Draft Resolution number 682, August 12th, 2019. Published on D.O.U, August 14th, 2019. Language(s): Portuguese. Number of pages: 41 Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=49363
Distribution date: 21 August 2019 | Final date for Comment: 21 October 2019
This draft resolution proposes the establishment of the Dossier for Active Pharmaceutical Ingredient (API) and of the Adequacy Charter of the Dossier for Active Pharmaceutical Ingredient.
Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)
Regulation Type: Regular notification
Draft Resolution number 688, August 12th, 2019. Published on D.O.U, August 14th, 2019. Language(s): Portuguese. Number of pages: 6. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=49406
Distribution date: 21 August 2019 | Final date for Comment: 21 October 2019
This draft resolution establishes criteria for certification of Good Manufacturing Practice for international companies that manufacture Active Pharmaceutical Ingredients (API).
Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)
Regulation Type: Regular notification
Limitation Requirements of Toxic and Harmful Substance in Fertilizers
Distribution date: 26 August 2019 | Final date for Comment: 25 October 2019
This standard specifies the terms and definitions, requirements, testing methods and inspection rules for toxic and harmful elements in fertilizers.
Products Covered: Fertilizers
Regulation Type: Regular notification
Please note that in the notification G/TBT/N/BRA/901 Item 5 should read: Title, number of pages and language(s) of the notified document: Draft Resolution number 687, August 12th, 2019. Published on D.O.U, August 14th, 2019.Language(s): Portuguese. Number of pages: 10. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=49293
Distribution date: 26 August 2019 | Final date for Comment: 07 May 2025
Products Covered: Biological products
Regulation Type: Corrigendum to Regular Notification
FDHA Ordinance on Drinking Water and Water in Public Baths and Shower Facilities (DWBSO)
Distribution date: 26 August 2019 | Final date for Comment: 25 October 2019
A maximum limit for perchlorate in water (drinking water) is established. It is set at 4 µg/l. Reason for this is health protection of consumers.
Products Covered: Drinking water
Regulation Type: 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 | Final date for Comment: 07 May 2025
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 | 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 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 | 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 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 | 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 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 | Final date for Comment: 07 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
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