| 1. | 通報成員：巴西 |
| 2. | 負(fù)責(zé)機(jī)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： Antibiotics (HS 2941); 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); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Pharmaceutical preparations and products of subheading Nos 3006.10.10 to 3006.60.90 (HS 3006); True hemp "Cannabis sativa L.", raw or processed, but not spun; tow and waste of true hemp, incl. yarn waste and garnetted stock (HS 5302)
ICS：[] HS：[] |
| 5. |
通報標(biāo)題：Normative Instruction number 71, 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 low risk notified medicines products, herbal medicinal products, and cannabis-based medicine 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 3 September 2020, section 1, page 75 2) Brazilian Official Gazette 170 on 03 September 2020, section 1, page 74 3) Resolution of the Collegiate Board - RDC No. 421 of 1 September 2020https://www.in.gov.br/web/dou/-/instrucao-normativa-in-n-71-de-1-de-setembro-de-2020-275656288https://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(zhǔn)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(jī)構(gòu)得到：
Brazilian Health Regulatory Agency (Anvisa) https://www.in.gov.br/web/dou/-/instrucao-normativa-in-n-71-de-1-de-setembro-de-2020-275656288 |
This Normative Instruction establishes the inclusion of a declaration in the label of low risk notified medicines products, herbal medicinal products, and cannabis-based medicine informing the existence of a new formula changing its composition.
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