Regulatory Updates

Distribution date: 25 May 2022

This Resolution contains provisions on the requirements for the market authorization of a sanitizing product intended for the disinfection of fruit and vegetables and for algaecide and fungicide products for swimming pools.The analysis methodology for a fungicide product must be the one recommended by the Association of Official Analytical Chemists - AOAC in its latest version, including Trichophyton mentagrophytes as a test microorganism.

Products Covered: Lubricating preparations (including cutting-oil preparations, bolt or nut release preparations, anti-rust or anti-corrosion preparations and mould release preparations, based on lubricants) and preparations of a kind used for the oil or grease treatment of textile materials, leather, furskins or other materials, but excluding preparations containing, as basic constituents, 70 % or more by weight of petroleum oils or of oils obtained from bituminous minerals. (HS code(s): 3403)

Regulation Type: Regular notification

Distribution date: 25 May 2022

This Resolution stablishes the Pilot for the Implementation of the Post-markt authorization Change Management Protocol for drugs with synthetic and semi-synthetic active principles, according to  item 4 of the ICH Q12 guideline - Post-market Change Management Protocol (PACMP).

Products Covered: 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)

Regulation Type: Regular notification

Distribution date: 25 May 2022

This Resolution stablishes the Pilot for the Implementation of the Post-markt authorization Change Management Protocol for drugs with synthetic and semi-synthetic active principles, according to  item 4 of the ICH Q12 guideline - Post-market Change Management Protocol (PACMP).

Products Covered: 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)

Regulation Type: Regular notification

Distribution date: 25 May 2022

This Resolution contains provisions on the sanitizing products categorized as bleach and their market authorization.

Products Covered: Organic surface-active agents (other than soap); surface-active preparations, washing preparations (including auxiliary washing preparations) and cleaning preparations, whether or not containing soap, other than those of heading 34.01. (HS code(s): 3402)

Regulation Type: Regular notification

Distribution date: 25 May 2022

This Resolution contains provisions on the sanitizing products categorized as bleach and their market authorization.

Products Covered: Organic surface-active agents (other than soap); surface-active preparations, washing preparations (including auxiliary washing preparations) and cleaning preparations, whether or not containing soap, other than those of heading 34.01. (HS code(s): 3402)

Regulation Type: Regular notification

Distribution date: 25 May 2022

This Resolution contains provisions on conditions for market authorization of sanitizing products with antimicrobial action.This Resolution incorporates the Common Market Group Resolution number 50/2006 into the national legal system.

Products Covered: Soap, organic surface-active agents, washing preparations, lubricating preparations, artificial waxes, prepared waxes, polishing or scouring preparations, candles and similar articles, modelling pastes, "dental waxes" and dental preparations with a basis of plaster (HS code(s): 34)

Regulation Type: Regular notification

Distribution date: 25 May 2022

This Resolution contains provisions on conditions for market authorization of sanitizing products with antimicrobial action.This Resolution incorporates the Common Market Group Resolution number 50/2006 into the national legal system.

Products Covered: Soap, organic surface-active agents, washing preparations, lubricating preparations, artificial waxes, prepared waxes, polishing or scouring preparations, candles and similar articles, modelling pastes, "dental waxes" and dental preparations with a basis of plaster (HS code(s): 34)

Regulation Type: Regular notification

Distribution date: 25 May 2022

This Resolution contains provisions on the technical regulation for a sanitizing product categorized as bleach based on sodium hypochlorite or calcium hypochlorite.This Resolution incorporates the MERCOSUR/GMC Resolution Number 03/2019 into the National Legal System, which provides for the Technical Regulation for sanitizing products based on additive hypochlorites.

Products Covered: Organic surface-active agents (other than soap); surface-active preparations, washing preparations (including auxiliary washing preparations) and cleaning preparations, whether or not containing soap, other than those of heading 34.01. (HS code(s): 3402)

Regulation Type: Regular notification

Distribution date: 25 May 2022

This Resolution contains provisions on the technical regulation for a sanitizing product categorized as bleach based on sodium hypochlorite or calcium hypochlorite.This Resolution incorporates the MERCOSUR/GMC Resolution Number 03/2019 into the National Legal System, which provides for the Technical Regulation for sanitizing products based on additive hypochlorites.

Products Covered: Organic surface-active agents (other than soap); surface-active preparations, washing preparations (including auxiliary washing preparations) and cleaning preparations, whether or not containing soap, other than those of heading 34.01. (HS code(s): 3402)

Regulation Type: Regular notification

Distribution date: 25 May 2022

This Resolution contains provisions on the procedure, fully electronic, for the notification to the The Brazilian Health Regulatory Agency (ANVISA) , of Sanitation Products of Risk I, and on the validity of the records of Sanitation Products of Risk 2

Products Covered: Organic surface-active agents (other than soap); surface-active preparations, washing preparations (including auxiliary washing preparations) and cleaning preparations, whether or not containing soap, other than those of heading 34.01. (HS code(s): 3402)

Regulation Type: Regular notification