The United Republic of Tanzania

TANZANIA INVESTMENT CENTRE

Tanzania Food and Drug Authority (TFDA) is responsible to protecting and promote public health by ensuring:

  • Quality, safety, and effectiveness of food, drugs, cosmetics, medical devices, laboratory equipment 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 TFDA regulated products should be registered by TFDA and issued with the PREMISES REGISTRATION CERTIFICATE.
  • After being manufactured/before being imported into the country, products which are regulated by TFDA 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 TFDA regulated products once their premises and products have been registered they should be issued with TFDA BUSINESS PERMIT.

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

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

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

  • Respective guidelines for the application for premises registration and business licensing and products registration are available through TFDA link https://www.tfda.go.tz/index/
  • Dully filled application form should be submitted to TFDA. Forms are available at TFDA 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
  • TFDA 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 TFDA 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 for premises registration and licensing and products registration are available in the TFDA FEES AND CHARGES REGULATIONS through TFDA link https://www.tfda.go.tz/index/


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