Africa Regulatory Update 04_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
Further to the CTFA Africa Regulatory Update of 14 March 2025 that read: “”¦the Zambia Medicines Regulatory Authority’s “Labelling Guidance on Cosmetic Powder Containing Talcum” notice to all manufacturers; wholesalers; retailers; and importers of cosmetics on 30 September 2024”¦advises”¦that the labelling requirements provided in the “Guidelines for Grant of Marketing Authorisation of Cosmetics in Zambia” must be complied with and that all cosmetic powders containing talcum must be indelibly labelled with a warning.”, below please be advised of the additional information received from ZAMRA as well as CTFA’s view on matters:
- “cosmetic powders” is interpreted to mean any and all powders containing talcum (e.g. whether the powder is pressed or not);
- compliance is already required; and
- although the labelling requirement is not present in the Guideline,
- the Guideline does require information on talc from a dossier perspective;
- the labelling requirement is as a result of the separate notification that CTFA considers an extension of the Guideline. ZAMRA has confirmed this as an additional requirement to what is contained in the Guideline; and
- the entire Guideline is mandatory – legally required to be implemented.
- Further information and the wording that should be used for the warning, are given in the ZAMRA Notice that is available from CTFA.
CTFA thanks and appreciates members raising their challenges for its consideration, and further engagement where required.