Notice to Stakeholders - Call for Annual Retention Fees 05.2022

The Botswana Medicines Regulatory Authority (BoMRA), referred to herein as the Authority, would like to notify all its valued stakeholders that the Medicines and Related Substances Act (MRSA) of 2013, Section 24 stipulates that "Where the Authority registers a medicine or cosmetic , the person who applied for the registration shall submit information to the Authority annually, in the prescribed manner accompanied by a prescribed fee" and that the Medicines and Related Substances Regulations (MRSR) of 2019, regulation 4 states that "A registration certificate issued in terms of regulation 3 shall be valid for five years subject to annual submission of information accompanied by a fee set in Schedule 5". Please note that the Authority has not been implementing these provisions of the legislation, having adopted a staged approach to implementation of the Act since commencing operations in 2018. Stakeholders are hereby notified that the Authority has decided to initiate implementation of the annual retention of the medicinal products, effective January 2023.
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File name: notice-to-stakeholders_call-for-annual-retention-fees_05.2022.pdf

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