Regulatory Updates

Resolution – RDC number 665, 30 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on Good Manufacturing Practices for Medical Devices and In Vitro Diagnostic Products.This resolution incorporates into the national legal system the Resolution of MERCOSUR (GMC) number 20, 17 November 2011, MERCOSUR/GMC/RES. nº 20/11, "MERCOSUR Technical Regulation on Good Manufacturing Practices for Medical Devices and In Vitro Diagnostic Products”.

Products Covered: HS (3006) - Medical Devices

Regulation Type: Regular notification

Human health

Resolution – RDC number 654, 24 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on Good Manufacturing Practices for Active Pharmaceutical Ingredients.

Products Covered: HS (3006) - Active Pharmaceutical Ingredients

Regulation Type: Regular notification

Human health

Resolution – RDC number 654, 24 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on Good Manufacturing Practices for Active Pharmaceutical Ingredients.

Products Covered: HS (3006) - Active Pharmaceutical Ingredients

Regulation Type: Regular notification

Human health

Resolution – RDC number 640, 24 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on the regularization of disposable personal hygiene products intended for body cleaning, which include brushes and sticks for oral hygiene, dental floss and tape, disposable sanitary pads, menstrual cups and flexible swabs.

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Personal hygiene products

Regulation Type: Regular notification

Human health

Resolution – RDC number 640, 24 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on the regularization of disposable personal hygiene products intended for body cleaning, which include brushes and sticks for oral hygiene, dental floss and tape, disposable sanitary pads, menstrual cups and flexible swabs.

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Personal hygiene products

Regulation Type: Regular notification

Human health

Resolution – RDC number 641, 24 March 2022

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Distribution date: 11 April 2022

This resolution defines criteria and procedures extraordinary and temporary for the manufacturing and marketing of antiseptic preparations or workshop sanitizers without prior notice authorization from Anvisa and gives other measures in view of the emergency international public health related to SARS-CoV-2.

Products Covered: HS (3003, 3004, 3303, 3304, 3305, 3306, 3307, 3402) - Medicaments, sanitizers, and cosmetics.

Regulation Type: Regular notification

E09. COVID-19 TBT Human health

Resolution – RDC number 641, 24 March 2022

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Distribution date: 11 April 2022

This resolution defines criteria and procedures extraordinary and temporary for the manufacturing and marketing of antiseptic preparations or workshop sanitizers without prior notice authorization from Anvisa and gives other measures in view of the emergency international public health related to SARS-CoV-2.

Products Covered: HS (3003, 3004, 3303, 3304, 3305, 3306, 3307, 3402) - Medicaments, sanitizers, and cosmetics.

Regulation Type: Regular notification

E09. COVID-19 TBT Human health

Resolution – RDC number 649, 24 March 2022

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Distribution date: 11 April 2022

This resolution establishes criteria and restrictions for marketing products that contain inhalant substances.

Products Covered: HS (32) - Glues, thinner, adhesives and correctors

Regulation Type: Regular notification

Human health

Resolution – RDC number 649, 24 March 2022

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Distribution date: 11 April 2022

This resolution establishes criteria and restrictions for marketing products that contain inhalant substances.

Products Covered: HS (32) - Glues, thinner, adhesives and correctors

Regulation Type: Regular notification

Human health

Resolution – RDC number 650, 25 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on criteria for inclusion, exclusion and updating of sanitizing products with lower potential risk manufactured within the scope of MERCOSUR and incorporates GMC MERCOSUR number 51/2006.

Products Covered: HS (3402) - Sanitizing products

Regulation Type: Regular notification

Human health

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