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Tanzania Food and Drugs Authority (TFDA) is a regulatory body under the Ministry of Health and Social Welfare which is responsible for regulating the quality and safety of food, drugs, cosmetics and medical devices. more about TFDA
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Drugs

PUBLIC NOTICE

The Tanzania Food and Drugs Authority would like to notify all prospective and current registration holders who intend to apply for new registration, renew or vary registration of registered human medicinal products in Tanzania that the Authority has issued revised guidelines for submission of applications. The guidelines and application forms are available online free of charge at www.tfda.or.tz    or in hard copies at a nominal fee of US$30 or equivalent in Tanzanian Shillings. The guidelines are:

  1. Guidelines on Submission of Documentation for Registration Human Medicinal Products, Fourth Edition, November, 2008.
  1. Application Guidelines for Variation of Registered Medicinal Products, First Edition, November, 2008

These guidelines which will come into operation on 1st January 2009 will replace the current “Application Guidelines Registration of Human Medicinal Products, Third Edition, June 2004. After they have come into operation, all applications shall be submitted in accordance with the new guidelines. Applications which will not comply with the new guidelines will not be accepted.

The authority wishes to thank you for having actively participated in the revision of the guidelines

M. Ndomondo-Sigonda
DIRECTOR GENERAL

Mns/hbs/nbc/

 

MAELEZO YA UTANGULIZI YA MKURUGENZI MKUU WA TFDA, M.NDOMONDO-SIGONDA WAKATI WA MKUTANO WA WAANDISHI WA HABARI KUHUSU MATOKEO YA OPERESHENI MAMBA, UKUMBI WA MAMLAKA TAREHE 5 OKTOBA, 2008 (Taarifa Kamili)

 

TAARIFA KWA UMMA KUHUSU MATOKEO YA OPERESHENI YA UKAGUZI WA DAWA BANDIA ILIYOTOLEWA NA MKURUGENZI WA UPELELEZI WA MAKOSA YA JINAI CP ROBERT MANUMBA (Taarifa Kamili)

 

 



 
Following is the list of Human drugs and Veterinary Drugs that has beenregistered from 26th June 2008  

Human Drugs

Veterinary Drugs

 
   
 
 
 
 
  1. Mkutano wa Wamiliki wa Maduka ya Dawa Baridi Mkoani Dar es Salaam, tarehe 17 January 2012.
    (Posted: 16th January, 2012)

  2. Announcement to all Parties Conducting Clinical Trials and those Providing Preventive Chemotherapy in Tanzania.
    (Posted: 30th December, 2011)

  3. Clarification on Inspection of Overseas Pharmaceutical Manufacturing Facilities by TFDA.
    (Posted: 21st December, 2011)

  4. Announcement to All Parties Involved or Conducting Clinical Trials in Tanzania.
    (Posted: 25th October, 2011)

  5. a) Utaratibu Mpya wa Kulipia Huduma za TFDA Kufanyika Kupitia Benki.
    (Imetolewa: 07 Oktoba, 2011)

    b) New Payment Systems for TFDA Services Through Bank Account.
    (Posted: 7th October, 2011)

  6. Tahadhari ya Uwepo wa Dawa Bandia kwenye Soko.
    (Imetolewa: 27 Septemba, 2011)

  7. Tangazo la Viwango Vipya vya Ada na Tozo 2011/2012.
    (Imetolewa: 23 Septemba, 2011)

  8. Taarifa kwa Umma Kuhusu Usalama wa Samaki Walioingizwa Nchini kutoka Japan, Tarehe 24, July 2011.
    (Imetolewa: 13 Septemba, 2011)


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