Distribution date: 27 April 2021 | Final date for Comment: 15 June 2021

Public Consultation proposal to establish technical requirements for research on pesticides residues and establishment of Maximum Residue Limits for the purpose of market authorization for pesticides in Brazil.

Products Covered: HS Code(s): 38089910 (pesticides)

Regulation Type: Regular notification

Distribution date: 27 April 2021 | Final date for Comment: 14 May 2021

Public Consultation Proposal to establish technical requirements for the import, commercialization, and donation of used reprocessed medical devices. 

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Regular notification

Distribution date: 27 April 2021

ANVISA issued RDC No. 494, 15 April 2021, that amends the Collegiate Board Resolution - RDC No. 283, of 17 May 2019, previously notified through G/TBT/N/BRA/871, which establishes technical requirements for investigation, control and elimination of nitrosamines potentially carcinogenic in active pharmaceutical ingredients (IFA) which are angiotensin II receptor antagonists; and is applied to companies that manufacture, import and fractionate active pharmaceutical ingredients (IFA). The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6260694/RDC_494_2021_.pdf/00d1e534-238d-46e8-a3a8-d225aff673f3

Products Covered: HS Codes: 2941; 30. (active pharmaceutical ingredients)

Regulation Type: Addendum to Regular Notification

Distribution date: 27 April 2021 | Final date for Comment: 31 May 2021

Public Consultation proposal to establish technical criteria for the concession or renewal of Good Manufacturing Practice Certificate for producers of medical devices.

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Regular notification

Distribution date: 27 April 2021

ANVISA Public Consultation No. 854, 24 June 2020 – previously notified through G/TBT/N/BRA/1033 – which establishes procedure for changes in the process of post-market authorization of sanitizing products, was adopted as Resolution – RDC number 492, 15 April 2021. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/5933505/RDC_492_2021_.pdf/e8a5f2e2-9a43-4b41-a087-a4a73fd20a73

Products Covered: HS Code(s): 3402; 340119; 340120; 330290 (sanitizing products)

Regulation Type: Addendum to Regular Notification

Distribution date: 26 April 2021 | Final date for Comment: 15 July 2021

Public Consultation proposal to establish the criteria for the exemption and substitution of relative bioavailability and bioequivalence studies.

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

Regulation Type: Regular notification

Distribution date: 22 April 2021 | Final date for Comment: 15 June 2021

Public Consultation No. 1035 establishes technical requirements for the software regularization as a medical device.

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); Dried glands and other organs for organo-therapeutic uses, whether or not powdered; extracts of glands or other organs or their secretions, for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, n.e.s. (HS code(s): 3001); Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); 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); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006)

Regulation Type: Regular notification

Distribution date: 22 April 2021 | Final date for Comment: 31 May 2021

Public Consultation No. 1031 proposes the updating of the Resolution – RDC number 367, 6 April 2020, which provides the control of import and export of substances, plants and medicines subject to special control

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: 22 April 2021 | Final date for Comment: 21 June 2021

This order seeks to ensure conformity to Ethylene Dichloride listed in the schedule to the specified Indian Standard.   

Products Covered: IS 869 : 2020 Ethylene Dichloride (HS code 29031500)

Regulation Type: Regular notification

Distribution date: 22 April 2021 | Final date for Comment: 21 June 2021

This order seeks to ensure conformity to Polycarbonate listed in the schedule to the specified Indian Standard.   

Products Covered: IS 14434:1998 Polycarbonate (HS code 39074000)

Regulation Type: Regular notification