| 1. | 通報成員：智利 |
| 2. | 負(fù)責(zé)機(jī)構(gòu)：Ministry of Health - Undersecretariat for Public Health |
| 3. |
通報依據(jù)的條款：Technical Regulation (Article 2.9.2)
通報依據(jù)的條款其他：
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| 4. | 覆蓋的產(chǎn)品：Radiopharmaceutical products
ICS：[] HS：[] |
| 5. |
通報標(biāo)題：Good Manufacturing Practices (GMP) for Radiopharmaceutical Products頁數(shù)：20 pages 使用語言：in Spanish 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡述： 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. | 相關(guān)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. |
擬批準(zhǔn)日期：
擬生效日期： |
| 10. | 意見反饋截至日期：60 days from notification |
| 11. |
文本可從以下機(jī)構(gòu)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 |
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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