Regulatory Updates
Normative Instruction number 136, 30 March 2022
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
Resolution – RDC number 659, 30 March 2022
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
Resolution – RDC number 659, 30 March 2022
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
Normative Instruction number 130, 30 March 2022
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
Normative Instruction number 130, 30 March 2022
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
Resolution – RDC number 638, 24 March 2022
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
Resolution – RDC number 638, 24 March 2022
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
Normative Instruction number 139, 30 March 2022
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
Normative Instruction number 139, 30 March 2022
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
Resolution – RDC number 637, 24 March 2022
Distribution date: 12 April 2022
This resolution contains provision on the obligation of all companies established in the country, which carry out the activities of manufacturing, importing, exporting, fractionating, storing, dispatching and distributing active pharmaceutical ingredients, to register, with Anvisa, all active pharmaceutical ingredients with which they work.
Products Covered: HS (3006) - Active Pharmaceutical Ingredients
Regulation Type: Regular notification
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