Working closely with the Minstry of Health, ColaLife arranged for the registration of Kit Yamoyo and its various components in Zambia through ZAMRA – the Zambia Medicines Regulatory Authority. This registration has been maintained and is now managed by Pharmanova, the manufacturer.
From the outset of the initial design process and trial in Zambia, ColaLife was supported by ZAMRA (previously known as the PRA), who provided advice and guidance, to ensure that the designs, contents and communication materials match with Zambian legal requirements and best practice. Our manufacturing partner, Pharmanova, led this process, though its existing relationship with ZAMRA and its experience in compliance with the regulatory environment.
The various approval documents can be downloaded below.
Kit components
- 2012 – Approval to market a re-sized ORS sachet (existing ORS formulation already approved)
- 2015 – Batch approval for new dispersible zinc tablet
Marketing approvals for the different Kit yamoyo formats
- 2015 – Approval to market Zinc and Kit Yamoyo flexi-pack, GRZ pack and Screw-top formats
- 2016 – Approval to market Kit Yamoyo Essential (new format without soap included)
