| 1. | 通報成員：巴西 |
| 2. | 負責機構(gòu)：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：Dried glands and other organs for organo-therapeutic uses, whether or not powdered; extracts of glands or other organs or their secretions, for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, n.e.s (HS 3001); Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS 3002); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS 3004); Pharmaceutical preparations and products of subheading Nos 3006.10.10 to 3006.60.90 (HS 3006)
ICS：[] HS：[] |
| 5. |
通報標題：Normative Instruction number 68, 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 Normative Instruction establishes the inclusion of a declaration in the label of medical devices informing the existence of a new formula changing its composition. |
| 7. | 目的和理由：Protection of human health or safety |
| 8. | 相關(guān)文件： 1) Brazilian Official Gazette 170 on 03 September 2020, section 1, page 74 2) Brazilian Official Gazette 170 on 03 September 2020, section 1, page 74 3) Resolution of the Collegiate Board - RDC No. 421 of 01 September 2020https://www.in.gov.br/web/dou/-/instrucao-normativa-in-n-68-de-1-de-setembro-de-2020-275656283https://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/432064 |
| 9. |
擬批準日期：
1 September 2021 擬生效日期： 1 September 2021 |
| 10. | 意見反饋截至日期：Not applied |
| 11. |
文本可從以下機構(gòu)得到：
Brazilian Health Regulatory Agency (Anvisa) https://www.in.gov.br/web/dou/-/instrucao-normativa-in-n-68-de-1-de-setembro-de-2020-275656283 |
This Normative Instruction establishes the inclusion of a declaration in the label of medical devices informing the existence of a new formula changing its composition.
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