Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Draft resolution number 1115, 15 September 2022; (3 page(s), in Portuguese)

This Draft Resolution proposes to establish a special procedure for the approval of clinical trials, certification of good manufacturing practices, and market authorization of new drugs for the treatment, diagnosis or prevention of rare diseases. 

The text of this draft resolution was rectified.