Mandate

The Legal and Enforcement Unit, under the direction of the Legal and Corporate Counsel, is responsible for providing BoMRA with legal services and undertaking the enforcement of the MRSA and related legislation. The Unit further provides Board secretarial services to the Medicines Regulatory Board.

Legal

During the financial year 2018/19, the decision was taken to review and amend the MRSA and to draft subsidiary legislation, including the Medicines and Related Substances Regulations. The process to amend the MRSA was necessitated by the need to ensure that the provisions of the MRSA, which was promulgated in 2013, are aligned to current practices in the industry, meet the international medicines regulatory standards and adequately address the Authority’s mandate to regulate veterinary medicines.

Enforcement

The Legal and Enforcement Unit is responsible for ensuring compliance with the MRSA. In this regard, the Unit is mandated to investigate and enforce provisions of the MRSA. The Unit works in collaboration with other Law Enforcement Agencies in discharging its mandate including the Botswana Police Service and Botswana Unified Revenue Services.

Way Forward

The key strategic initiatives for the Legal and Enforcement Unit as outlined in the 2019 - 2024 Strategic plan are as follows:

  • Ensure Compliance to Legislation
  • Improve Corporate Governance with Effective Practices

The initiatives are aimed at ensuring that the appropriate resources and structures are in place and optimised to ensure adherence to the MRSA, in line with the Authority’s mandate. In addition, the Authority intends to put in place structures to ensure that the Board and the Authority maintain good corporate governance practices.