Distribution date: 08 August 2023 | Final date for Comment: 03 September 2023

The draft amendments to the Pharmacopoeia of the Eurasian Economic Union provides for 46 general pharmacopoeia articles added, in terms of biological tests, biological medicinal products and radiopharmaceuticals.

Products Covered: Medical products

Regulation Type: Regular notification

Distribution date: 09 August 2023 | Final date for Comment: 08 October 2023

Draft Resolution 1155, 6 April 2023 - previously notified through   G/SPS/N/BRA/2154  - was adopted as Normative Instruction 234, 1 August 2023. The regulation includes the active ingredient P71: PYRIOPHENONE on the Monograph List of Active Ingredients for Pesticides, Sanitizing Disinfectants  and Wood Preservatives, published by Normative Instruction 103, 19 October 2021, in the Brazilian Official Gazette (DOU - Diário Oficial da União). The final text is available only in Portuguese and can be downloaded at:

Products Covered: Organic chemicals (HS code(s): 29); Environment. Health protection. Safety (ICS code(s): 13)

Regulation Type: Addendum to Regular Notification

Distribution date: 09 August 2023 | Final date for Comment: 08 October 2023

Draft Resolution 1157, 6 April 2023 - previously notified through  G/SPS/N/BRA/2157  - was adopted as Normative Instruction 233, 1 August 2023. The regulation amends the monographs of the active ingredients B41 - Boscalid, C07 - Kasugamycin, C10 - Cypermethrin, C18 - Chlorothalonil, C25 - Cartap Hydrochloride, C32 - Clethodim, C55 - Copper-based compounds, C63 - Lambda-Cyhalothrin, D06 - Deltamethrin, D21 - Diquat, G05 - Ammonium Glufosinate, H07 - Methyl Haloxyfop-P, I12 - Imazapyr, I20 - Imazapik, I30 - Impirfluxam, M45 - Mandipropamide, O21 - Oxathiapiproline, P23 - Propamocarb, S13 - S-Metolachlor, T14 - Methyl Thiophanate, T48 - Thiamethoxam on the Monograph List of Active Ingredients for Pesticides, Sanitizing Disinfectants and Wood Preservatives, published by Normative Instruction 103, 19 October 2021, in the Brazilian Official Gazette (DOU - Diário Oficial da União). The final text is available only in Portuguese and can be downloaded at:

Products Covered: Organic chemicals (HS code(s): 29); Environment. Health protection. Safety (ICS code(s): 13)

Regulation Type: Addendum to Regular Notification

Distribution date: 09 August 2023 | Final date for Comment: 08 October 2023

Draft resolution 1153, 6 April 2023 - previously notified through   G/SPS/N/BRA/2152  - was adopted as Normative Instruction 239, 1 August 2023.  The regulation includes item A58.2 - HYDROALCOHOLIC EXTRACT OF NEEM in the monograph of the active ingredient A58 – AZADIRACHTA INDICA on the Monograph List of Active Ingredients for Pesticides, Sanitizing Disinfectants and Wood Preservatives, published by Normative Instruction 103, 19 October 2021, in the Brazilian Official Gazette (DOU - Diário Oficial da União). The final text is available only in Portuguese and can be downloaded at:  

Products Covered: Organic chemicals (HS code(s): 29); Environment. Health protection. Safety (ICS code(s): 13)

Regulation Type: Addendum to Regular Notification

Distribution date: 10 August 2023 | Final date for Comment: 29 April 2025

Health requirements for the entry into Chile of seabird guano and repeal of Exempt Resolution No. 686 of 1991 Chile hereby advises that Exempt Resolution No. 4785 of 2023, "Health requirements for the entry into Chile of seabird guano and repeal of Exempt Resolution No. 686 of 1991", was published in the Official Journal on 8 August 2023 and will enter into force 90 days after that date. https://members.wto.org/crnattachments/2023/SPS/CHL/23_11640_00_s.pdf

Products Covered: Guano de aves marinas

Regulation Type: Addendum to Regular Notification

Distribution date: 10 August 2023 | Final date for Comment: 29 April 2025

Resolution 626, 09 March 2022 - previously notified through  G/TBT/N/BRA/1320 - which contains provisions on the prohibition of the use of preparations containing the substance Lidocaine, Brazilian Common Denomination (BCD) nº 05313, in the pharmaceutical form, oral solution for internal use, except in the pharmaceutical form spray for topical application on mucous membranes, provided that the applicator is equipped with a device that guarantees the exact dose of application, will be revoked by Resolution 802, 20 July 2023.  The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6627746/RDC_802_2023_.pdf/5b8d24e2-b794-4028-9a2f-46f8345aed8e 

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Addendum to Regular Notification

Distribution date: 10 August 2023 | Final date for Comment: 29 April 2025

Normative Instruction 162, 01 July 2022 - previously notified through  G/TBT/N/BRA/1417 - which establishes  the  acceptable  daily intake  (ADI),  the  acute  reference  dose  (DRfA)  and  maximum  residue  limits  (MRL)  for active pharmaceuticals ingredients (API) of veterinary drugs in foods of animal origin, was changed by Normative Instruction 241, 03 August 2023.   The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6637201/IN_241_2023_.pdf/dd2c2335-48ad-4bfb-b807-cb69ea5b9e94

Products Covered: Pharmaceutical goods specified in Note 4 to this Chapter. (HS code(s): 3006)

Regulation Type: Addendum to Regular Notification

Distribution date: 10 August 2023 | Final date for Comment: 28 August 2023

This Draft Resolution contains provisions on definition, classification, technical requirements for labeling and packaging, parameters for microbiological control, as well as technical requirements and procedures for the regulation of personal hygiene products, cosmetics and perfumes.

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33)

Regulation Type: Regular notification

Distribution date: 10 August 2023 | Final date for Comment: 28 August 2023

This Draft Resolution contains provisions on health requirements for safety and efficacy for post-marketing registration alterations of synthetic and semi-synthetic drugs classified as new or innovative.

Products Covered: 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); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 10 August 2023 | Final date for Comment: 25 September 2022

This draft resolution contains provisions on the conditions and procedures for registering pre-pandemic influenza vaccines, updating to a pandemic strain and authorization for the use, marketing and monitoring of pandemic influenza vaccines. It is important to highlight that, when the absence or incompleteness of national regulation, and as long as there is no incompatibility, the adoption of guides and guidelines by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification