Regulatory Updates

Distribution date: 25 May 2022

The Resolution – RDC Nº 563, 15 September 2021 - previously notified through G/TBT/N/BRA/1265/Add.1 - which contains provision on, in an extraordinary and temporary manner, the requirements for the import and use of human immunoglobulin, due to the international public health emergency related to SARS-CoV 2., was changed by Resolution - RDC number 686, 13 May 2022 .  The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6326437/RDC_686_2022_.pdf/73dbab54-eded-488e-8500-887662829d20

Products Covered:

Regulation Type: Corrigendum to Regular Notification

Distribution date: 25 May 2022

This Resolution contains provisions on the indication for the use of sanitizing products in the "Sterilizing" category, for application in the form of immersion, the indication for the use of sanitizing products currently categorized as "Hospital Disinfectant for Semi-Critical Items.

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 indication for the use of sanitizing products in the "Sterilizing" category, for application in the form of immersion, the indication for the use of sanitizing products currently categorized as "Hospital Disinfectant for Semi-Critical Items.

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 products with antimicrobial action used in critical and semi-critical articles, and their market authorization.This Resolution incorporates the GMC MERCOSUR Resolution number 19/2010.

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 products with antimicrobial action used in critical and semi-critical articles, and their market authorization.This Resolution incorporates the GMC MERCOSUR Resolution number 19/2010.

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 procedures and requirements for the maintenance of authorizations already granted and for new requests for temporary authorization for emergency use (AUE), on an experimental basis, of medicines and vaccines against Covid-19 to face the SARS-CoV-2 pandemic .The evaluation and authorization procedure through the EAU will only apply to new vaccines, provided that they are indicated by the Brazilian Ministry of Health as necessary to support the vaccination program in Brazil.For the purposes of this Resolution, it considers a listed regulatory authority to be the World Health Organization, regulatory authorities founding members and permanent members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use  (ICH) and the Regulatory Agency for Medicines and Health Products of the United Kingdom. Kingdom (MHRA).

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 procedures and requirements for the maintenance of authorizations already granted and for new requests for temporary authorization for emergency use (AUE), on an experimental basis, of medicines and vaccines against Covid-19 to face the SARS-CoV-2 pandemic .The evaluation and authorization procedure through the EAU will only apply to new vaccines, provided that they are indicated by the Brazilian Ministry of Health as necessary to support the vaccination program in Brazil.For the purposes of this Resolution, it considers a listed regulatory authority to be the World Health Organization, regulatory authorities founding members and permanent members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use  (ICH) and the Regulatory Agency for Medicines and Health Products of the United Kingdom. Kingdom (MHRA).

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 industrialization, exposure for sale or delivery for consumption, in all its phases, of hydrated ethyl alcohol in all grades and of anhydrous ethyl alcohol, as a product intended for surface cleaning, disinfection and antisepsis of the skin or substance.

Products Covered: Acyclic alcohols and their halogenated, sulphonated, nitrated or nitrosated derivatives. (HS code(s): 2905)

Regulation Type: Regular notification

Distribution date: 25 May 2022

This Resolution contains provisions on the industrialization, exposure for sale or delivery for consumption, in all its phases, of hydrated ethyl alcohol in all grades and of anhydrous ethyl alcohol, as a product intended for surface cleaning, disinfection and antisepsis of the skin or substance.

Products Covered: Acyclic alcohols and their halogenated, sulphonated, nitrated or nitrosated derivatives. (HS code(s): 2905)

Regulation Type: Regular notification

Distribution date: 24 May 2022 | Final date for Comment: 23 July 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Cyantraniliprole.

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.01, 08.02, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Coffee, tea, mate and spices (HS codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS codes: 10.05 and 10.06)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.05, 12.06, 12.07 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification