| 1. | 通報成員:菲律賓 |
| 2. | 負責機構:ENGR. ANA TRINIDAD F. RIVERA;Director IV;Center for Cosmetics Regulation and Research (CCRR);Food and Drug Administration;DEPARTMENT OF HEALTH |
| 3. |
通報依據的條款:Article 2.9.2 [X], 2.10.1 [??], 5.6.2 [??], 5.7.1 [??]
通報依據的條款其他:
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| 4. | 覆蓋的產品:Heated Tobacco Products (HTPs); Tobacco, tobacco products and related equipment (ICS 65.160)
ICS:[] HS:[] |
| 5. |
通報標題:Application Procedure for Product Marketing Authorizations through the FDA Electronic Portal (E-portal) System for Heated Tobacco Products頁數:11 使用語言:英語 鏈接網址: |
| 6. |
內容簡述: This Circular is being issued to provide the procedural guidelines and documentary requirements for the FDA Product Marketing Authorization application through the FDA e-Portal System covering all manufacturers, traders, and importers of HTPs applying for product marketing authorizations under the Center for Cosmetics Regulation and Research. |
| 7. | 目的和理由:Protection of human health or safety; Reducing trade barriers and facilitating trade |
| 8. | 相關文件: Republic Act No. 9711 - FDA Act of 2009 Republic Act No. 11032 - Ease of Doing Business and Efficient and Government Service Delivery Act of 2018? Section 144 of Republic Act No. 11467, Section II of Executive Order No. 106? G/TBT/N/PHL/234 |
| 9. |
擬批準日期:
This Circular shall take effect 15 days after publication in a newspaper of general circulation and the Office of National Administrative Register of the UP Law Center. 擬生效日期: This Circular shall take effect 15 days after publication in a newspaper of general circulation and the Office of National Administrative Register of the UP Law Center. |
| 10. | 意見反饋截至日期:60 days from notification |
| 11. |
文本可從以下機構得到:
MR. NEIL P. CATAJAY https://members.wto.org/crnattachments/2020/TBT/PHL/20_5077_00_e.pdf |
This Circular is being issued to provide the procedural guidelines and documentary requirements for the FDA Product Marketing Authorization application through the FDA e-Portal System covering all manufacturers, traders, and importers of HTPs applying for product marketing authorizations under the Center for Cosmetics Regulation and Research.