1. | 通报成员:巴西 |
2. | 负责机构:Brazilian Health Regulatory Agency (ANVISA) |
3. |
通报依据的条款:Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ]
通报依据的条款其他:
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4. | 覆盖的产品:Products subject to public health surveillance
ICS:[] HS:[] |
5. |
通报标题:Resolution – RDC number 421, 1 September 2020页数:2 使用语言:葡萄牙语 链接网址: |
6. |
内容简述: 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. | 相关文件: 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+motivação+da+proposta+e+justificativas+para+as+dispensas+de+AIR+e+de+CP/8a2e6548-45b2-4631-94da-3cbcdcb1af67 |
9. |
拟批准日期:
25 September 2020 拟生效日期: 25 September 2020 |
10. | 意见反馈截至日期:Not applied |
11. |
文本可从以下机构得到:
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