RDC Nº 204, December 27th, 2017

Protection of human health or safety (TBT)

3003 3004: Medicaments

Link to ePing

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); 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); 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)

11.120.10 - Medicaments; 11.120.10 - Medicaments

Human health

RDC Nº 204, December 27th, 2017 - previously notified throughG/TBT/N/BRA/782- which provides for the classification in the priority category, of registration petitions, post registration and prior consent in clinical trial of medicines., was changed by Resolution 811, 18 August 2023The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6298833/RDC_811_2023_.pdf/5882959d-e982-4c7a-8460-042199a9d8bf

1:File here 2:File here

EN:File here

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