TMDA Southern Highlands Zone which was established in 2007 and the delegation of selected regulatory functions to Local Government Authorities have played a significant role in bringing regulatory services closer to the public and improving service delivery. ThenEstablishment of TMDA zone offices have strengthened TMDA’s capacity to serve customers, particularly those in remote and underserved areas.

To further enhance accessibility and efficiency, the Minister responsible for health, pursuant to Section 121 of the Tanzania Food, Drugs and Cosmetics Act, Cap. 219, delegated certain functions and powers of the Authority to Local Government Authorities through Government Notice No. 476 of 2015.

The establishment of zone offices under Section 5(1) of the Act has therefore been instrumental in facilitating the effective implementation of TMDA’s regulatory mandate and ensuring that its services are more accessible to the public throughout the country.

Southern Highlands Zone office carry out responsibilities through three dedicated desks namely Medicines Control, Medical Devices and Diagnostics Control and support services. The following are functions performed under each desk; -

Medicines Control Desk

• Registration and issuance of permits for premises dealing with medicinal products;
• Inspection of medicinal products and premises;
• Control of importation and exportation of medicines;
• Maintenance and updating of register of medicines premises;
• Issuance of import permits and controlling the consumption of narcotics and psychotropic substances;
• Conducting post marketing surveillance (PMS) and pharmacovigilance activities;
• Supervising quality assurance centers;
• Monitoring advertisement and product promotional activities;
• Participating in GCP inspection of trials conducted in the zone;
• Participating in GMP inspection of facilities in the zone; and
• Handling of recall and disposal of unfit medicinal products.

Medical Devices and Diagnostics Control Desk

• Registration and issuance of permits for premises dealing with medical devices and diagnostics;
• Inspection of medical devices and diagnostics and premises;
• Control of importation and exportation of medical devices and diagnostics;
• Maintenance and updating of register of medical devices and diagnostics premises;
• Conducting post marketing surveillance (PMS) and vigilance activities;
• Monitoring advertisement and product promotional activities;
• Participating in GCP inspection of medical device and diagnostic trials conducted in the zone;
• Participating in quality audit of facilities in the zone; and
Handling of recall and disposal of unfit medical devices and diagnostics;

Support Services Desk

• Managing office facilities, buildings, security services and station upkeep;
• Managing human and financial resources;
• Monitoring and coordinating inspections conducted by LGAs;
• Creating awareness to the public and market TMDA services;
• Fostering cooperation and collaboration with LGAs and other stakeholders; and
• Participating in operational researches, programmes and projects;