Draft resolution 1245, 20 March 2024

Protection of human health or safety (TBT)

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); Medicaments (ICS code(s): 11.120.10)

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 for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006)

11.120.10 - Medicaments

Human health

This Draft Resolution contains provisions on the validation of bioanalytical methods and analysis of study samples for regulatory submissions of industrialized medicines for human use.The bioanalytical method used to quantify the drug in matrix biological must be described in detail, and Guide nº XX, of XX 2024, which deals with the validation of bioanalytical methods and sample analysis study (ICH M10 - Bioanalytical method validation and study sample analysis /ICH M10 - validation of bioanalytical methods and analysis of study samples), and its updates.

1:File here 2:File here 4:File here 6:File here

EN:File here

FR:File here

ES:File here

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