Africa Regulatory Update 07_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.
Botswana
Mandatory listing of cosmetics and final Guideline for the Regulation of Cosmetics
In CTFA’s Africa Regulatory Update of 13 November 2025, members were notified that the listing of cosmetics with the Botswana Medicines Regulatory Authority (BoMRA) had become mandatory, following a voluntary period that had been granted previously.
Members were invited to lodge queries for CTFA to take to the regulator along with its own, on matters where clarity was required. Below, please find the queries and the respective responses from BoMRA. Please note that some queries were not explicitly addressed by the Regulator – CTFA will follow-up in due course (e.g. availability of training; and cosmetic labeling guidance).
Please provide CTFA with any other queries by Tuesday, 9 December 2025.
| Query to BoMRA | Response from BoMRA/CTFA |
Reference is made to compliance being required to the European Union cosmetic regulation EC1223/2009, or to BOS688-1 and -2. Please confirm that the most recent amended version of EC1223/2009 must be used for compliance purposes. | Compliance should be to the latest versions of these documents. No one is forced to comply with one over the other. EC1223/2009 is freely accessible, and where users require, they can certify against the BOS standard hence the use of both. |
Please confirm that it is expected that by 1 April 2026 all existing cosmetics currently on the market in Botswana are listed, and that any new products for the market should follow the listing requirements already as the system is open (i.e. do not wait for 1 April 2026 to list products). Can the six-month lead time be extended? | All cosmetics marketed in Botswana should be listed by 1 April 2026. There will be no extensions. Listing is open and has been for some time, applicants are encouraged to start the listing process and not wait for the deadline. |
CTFA notes that there are no listing fees at present. Please confirm that already listed products will also not be subject to listing fees. Are fees going to be instituted in the future? If so, when? What will the fees be? Please confirm that there will not be retrospective fee liability placed on regulated entities. | No listing fees at present and the regulator will communicate any changes to fees. |
Is there any mass upload option available on the portal so that companies can list products in bulk? | There is no mass upload functionality yet. |
Under 3.1.5 of the draft Guideline, it is stated: “Responsible Persons – Entities or person(s) involved in the supply chain of cosmetic products with regard to their eventual sale or manufacture in Botswana. These include importers, retailers, manufacturers, distributors, and exporters.” But under 9.2 it is stated: “Applications shall be completed by responsible persons who reside in Botswana”. The guidance under 9.2 implies that the RP must reside in Botswana. However, the draft Guideline is ambiguous in this regard – 3.1.5 does not state this requirement, so there is confusion. Please clarify. | BoMRA did not respond explicitly. CTFA interpretation: Due to the change made to Section 3.1.5 and read with Section 9.2 – it appears that only a Responsible Person residing in Botswana can import/sell/distribute – and complete the necessary applications. |
What is the status of the draft Guideline and comments that were submitted by stakeholders? | A final Guideline was made effective 24 November 2025 and is considered mandatory to implement. It will be available from CTFA as soon as sharing permission is generated from BoMRA. There has been no further opportunity to discuss the draft or engage with the Regulator on the draft Guideline, besides providing initial comments. |
What is the legal status of the listing requirement and Guideline? | Section 60(2) and (4) of the Medicines and Related Substances Regulation 2019 specifically, Part VI in general. Part XI of the Medicines and Related Substances Act 2013. Both are available from CTFA. |
| Should there be any queries or if you would like further information/documentation, please do not hesitate to contact: Dr Glen Malherbe – glen@ctfa.co.za / 082 908 3383. |
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