Distribution date: 02 April 2019 | Final date for Comment: 01 June 2019

This draft East African Standard specifies the requirements, sampling and methods of test for men’s closed shoes.

Products Covered: FOOTWEAR, GAITERS AND THE LIKE; PARTS OF SUCH ARTICLES (HS code(s): 64); Footwear (ICS code(s): 61.060)

Regulation Type: Regular notification

Distribution date: 02 April 2019 | Final date for Comment: 01 June 2019

This draft East African Standard specifies the requirements, sampling and methods of test for men’s closed shoes.

Products Covered: FOOTWEAR, GAITERS AND THE LIKE; PARTS OF SUCH ARTICLES (HS code(s): 64); Footwear (ICS code(s): 61.060)

Regulation Type: Regular notification

Distribution date: 02 April 2019 | Final date for Comment: 01 June 2019

This Draft East African Standard specifies the requirements, sampling and methods of test for ladies’ open shoes. This standard applies to ladies’ open shoes of all constructions and all types of materials and designs.

Products Covered: FOOTWEAR, GAITERS AND THE LIKE; PARTS OF SUCH ARTICLES (HS code(s): 64); Footwear (ICS code(s): 61.060)

Regulation Type: Regular notification

Distribution date: 02 April 2019 | Final date for Comment: 01 June 2019

This Draft East African Standard specifies the requirements, sampling and methods of test for ladies’ open shoes. This standard applies to ladies’ open shoes of all constructions and all types of materials and designs.

Products Covered: FOOTWEAR, GAITERS AND THE LIKE; PARTS OF SUCH ARTICLES (HS code(s): 64); Footwear (ICS code(s): 61.060)

Regulation Type: Regular notification

Distribution date: 02 April 2019 | Final date for Comment: 01 June 2019

This Draft East African Standard specifies the requirements, sampling and methods of test for children’s shoes (above 2 to 6 years).

Products Covered: FOOTWEAR, GAITERS AND THE LIKE; PARTS OF SUCH ARTICLES (HS code(s): 64); Footwear (ICS code(s): 61.060)

Regulation Type: Regular notification

Distribution date: 02 April 2019 | Final date for Comment: 01 June 2019

This Draft East African Standard specifies the requirements, sampling and methods of test for children’s shoes (above 2 to 6 years).

Products Covered: FOOTWEAR, GAITERS AND THE LIKE; PARTS OF SUCH ARTICLES (HS code(s): 64); Footwear (ICS code(s): 61.060)

Regulation Type: Regular notification

Distribution date: 02 April 2019 | Final date for Comment: 01 June 2019

This Draft East African Standard specifies the requirements, sampling and methods of test for children’s shoes (above 2 to 6 years).

Products Covered: FOOTWEAR, GAITERS AND THE LIKE; PARTS OF SUCH ARTICLES (HS code(s): 64); Footwear (ICS code(s): 61.060)

Regulation Type: Regular notification

Distribution date: 02 April 2019 | Final date for Comment: 01 June 2019

This Draft East African Standard specifies the requirements, sampling and methods of test for children’s shoes (above 2 to 6 years).

Products Covered: FOOTWEAR, GAITERS AND THE LIKE; PARTS OF SUCH ARTICLES (HS code(s): 64); Footwear (ICS code(s): 61.060)

Regulation Type: Regular notification

Distribution date: 02 April 2019 | Final date for Comment: 07 June 2019

The regulatory proposal seeks to address cases where generic drug products sometimes differ from their Canadian Reference Product (CRP) (e.g., a different salt, hydrate, or solvate of the medicinal ingredient), leading to difficulties in determining whether drugs could or could not be approved via the Abbreviated New Drug Submission (ANDS) pathway. In certain cases, in both generic and brand name drugs, it is possible that there is a change in the form of a medicinal ingredient during manufacturing of a drug. This type of change is referred to as an “in-situ change.” In such cases, the form of the medicinal ingredient in the dosage form is different from the form of the “input ingredient” used in the manufacturing process (the active pharmaceutical ingredient). The regulatory proposal also suggests consequential changes to ensure the definition of  ‘new active substance’ remains aligned with the definition of ‘innovative drug’; and, the definition of ”new active substance” in the Fees in Respect of Drugs and Medical Devices Regulations remains aligned with the definition of “innovative drug” in the Food and Drug Regulations (FDR).

Products Covered: Drug Products (ICS: 11.120)

Regulation Type: Regular notification

Distribution date: 02 April 2019 | Final date for Comment: 07 June 2019

The regulatory proposal seeks to address cases where generic drug products sometimes differ from their Canadian Reference Product (CRP) (e.g., a different salt, hydrate, or solvate of the medicinal ingredient), leading to difficulties in determining whether drugs could or could not be approved via the Abbreviated New Drug Submission (ANDS) pathway. In certain cases, in both generic and brand name drugs, it is possible that there is a change in the form of a medicinal ingredient during manufacturing of a drug. This type of change is referred to as an “in-situ change.” In such cases, the form of the medicinal ingredient in the dosage form is different from the form of the “input ingredient” used in the manufacturing process (the active pharmaceutical ingredient). The regulatory proposal also suggests consequential changes to ensure the definition of  ‘new active substance’ remains aligned with the definition of ‘innovative drug’; and, the definition of ”new active substance” in the Fees in Respect of Drugs and Medical Devices Regulations remains aligned with the definition of “innovative drug” in the Food and Drug Regulations (FDR).

Products Covered: Drug Products (ICS: 11.120)

Regulation Type: Regular notification