add Methoxyflurane . 加入 度伐人单抗 . (4) 附表 1,A 分部,在 艾多沙班;

其盐类 项目之后―― 加入 艾米希组单抗 . (5) 附表 1,A 分部,在 尼群地平 项目之后―― 加入 古塞库人单抗 . (6) 附表 1,A 分部,在 伊马替尼;

其盐类 项目之后―― 加入 伊珠单抗奥加米星 . (7) 附表 1,A 分部,在 利多氟嗪 项目之前―― 加入 利多卡因;

其盐类;

但限於与丙胺卡因混合或与丙胺 卡因的盐类混合,并拟用於治疗早泄者 . (8) 附表 1,A 分部―― 废除 利多卡因;

其盐类与丁卡因的混合物,或与丁卡 因的盐类的混合物 项目 代以 利多卡因;

其盐类;

但限於与丁卡因 ( 属经苯甲酸的衍 生物酯化的氨基醇 ) 混合或与丁卡因的盐类混合者 . (9) 附表 1,A 分部,在 甲氧苄啶 项目之后―― 加入 甲氧氟烷 . 第3条?? Section

3 Pharmacy and Poisons (Amendment) (No. 5) Regulation

2018 《2018 年药剂业及毒药 ( 修订 ) ( 第5号)规例》

2018 年第

191 号法律公告 B4900 L.N.

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2018 B4901 (10) Schedule 1, Division A, after item Nintedanib;

its salts ― Add Niraparib;

its salts . (11) Schedule 1, Division A, item Pharmaceutical products for human parenteral administration containing the following or their salts, as active ingredients, except in mixture with insulin , after sub-item Cimetidine ― Add Citicoline . (12) Schedule 1, Division A― Repeal item Tetracaine (being an amino alcohol esterified with a derivative of benzoic acid);

its salts in mixture with lignocaine or in mixture with the salts of lignocaine . (13) Schedule 1, Division A, after item Vortioxetine;

its salts ― Add Voxilaprevir;

its salts . 3. Schedule

3 amended (substances required by regulation

9 to be sold by retail only upon a prescription given by a registered medical practitioner, registered dentist or registered veterinary surgeon) (1) Schedule 3, Division A, after item Brinzolamide;

its salts ― Add Brivaracetam;

its salts . (10) 附表 1,A 分部,在 尼芬那宗 项目之后―― 加入 尼拉帕利;

其盐类 . (11) 附表 1,A 分部, 供注射入人体的药剂制品,并包含 ( 作 为有效成分 ) 以下物质或它们的盐类,但与胰岛素的混 合物除外 项目,在 玻璃酸酶 分项之后―― 加入 胞磷胆碱 . (12) 附表 1,A 分部―― 废除 丁卡因 ( 属经苯甲酸的衍生物酯化的氨基醇 );

其 盐类与利多卡因的混合物,或与利多卡因的盐类的混合 物 项目. (13) 附表 1,A 分部,在 伏立康唑;

其盐类 项目之后―― 加入 伏西瑞韦;

其盐类 . 3. 修订附表

3 ( 第9条规定仅可按照注册医生、注册牙医或注 册兽医开出的处方而以零售方式销售的物质 ) (1) 附表 3,A 分部,在 布比卡因;

其盐类 项目之后―― 加入 布立西坦;

其盐类 . 第3条?? Section

3 Pharmacy and Poisons (Amendment) (No. 5) Regulation

2018 《2018 年药剂业及毒药 ( 修订 ) ( 第5号)规例》

2018 年第

191 号法律公告 B4902 L.N.

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2018 B4903 (2) Schedule 3, Division A, after item Citalopram;

its salts ― Add Citicoline;

its salts;

when contained in pharmaceutical products intended to be used for the treatment of cognitive and neurological disorders associated with cerebrovascular disease or brain injury, or both . (3) Schedule 3, Division A, after item Duloxetine;

its salts ― Add Durvalumab . (4) Schedule 3, Division A, after item Embutramide ― Add Emicizumab . (5) Schedule 3, Division A, after item Guanfacine;

its salts ― Add Guselkumab . (6) Schedule 3, Division A, after item Inosine pranobex ― Add Inotuzumab ozogamicin . (7) Schedule 3, Division A, after item Lidoflazine ― Add Lignocaine;

its salts;

when in mixture with prilocaine or in mixture with the salts of prilocaine, and intended to be used for the treatment of premature ejaculation . (2) 附表 3,A 分部,在 钆塞酸;

其盐类 项目之后―― 加入 胞磷胆碱;

其盐类;

但限於包含在拟用於治疗脑血管 病或脑损伤 ( 或脑血管病兼脑损伤 ) 相关的认知及神 经失调的药剂制品内者 . (3) 附表 3,A 分部,在 度他雄胺 项目之后―― 加入 度........