Committee on Technical Barriers to Trade - Notification - Brazil - Pharmaceutical products - Addendum

NOTIFICATION

Addendum

The following communication, dated 21 November 2024, is being circulated at the request of the delegation of Brazil.

 

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Title: Draft Resolution number 760

 

Reason for Addendum:

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Comment period changed - date:

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Notified measure adopted - date:

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Notified measure published - date:

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Notified measure enters into force - date:

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Text of final measure available from[1]:

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Notified measure withdrawn or revoked - date:

Relevant symbol if measure re-notified:

[X]

Content or scope of notified measure changed and text available from1:

https://antigo.anvisa.gov.br/documents/10181/3855414/RDC_942_2024_.pdf/bf46fb32-1ddb-4ba9-abf4-e6fac15966e2

https://members.wto.org/crnattachments/2024/TBT/BRA/modification/24_07917_00_x.pdf

New deadline for comments (if applicable):

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Interpretive guidance issued and text available from1:

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Other:

 

Description: Resolution 742, 10 August 2022 - previously notified through G/TBT/N/BRA/955/Add.1 - which establishes the minimal technical requirements for relative bioavailability and bioequivalence studies that supports dossier of consent for clinical research, market authorization or post-market authorization of medicines, in the terms of this resolution, was changed by Resolution 942, 18 November 2024.

The final text is available only in Portuguese and can be downloaded at:

https://antigo.anvisa.gov.br/documents/10181/3855414/RDC_942_2024_.pdf/bf46fb32-1ddb-4ba9-abf4-e6fac15966e2

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[1] This information can be provided by including a website address, a pdf attachment, or other information on where the text of the final/modified measure and/or interpretive guidance can be obtained.