Chemical Regulatory Updates – Latest Global Changes

Resolution - RDC number 721, 01 July 2022

Distribution date: 07 October 2022 | Final date for Comment: 05 May 2025

The Resolution - RDC number 721, 01 July 2022 - previously notified through  G/TBT/N/BRA/1412 - contains provisions on marketing authorization, renewal of marketing authorization, post-marketing authorization changes and notification of industrialized dynamized drugs., was republished.  The republished text is available only in Portuguese and can be downloaded at:  https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-721-de-1-de-julho-de-2022-*-429194963

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Corrigendum to Regular Notification

Human health

Draft Normative Instruction number 931, 13 October 2020

Distribution date: 07 October 2022 | Final date for Comment: 05 May 2025

The Draft Normative Instruction number 931, 13 October 2020 - previously notified through G/TBT/N/BRA/1094 - which establishes new codes for the administrative request of market authorization for new and innovative synthetic and semisynthetic medicines, was adopted as  Normative Instruction number 184, 28 September 2022. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/5457402/IN_184_2022_.pdf/ad7438ee-2b82-47df-bc21-23c1f6e94739

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); 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

Human health

Draft Resolution number 932, 13 October 2020.

Distribution date: 07 October 2022 | Final date for Comment: 05 May 2025

The Draft Resolution number 932, 13 October 2020 - previously notified through G/TBT/N/BRA/1095 - which establishes criteria for the concession of market authorization for medicines with synthetic and semisynthetic active principles for human use categorized as new, innovative, generic, and similar, was adopted as Resolution - RDC number 753, 28 September 2022 The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/5457402/RDC_753_2022_.pdf/366cc4a2-4857-4902-b4a1-07769cf962c8

Regulation Type: Addendum to Regular Notification

Human health

Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of the Republic of Kazakhstan on the introduction of temporary restrictions on the importation to the territory of Kazakhstan from the autonomous community of Andalusia of Spain of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and cutting birds, as well as transit through the territory of Kazakhstan of live birds from the above territory

Distribution date: 11 October 2022 | Final date for Comment: 05 May 2025

The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports that on the basis of the official notification of the World Organisation for Animal Health (OIE), outbreaks of Newcastle disease was registered in the autonomous community of Andalusia of Spain. In this regard, since 15 July 2022, temporary restrictions have been introduced on the importation to the territory of Kazakhstan from the autonomous community of Andalusia of Spain of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (at least 70 °C), feed and feed additives for birds (with the exception of feed additives of chemical and microbiological synthesis), trophies of the chase that have not undergone taxidermy treatment (feather game), used equipment for keeping, slaughtering and cutting birds, as well as transit through the territory of Kazakhstan of live poultry from the above territory. With regard to the above goods shipped before 15 July 2022, the decision to let them pass is made in the usual manner.

Products Covered: Live poultry, hatching eggs, down and feathers, poultry meat, all poultry products, fodder and feed additives for birds, trophies of the chase, used equipment for the maintenance, slaughter and cutting of birds

Regulation Type: Emergency notifications (SPS)

Animal health Human health Newcastle Disease Food safety Animal diseases Pest- or Disease- free Regions / Regionalization Zoonoses

Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of the Republic of Kazakhstan on the introduction of temporary restrictions on the importation to the territory of Kazakhstan from the Departments of Dordogne, Charente, Landes, Lot-et-Garonne, Lot, Aveyron and Cantal, France of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and cutting birds, as well as transit through the territory of Kazakhstan of live birds from abovementioned territories

Distribution date: 11 October 2022 | Final date for Comment: 05 May 2025

The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports that on the basis of the official notification of the World Organisation for Animal Health (notification on the official website of the OIE WAHIS), outbreaks of avian influenza were registered in the Departments of Dordogne, Charente, Landes, Lot-et-Garonne, Lot, Aveyron and Cantal, France. In this regard, since 30 May 2022, temporary restrictions have been introduced on the importation to the territory of Kazakhstan from the administrative territories of the Departments of Dordogne, Charente, Landes, Lot-et-Garonne, Lot, Aveyron and Cantal of France of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (at least 70 °C), feed and feed additives for birds (with the exception of feed additives of chemical and microbiological synthesis), trophies of the chase that have not undergone taxidermy treatment (feather game), used equipment for keeping, slaughtering and cutting birds, as well as transit through the territory of Kazakhstan of live poultry from abovementioned territories. With regard to the above goods shipped before 30 May 2022, the decision to let them pass is made in the usual manner.

Regulation Type: Emergency notifications (SPS)

Avian Influenza Human health Animal health Food safety Animal diseases Pest- or Disease- free Regions / Regionalization Zoonoses

National Standard of the P.R.C., Escape Apparatus for Building Fire Part 8: Chemical Oxygen Respiratory Protective Devices for Self-rescue from Fire

Distribution date: 14 October 2022 | Final date for Comment: 13 December 2022

This document specifies the terms and definitions, models and specifications, technical requirements, test methods, inspection rules, markings, packaging, transportation and storage of chemical oxygen respiratory protective devices for self-rescue from fire .This document applies to the disposable chemical oxygen fire self rescue respirator with potassium peroxide as the oxygen generating agent, which is used for personnel to escape in the case of oxygen deficiency in the event of fire. This document does not apply to working and rescue respirators, nor to diving respirators.

Products Covered: Chemical oxygen respiratory protective devices for self-rescue from fire (HS code(s): 9020); (ICS code(s): 13.220.10)