Regulatory Updates

Distribution date: 21 October 2021 | Final date for Comment: 20 December 2021

This Working Draft East African Standard defines the terms used in the disinfectant and antiseptic industry.

Products Covered: Disinfectants, put up in forms or packings for retail sale or as preparations or articles (excl. goods of subheading 3808.59) (HS code(s): 380894); Products of the chemical industry (ICS code(s): 71.100)

Regulation Type: Regular notification

Distribution date: 21 October 2021 | Final date for Comment: 20 December 2021

This Working Draft East African Standard defines the terms used in the disinfectant and antiseptic industry.

Products Covered: Disinfectants, put up in forms or packings for retail sale or as preparations or articles (excl. goods of subheading 3808.59) (HS code(s): 380894); Products of the chemical industry (ICS code(s): 71.100)

Regulation Type: Regular notification

Distribution date: 21 October 2021 | Final date for Comment: 20 December 2021

This Working Draft East African Standard defines the terms used in the disinfectant and antiseptic industry.

Products Covered: Disinfectants, put up in forms or packings for retail sale or as preparations or articles (excl. goods of subheading 3808.59) (HS code(s): 380894); Products of the chemical industry (ICS code(s): 71.100)

Regulation Type: Regular notification

Distribution date: 21 October 2021 | Final date for Comment: 20 December 2021

This Working Draft East African Standard defines the terms used in the disinfectant and antiseptic industry.

Products Covered: Disinfectants, put up in forms or packings for retail sale or as preparations or articles (excl. goods of subheading 3808.59) (HS code(s): 380894); Products of the chemical industry (ICS code(s): 71.100)

Regulation Type: Regular notification

Distribution date: 20 October 2021

We are publishing a protocol under regulation 39A of the Medical Devices Regulations 2002 which will allow certain Coronavirus test devices to remain on the market after 31 October without approval under regulation 38A(5).  These tests are the subject of a pending application for validation approval and will have to be removed from the market within 10 working days if their application is refused.  Permitting the tests listed in the protocol to remain on the market without approval is considered a necessary and proportionate measure to address the serious public health risk that a shortage of tests could create over the winter.  The protocol will expire on 28 February 2022.

Products Covered: HS3822

Regulation Type: Addendum to Regular Notification

Distribution date: 18 October 2021

The Resolution – RDC number335, 24 January 2020 - previously notified through G/TBT/N/BRA/961 – which establishes the criteria and procedure for the import of Cannabis-based products per individual person, for personal use, upon medical prescription from a legally qualified professional, for health treatment, was changed by Resolution - RDC number 570, 6 October 2021. 

Products Covered: HS CODE: 30049099; 3006; 5302 (cannabis-based medicine, its derivatives and synthetic analogues)

Regulation Type: Addendum to Regular Notification

Distribution date: 15 October 2021 | Final date for Comment: 14 November 2021

Amendment of the provisions for fee and quantity in the “Recombinant Adsorbed Hepatitis B Vaccine (Prepared from Yeast)”. Deletion of the provision for MPL content test in “Recombinant Adsorbed Bivalent Human Papillomavirus-like particle  Vaccine (derived from Trichoplusia ni cells)”. Deletion of a part of the provision for  potency test in “Human prothrombin complex” and “Freeze-dried activated human blood coagulation factor VII concentrate containing factor X.” Deletion of the provision for rabbit pyrogen test in “Freeze-dried ion-exchange-resin treated human normal immunoglobulin” and “Human anti-thrombin III.”

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 14 October 2021

Products Covered:

Regulation Type: Corrigendum to Regular Notification

Distribution date: 12 October 2021

- __________

Products Covered: Pharmaceutical products (HS code(s): 30); Essential oils and resinoids; perfumery, cosmetic or toilet preparations (HS code(s): 33); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, fly-papers). (HS code(s): 3808); Pharmaceutics (ICS code(s): 11.120); Pesticides and other agrochemicals (ICS code(s): 65.100); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Addendum to Regular Notification

Distribution date: 08 October 2021 | Final date for Comment: 07 November 2021

Amendment of the provisions for Potency test in the “Recombinant Adsorbed Hepatitis B Vaccine (Prepared from Yeast)”. Amendment of the provisions for Final bulk and final product in the “Polyethylene Glycol-treated Human Anti-HBs Immunoglobulin”, and for Test procedures in the “Test for Measuring the Potency of Human Anti-HBs Immunoglobulin”.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)

Regulation Type: Regular notification