Resolution – RDC number 471, 23 February 2021

Protection of human health or safety (TBT)

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 for 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); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

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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 for 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; 3006 - Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90; 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 for 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; 3006 - Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90

11.120 - Pharmaceutics; 11.120 - Pharmaceutics

Human health

Normative instruction 244, 21 August 2023, the list of substances classified as antimicrobial for use under prescription, alone or in association, which the resolution 471, 23 February 2023, which contains provisions on criteria for the prescription, dispensing, control, packaging and labeling of drugs based on substances classified as antimicrobials for use under prescription, alone or in combination.The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6644859/IN_244_2023_.pdf/c111ee17-6f8f-42ab-9bcc-8dd86bbcdf63

1:File here 2:File here

EN:File here

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