Overview

Tanzania Medicines and Medical Devices Authority (TMDA) is an Executive Agency under the Ministry of Health, Community Development, Gender, Elderly and Children (MOHCDGE). TMDA is responsible for regulating safety, quality and effectiveness of medicines, medical devices and diagnostics. TMDA main responsibility is stated in the Health policy, 2007 and its mandate is stipulated in the Tanzania food, drugs and cosmetics act (TFDCA) cap. 219 as amended by the Finance Act of 2019. The act provides for the efficient and comprehensive Regulation and control of safety and quality of medicines, medical devices and diagnostics in Tanzania mainland. In order to improve public service delivery, TMDA is managed as an Executive Agency in accordance with the Executive Agencies Act, cap. 245 as amended in 2009.

Tanzania Medicines and Medical Devices Authority (TMDA) is responsible to protecting and promote public health by ensuring:

• Quality, safety, and effectiveness of human and veterinary medicines, herbal medicines, medical devices and diagnostics,
• It is charged on both locally produced goods and services and on imports.
• Premises which are intended to be used for the manufacturer, storage and sale of TMDA regulated products should be registered by TMDA and issued with the PREMISES REGISTRATION CERTIFICATE.
• After being manufactured/before being imported into the country, products which are regulated by TMDA should be registered and Issued with PRODUCT REGISTRATION CERTIFICATE so that they are authorized to be placed on the market.
• All manufacturers and dealers of TMDA regulated products once their premises and products have been registered they should be issued with TMDA BUSINESS PERMIT.

Categories

Categories of TMDA regulated Investments are the manufacturers and dealers of:

• Human and Veterinary medicines
• Medical devices
• Laboratory equipment
• Diagnostics

Who Qualifies

• Any person who is dealing with manufacturing, importation and distribution of Medicines, medical devices, laboratory equipment and diagnostics.

How to apply

• Respective guidelines for the application for premises registration and business licensing and products registration are available through TMDA link https://www.tmda.go.tz/
• Dully filled application form should be submitted to TMDA. Forms are available at TMDA website
• Submission of copy of BRELA certificate,
• Submission of copy TIC certificate,
• Submission of copy of memorandum and article of association,
• Submission of copy of premises drawing indicating premises layout, contract with superintendent and letter of acceptance to supervise the business.
• Submission of copy Environmental clearance certificate issued by National Environment Management Council (NEMC) if applicable
• TMDA will conduct premises inspection to examine if it conforms to the requirements.
• Once the premises is found to conform to the requirements, premises will be registered and issued with PREMISES REGISTRATION CERTIFICATE.
• Thereafter the applicants who are the manufacturer will be asked to produce samples and submit to TMDA for product registration purposes while dealers will be issued with BUSINESS LICENCE.
• For the manufacturers, once the products samples have been tested and found to qualify with quality and safety specifications, PRODUCTS REGISTRATION CERTIFICATE will be issued.
• Manufacturers whom their premises and products have qualified will finally be issued with BUSINESS PERMIT allowing them to produce for market.

Cost

Cost for premises registration and licensing and products registration are available in the TMDA FEES AND CHARGES REGULATIONS through TMDA link https://www.tmda.go.tz/