Distribution date: 14 September 2021 | Final date for Comment: 13 November 2021

This Draft Uganda Standard covers the chemical and physical analysis of the commonly available grades of ethylene glycol, diethylene glycol, triethylene glycol, propylene glycol, and dipropylene glycol.

Products Covered: Ethylene Glycols, Propylene Glycols

Regulation Type: Regular notification

Distribution date: 13 September 2021

Proposal for a Resolution which establishes the Pilot Implementation of the Post-Market Authorization Change Management Protocol (PGMP) for drugs with synthetic and semi-synthetic active ingredients.

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: Regular notification

Distribution date: 13 September 2021 | Final date for Comment: 12 November 2021

This Draft Uganda Standard covers the determination of silicon in engine coolant by inductively coupled plasma-atomic emission spectroscopy (ICP-AES). Silicon can be determined as low as the range of 5 ppm by this test method. Other elements also found in engine coolant can be determined by this method. This test method is applicable to the determination of dissolved or dispersed elements.

Products Covered: Engine Coolant

Regulation Type: Regular notification

Distribution date: 13 September 2021

The Resolution number 483, 19 March 2021 - previously notified through  G/TBT/N/BRA/1154  - which establishes exceptional and temporary technical requirements for the import of new medical devices and medicines identified as indispensable for use in healthcare services due to the international public health emergency related to the SARS-CoV-2, was changed by Resolution - number 561, 1 September 2021. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6245812/RDC_561_2021_.pdf/d6545c5c-7c94-4297-b37d-c96e14117abb

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis, incl. natural concentrates, derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent (HS code(s): 2936); Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof "incl. chain modified polypeptides", used primarily as hormones (HS code(s): 2937); Antibiotics (HS code(s): 2941); PHARMACEUTICAL PRODUCTS (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 13 September 2021

This resolution disposes about the market authorization of the products used in the procedure of the permanent artificial pigmentation of the skin.

Products Covered: Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 13 September 2021

The last draft version of Israel's Pharmacists' Regulations (Cosmetics) 5778-2018 notified in G/TBT/N/ISR/709/Add.2 was withdrawn and a newly revised draft should be notified to the TBT within few months. The new regularization of cosmetics is part of a new national reform incorporated into 'Israel's Economic Policy Law (Legislation Amendments for the Implementation of the Economic Policy for Budget Years 2021 and 2022), 5781-2021, Chapter 23: Import' notified in G/TBT/N/ISR/1217. This reform should be approved by the Knesset (Israel's Parliament) in November 2021, and shortly after that, the new regulations will be circulated for comments and notified to the TBT.

Products Covered: Cosmetics (HS: Chapter 33; ICS: 71.100.70).

Regulation Type: Addendum to Regular Notification

Distribution date: 13 September 2021 | Final date for Comment: 12 November 2021

This Draft Uganda Standard covers the determination of the equilibrium boiling point of engine coolants. The equilibrium boiling point indicates the temperature at which the sample will start to boil in a cooling system under equilibrium conditions at atmospheric pressure.

Products Covered: Engine Coolants

Regulation Type: Regular notification

Distribution date: 13 September 2021

TITLE: Revision to Restrictions on Shipment or Use for Human Blood and Blood Components Exceptions; Technical Amendment AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS) ACTION: Final rule; technical amendment SUMMARY: The Food and Drug Administration (FDA or we) is amending the biologics regulation to improve clarity and revise an incorrect citation. This action is being taken to ensure the accuracy and clarity of the biologics regulation. DATES: This rule is [effective] 7 September 2021. This final rule; technical amendment is identified by Docket Number FDA-2021-N-0011. The Docket Folder is available at https://www.regulations.gov/docket/FDA-2021-N-0011/document and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Final Rule published 22 May 2015:https://www.govinfo.gov/content/pkg/FR-2015-05-22/html/2015-12228.htmhttps://www.govinfo.gov/content/pkg/FR-2015-05-22/pdf/2015-12228.pdf The May 2015 final rule as well as previous actions notified under the symbol G/TBT/N/USA/324 are identified by Docket Number FDA-2006-N-0040 (formerly Docket No. 2006N-0221). The Docket Folder is available at https://www.regulations.gov/docket/FDA-2006-N-0040/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.

Products Covered: Human blood (HS:  3002) (ICS:  11)

Regulation Type: Addendum to Regular Notification

Distribution date: 13 September 2021 | Final date for Comment: 12 November 2021

The notified Regulation establishes the regulatory provisions of Article 8 of Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products), amended by Law No. 31091, in order to regulate the conditional sanitary registration of medicines and biological products with phase III clinical studies.

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

Regulation Type: Regular notification

Distribution date: 13 September 2021

This resolution disposes about the improvement of the control and inspection of anorectic psychotropic substances and provides other measures.

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); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification