| 1. | 通報成員：巴西 |
| 2. | 負責機構：Brazilian Health Regulatory Agency (ANVISA) |
| 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：
|
| 4. | 覆蓋的產(chǎn)品：Products subject to public health surveillance
ICS：[] HS：[] |
| 5. |
通報標題：Resolution – RDC number 421, 1 September 2020頁數(shù)：2 使用語言：葡萄牙語 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡述： This Resolution – RDC establishes the inclusion of a declaration in the label of products subject to public health surveillance informing the existence of a new formula changing its composition. The publication of this resolution was made in compliance with a judicial determination |
| 7. | 目的和理由：Protection of human health or safety |
| 8. | 相關文件： 1) Brazilian Official Gazette 170 on 03 September 2020, section 1, page 74 2) Resolution of the Collegiate Board - RDC No. 421 of 01 September 2020 3) Proposal motivation and justifications for RIA and public consultation exemptionshttps://www.in.gov.br/web/dou/-/resolucao-de-diretoria-colegiada-rdc-n-421-de-1-de-setembro-de-2020-275656506http://antigo.anvisa.gov.br/legislacao#/visualizar/432064http://antigo.anvisa.gov.br/documents/10181/5900558/Parecer+com+motiva?§?￡o+da+proposta+e+justificativas+para+as+dispensas+de+AIR+e+de+CP/8a2e6548-45b2-4631-94da-3cbcdcb1af67 |
| 9. |
擬批準日期：
25 September 2020 擬生效日期： 25 September 2020 |
| 10. | 意見反饋截至日期：Not applied |
| 11. |
文本可從以下機構得到：
Brazilian Health Regulatory Agency (Anvisa) |
This Resolution – RDC establishes the inclusion of a declaration in the label of products subject to public health surveillance informing the existence of a new formula changing its composition.
The publication of this resolution was made in compliance with a judicial determination
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