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 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 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 3005); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS 3006)
Draft Resolution number 932, 13 October 2020. (17 page(s), in Portuguese)
This draft resolution establishes criteria for the concession of market authorization for medicines with synthetic and semisynthetic active principles for human use categorized as new, innovative, generic, and similar.