Regulatory Updates
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
Normative Instruction number 137, 30 March 2022
Distribution date: 12 April 2022
This normative instruction contains provisions on Good Manufacturing Practices complementary to Blood-derived Medicines.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
Normative Instruction number 137, 30 March 2022
Distribution date: 12 April 2022
This normative instruction contains provisions on Good Manufacturing Practices complementary to Blood-derived Medicines.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
Normative Instruction number 138, 30 March 2022
Distribution date: 12 April 2022
This normative instruction contains provisions on Good Manufacturing Practices complementary to qualification and validation activities.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
Normative Instruction number 138, 30 March 2022
Distribution date: 12 April 2022
This normative instruction contains provisions on Good Manufacturing Practices complementary to qualification and validation activities.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
Normative Instruction number 132, 30 March 2022
Distribution date: 12 April 2022
This normative instruction contains provisions on Good Manufacturing Practices complementary to Liquid Medicines, Creams or Ointments.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
Normative Instruction number 132, 30 March 2022
Distribution date: 12 April 2022
This normative instruction contains provisions on Good Manufacturing Practices complementary to Liquid Medicines, Creams or Ointments.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
The notification G/TBT/N/BRA/1313 was circulated erroneously and should therefore be considered null and void since the Normative Instruction number 19, 23 February 2022, was already notified through the notification G/TBT/N/BRA/1310.
Distribution date: 12 April 2022
Products Covered: Medical Devices (HS 3006)
Regulation Type: Corrigendum to Regular Notification
The notification G/TBT/N/BRA/1313 was circulated erroneously and should therefore be considered null and void since the Normative Instruction number 19, 23 February 2022, was already notified through the notification G/TBT/N/BRA/1310.
Distribution date: 12 April 2022
Products Covered: Medical Devices (HS 3006)
Regulation Type: Corrigendum to Regular Notification
Normative Instruction number 134, 30 March 2022
Distribution date: 12 April 2022
This normative instruction contains provisions on Good Manufacturing Practices complementary to the computerized systems used in the manufacture of medicines.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
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