| 1. | 通報成員：菲律賓 |
| 2. | 負(fù)責(zé)機(jī)構(gòu)：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(jù)的條款：Article 2.9.2 [X], 2.10.1 [??], 5.6.2 [??], 5.7.1 [??]
通報依據(jù)的條款其他：
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| 4. | 覆蓋的產(chǎn)品：Heated Tobacco Products (HTPs); Tobacco, tobacco products and related equipment (ICS 65.160)
ICS：[] HS：[] |
| 5. |
通報標(biāo)題：Procedure for Pre-Application Documentary Evaluation (PADE) for Heated Tobacco Products seeking Registration under the Food and Drug Administration頁數(shù)：6 使用語言：英語 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡述： This Circular is being issued to provide the supplemental procedures and guidelines for the issuance of a Pre-application Documentary Evaluation (PADE) certificate as part of the requirements of HTP registration for the issuance of an FDA Electronic Registration Number (FERN) certificate. It shall cover all manufacturers, traders, and importers that seek to apply for a FERN certification of their HTPs. |
| 7. | 目的和理由：Protection of human health or safety; Reducing trade barriers and facilitating trade; Other |
| 8. | 相關(guān)文件： Republic Act No. 11467 - An Act Amending Sections 109, 141, 142, 143, 144, 147, 152, 263, 263-A, 265 and 288-A and Adding Section 290-A to Republic Act 8424, as amended, otherwise known as the National Internal Revenue Code of 1997 and for other purposes Republic Act 9711 - FDA Act of 2009? Executive Order No. 106? |
| 9. |
擬批準(zhǔn)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(jī)構(gòu)得到：
MR. NEIL P. CATAJAY https://members.wto.org/crnattachments/2020/TBT/PHL/20_5080_00_e.pdf |
This Circular is being issued to provide the supplemental procedures and guidelines for the issuance of a Pre-application Documentary Evaluation (PADE) certificate as part of the requirements of HTP registration for the issuance of an FDA Electronic Registration Number (FERN) certificate. It shall cover all manufacturers, traders, and importers that seek to apply for a FERN certification of their HTPs.
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