27 Nov 2019

The Botswana Medicines Regulatory Authority (BOMRA) was officially launched in July 2019, and it is currently working with similar Medicines Regulatory Authorities to harmonise medicines registration in the Afro region, the Minister of Health and Wellness Dr Lemogang Kwape has said.

Answering a question in Parliament, Dr Kwape further explained that subsidiary legislation called Medicines and related Substance Regulation was being finalised following consultations with relevant stakeholders which included the business community.

“These regulations will replace the ones from the Drugs and Related Substance Act of 1992 and allow most of the provisions of the act to be implemented,” he said.

According to Minister Kwape, once the process is complete, the authority will significantly improve the turnaround time of medicines registration in the country.

He said the Medicines and Substances Act of 2013 had been implemented since its ascent in July 2013 of which the implementation began with the formation BOMRA which is a parastatal established by the Act.

He explained that the first Board of BOMRA was appointed in 2016 noting that all medicines regulatory services were transferred to BOMRA.

He also added that the act underwent consequential amendment in 2018, noting that further amendments of the act were currently being drafted to cater for veterinary medicines and medical devices, alignment with African Model Law which was previously inadequately addressed.

The minister was responding to a question by the Member of Parliament for Mahalapye West Mr Daniel Tshere who wanted an update on the implementation of the Medicines and Related Substances Act of 2013 and to further state why it was not fully implemented. ENDS