Regulatory Updates

DEAS 123: 2021, Distilled water — Specification, Second Edition

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

This Draft East African Standard prescribes the requirements, sampling and test methods for distilled water.

Products Covered: Ordinary natural water, not containing added sugar, other sweetening matter or flavoured; ice and snow (excl. mineral waters and aerated waters, sea water, distilled water, conductivity water or water of similar purity) (HS code(s): 220190); Chemical reagents (ICS code(s): 71.040.30)

Regulation Type: Regular notification

DEAS 123: 2021, Distilled water — Specification, Second Edition

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

This Draft East African Standard prescribes the requirements, sampling and test methods for distilled water.

Products Covered: Ordinary natural water, not containing added sugar, other sweetening matter or flavoured; ice and snow (excl. mineral waters and aerated waters, sea water, distilled water, conductivity water or water of similar purity) (HS code(s): 220190); Chemical reagents (ICS code(s): 71.040.30)

Regulation Type: Regular notification

DEAS 384: 2021,Disinfectants and antiseptics - Glossary, Second Edition

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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

DEAS 384: 2021,Disinfectants and antiseptics - Glossary, Second Edition

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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

DEAS 384: 2021,Disinfectants and antiseptics - Glossary, Second Edition

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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

DEAS 384: 2021,Disinfectants and antiseptics - Glossary, Second Edition

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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

Medical Devices Regulations 2002

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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

E09. COVID-19 TBT

Resolution – RDC number 335, 24 January 2020

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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

Partial amendment to the Public Notice on National Release Testing

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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

Se adjunta el texto de la descripción que fue omitido en la G/TBT/N/PAN/113/Add.1. Descripción: Se retiró el último Borrador de Decreto Ejecutivo, Que reglamenta la Ley 1 de 10 de enero de 2001, Sobre Medicamentos y Otros Productos para la Salud Humana (131 página (s), en español) de Panamá notificado en el documento G/TBT/N/PAN/113 y se debería notificar al OTC un nuevo borrador revisado dentro de unos meses. Actualmente existe una iniciativa de la Asamblea Nacional de Diputados de Panamá de modificar la Ley 1 de 10 de enero de 2001, y poco después, la nueva regulación que será reglamentada se distribuirá para comentarios y se notificará al OTC.

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Distribution date: 14 October 2021

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Regulation Type: Corrigendum to Regular Notification

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