Complementary guidelines to the manufacture of liquids, creams and ointments The draft normative instruction regarding Complementary guidelines to the manufacture of liquids, creams and ointments of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 41, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:

Distribution date: 28 August 2019 | Final date for Comment: 07 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to computerised systems The draft normative instruction regarding Complementary guidelines to computerised systems of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 43, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:

Distribution date: 28 August 2019 | Final date for Comment: 07 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the manufacture of medicinal products derived from human blood or plasma The draft normative instruction regarding Complementary guidelines to the manufacture of medicinal products derived from human blood or plasma of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 46, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:

Distribution date: 28 August 2019 | Final date for Comment: 07 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the manufacture of investigational medicinal products The draft normative instruction regarding Complementary guidelines to the manufacture of investigational medicinal products of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 45, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:

Distribution date: 28 August 2019 | Final date for Comment: 07 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the sampling of starting and packaging materials The draft normative instruction regarding Complementary guidelines to the sampling of starting and packaging materials of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 40, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:

Distribution date: 28 August 2019 | Final date for Comment: 07 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the manufacture of pressurised metered dose aerosol preparations for inhalation The draft normative instruction regarding Complementary guidelines to the manufacture of pressurised metered dose aerosol preparations for inhalation of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 42, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:

Distribution date: 28 August 2019 | Final date for Comment: 07 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the qualification and validation The draft normative instruction regarding Complementary guidelines to the qualification and validation of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 47, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:

Distribution date: 28 August 2019 | Final date for Comment: 07 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the reference and retention samples The draft normative instruction regarding Complementary guidelines to the reference and retention samples of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 48, 21 August 2019The full text is available only in Portuguese and can be downloaded at:

Distribution date: 28 August 2019 | Final date for Comment: 07 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the manufacture of herbal medicinal products The draft normative instruction regarding Complementary guidelines to the manufacture of herbal medicinal products of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 39, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:

Distribution date: 28 August 2019 | Final date for Comment: 07 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the use of ionising radiation in the manufacture of medicinal products The draft normative instruction regarding Complementary guidelines to the use of ionising radiation in the manufacture of medicinal products of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 44, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:

Distribution date: 28 August 2019 | Final date for Comment: 07 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Submit your email ID to receive notifications about upcoming courses and events