Africa Regulatory Update 06_2025

These ad-hoc Africa Regulatory Updates are intended to inform all members of developments, even if queries were received from specific members. Due to increased email burdens, information is shared when of sufficient volume and/or importance.

Zambia

CTFA has received reports that the Zambia Medicines Regulatory Authority (ZAMRA) online portal may be experiencing challenges, as expected system emails bounce or are not responded to. CTFA engaged with the regulator on this matter as well as on listings and the status of the implementation of the Regulations. Please note the information below and alert CTFA to any challenges being experienced.

• “The listing phase of an application is a regulatory process employed to on board products already on the market as well as those that are entering the market for the first time. It is a less stringent process as the information required is gathered via an abridged format. Products are captured and registered via the abridged and simplified format. This process is applied by regulators during a grace period preceding full implementation of regulations. It allows regulators to know among other things (i) where a product is coming from (ii) who is importing the product (iii) what the product contains. The Listing Phase also involves the first level of product regulation which is import controls.”
• “The deadline as communicated is still the 24th of September, 2026”.
• “All requirements are in place as stated in the Medicine and Allied Substances Act (No. 3) of 2013; the Statutory Instrument No. 38 of 2016 on Fees; and the Grant of Marketing Authorization of Cosmetics Guidelines.”. In other words, the legal requirements including fees have not changed/been withdrawn or paused).
• “Where any client faces challenges or requires guidance or clarifications on the Listing or Grant of Marketing Authorization processes or requirements, the institutional email is active as always (pharmacy@zamra.co.zm); our online portal via our IT team can be contacted at helpdesk@zamra.co.zm; and the technical team under the Allied Substances Unit can be contacted at allied@zamra.co.zm.”.
• “For queries, clarifications or guidance that may be required, clients may use the official ZAMRA email address pharmacy@zamra.co.zm or the Allied Substances Unit email allied@zamra.co.zm.”

Botswana

Following the release of the draft Cosmetic Regulation Guideline in 2024 on which CTFA provided input as well as the updates distributed by CTFA on 7 and 28 February 2025, CTFA confirms that the regulator has not implemented any changes to the status quo as yet.

• The draft Guideline is still being considered by the regulator.
• Although the listing of products is currently voluntary, there are certain requirements that a cosmetic product must comply with, such as Good Manufacturing Practice; Botswana Standards 688-1 and -2; and labelling requirements (Regulations); among others.

The Act; Regulations; and draft Guideline that indicates other compliance requirements and exemptions in place, are available from CTFA. 

Please be reminded of the proposed fee schedule that was released for 2025/26 to reflect cost recovery, as well as the updated payment reference validation enforcement.

Should the company wish to list products, please visit the BRIMS portal at https://brims.bomra.co.bw. The listing process currently does not attract any regulatory fees.