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                [G/TBT/N/THA/440]泰国:关于无菌药品用酚醛塑料容器的泰国工业标准草案(TIS531-25XX)

                来源: 发布时间:2014-12-02 点击量:

                 

                世贸易组织
                G/TBT/N/THA/440
                2014-12-01
                14-6959
                 
                技术性贸易壁垒
                原文:英语
                通  报


                以次通报根据TBT存照第10.6条分发
                1.
                通报分子:泰国
                如可能,列出涉及的地域政府名称 ( 3.2条和7.2 条):
                2.
                负责机构:工业部泰国工业标准协会(TISI)
                3.
                通报依据条款:2.9.2
                4.
                覆盖的豪门国际: 制药业用设备 ICS:11.120.99 HS:9018.90
                HS编码:9018.90   ICS编码:11.120.99
                5.
                通报标题: 关于无菌药品用酚醛塑料容器的泰国工业标准草案(TIS531-25XX)

                语言:泰语 页数:43页 链接网址:
                6.
                内容简述: 泰国工业标准协会(TISI)已经提议取消TIS 531-2546(2003)无菌药品用酚醛塑料容器,并且用TIS 531-25XX作为强制性标准取代它。本标准草案仅涵盖用于注射到体内的液体无菌药品用酚醛塑料容器。其规定了类型、料、要求、标识和标签、取样和合格标准,以及测试。
                7.
                目标与理由:安好和消费者保护 
                8.
                相关文件:欧洲药典第7版,2011年卷• 阿曼药典第十五版(JPXV)2006年• 美国药典,第35修订版,2012年• ISO15747:2010青筋注射用酚醛塑料容器• ISO10993-5:2009医疗器械的底栖生物学评估-第5部分:体外细胞毒性试验• 世保健组织(WHO)日内瓦1974年药品用酚醛塑料容器–试验和控制
                9.
                拟批准日子:待定
                拟生效日子:待定
                10.
                意见反馈截止日子: 自分发日子起60天
                NOTIFICATION
                The following notification is being circulated in accordance with Article 10.6
                 

                1.
                Notifying Member: Thailand
                If applicable, name of local government involved (Article 3.2 and 7.2):
                2.
                Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:
                Thailand WTO/TBT Enquiry Point and Notification Authority
                Thai Industrial Standards Institute (TISI)
                Ministry of Industry
                Tel.: (662) 202 3504, 202 3523
                Fax: (662) 202 3511, 354 3041
                E-mail: thaitbt@tisi.go.th
                 
                3.
                Notified under Article 2.9.2 [ X ], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:
                4.
                Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Equipment for pharmaceutical industry� (HS: 9018.90; ICS: 11.120.99)
                5.
                6.
                Description of content: The Thai Industrial Standards Institute (TISI) has proposed to withdraw TIS 531-2546(2003) Plastic containers for sterile pharmaceutical products, and replace it with TIS 531-25XX as a mandatory standard. This draft standard covers only plastic containers for liquid sterile pharmaceutical products intended for injection into the body. It specifies types, materials, requirements, marking and labeling, sampling and criteria for conformity, and testing.
                7.
                Objective and rationale, including the nature of urgent problems where applicable: Safety and consumer protection
                8.
                Relevant documents:
                          European Pharmacopoeia 7th Edition, volume 2011
                          The Japanese Pharmacopoeia Fifteenth Edition (JP XV) 2006
                          The United States Pharmacopoeia, 35 Revision, 2012
                          ISO 15747: 2010  Plastic containers for intravenous injections
                          ISO 10993-5: 2009  Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
                          WHO Geneva 1974  Plastic containers for pharmaceuticals � testing and control
                9.
                Proposed date of adoption: To be determined
                Proposed date of entry into force: To be determined
                10.
                Final date for comments: 60 days from the circulation date
                11.
                Texts available from: National enquiry point [ X] or address, telephone and fax numbers and email and website addresses, if available, of other body:
                Thailand WTO/TBT Enquiry Point and Notification Authority
                Thai Industrial Standards Institute
                Tel: (66 2) 202 3504, 202 3523
                Fax: (66 2) 202 3511, 354 3041
                E-mail: thaitbt@tisi.go.th
                 



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