Regulatory Updates

Distribution date: 25 May 2022

This Resolution contains provisions on criteria for the regularization of cleaning products and the like and on the biodegradability of anionic surfactants.This Resolution incorporates into the national legal system the Resolutions of the Common Market Group nº 24/2005 and 47/2007.

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 criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices.This resolution requests a declaration that indicates whether the products that are or will be marketed in Brazil are legalized in the country of origin and countries that are part of MERCOSUR and IMDRF

Products Covered: Pharmaceutical goods specified in Note 4 to this Chapter. (HS code(s): 3006)

Regulation Type: Regular notification

Distribution date: 25 May 2022

This Resolution contains provisions on the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices.This resolution requests a declaration that indicates whether the products that are or will be marketed in Brazil are legalized in the country of origin and countries that are part of MERCOSUR and IMDRF

Products Covered: Pharmaceutical goods specified in Note 4 to this Chapter. (HS code(s): 3006)

Regulation Type: Regular notification

Distribution date: 25 May 2022

This Resolution contains provisions on enzymatic detergents for restricted use in health care establishments with indication for cleaning medical devices. In order to obtain the sanitary authorization of the products covered by this Resolution, the following documents must be presented documentation from the supplier of all enzymes contained in the formulation, informing the nomenclature adopted by the International Union or Biochemistry and Molecular Biology - IUBMB, including the complete code number and description of the biological origin containing the genus and species.

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 enzymatic detergents for restricted use in health care establishments with indication for cleaning medical devices. In order to obtain the sanitary authorization of the products covered by this Resolution, the following documents must be presented documentation from the supplier of all enzymes contained in the formulation, informing the nomenclature adopted by the International Union or Biochemistry and Molecular Biology - IUBMB, including the complete code number and description of the biological origin containing the genus and species.

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 packaging and labeling requirements for the market authorization of a sanitizing product that is corrosive to the skin or that causes serious eye damage.This Resolution applies to national or imported sanitizing products that presents corrosive characteristics, in tests carried out following the Organization for Economic Co-operation and Development - OECD methodologies or their updates, or alternative methodologies, as long as they are recognized by the health authority.

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 packaging and labeling requirements for the market authorization of a sanitizing product that is corrosive to the skin or that causes serious eye damage.This Resolution applies to national or imported sanitizing products that presents corrosive characteristics, in tests carried out following the Organization for Economic Co-operation and Development - OECD methodologies or their updates, or alternative methodologies, as long as they are recognized by the health authority.

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 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 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