TBT BSN | Notification

Notification Detail :: G/TBT/N/BRA/1024/Add.3

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Draft Resolution no. 815, 01 June 2020

Objective

Protection of human health or safety (TBT)

Product Covered

Antibiotics (HS code(s): 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 code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 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 code(s): 3005); Pharmaceutics (ICS code(s): 11.120)

Document Notification

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HSCODE

2941 - Antibiotics; 3003 - 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); 3004 - Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006); 3005 - 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; 2941 - Antibiotics; 3003 - 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); 3004 - Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006); 3005 - 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

ICSCODE

11.120 - Pharmaceutics; 11.120 - Pharmaceutics

Keywords

Labelling; Labelling

Specific Regions

Description

The resolution 768, 12 December 2023 - previously notified through  G/TBT/N/BRA/1024/Add.1 - which establish rules for drug labeling, was changed by Resolution 808, 04 August 2023.The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/3426875/RDC_808_2023_.pdf/18f7326c-eab1-4e6a-acea-f31a9cb10887

Notified Document

1:File here

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/1024/Add.3

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