Distribution date: 26 March 2021 | Final date for Comment: 15 May 2021

This Draft Resolution includes the active ingredient N13 - Neochrysocharis formosa in the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers.

Products Covered: HS Code(s): 38089910; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 26 March 2021 | Final date for Comment: 15 May 2021

This Draft resolution incorporates the following changes for the active ingredient S13 - S-METOLACLORO (S-metolachlor) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of pre emergency use (application):- includes the sorghum culture with MRL of 0.01 mg/kg and safety security period "Not determined due to the modality of use (application).

Products Covered: HS Code(s): 1007; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 26 March 2021 | Final date for Comment: 15 May 2021

This Draft resolution incorporates the following changes for the active ingredient B26 - BIFENTRINA (bifenthrin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- changes the MRL of tne cotton culture from 0.05 to 0.06 mg/kg;- includes the acerola, blackberry, cocoa, cupuacu, raspberry, guarana, kiwi, passion fruit, blueberry, strawberry, Brazilian cherry, and pomegranate cultures with MRL of 0.01 mg/kg and safety security period of 14 days;- includes the phrase at item "k": "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the sum of the isomers of the active ingredient bifenthrin".- includes the phrase at item "n" Acute Reference Dose (ARfD): 0.01 mg/kg b.w. (source: JMPR*, 2009);- includes the phrase: "*Joint FAO/WHO Meeting on Pesticide Residues".

Products Covered: HS Code(s): 18, 52, 081020, 081090, 081040, 080920, 3295, 08105000, 081190, 08109090, cupuacu; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 26 March 2021 | Final date for Comment: 15 May 2021

This Draft resolution incorporates the following changes for the active ingredient I18 - ISOXAFLUTOL (isoxaflutole) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes the cotton culture with safety security period "Not determined due to the modality of use (application)", in the modality of pre emergency use (application);- includes the weeds culture in the modality of pre emergency use (application);- includes the cotton culture tolerant to isoxaflutole in the modality of pre emergency use (application);- includes the cotton culture tolerant to isoxaflutole in the modality of early post emergency use (application);- includes the phrase at item "l": Acute Reference Dose (ARfD): Not applicable (source: JMPR*, 2013);- includes the phrase: "*Joint FAO/WHO Meeting on Pesticide Residues";- includes the phrase at item "m": "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the sum of the active ingredient isoxaflutole and its metabolit diquetonitrila (CAS n. 143701-75-1), expressed as isoxaflutole".

Products Covered: HS Code(s): 52, weeds; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 26 March 2021 | Final date for Comment: 16 May 2025

This resolution establishes exceptional and temporary procedure for the market authorization on an emergency basis of anaesthetics, sedatives, neuromuscular blockers, and other hospital medicines used for the maintenance of patients’ lives use in healthcare services to tackle the national public health emergency related to the outbreak of the new coronavirus (SARS-CoV-2).

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: Regular notification

Distribution date: 26 March 2021 | Final date for Comment: 16 May 2025

The Draft Resolution number 876, 23 July 2020 – previously notified through G/TBT/N/BRA/1070 – which establishes the economic monitoring for medical devices, was adopted as Resolution – RDC number 478, 12 March 2021.    The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/4247877/RDC_478_2021_.pdf/294efeb7-32cd-43d1-b770-f4e577b62c22

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 26 March 2021 | Final date for Comment: 16 May 2025

The Draft Normative Instruction number 877, 27 July 2020 – previously notified through G/TBT/N/BRA/1069 - which establishes the list of medical devices selected to economic monitoring by Anvisa, was adopted as Normative Instruction number 84, 12 March 2021.         The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/4247877/IN_84_2021_.pdf/0a7d86cc-c0b9-40ed-9e68-23c89d4621be

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 26 March 2021 | Final date for Comment: 16 May 2025

The Resolution – RDC number 392, 26 May 2020 – previously notified through G/TBT/N/BRA/1032 – which establishes temporary and extraordinary criteria for the application of exceptionalities to specific technical requirements of the Good Manufacturing and Import Practice of Medicinal Products and Active Pharmaceutical Ingredients, due to the international public health emergency of the new coronavirus (Covid-19) – was changed by the Resolution – RDC number 482, 19 March 2021. This resolution establishes exceptionalities for the use of non-medicinal oxygen cylinder, industrial cylinder filling ramps for the filling of medicinal cylinders, and industrial gas filling unit for the filling of medicinal gases. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/5893706/RDC_482_2021_.pdf/12dc0b32-f1e3-4489-b913-e57a9354e41a

Products Covered: HS Code(s): 2941; 3003; 3004; 3005; 3006 (pharmaceutical products).

Regulation Type: Addendum to Regular Notification

Distribution date: 26 March 2021 | Final date for Comment: 16 May 2025

This resolution establishes exceptional and temporary technical requirements for the import of new medical devices and medicines identified as indispensable for the use in healthcare services due to the international public health emergency related to the SARS-CoV-2.

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis, incl. natural concentrates, derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent (HS code(s): 2936); Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof "incl. chain modified polypeptides", used primarily as hormones (HS code(s): 2937); Antibiotics (HS code(s): 2941); PHARMACEUTICAL PRODUCTS (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 26 March 2021 | Final date for Comment: 16 May 2025

The Draft Normative Instruction number 878, 23 July 2020 – previously notified through G/TBT/N/BRA/1068 – which establishes technical requirements for medical devices selected to economic monitoring by Anvisa, was adopted as Normative Instruction number 85, 12 March 2021.        The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/4247877/IN_85_2021_.pdf/c62ef4d8-6bcd-4ca0-94a9-f57f4e4d938b

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification