Regulatory Updates
Notice of Intent to Amend: Prescription Drug List (PDL): Tramadol (1 page, available in English and French)
Distribution date: 07 April 2021
The purpose of this Notice of Intent to Amend is to notify stakeholders that Health Canada will remove tramadol from both the Human and Veterinary sections of the Prescription Drug List when the addition of tramadol to Schedule I to the Controlled Drugs and Substances Act and to the Narcotic Control Regulations comes into force on 31 March 2022.
Products Covered: Prescription status of medicinal ingredients for human use
Regulation Type: Regular notification
National Standard of the P.R.C., Feed additives-Part 3: Minerals and their complexes (or chelates)-Potassium iodate
Distribution date: 07 April 2021 | Final date for Comment: 06 June 2021
This part of GB 7300 specifies the requirements, sampling, test methods, inspection rules, labelling, packaging, transportation, storage and shelf life of feed additive potassium iodate. The standard is applicable to feed additive potassium iodate prepared by potassium chlorate oxidation method and electrolysis method. All technical contents of this part are mandatory.
Products Covered: Feed additive Potassium iodate
Regulation Type: Regular notification
National Standard of the P.R.C., Inert Gas Agent
Distribution date: 07 April 2021 | Final date for Comment: 06 June 2021
This standard specifies terms and definitions, requirements, test methods and inspection rules for inert gas agents. This standard is applicable to inert gas agents.
Products Covered: Inert gas agent
Regulation Type: Regular notification
Amendment of the Compulsory Specification for frozen lobsters and frozen lobster products derived therefrom - VC 8020
Distribution date: 07 April 2021 | Final date for Comment: 06 June 2021
This Compulsory Specification requires that frozen lobsters and frozen lobster products derived therefrom for direct consumption or further processing, which are to be offered for sale, comply with this Compulsory Specification and the requirements of the latest edition of the South African National Standard (SANS) 2074 which applies to the manufacture, production, processing, and treatment of the products covered by this specification. The hygiene requirements for the product, as well as chemical and microbiological contaminant requirements for the product, and the requirements for employees at the packing facility, shall comply with the requirements of the latest edition of SANS 2074.
Products Covered: Frozen lobster, frozen lobster products and products derived therefrom, i.e. HS Codes: 03 and 16
Regulation Type: Regular notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 07 April 2021
The proposed maximum residue limits (MRLs) for Pyriproxyfen notified in G/SPS/N/JPN/788 (dated 19 October 2020) were adopted and published on 3 February 2021.The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 07 April 2021
The proposed maximum residue limits (MRLs) for Bixafen notified in G/SPS/N/JPN/785 (dated 19 October 2020) were adopted and published on 3 February 2021.The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 07 April 2021
The proposed maximum residue limits (MRLs) for Pyrifluquinazon notified in G/SPS/N/JPN/787 (dated 19 October 2020) were adopted and published on 3 February 2021.The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 07 April 2021
The proposed maximum residue limits (MRLs) for Azoxystrobin notified in G/SPS/N/JPN/784 (dated 19 October 2020) were adopted and published on 3 February 2021.The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 07 April 2021
The proposed maximum residue limits (MRLs) for Cyflufenamid notified in G/SPS/N/JPN/786 (dated 19 October 2020) were adopted and published on 3 February 2021.The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
TITLE: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Corrections AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS) ACTION: Final rule; correcting amendments SUMMARY: On 31 August 2016, the Food and Drug Administration (FDA or Agency) published an amended final rule that listed inaccurate cross- references to FDA's drug establishment registration and drug listing regulations. This document corrects the inaccurate cross-references used in the final regulations. This rule is effective 1 April 2021. This final rule; correcting amendments and previous actions notified under the symbol G/TBT/N/USA/214 are identified by Docket Number FDA-2005-N-0464. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/FDA-2005-N-0464/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.
Distribution date: 06 April 2021
Products Covered: Human and animal drugs (HS Chapter 3004; ICS: 11.120, 11.220)
Regulation Type: Corrigendum to Regular Notification
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