Regulatory Updates
Proposed new standard for medicine serialisation and data matrix codes - Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021
Distribution date: 01 April 2021
In March 2021, a new standard, Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 was registered on the Federal Register of Legislation. The standard commences on 1 January 2023. TGO 106 does not mandate medicine serialisation or the application of data matrix codes to medicines, but sets out the technical requirements if the medicine sponsor implements either of these. Medicines released for supply from 1 January 2023 must comply with the requirements of TGO 106 if they: are serialised include a data matrix code which encodes the Global Trade Item Number (GTIN). TGO 106 defines the requirements for the presentation and content of data matrix codes including human readability requirements and relationship with other machine readable codes. The requirements include: Where a medicine is serialised this must be represented by a serial number encoded into a data matrix code that complies with the GS1 General Specifications for a DataMatrix. If a data matrix code containing a GTIN is applied to a unit of a medicine, this must be formatted as a GS1 DataMatrix that complies with the GS1 General Specifications. TGO 106 does not set out any requirements regarding reporting, storage and verification of serialisation data.
Products Covered: Medicines
Regulation Type: Addendum to Regular Notification
Revision of the Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (revision of Agricultural Chemical Residue Standards)
Distribution date: 01 April 2021 | Final date for Comment: 31 May 2021
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Prochloraz
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, nuts and 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 or vegetable fats and oils (HS Codes: 15.01, 15.02, 15.06 and 15.12)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (revision of Agricultural Chemical Residue Standards)
Distribution date: 01 April 2021
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Kasugamycin
Products Covered: -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 and 07.13) -Edible fruit, nuts and peel of citrus fruit (HS Codes: 08.02, 08.04, 08.05, 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: 10.06)-Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.07 and 12.12)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (revision of Agricultural Chemical Residue Standards)
Distribution date: 01 April 2021 | Final date for Comment: 31 May 2021
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Fenpropathrin
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, 07.07, 07.09, 07.10 and 07.13) -Edible fruit, nuts and 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 and spices (HS Codes: 09.01, 09.02, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02, 12.07 and 12.10)-Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (revision of Agricultural Chemical Residue Standards)
Distribution date: 01 April 2021
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Feed additive: Dibutylhydroxytoluene.
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 and 03.06)-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: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (revision of Agricultural Chemical Residue Standards)
Distribution date: 01 April 2021
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: 1-Methylcyclopropene
Products Covered: -Edible vegetables and certain roots and tubers (HS Codes: 07.01 and 07.10)-Edible fruit and nuts (HS Codes: 08.03, 08.08, 08.09, 08.10 and 08.11)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (revision of Agricultural Chemical Residue Standards)
Distribution date: 01 April 2021
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Chloropicrin
Products Covered: -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 peel of citrus fruit (HS Codes: 08.07, 08.08, 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, 10.02, 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, 12.07 and 12.12)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (revision of Agricultural Chemical Residue Standards)
Distribution date: 01 April 2021 | Final date for Comment: 31 May 2021
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Validamycin
Products Covered: -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 and 07.14) -Edible fruit and peel of citrus fruit (HS Codes: 08.05, 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: 10.05 and 10.06)-Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.07 and 12.12)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (revision of Agricultural Chemical Residue Standards)
Distribution date: 01 April 2021
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Veterinary drug: Trenbolone Acetate.
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, birds' eggs and natural honey (HS Codes: 04.01, 04.07, 04.08 and 04.09) -Animal originated products (HS Code: 05.04)-Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Rectification of the Resolution – RDC number 471, 23 February 2021
Distribution date: 31 March 2021
The Resolution – RDC number 471, 23 February 2021 – previously notified through G/TBT/N/BRA/1143 – which establishes criteria for prescription, exemption, control, packaging, and labelling of medicines based on substances categorized as antimicrobial for use under prescription, isolated or associated, was rectified. The rectified text is available only in Portuguese and can be downloaded at: https://www.in.gov.br/web/dou/-/retificacao-310903837
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 for 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
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