Distribution date: 19 December 2022

The RDC Nº 205, 28 December 2017 - previously notified through G/TBT/N/BRA/784 - which establishes special procedure for approval of clinical trials, good manufacturing practices certification and registration of new medicines for treatment, diagnosis or prevention of rare diseases, was changed by Resolution - Resolution - RDC number 763, 25 November 2022   The Resolution - RDC 763, 25 November 2022, was republished on 02 December 2022.The republished text is available only in Portuguese and can be downloaded at:https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-763-de-25-de-novembro-de-2022-*-447341166  

Products Covered: 3003 3004: Medicaments

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022

The Draft Resolution number 989, 15 December 2020  - previously notified through G/TBT/N/BRA/1118 - which establishes technical requirements for the development, harmonization, updating, publication, and provision of medicine leaflets to patients andhealthcare professionals, was adopted as Resolution - RDC number 769, 12 December 2022. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6165008/RDC_769_2022_.pdf/f2ae47ac-dd5b-42c4-9d64-875315028dda 

Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022

The Draft Resolution no. 815, 01 June 2020 - previously notified through G/TBT/N/BRA/1024 - which establishes technical requirements for the labelling of medicines, was adopted as the Resolution - RDC number 768, 12 December 2022. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/3426875/RDC_768_2022_.pdf/dbe15026-544d-42f1-8792-09658b8c8fda   

Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022

The proposed maximum residue limits (MRLs) for Cyfluthrin notified in G/SPS/N/JPN/1034 (dated 24 May 2022) were adopted and published on 26 October 2022.The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Coffee, tea, mate and spices (HS codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)Cocoa (HS code: 18.01)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022

The proposed maximum residue limits (MRLs) for Pencycuron notified in G/SPS/N/JPN/1030 (dated 24 May 2022) were adopted and published on 26 October 2022.The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.08 and 02.09)Fish and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)Dairy produce (HS code: 04.01)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.09, 07.10 and 07.14)Mate (HS code: 09.03)Cereals (HS code: 10.06)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS code: 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022

The proposed maximum residue limits (MRLs) for Lubabegron notified in G/SPS/N/JPN/1032 (dated 24 May 2022) were adopted and published on 26 October 2022.The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02 and 02.06)Animal originated products (HS code: 05.04)Animal fats and oils (HS code: 15.02)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022

The proposed maximum residue limits (MRLs) for Afidopyropen notified in G/SPS/N/JPN/1025 (dated 23 May 2022) were adopted and published on 26 October 2022.The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.04, 07.05, 07.07, 07.09, 07.10 and 07.14)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.01, 08.02, 08.04, 08.05, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Mate and spices (HS codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS codes: 10.01, 10.04, 10.07 and 10.08)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.07 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022

The proposed maximum residue limits (MRLs) for Flufenoxuron notified in G/SPS/N/JPN/1028 (dated 24 May 2022) were adopted and published on 26 October 2022.The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Fish and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Tea, mate and spices (HS codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS code: 10.05)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.07 and 12.12)Animal or vegetable fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022

The proposed maximum residue limits (MRLs) for Cyantraniliprole notified in G/SPS/N/JPN/1027 (dated 24 May 2022) were adopted and published on 26 October 2022.The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.01, 08.02, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Coffee, tea, mate and spices (HS codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS codes: 10.05 and 10.06)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.05, 12.06, 12.07 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022

The proposed maximum residue limits (MRLs) for Bacitracin notified in G/SPS/N/JPN/1029 (dated 24 May 2022) were adopted and published on 26 October 2022.The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08)Animal originated products (HS code: 05.04)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Addendum to Regular Notification