Steps (31)
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Apply for medicine registration
(3)
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Obtain GMP compliance certificate
(4)
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Obtain medicine registration certificate
(1)
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Obtain registration certificate of premises for wholesale medicine
(5)
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Obtain medicines import permit
(3)
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Obtain certificate of radioactivity analysis
(3)
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Pre-clearance documentation
(1)
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Clearance of medicine through Julius Nyerere International Airport (JNIA)
(11)
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5
Pay fee
(last modified: 13/12/2021)
(last modified: 13/12/2021)
You can pay for this step online
language Pay online
Costs( see details ) |
Timeframe ( see details ) |
||
|
USD
30,250
|
|
Requirements
1.
TMDA profoma invoice (original)
Cost USD 250
TZS
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| GMP Inspection fee per block (Domestic) | |
|
USD
250
|
|
| GMP inspection fee for facilities of food, pharmaceuticals and medical devices per block (Foreign) | |
|
or
USD
4,000
East Africa
|
|
|
or
USD
5,000
Rest of Africa
|
|
|
or
USD
6,000
Asia
|
|
|
or
USD
7,000
Europe
|
|
|
or
USD
8,000
America
|
Payment methods:
cash, Mobile money
For Mpesa, Dial *150*00# .For Tigopesa, Dial *150*01# . For Airtelmoney, Dial *150*60#. For Halopesa, Dial *150*88#. Select government payment, payment number will be the control number. The payment number for both platforms is the valid control number obtained from the Tanzania Medicines and Medical devices Authority (TMDA). Payments can also be made through banks using the control number.
Time frame
Attention at counter:
Max. 5mn
Legal justification
1.
Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015
Section 8(1&2
Section 8(1&2
Recourse: Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office
Entity in charge
Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office
Off Mandela Road, Mabibo - External , Dar es Salaam P.O. Box 77150, Dar Es Salaam
Tel: +255 222 450 512 / +255 222 450 751 / +255 800 110 084
Fax: +255 222 450 793
Email: tmda.go.tz, info@tmda.go.tz
Website: https://www.tmda.go.tz/
Directions: Google maps
The office is closed during weekend and public holiday.
Tel: +255 222 450 512 / +255 222 450 751 / +255 800 110 084
Fax: +255 222 450 793
Email: tmda.go.tz, info@tmda.go.tz
Website: https://www.tmda.go.tz/
Directions: Google maps
The office is closed during weekend and public holiday.
Unit in charge
Communication and Public Education Section
| Mon: | 08:30 - 13:00, 14:00 - 17:00 |
| Tue: | 08:30 - 13:00, 14:00 - 17:00 |
| Wed: | 08:30 - 13:00, 14:00 - 17:00 |
| Thu: | 08:30 - 13:00, 14:00 - 17:00 |
| Fri: | 08:30 - 13:00, 14:00 - 17:00 |
| The office is closed during weekend and public holiday. | |
Person in charge
Gaudensia Simwanza
Manager, Communication and public Education
Tel: +255 713616 263
Email: info@tfda.go.tz, gaudencia.simwanza@tfda.go.tz
Tel: +255 713616 263
Email: info@tfda.go.tz, gaudencia.simwanza@tfda.go.tz
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