| 1. | 通報(bào)成員：秘魯 |
| 2. | 負(fù)責(zé)機(jī)構(gòu)：Ministry of Health |
| 3. |
通報(bào)依據(jù)的條款：Technical Regulation (Article 2.9.2)
通報(bào)依據(jù)的條款其他：
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| 4. | 覆蓋的產(chǎn)品：Pharmaceutical products; Fish, fresh or chilled, excluding fish fillets and other fish meat of heading 03.04 (HS 0302); Glands and other organs for organo-therapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included (HS 3001); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale (HS 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale (HS 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Pharmaceutical goods specified in Note 4 to this Chapter (HS 3006)
ICS：[] HS：[] |
| 5. |
通報(bào)標(biāo)題：Draft Regulations governing major changes to pharmaceutical products in the sanitary register頁數(shù)：22 pages 使用語言：in Spanish 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡述： The notified draft Regulations provide for major changes in the sanitary register, as they may have repercussions on the quality, safety and effectiveness of pharmaceutical products, and establish the conditions and documents required for such changes. |
| 7. | 目的和理由：Protection of human health or safety |
| 8. | 相關(guān)文件： 1.Ley N° 29459, Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios; 2.Decreto Supremo N° 016-2011/SA, Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios. |
| 9. |
擬批準(zhǔn)日期：
To be determined 擬生效日期： Six months following publication in the Official Journal, El Peruano |
| 10. | 意見反饋截至日期：17 December 2019 |
| 11. |
文本可從以下機(jī)構(gòu)得到：
Ministerio de Comercio Exterior y Turismo (MINCETUR) Calle Uno Oeste No 50 - Urb. Córpac - Lima 27 - Peru Tel.: (+51-1) 513-6100, Ext. 1223 and 1239 Email: otc@mincetur.gob.pe |
The notified draft Regulations provide for major changes in the sanitary register, as they may have repercussions on the quality, safety and effectiveness of pharmaceutical products, and establish the conditions and documents required for such changes.
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