TBT BSN | Notification

Notification Detail :: G/TBT/N/BRA/758/Add.1

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Resolution - RDC n. 187, November 8th, 2017.

Objective

Protection of human health or safety (TBT)

Product Covered

3002 - Blood

Document Notification

Link to ePing

HSCODE

3002 - 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; 3002 - 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

ICSCODE

11.040.20 - Transfusion, infusion and injection equipment; 11.040.20 - Transfusion, infusion and injection equipment

Keywords

Human health; Human health

Specific Regions

Description

Resolution - RDC n. 187, November 8th, 2017 - previously notified through G/TBT/N/BRA/758 - which establishes the minimum requirements for the registration of Hyperimmune Serum in order to guarantee the quality, safety and efficacy of these products, was revoked by Resolution 914, 19 September 2024. The final text is available only in Portuguese and can be downloaded at: https://antigo.anvisa.gov.br/documents/10181/6873824/RDC_914_2024_.pdf/754dff2a-fbe5-4a89-81ad-476ea4b77ac3

Notified Document

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/BRA/758/Add.1

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