Normative Instruction number 123, 24 March 2022
Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025
This normative instruction approves the Inspection Roadmap for Medicines Bioavailability/Bioequivalence Centers.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
Normative Instruction number 123, 24 March 2022
Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025
This normative instruction approves the Inspection Roadmap for Medicines Bioavailability/Bioequivalence Centers.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
Normative Instruction number 134, 30 March 2022
Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025
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
Normative Instruction number 134, 30 March 2022
Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025
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
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 | Final date for Comment: 06 May 2025
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 | Final date for Comment: 06 May 2025
Products Covered: Medical Devices (HS 3006)
Regulation Type: Corrigendum to Regular Notification
Normative Instruction number 132, 30 March 2022
Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025
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 | Final date for Comment: 06 May 2025
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 138, 30 March 2022
Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025
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 | Final date for Comment: 06 May 2025
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
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