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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.

2. 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)

Human Drugs

Veterinary Drugs

• Renewal of business permit for local food processors /
  Manufacturers for the year 2010/2011

(Posted: 01st April, 2010 )

• Phasing out and limiting use of standard disposable syringes in favour of autodisable syringes

(Posted: 22 April, 2010 )

• Temporary Suspension of Importation and Distribution of Milk from CHINA

(Posted: 23 September, 08 )

• Kusitishwa kwa Uingizaji na Usambazaji wa Maziwa Kutoka Nchini CHINA

(Posted: 23 September,08)

• Deviations From U.S. Current Good Manufacturing Practices (cGMP) Requirements at Ranbaxy Manufacturing Facilities at Dewas and Paonta Sahib in India.

(Posted: 22 September,08)

• Upungufu Katika Kutimiza Viwango Bora Vya Uzalishaji Dawa (GMP) Ulioonekana katika Viwanda Vya Ranbaxy vilivyoko Dewas na Paonta Sahib Nchini India

(Posted: 22 September, 08)

• Invitation for Tenders (IFT)

(Posted: 16 September,08)

• Baseline Survey Report on Food Manufacturing Plants Profile in Tanzania Mainland .

(Posted: 11 September,08)

• invitation for prequalification ofsuppliers and service providers for the financial year 2008/09.

(Postef: 11 September,08)

• General Procurement Notice (GPN)

(Posted: 10 September,08)

• Recall from Distribution: LACTOGEN 1 INFANT Formula Batch Code 73100179 L1 Manufactured in South Africa.

• Extension of notification for cosmetics products.
• Extension of notification for pre-packed food products
• Alert notice on the use of actellic including actellic super dust in preservation of dried fish.