Notice of Intent to Amend the Prescription Drug List (PDL): Metamizole (dipyrone)
Distribution date: 20 January 2022 | Final date for Comment: 07 May 2025
The purpose of this Notice of Intent to Amend is to notify that, as a result of a scientific review and public consultation, Health Canada will add the ingredient metamizole (also known as “dipyrone”) to the Veterinary section of the Prescription Drug List. The human section of the Prescription Drug List will not be revised. Health Canada has conducted a scientific review of new metamizole products against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations that led to this decision. There is no change from what was proposed in the 23 April 2021 Notice of Consultation, notified under G/TBT/N/CAN/639. This revision will enter into force six months from the date that the Notice of Intent to Amend is posted on the Health Canada website.
Products Covered: Prescription status of medicinal ingredients for veterinary use
Regulation Type: Addendum to Regular Notification
Partial amendment to the Public Notice on National Release Testing
Distribution date: 20 January 2022 | Final date for Comment: 10 February 2022
Amendment of the provisions for fee and quantity and deletion of the leukopenic toxicity test in the section for “Influeza HA Vaccine”.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
National Standard of the P.R.C., Motor Vehicle Coolant—Part1:Fuel Vehicle Engine Coolant
Distribution date: 20 January 2022 | Final date for Comment: 21 March 2022
This document specifies the product classification, technical requirements, test methods, inspection rules, marking, packaging, transportation and storage for fuel vehicle engine coolant. This document applies to fuel vehicle engine coolant for light-duty engine and heavy-duty engine, and gas vehicle engine coolant can be followed by reference.
Products Covered: Fuel vehicle engine coolant
Regulation Type: Regular notification
(1) Partial amendment to the Minimum Requirements for Biological Products (2) Partial amendment to the Public Notice on National Release Testing
Distribution date: 20 January 2022 | Final date for Comment: 19 February 2022
(1) The test for abnormal toxicity (“test for freedom from abnormal toxicity”) will be deleted from 15 monographs including those for live vaccines, B Hepatitis Vaccine, recombinant Human Papillomavirus-like Particle Vaccine and recombinant Herpes Zoster Vaccine. (2) The fee, criterion and test sample quantity for National Release Testing of related vaccines will be partially amended.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
DUS 2229-2:2020, Surgical gauze - Specification - Part 2: Petrolatum, First edition
Distribution date: 24 January 2022 | Final date for Comment: 07 May 2025
The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS 2229-2:2020, Surgical gauze - Specification - Part 2: Petrolatum, First edition; notified in G/TBT/N/UGA/1217 and G/TBT/N/UGA/1217/Add.1 entered into force on 26 November 2021. The Uganda Standard, US 2229-2:2020, Surgical gauze - Specification - Part 2: Petrolatum, First edition, can be purchased online through the link: https://webstore.unbs.go.ug/
Products Covered: Petrolatum gauze
Regulation Type: Addendum to Regular Notification
DUS 2276:2020, Medical cotton swabs — Specification, First Edition
Distribution date: 25 January 2022 | Final date for Comment: 07 May 2025
The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS 2276:2020, Medical cotton swabs — Specification, First Edition; notified in G/TBT/N/UGA/1245 and G/TBT/N/UGA/1245/Add.1 entered into force on 26 November 2021. The Uganda Standard, US 2276:2020, Medical cotton swabs — Specification, First Edition can be purchased online through the link: https://webstore.unbs.go.ug/
Products Covered: Medical cotton swabs
Regulation Type: Addendum to Regular Notification
DUS 2275:2020, Castor oil for cosmetic industry — Specification, First Edition
Distribution date: 26 January 2022 | Final date for Comment: 07 May 2025
The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS 2275:2020, Castor oil for cosmetic industry — Specification, First Edition; notified in G/TBT/N/UGA/1243 and G/TBT/N/UGA/1243/Add.1 entered into force on 26 November 2021. The Uganda Standard, US 2275:2021, Castor oil for cosmetic industry — Specification, First Edition, can be purchased online through the link: https://webstore.unbs.go.ug/
Products Covered: Castor oil for cosmetic industry
Regulation Type: Addendum to Regular Notification
Resolución 40433 de 2021 "Por la cual se expide el Reglamento Técnico de Emergencia sobre algunos parámetros de calidad de los combustibles líquidos derivados del petróleo, de los biocombustibles y sus mezclas" (Resolution No. 40433 of 2021 "Issuing the Emergency Technical Regulation on quality parameters for petroleum-based liquid fuels, biofuels and their blends") (6 pages, in Spanish)
Distribution date: 27 January 2022 | Final date for Comment: 07 May 2025
The purpose of Resolution No. 40433 of 2021 is to issue the Emergency Technical Regulation establishing quality parameters and requirements for diesel fuel and its blends with biofuels and basic gasolines and gasolines oxygenated with denatured anhydrous fuel ethanol, for use in compression- and spark-ignition engines respectively, with a view to protecting the environment and health and improving the quality of liquid fuels.
Products Covered: - "Petroleum spirit not containing tetraethyl lead, for motor vehicles", classified under tariff subheading 27.10.12.13.00 or the tariff subheadings that replace it; - "Other petroleum spirit not containing tetraethyl lead", classified under tariff subheading 27.10.12.19.00 or the tariff subheadings that replace it; - "Other medium oils and preparations (diesel) of which less than 90% distils at a temperature of 210°C and 65% at a temperature of 150°C", classified under tariff subheading 27.10.19.19.00 or the tariff subheadings that replace it; - "Biodiesel and mixtures thereof, not containing or containing less than 70% by weight of petroleum oils or oils obtained from bituminous minerals", classified under tariff subheading 38.26.00.00.00 or the tariff subheadings that replace it; - "Ethyl alcohol and other spirits, denatured, of any strength", classified under tariff subheading 22.07.20.00.00 or the tariff subheadings that replace it; - "Undenatured ethyl alcohol of an alcoholic strength by volume of 80% vol. or higher" and "denatured anhydrous fuel ethanol", classified under tariff subheading 22.07.10.00.00 or the tariff subheadings that replace it.
Regulation Type: Regular notification
Draft resolution number 1068, 19 January 2021
Distribution date: 28 January 2022 | Final date for Comment: 26 March 2022
This draft resolution is regarded the proposal for inclusion of active ingredient ingredient I30 - Inpirfluxam of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Normative Instruction number 103 - 19 October 2021 on the Brazilian Official Gazette (DOU - Diário Oficial da União).
Products Covered: HS Code(s): 1201; ICS Code(s): 13, 65
Regulation Type: Regular notification
Proposed amendments to the “Regulation on the Labelling of Precautions for Use of Cosmetics and Ingredients as Allergens”
Distribution date: 28 January 2022 | Final date for Comment: 29 March 2022
The “Regulation on the Labelling of Precautions for Use of Cosmetics and Ingredients as Allergens” is being amended by the Ministry of Food and Drug Safety (MFDS) as follows:Of the precautions for use indicated for each type of cosmetic products, a cautionary note to the type of vulvar cleansing agents, ''Use only on the vulva and not inside the vagina itself.”, has been added.
Products Covered: Cosmetic Product
Regulation Type: Regular notification
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