G/TBT/N/CHL/506-Good Manufacturing Practices (GMP) for Radiopharmaceutical Products-广东省应对技术性贸易壁垒信息平台-广东省WTO/TBT预警|TBT通报|WTO通报|出口预警|贸易壁垒

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G/TBT/N/CHL/506
2019-10-30

技术性贸易壁垒

通报

以下通报根据TBT协定第10.6条分发

1.	通报成员：智利
2.	负责机构：Ministry of Health - Undersecretariat for Public Health
3.	通报依据的条款：Technical Regulation (Article 2.9.2) 通报依据的条款其他：
4.	覆盖的产品：Radiopharmaceutical products ICS：[] HS：[]
5.	通报标题： Good Manufacturing Practices (GMP) for Radiopharmaceutical Products 页数：20 pages 使用语言：in Spanish 链接网址：
6.	内容简述： The notified Technical Standard establishes guidelines, the main aim of which are to set out the basic specific requirements for the manufacturing of radiopharmaceutical products, and to supplement, in an Annex, the requirements established for sterile and non-sterile pharmaceutical products in Technical Standard No. 127 of 2013 of the Ministry of Health (MINSAL) on Good Manufacturing Practices (GMP) for the pharmaceutical industry, published pursuant to MINSAL Exempt Decree No. 159 of 11 April 2013, which updates Technical Standard No. 127 adopted in 2012. In view of the above, establishments manufacturing sterile radiopharmaceutical products must comply with the notified Standard, as well as with Annex No. 2 of Technical Standard No. 127, which updates and amends the Standard. This Technical Standard shall apply to the manufacturing procedures used by pharmaceutical laboratories producing radiopharmaceutical products and research institutions developing radiopharmaceuticals.
7.	目的和理由：Protection of human health or safety; Quality requirements.
8.	相关文件： Norma Técnica Nº 127 de 2013 del Ministerio de Salud sobre Buenas Prácticas de Manufactura (BPM/GMP) para la Industria de Productos Farmacéuticos, published pursuant to Decreto Exento MINSAL Nº 159 of 11 April 2013, which updates Norma Técnica Nº 127 adopted in 2012;Anexo Nº 2 de la Norma Técnica Nº 127, which updates and amends the Standard;Reglamento del Sistema Nacional de Control de los Productos Farmacéuticos de Uso Humano (D.S Nº 3/2010) en el Código Sanitario.
9.	拟批准日期：拟生效日期：
10.	意见反馈截至日期：60 days from notification
11.	文本可从以下机构得到： Subsecretaría de Relaciones Económicas Internacionales - Ministerio de Relaciones Exteriores de Chile (Undersecretariat for International Economic Relations, Ministry of Foreign Affairs of Chile) Teatinos 180, piso 11 Tel.: (+56)-2- 2827 5250 Fax: (+56)-2- 2380 9494 Email: Tbt_Chile@direcon.gob.cl

Good Manufacturing Practices (GMP) for Radiopharmaceutical Products

The notified Technical Standard establishes guidelines, the main aim of which are to set out the basic specific requirements for the manufacturing of radiopharmaceutical products, and to supplement, in an Annex, the requirements established for sterile and non-sterile pharmaceutical products in Technical Standard No. 127 of 2013 of the Ministry of Health (MINSAL) on Good Manufacturing Practices (GMP) for the pharmaceutical industry, published pursuant to MINSAL Exempt Decree No. 159 of 11 April 2013, which updates Technical Standard No. 127 adopted in 2012.

In view of the above, establishments manufacturing sterile radiopharmaceutical products must comply with the notified Standard, as well as with Annex No. 2 of Technical Standard No. 127, which updates and amends the Standard.

This Technical Standard shall apply to the manufacturing procedures used by pharmaceutical laboratories producing radiopharmaceutical products and research institutions developing radiopharmaceuticals.

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