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 1108, 18 August 2022;; (20 page(s), in Portuguese)
This Draft Resolution is regarded to a proposal for a Normative Instruction that establishes the modalities and criteria applied for the optimized analysis procedure, in which the evaluations conducted by the Equivalent Foreign Regulatory Authority (EFRA) are used to analyze the market authorization and post-market authorization petitions of medicines and biological products, and a letter of adequacy of active pharmaceutical ingredient (CADIFA), in national territory.
According to the proposal, it is designated as Equivalent Foreign Regulatory Authority (EFRA), the institution that has similar measures and controls in relation to the regulatory process adopted by Anvisa and meets, among other requirements, the adoption of international standards and norms equivalent to those currently adopted by Anvisa applicable to active pharmaceutical ingredient, medicines and biological products and their active substances, in particular those established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the World Health Organization (WHO);