Africa Regulatory Update 01_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.

Republic of Botswana

In PRT Notification 24/2024, CTFA alerted members to an engagement held by the Botswana Medicines Regulatory Authority (BoMRA) on the future of cosmetic regulation. Since then, a draft Guideline was published (December 2024) and members were invited to submit input towards CTFA's review and consolidation of a submission to BoMRA for consideration.

It should be noted that CTFA expects the Guideline to come into force this year and although cosmetics have been “exempted from registration per section 23 (3a) of the Act.", (do not require authorisation or pre-approval before their importation and sale), there are other requirements. Although "in 2022, there was a voluntary listing exercise in which [BoMRA] called ”¦ stakeholders to list all the products that they are intending to sell or that are selling in the Botswana market ... This exercise ended in September of 2022. But since then, it has since resumed via [the BoMRA] portal called BRIMS, in which stakeholders are encouraged to continue to list their cosmetic products. The products that were listed in the 2022 exercise have since been migrated and are accessible on the BRIMS portal...so importers, exporters, manufacturers, distributors and retailers must list...".

CTFA awaits feedback from and further engagement with BoMRA.

A copy of the draft Guideline and CTFA’s submission is available on request.

Republic of Zambia

Members have been kept updated on developments with regards to the further regulation of cosmetics by the Zambia Medicines Regulatory Authority (ZAMRA). Specific queries are still being received and addressed by CTFA.

As recently as last week, queries to CTFA have surrounded costs/fees; the online portal; and the grace period for listing of cosmetic products. Below, please find an update.

Costs/fees
CTFA approached ZAMRA on this topic from the outset, when the process was announced by social media to apply from 9 September 2024. CTFA understands that the costs are high and has raised this with ZAMRA repeatedly. Unfortunately, ZAMRA is not wiling to enter into discussion regarding this - the “Statutory Instrument SI 38 of 2016”. This document was previously made available to CTFA members, along with additional resources. Furthermore, the registration fees are reported to be the same for all “Allied Substances”.

Online portal
Concerns regarding accessibility have been received and ZAMRA is open to receive comment as indicated by CTFA previously. Please send all comments in this regard to CTFA so that the Association can engage with the ZAMRA. CTFA is not able to test the system itself.
ZAMRA confirmed on Sunday that they are receiving listings successfully via the portal. A Self-Service Portal Manual for the portal (https://www.zamra.co.zm/e-services-portal/) is available from CTFA.

Grace period
We appreciate members informing us of media reports that they have come across, whether they be in the conventional or on social media platforms.
A recent media report suggested that the previously confirmed grace period of up to 24 months from 9 September 2024 was no longer in effect. CTFA immediately reached out and ZAMRA confirmed that “The grace period as officially communicated still stands and has 24 months from 9 September 2024.”. CTFA recommends members read this quote as “up to” as ZAMRA had previously indicated.
Furthermore, ZAMRA has gone further and engaged with their Public Relations Team regarding this matter – to include the set grace period in all their communications to industry on the matter.

For a copy of previous updates regarding ZAMRA and the regulation of cosmetics in Zambia, please make contact.