Regulatory Updates
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
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
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
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
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
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
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the manufacture of radiopharmaceuticals The draft normative instruction regarding Complementary guidelines to the manufacture of radiopharmaceuticals 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 37, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:
Distribution date: 27 August 2019
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the manufacture of biological medicinal substances and products for human use The draft normative instruction regarding Complementary guidelines to the manufacture of biological medicinal substances and products for human use 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 36, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:
Distribution date: 27 August 2019
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the manufacture of medicinal gases The draft normative instruction regarding Complementary guidelines to the manufacture of medicinal gases 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 38, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:
Distribution date: 27 August 2019
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Good Practice Guidelines for the Manufacture of Medicines The draft resolution regarding Good Practice Guidelines for the Manufacture of Medicines 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 Resolution – RDC 301, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:
Distribution date: 27 August 2019
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the manufacture of sterile medicinal products The draft normative instruction regarding Complementary guidelines to the manufacture of sterile 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 35, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:
Distribution date: 27 August 2019
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
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