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Steps (31) arrow_drop_up arrow_drop_down
Apply for medicine registration  (3) expand_more expand_less
Obtain GMP compliance certificate  (4) expand_more expand_less
Obtain medicine registration certificate  (1) expand_more expand_less
Obtain registration certificate of premises for wholesale medicine  (5) expand_more expand_less
Obtain medicines import permit  (3) expand_more expand_less
Obtain certificate of radioactivity analysis  (3) expand_more expand_less
Pre-clearance documentation  (1) expand_more expand_less
Clearance of medicine through Julius Nyerere International Airport (JNIA)  (11) expand_more expand_less

certification bar

3
Submit medicine sample
(last modified: 13/12/2021)

Contact details

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.

Unit in charge

Medicines and medical devices registration customer window.

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

Prosper Mwandepa

Data entry technician
Tel: +255 699 707 774
Email: mis@tfda.go.tz

Expected results

Appointment

Requirements

1. 01 - Libre deuda de patente
Medicine samples

Time frame

Waiting time in queue: Max.  10mn
Attention at counter: Max.   15mn

Legal justification

1. The Tanzania Food, Drugs and Cosmetics (Registration of Medicinal products) Regulations, 2015
The Tanzania Food, Drugs and Cosmetics (Registration of Medicinal products) Regulations, 2015
Sections 5, 6
2. The Tanzania Food, Drugs and Cosmetics Act, 2003
The Tanzania Food, Drugs and Cosmetics Act, 2003
Sections 51, 52

Additional information

The certificate of registration will issues to the trader once Good Manufacturing Practice (GMP) has been done.

Who certified this information ?

Damas NYANG'ANYI, Ag. Director of Business Support, 18/12/2018

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.

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
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