Regulatory Updates

Distribution date: 23 September 2024 | Final date for Comment: 22 November 2024

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 in vitro diagnostic 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 Customs Tariff

Regulation Type: Regular notification

Distribution date: 20 September 2024

Mexico hereby advises of the publication of the draft amendments to various points of Mexican Official Standard NOM-059-SSA1-2015: Good manufacturing practices for medicinal products, published on 5 February 2016, which establishes a reliance scheme to optimize the entry process for safe, effective and quality new treatment options for illnesses requiring advanced therapies (mainly biotechnological medicines) such as cancer and diabetes mellitus. __________

Products Covered: Medicaments (HS 30.04) ;

Regulation Type: Addendum to Regular Notification

Distribution date: 19 September 2024 | Final date for Comment: 18 November 2024

The provisions of the notified Decree, drafted to implement Law No. 28-07 on food safety, seek primarily to: • Define marketed edible vegetable fats and oils; • Establish the names under which such fats and oils can be marketed; • Establish physico-chemical characteristics by Ministerial Order; • Define lawful and unlawful operations involving vegetable fats and oils; • Remove the provision on the nominal volumes in which oils can be presented to the buyer in retail trade; and • Define modalities for the labelling and presentation for sale of edible vegetable fats and oils. The notified draft Decree provides for the repeal of the provisions on vegetable fats and oils set out in the above-mentioned Order of 22 November 1921, in particular those of Articles 5, 6, 7, 8 and 8 bis, and the repeal of Decree No. 2-62-217 of 3 Hija 1381 (8 May 1962) governing the manufacture of edible oils.

Products Covered: Marketed edible vegetable fats and oils

Regulation Type: Regular notification

Distribution date: 18 September 2024 | Final date for Comment: 17 November 2024

This  Draft  East  African  Standard  specifies the requirements, sampling and test methods for round, oval, square and rectangular section stainless steel for use to manufacture furniture. 

Products Covered: Tubes, pipes and hollow profiles, welded, of circular cross-section, of stainless steel (excl. products having internal and external circular cross-sections and an external diameter of > 406,4 mm, and products of a kind used for oil or gas pipelines or of a kind used in drilling for oil or gas) (HS code(s): 730640); Steel pipes and tubes for specific use (ICS code(s): 77.140.75)

Regulation Type: Regular notification

Distribution date: 18 September 2024 | Final date for Comment: 17 November 2024

This  Draft  East  African  Standard  specifies the requirements, sampling and test methods for round, oval, square and rectangular section stainless steel for use to manufacture furniture. 

Products Covered: Tubes, pipes and hollow profiles, welded, of circular cross-section, of stainless steel (excl. products having internal and external circular cross-sections and an external diameter of > 406,4 mm, and products of a kind used for oil or gas pipelines or of a kind used in drilling for oil or gas) (HS code(s): 730640); Steel pipes and tubes for specific use (ICS code(s): 77.140.75)

Regulation Type: Regular notification

Distribution date: 18 September 2024 | Final date for Comment: 17 November 2024

This  Draft  East  African  Standard  specifies the requirements, sampling and test methods for round, oval, square and rectangular section stainless steel for use to manufacture furniture. 

Products Covered: Tubes, pipes and hollow profiles, welded, of circular cross-section, of stainless steel (excl. products having internal and external circular cross-sections and an external diameter of > 406,4 mm, and products of a kind used for oil or gas pipelines or of a kind used in drilling for oil or gas) (HS code(s): 730640); Steel pipes and tubes for specific use (ICS code(s): 77.140.75)

Regulation Type: Regular notification

Distribution date: 18 September 2024 | Final date for Comment: 17 November 2024

This  Draft  East  African  Standard  specifies the requirements, sampling and test methods for round, oval, square and rectangular section stainless steel for use to manufacture furniture. 

Products Covered: Tubes, pipes and hollow profiles, welded, of circular cross-section, of stainless steel (excl. products having internal and external circular cross-sections and an external diameter of > 406,4 mm, and products of a kind used for oil or gas pipelines or of a kind used in drilling for oil or gas) (HS code(s): 730640); Steel pipes and tubes for specific use (ICS code(s): 77.140.75)

Regulation Type: Regular notification

Distribution date: 18 September 2024 | Final date for Comment: 17 November 2024

This  Draft  East  African  Standard  specifies the requirements, sampling and test methods for round, oval, square and rectangular section stainless steel for use to manufacture furniture. 

Products Covered: Tubes, pipes and hollow profiles, welded, of circular cross-section, of stainless steel (excl. products having internal and external circular cross-sections and an external diameter of > 406,4 mm, and products of a kind used for oil or gas pipelines or of a kind used in drilling for oil or gas) (HS code(s): 730640); Steel pipes and tubes for specific use (ICS code(s): 77.140.75)

Regulation Type: Regular notification

Distribution date: 16 September 2024

Resolution 773, 15 February 2023 - previously notified through G/TBT/N/BRA/1341/Add.1 - which contains provisions on the obligation to describe the composition in Portuguese on the labelling of personal hygiene products, cosmetics, nd perfumes, was revoked by Resolution 898, 28 August 2024. The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/6856654/RDC_898_2024_.pdf/05529364-3316-4e12-afcc-370ab79863eb 

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Toiletries, cosmetics and perfumes

Regulation Type: Addendum to Regular Notification

Distribution date: 16 September 2024

Draft Resolution 15, 14 May 2013 - previously notified through G/TBT/N/BRA/532 - which establishes requirements to commercialize traditional Chinese medicine products in Brazil, was adopted as Resolution 901, 06 September 2024.   The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/6862052/RDC_901_2024_.pdf/09e9ff01-c087-4c15-9849-626c7d42cf30 

Products Covered: Traditional Chinese Medicine products (HS:30.00)

Regulation Type: Addendum to Regular Notification