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United Republic of Tanzania  
 
  • Mwl. Julius K. Nyerere
  • Mh. Amani Abeid Karume
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Home HOW DO I Register
GOVERNMENT OFFICE RESPONSIBLE
Tanzania Food and Drugs Authority - TFDA

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A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins. In Tanzania, Section 51 (1) of the 2003 Act, mandates the TFDA to register all medicines including vaccines

Requirements:

  • The product should be for the public interest
  • Should be safe, efficacious and of acceptable quality
  • The premises and manufacturing operation should comply with the current GMP requirements
  • The product should comply with any other requirements as may be prescribed by the Authority Pre-clinical toxicological data
  • Should be of Clinical safety and efficacy data.

Procedures:

  •  Submit the  data on the chemistry, manufacturing and quality of immunogenic substance
  • The TFDA may by giving reasons in writing refuse, suspend, cancel or revoke the registration
    of a vaccine, or amend the conditions of its registration.
  • The Validity of registration is 5 years.
Source: Government Portal Content Team, Last Reviewed on: 23-11-2015
 
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