Amendment of the Collegiate Board Resolution - RDC No. 346, 12 March 2020

页数：使用语言：
链接网址：

内容简述：

The following communication, dated 19 October 2020, is being circulated at the request of the delegation of Brazil.

Reason for Addendum:
[ ]	Comment period changed - date:
[ ]	Notified measure adopted - date:
[ ]	Notified measure published - date:
[ ]	Notified measure enters into force - date:
[ ]	Text of final measure available from:
[ ]	Notified measure withdrawn or revoked - date: Relevant symbol if measure re-notified:
[X]	Content or scope of notified measure changed New deadline for comments (if applicable):
[ ]	Interpretive guidance issued and text available from1:
[X]	Other: href="https://www.in.gov.br/web/dou/-/resolucao-de-diretoria-colegiada-rdc-n-419-de-1-de-setembro-de-2020-275655953" https://www.in.gov.br/web/dou/-/resolucao-de-diretoria-colegiada-rdc-n-419-de-1-de-setembro-de-2020-275655953

Description: Resolution – RDC number 346, 1 March 2020 – previously notified through G/TBT/N/BRA/984 – which establishes extraordinary and temporary criteria and procedure for Good Manufacture Practice Guidelines for market authorization and post-market registration amendments of Active Pharmaceutical Ingredients, medicines, and healthcare products due to the international public health emergency of the new coronavirus (Covid-19), was changed by the Resolution – RDC number 419, 1 September 2020.

目的和理由：

相关文件：

拟批准日期：
拟生效日期：

10.

意见反馈截至日期：

11.

文本可从以下机构得到：

Amendment of the Collegiate Board Resolution - RDC No. 346, 12 March 2020

The following communication, dated 19 October 2020, is being circulated at the request of the delegation of Brazil.

Reason for Addendum:
[ ]	Comment period changed - date:
[ ]	Notified measure adopted - date:
[ ]	Notified measure published - date:
[ ]	Notified measure enters into force - date:
[ ]	Text of final measure available from:
[ ]	Notified measure withdrawn or revoked - date: Relevant symbol if measure re-notified:
[X]	Content or scope of notified measure changed New deadline for comments (if applicable):
[ ]	Interpretive guidance issued and text available from1:
[X]	Other: href="https://www.in.gov.br/web/dou/-/resolucao-de-diretoria-colegiada-rdc-n-419-de-1-de-setembro-de-2020-275655953" https://www.in.gov.br/web/dou/-/resolucao-de-diretoria-colegiada-rdc-n-419-de-1-de-setembro-de-2020-275655953

通报原文：

附件：

[{"filename":"bra984a2.docx","fileurl":"/upload/2021/note_attachfiles/299998/attachfiles/bra984a2.docx","truename":"廖美娴","uploadtime":"2021-08-17 14:34:12","userid":"80"}]