TMDA Legal Service Unit [LSU]

Manager - Legal Services Unit (MLS).
The Legal Services Unit is now under Adv. Iskari Chotusinga Fute

TMDA Legal Service Unit provides in house legal services in accordance with the basic legal framework of TMDA establishment. These includes legal advisory services to the Director General and TMDA members, assisting in the formulation of Legal instruments on Medicines, Medical Devices, and Diagnostics control for which the Director-General is accountable for their safety, quality and effectiveness. The Unit publishes legal documents and maintains a list of national legislations, TMDA related cases and agreements for which TMDA is a party or has interests. The Unit handles and coordinates all litigations or disputes concerning safety, quality and effectiveness of Medicines, Medical Devices and Diagnostics.

The LSU goal is to offer legal services that are in line with National Policies, international legal instruments and that contributes to the mitigation of risks evolved in the human use and consumption of Medicines, Medical Devices and Diagnostics, elimination of falsified and substandard products as well as fostering sustainable management and use of institutional resources.

The LSU is comprised of three (3) lawyers versed with professional and practicing skills of the Bar Association of Tanzania working closely with other administrative staff, associate professional officers and consultants. TMDA lawyers are designated State Attorneys working closely under the supervision of the office of Attorney General and in collaboration with the Solicitor General, the Director of Public Prosecution, the Judiciary, Quasi and non-quasi-judicial bodies.

The LSU expertise is drawn from a multiple and wide professional coverage on corporate and pharmaceutical laws, well vested in providing guidance to the domestic regulators on appraising and potentially reforming domestic pharmaceutical regulatory frameworks. Regulatory legal frameworks can support an enabling protection of public health by addressing a number of issues on compliance, dispute resolution methods and by promoting transparency.

The LSU also coordinates the proceedings of the TMDA Ministerial Advisory Board as the focal section of the Board Secretariat. The Unit records all proceedings of the Ministerial Advisory Boards for ordinary and extra ordinary meetings. The signed minutes are also under the custody of the Unit including extracts resolutions to advise the responsible Minister and any related regulations applicable for management of Board proceedings.

Using the feedback information from in house clients, the Unit keeps on updating a number of legal fields to address the current issues as they emerge from time to time in the Pharmaceutical legal framework. Therefore, both regional and international new requirements in the policies, laws or regulations applicable to national legislations on medicines and medical Devices are regularly incorporated timely.