Regulatory Updates

Distribution date: 14 December 2021 | Final date for Comment: 12 February 2022

This Draft East African Standard specifies requirements, sampling and test methods for crepe bandages.

Products Covered: Crepe bandages

Regulation Type: Regular notification

Distribution date: 13 December 2021 | Final date for Comment: 11 February 2022

This Draft East African Standard specifies requirements, sampling and test methods for non-woven disposable wet wipes applicable for general personal hygiene and sanitizing purposes 

Products Covered: Disposable wet wipes

Regulation Type: Regular notification

Distribution date: 13 December 2021 | Final date for Comment: 11 February 2022

This Draft East African Standard specifies requirements, sampling and test methods for non-woven disposable wet wipes applicable for general personal hygiene and sanitizing purposes 

Products Covered: Disposable wet wipes

Regulation Type: Regular notification

Distribution date: 13 December 2021 | Final date for Comment: 11 February 2022

This Draft East African Standard specifies requirements, sampling and test methods for non-woven disposable wet wipes applicable for general personal hygiene and sanitizing purposes 

Products Covered: Disposable wet wipes

Regulation Type: Regular notification

Distribution date: 13 December 2021 | Final date for Comment: 11 February 2022

This Draft East African Standard specifies requirements, sampling and test methods for non-woven disposable wet wipes applicable for general personal hygiene and sanitizing purposes 

Products Covered: Disposable wet wipes

Regulation Type: Regular notification

Distribution date: 13 December 2021 | Final date for Comment: 11 February 2022

This Draft East African Standard specifies requirements, sampling and test methods for non-woven disposable wet wipes applicable for general personal hygiene and sanitizing purposes 

Products Covered: Disposable wet wipes

Regulation Type: Regular notification

Distribution date: 09 December 2021

The purpose of this Notice of Amendment is to announce that Health Canada’s notified addition of Epinephrine topical solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ml (1:1000) to the Prescription Drug List has now entered into force. Both the Human and the Veterinary parts of the List have been updated.

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Addendum to Regular Notification

Distribution date: 09 December 2021 | Final date for Comment: 07 February 2022

The purpose of the revision is to enable adequate quality control of pharmaceuticals by harmonizing national standards and specifications with internationally established practices, and to facilitate the distribution of advanced pharmaceuticals of high quality in line with cutting-edge scientific technology by reflecting the latest R&D outcomes in the Pharmacopoeia.   a. Modification and modernization of validation methods, including revisions and error corrections (18 cases, Monographs Part I & Part II, General Tests, General Information)  b. Addition of an item “Gemifloxacin Mesylate Tab” (1 case, Monographs Part I)

Products Covered: Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 08 December 2021 | Final date for Comment: 07 January 2022

The Minimum Requirements for Radiopharmaceuticals will be partially amended to revise the purity test for a radiopharmaceutical.

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

Regulation Type: Regular notification

Distribution date: 07 December 2021

The resolution provides for import, sale and donation of used and reconditioned medical devices.

Products Covered: Medical devices (HS 3006)

Regulation Type: Regular notification