Regulatory Updates

Distribution date: 18 May 2022 | Final date for Comment: 17 July 2022

This document stipulates the category, technical requirements, testing methods, inspection rules, marking, packing, transportation and storage of coal mine self-rescuer( including chemical oxygen self-rescuer and compressed oxygen self-rescuer).This document applies to chemical oxygen self-rescuer  and compressed oxygen self-rescuer used in coal mines.

Products Covered: Self-rescuer for coal mine(including chemical  oxygen self-rescuer and compressed oxygen self-rescuer) (HS code(s): 9020); (ICS code(s): 13.100)

Regulation Type: Regular notification

Distribution date: 11 May 2022

This resolution contains provisions on odour neutralizing sanitizing products, a result of the consolidation of previous regulations, without change of merit.

Products Covered: HS (3402) - Sanitizing products

Regulation Type: Regular notification

Distribution date: 11 May 2022

This resolution contains provisions on odour neutralizing sanitizing products, a result of the consolidation of previous regulations, without change of merit.

Products Covered: HS (3402) - Sanitizing products

Regulation Type: Regular notification

Distribution date: 11 May 2022

This resolution contains provisions on the way of defining the Manufacturer Price (PF) and the Maximum Consumer Price (PMC) of medicines on 31 March 2022, establishes the form of presentation of the Marketing Report to the Medicines Market Regulation Chamber and regulates the advertising of pharmaceutical product prices.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 11 May 2022

This resolution contains provisions on the way of defining the Manufacturer Price (PF) and the Maximum Consumer Price (PMC) of medicines on 31 March 2022, establishes the form of presentation of the Marketing Report to the Medicines Market Regulation Chamber and regulates the advertising of pharmaceutical product prices.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 11 May 2022

This resolution contains provisions on bacteria-based sanitizing products, a result of the consolidation of previous regulations, without change of merit.This resolution incorporates into the national legal system the MERCOSUR/GMC Resolution number 63/14.

Products Covered: HS (3402) - Sanitizing products

Regulation Type: Regular notification

Distribution date: 11 May 2022

This resolution contains provisions on bacteria-based sanitizing products, a result of the consolidation of previous regulations, without change of merit.This resolution incorporates into the national legal system the MERCOSUR/GMC Resolution number 63/14.

Products Covered: HS (3402) - Sanitizing products

Regulation Type: Regular notification

Distribution date: 11 May 2022

The Normative Instruction number 130, 30 March 2022 - previously notified through G/TBT/N/BRA/1366 - which contains provisions on Good Manufacturing Practices complementary to Herbal Medicinal products, was rectified. The rectified text is available only in Portuguese and can be downloaded at: https://www.in.gov.br/en/web/dou/-/retificacao-397562871

Products Covered: HS (3003-3004) - Herbal medicinal products

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2022

The Normative Instruction number 130, 30 March 2022 - previously notified through G/TBT/N/BRA/1366 - which contains provisions on Good Manufacturing Practices complementary to Herbal Medicinal products, was rectified. The rectified text is available only in Portuguese and can be downloaded at: https://www.in.gov.br/en/web/dou/-/retificacao-397562871

Products Covered: HS (3003-3004) - Herbal medicinal products

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2022 | Final date for Comment: 25 June 2022

This draft resolution proposes a review of Resolution – RDC number 98, 08 January 2016, which contains provisions on the criteria and procedures for classifying medicaments as non-prescription medicaments and reclassifying them as prescription medicaments and other measures.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification