Regulatory Updates

Distribution date: 22 November 2024

Draft resolution 1245, 20 March 2024 - previously notified through G/TBT/N/BRA/1528 - which contains provisions on the validation of bioanalytical methods and analysis of study samples for regulatory submissions of industrialized medicines for human use, was adopted as Resolution 641, 18 November 2024.  The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/3855414/RDC_941_2024_.pdf/fd356c37-661b-4c84-8f20-8e582b4e2f3f 

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); Medicaments (ICS code(s): 11.120.10)

Regulation Type: Addendum to Regular Notification

Distribution date: 22 November 2024 | Final date for Comment: 21 January 2025

The purpose of the notified draft Regulations is to establish the regulatory provisions for Law No. 29459 - Law on pharmaceutical products, medical devices and sanitary products - governing the registration, control and sanitary surveillance of medical devices, and accessories thereof, to ensure their safety and performance, with a view to protecting public health.

Products Covered: Pharmaceutical products classified under Chapter 30 of the Harmonized System or the Customs Tariff 2022.

Regulation Type: Regular notification

Distribution date: 22 November 2024

Resolution 742, 10 August 2022  - previously notified through G/TBT/N/BRA/955/Add.1 - which establishes the minimal technical requirements for relative bioavailability and bioequivalence studies that supports dossier of consent for clinical research, market authorization or post-market authorization of medicines, in the terms of this resolution, was changed by Resolution 942, 18 November 2024. The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/3855414/RDC_942_2024_.pdf/bf46fb32-1ddb-4ba9-abf4-e6fac15966e2 

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

Regulation Type: Addendum to Regular Notification

Distribution date: 22 November 2024

The proposed regulatory amendments notified in G/TBT/N/CAN/698 (dated June 20, 2023) were adopted and published in the Canada Gazette, Part II on November 20, 2024 as the Tents Regulations. The former Tents Regulations had not changed substantively since they were introduced in 1988 and referenced an outdated industry standard that addresses the flammability issues associated with tent materials commonly used at the time. The performance requirements in the former Regulations were less suited to address flammability hazards for the types of tent materials sold in the market today, which are mainly composed of synthetic textile materials.  Health Canada has updated the flammability and fire-safety labelling requirements in the Tents Regulations with contemporary requirements set out in the Canadian General Standards Board standard CAN/CGSB-182.1-2020 Flammability and Labelling Requirements for Tents, using an ambulatory incorporation by reference.  Health Canada also added appropriate flammability performance and fire-safety labelling requirements to the Toys Regulations in order to continue regulating children’s play tents not intended to be used as outdoor shelters. These children’s play tents, defined as a “toy intended to be entered by a child”, are subject to the flammability performance requirements from the International Organization for Standardization standard ISO 8124-2:2014 Safety of toys — Part 2: Flammability using an ambulatory incorporation by reference. Fire-safety labelling requirements are also set out in the Toys Regulations for these products. Consequential amendments to the Textile Flammability Regulations exclude products captured in the scope of the amended Toys Regulations. The Regulations came into force on the date on which they are published in Canada Gazette, Part II (November 20, 2024). A transitional provision of 2 years following the date the Regulations come into force is provided to allow the depletion of existing stock and introduction of products that comply with the new requirements.

Products Covered: Tents: of synthetic fibres (HS Code 6306.22.00), of nylon or other polyamides (6306.22.00.30), of polyesters (HS Code 6306.22.00.40), other (HS Code 6306.22.00.90), of other textile materials (HS Code 6306.29.00.00).

Regulation Type: Addendum to Regular Notification

Distribution date: 21 November 2024 | Final date for Comment: 20 January 2025

This draft Commission Implementing Decision does not approve ethylene oxide as an existing active substance for use in biocidal products of product-type 2.The Commission services concluded that none of the uses of ethylene oxide that the applicant included in the application for approval under the Regulation (EU) No 528/2012 (the BPR), or mentioned as further intended uses in their communication with the Commission, are covered by the scope of the BPR, but instead fall within the scope of the Union legislation on medicinal products or on medical devices.

Products Covered: Biocidal products

Regulation Type: Regular notification

Distribution date: 19 November 2024 | Final date for Comment: 18 January 2025

The draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of the Procedure for State Registration (Reregistration) of Medicines" has been developed to establish a unified mechanism for the state registration (reregistration) of medicines, including finished medicines, immunobiological medicinal products. The draft Resolution proposes to approve a new Procedure for the State Registration (Reregistration) of Medicines, which provides for:- the procedure for the state registration (reregistration) of medicines, including finished medicines, immunobiological medicinal products, and medicinal products under obligations;- the mechanism for amending the registration dossier materials;- the procedure for making decisions on suspension, cancellation and termination of state registration of a medicine and decisions to refuse state registration of a medicine;- the procedure for evaluating periodically updated safety reports on medicines and making appropriate decisions;- the amount of fees for state registration (reregistration) of medicines and the cost of services for the evaluation of registration dossier materials.

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 19 November 2024 | Final date for Comment: 19 December 2024

The Minimum Requirements for Biological Products will be amended as follows:The standard for “High dose Influenza HA Vaccine” that is to be newly approved will be added. And regarding the standard for “pH4-Treated Normal Human Immunoglobulin (Subcutaneous injection)”, the section of “Final bulk and final product” will be partially amended. The Public Notice on National Release Testing will be amended as follows:The criterion, fee, and quantity for “High dose Influenza HA Vaccine” that is to be newly approved will be added. And the quantity for “pH4-Treated Normal Human Immunoglobulin (Subcutaneous injection)” will be partially amended. In addition, the criterion, fee, and quantity for “Lyophilized Human Prothrombin Complex Concentrate”, “pH4-Treated Normal Human Immunoglobulin”, and “Polyethylene Glycol Treated Normal Human Immunoglobulin” will be partially amended.

Products Covered: Pharmaceutical products (HS: 30)

Regulation Type: Regular notification

Distribution date: 19 November 2024 | Final date for Comment: 18 January 2025

The draft Order has been developed to establish the procedure for issuing or refusing to issue permits for parallel imports of medicines, including amendments, suspension, renewal, cancellation or termination of such permits. It also aims to ensure the control and pharmacovigilance over medicines, including medical immunobiological products, imported into Ukraine for the purposes of parallel imports and in circulation during the term of validity of the parallel import permit. 

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 15 November 2024 | Final date for Comment: 14 January 2025

In response to the amendments to the Tariff Codes, and the “Fee-Charging Standards for Lot Release, Reference Materials, and Testing of Foods, Drugs and Cosmetics,” Attachment 1 to Attachment 3 of the "Regulations for the Inspection and Examination of Imported Medical Devices" are proposed to be modified based on the current situation.

Products Covered: Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, whether or not put up in the form of kits (excl.those of heading 3006); certified reference materials (HS code(s): 3822)

Regulation Type: Regular notification

Distribution date: 15 November 2024 | Final date for Comment: 14 January 2025

This draft Malawi standard specifies the requirements, methods of sampling and tests for carbon dioxide used for the carbonation of beverages.

Products Covered: (HS code(s): 29); (ICS code(s): 67.160.01)

Regulation Type: Regular notification