Regulatory Updates

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

This Draft Uganda Standard covers the determination of ash content after ignition of commercial engine coolants and antirusts, as packaged or after use.

Products Covered: Engine Coolants

Regulation Type: Regular notification

Distribution date: 14 September 2021

This resolution establishes the minimum identity and quality requirements for breast implants and the product conformity certification requirement under the Brazilian System of Conformity Assessment (BSCA).

Products Covered: HS (3006) - breast implants

Regulation Type: Regular notification

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

This Draft Uganda Standard covers the determination of the relative density of glycols, glycerin, heat transfer fluids, engine coolant concentrates, and aqueous engine coolants

Products Covered: Anti-freezing preparations and prepared de-icing fluids (excl. prepared additives for mineral oils or other liquids used for the same purposes as mineral oils) (HS code(s): 3820); Refrigerants and antifreezes (ICS code(s): 71.100.45)

Regulation Type: Regular notification

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

This Draft Uganda Standard describes a procedure for the visual measurement of the color of essentially light colored liquids. It is applicable only to materials in which the color-producing bodies present have light absorption characteristics nearly identical with those of the platinum-cobalt color standards used.

Products Covered: Paints, Varnishes

Regulation Type: Regular notification

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

This Draft Uganda Standard specifies the requirements, sampling and methods of test for three types of non-woven surgical dressings; unpadded swabs, padded swabs and surgical pads

Products Covered: Non-woven surgical dressing

Regulation Type: Regular notification

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

This Draft Uganda Standard covers the determination of iron in the range from 1 to 100 μg.

Products Covered: Iron

Regulation Type: Regular notification

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