Regulatory Updates

Normative Instruction number 135, 30 March 2022

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Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to Ionizing Radiation in the manufacture of medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Normative Instruction number 136, 30 March 2022

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Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to Experimental Medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Normative Instruction number 136, 30 March 2022

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Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to Experimental Medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Resolution – RDC number 659, 30 March 2022

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Distribution date: 12 April 2022

This resolution contains provisions on the control of import and export of substances, plants and medicines subject to special control.

Products Covered: HS (3003-3004) Medicaments

Regulation Type: Regular notification

Human health

Resolution – RDC number 659, 30 March 2022

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Distribution date: 12 April 2022

This resolution contains provisions on the control of import and export of substances, plants and medicines subject to special control.

Products Covered: HS (3003-3004) Medicaments

Regulation Type: Regular notification

Human health

Normative Instruction number 130, 30 March 2022

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Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to Herbal Medicinal products.

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

Regulation Type: Regular notification

Human health

Normative Instruction number 130, 30 March 2022

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Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to Herbal Medicinal products.

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

Regulation Type: Regular notification

Human health

Resolution – RDC number 638, 24 March 2022

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Distribution date: 12 April 2022

This resolution contains provisions on the framing of menthol-containing products such as medicines, medical devices or personal hygiene products, cosmetics and perfumes.

Products Covered: HS (3003, 3004, 3006,3303, 3304, 3305, 3306, 3307) – Medicaments, medical devices, toiletries, cosmetics and perfumes

Regulation Type: Regular notification

Human health

Resolution – RDC number 638, 24 March 2022

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Distribution date: 12 April 2022

This resolution contains provisions on the framing of menthol-containing products such as medicines, medical devices or personal hygiene products, cosmetics and perfumes.

Products Covered: HS (3003, 3004, 3006,3303, 3304, 3305, 3306, 3307) – Medicaments, medical devices, toiletries, cosmetics and perfumes

Regulation Type: Regular notification

Human health

Normative Instruction number 139, 30 March 2022

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Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to the reference and retention samples.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

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