Reference is made to the above subject matter and the call for payment of annual retention fees letter MRA 1/9/2 vol I (126) and MRA 6/1/2 vol Vil (403).
The Botswana Medicines Regulatory Authority (BoMRA) herein referred to as the Authority would like to notify all stakeholders that, in terms of Section 24 (4) of the Medicines and Related Substances Act of 201 3, “where the Authority registers a medicine the person who applied for the registration shall submit information to the Authority annually, in the prescribed manner accompanied by a prescribed fee”. This provision aims to maintain the medicines registers in an updated state. Thus, all Marketing Authorization Holders (MAHs) are required to submit information and pay annual retention fees for the products they intend to retain on the Medicines Register for the 2023/2024 financial year.
The Authority (BoMRA) sent communication (list of products due for annual retention highlighting information to be submitted and sales orders (quotes)) to the MAHs in November and December 2022. All MAHs are reminded to pay the requisite annual retention fees by the 31st of January 2023.
All the MAHs who have product registrations in Botswana, but have not yet received the communication referenced in paragraph 3 above, should contact BoMRA on email@example.com. Further, any annual retentions related enquiries please contact BoMRA on the same email address.