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香港卫生局长《药剂业及毒药条例》决议案发言时间:2010-02-22 09:44来源:口译网 作者:口译网 点击:1109次
以下为香港食物及卫生局局长周一岳2010年1月20日在立法会会议上根据《药剂业及毒药条例》动议决议案通过《2009年药剂业及毒药（修订）（第5号）规例》及《2009年毒药表（修订）（第5号）规例》致辞全文：
Following is the speech by the Secretary for Food and Health, Dr York Chow, in moving a motion on the proposed resolution on Pharmacy and Poisons(Amendment)(No.5)Regulation 2009 and Poisons List(Amendment)(No.5)Regulation 2009 under the Pharmacy and Poisons Ordinance in the Legislative Council on January 20, 2010:
主席：
President，我谨动议通过议程所印载，以我名义提出的议案。
I move that the motion under my name, as printed on the Agenda, be paed.现时，我们根据《药剂业及毒药条例》制定的一套注册和监察制度，规管药剂制品的销售及供应。根据该条例订立的《毒药表规例》及《药剂业及毒药规例》，分别载列一个毒药表及数个附表。毒药表内不同部分及各附表上的药物，在销售条件及备存记录方面均受到不同程度的管制。
Currently, we regulate the sale and supply of pharmaceutical products through a registration and monitoring system set up in accordance with the Pharmacy and Poisons Ordinance.The Ordinance maintains a Poisons List under the Poisons List Regulations and several Schedules under the Pharmacy and Poisons Regulations.Pharmaceutical products put under different parts of the Poisons List and different Schedules are subject to different levels of control in regard to the conditions of sale and keeping of records.为保障市民健康，某些药剂制品必须在注册药剂师在场监督下，在药房出售；某些药剂制品的销售详情则须妥为记录，包括销售日期、购买人的姓名及地址、药物名称及数量，以及购买该药物的目的；另一些药剂制品则须有注册医生、牙医或兽医的处方，才可出售。
For the protection of public health, some pharmaceutical products can only be sold in pharmacies under the supervision of registered pharmacists and in their presence.For certain pharmaceutical products, proper records of the particulars of the sale must be kept, including the date of sale, the name and addre of the purchaser, the name and quantity of the medicine and the purpose for which it is required.The sale of some pharmaceutical products must be authorised by prescription from a registered medical practitioner, dentist or veterinary surgeon.因应四种药物的注册申请，药剂业及毒药管理局建议，在毒药表的第一部及《药剂业及毒药规例》的附表1及附表3内加入以下四种药物，它们分别是：
Arising from an application for registration of four pharmaceutical products, the Pharmacy and Poisons Board proposes to add the following four substances to Part I of the Poisons List and the First and Third Schedules to the Pharmacy and Poisons Regulations:
（a）来那度胺；其盐类；
（b）Melatonin；其盐类；但限于包含在拟用于治疗失眠症的药剂制品内者；（c）托珠单抗；及（d）Ustekinumab
(a)Lenalidomide;its salts(b)Melatonin;its salts;when contained in pharmaceutical products intended to be used for the treatment of insomnia(c)Tocilizumab(d)Ustekinumab
含有以上物质的药剂制品及制剂必须根据处方，在注册药剂师在场监督下于药房出售。
Pharmaceutical products containing the above substances must then be sold in pharmacies under the supervision of registered pharmacists and in their presence, with the support of prescriptions.我们建议修订规例在今年一月二十二日刊宪后即时生效，以便尽早对含有这些物质的药剂制品加以管制，并让这些药剂制品早日在市场销售。
We propose that these amendment regulations take immediate effect upon gazettal on January 22, 2010 to allow early control and sale of the relevant medicine.上述两条修订规例是由药剂业及毒药管理局拟定。该局根据《药剂业及毒药条例》成立，是负责规管药剂制品的法定机构，成员来自药剂业、医疗界和学术界。鉴于上述药物的效用、毒性和潜在副作用，该局认为必须作出有关的拟议修订。
The two Amendment Regulations are made by the Pharmacy and Poisons Board, which is a statutory authority established under the Ordinance to regulate pharmaceutical products.The Board comprises members engaged in the pharmacy, medical and academic profeions.The Board considers the proposed amendments neceary in view of the potency, toxicity and potential side effects of the medicine concerned.主席，我谨此陈词，提出上述动议。
With these remarks, President, I move the motion.原文链接：http://www.daodoc.com/
