Regulatory Updates

Resolution – RDC number 643, 24 March 2022

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Distribution date: 11 April 2022

This resolution establishes technical definitions and requirements of cosmetics related to skin tanning, as well as labelling warning for tan activators/accelerators.

Products Covered: HS (3304-3307) - Skin tanning related cosmetics

Regulation Type: Regular notification

Labelling Human health

Resolution – RDC number 675, 30 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on the suitable of drugs that already received the market registration.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Resolution – RDC number 675, 30 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on the suitable of drugs that already received the market registration.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Resolution – RDC number 639, 24 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on the technical requirements for the regularization of personal hygiene products, cosmetics and children's perfumes.

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Toiletries, cosmetics and perfumes

Regulation Type: Regular notification

Human health

Resolution – RDC number 639, 24 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on the technical requirements for the regularization of personal hygiene products, cosmetics and children's perfumes.

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Toiletries, cosmetics and perfumes

Regulation Type: Regular notification

Human health

Resolution – RDC number 642, 24 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on the criteria for inclusion, exclusion and alteration of the concentration of substances used in personal hygiene products, cosmetics and perfumes in lists and internalizes GMC MERCOSUR Resolution number 133/96.

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Toiletries, cosmetics and perfumes

Regulation Type: Regular notification

Human health

Resolution – RDC number 642, 24 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on the criteria for inclusion, exclusion and alteration of the concentration of substances used in personal hygiene products, cosmetics and perfumes in lists and internalizes GMC MERCOSUR Resolution number 133/96.

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Toiletries, cosmetics and perfumes

Regulation Type: Regular notification

Human health

Resolution – RDC number 658, 30 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on the General Guidelines for Good Manufacturing Practices for Medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Resolution – RDC number 658, 30 March 2022

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Distribution date: 11 April 2022

This resolution contains provisions on the General Guidelines for Good Manufacturing Practices for Medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

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

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