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Steps (13) arrow_drop_up arrow_drop_down
Obtain NEMC enviromental assessment certificate  (2) expand_more expand_less
Procure scoping report and TORs  (2) expand_more expand_less
Obtain scoping report and TORs approval  (2) expand_more expand_less
Actual EIA assessment  (1) expand_more expand_less
Obtain pharmaceuticals Manufacturing license  (6) expand_more expand_less

8
Submit application for permit and premise registration
(last modified: 14/09/2020)

Contact details

Entity in charge

Tanzania Medicines and Medical Devices Authority (TMDA) HQ

Off Mandela Road, Mabibo - External, Dar es Salaam P.o.Box: 77150
Tel: +255 22 2450512 / +255 22 2450751
Tel. 1: +255 22 2450793
Email: info@tmda.go.tz
Website: www.tfda.or.tz

Unit in charge

TMDA Customer Service

Mon: 08:30 - 01:00, 02:30 - 00:00
Tue: 08:30 - 01:00, 02:30 - 00:00
Wed: 08:30 - 01:00, 02:30 - 00:00
Thu: 08:30 - 01:00, 02:30 - 00:00
Fri: 08:30 - 01:00, 02:30 - 00:00

Person in charge

Sigifrid Mtey

TFDA Customer Service officer
Tel: +255 653649019
Email: sigimtey@gmail.com

Expected results

TMDA proforma invoice

Requirements

1. Application for license form 0003 (TFDA)
Application for license form 0003 (TFDA) (original)
2. Premise Registration form 0001 (TMDA)
Premise Registration form 0001 (TMDA) (original)
3. 01 - Libre deuda de patente
Certified Certificate of incentives (Simple copy)
4. 01 - Libre deuda de patente
Memorandum and Articles of Association or charter or statutes (Simple copy)
5. 01 - Libre deuda de patente
Environmental Clearance Certificate (Simple copy)
6. 01 - Libre deuda de patente
Plant lay-out (Simple copy)

Time frame

Waiting time in queue: Max.  5mn
Attention at counter: Min.   5mn - Max.   10mn

Legal justification

1. THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003
Article S.22
2.
The Tanzania Medicines and Medical Devices Act, Cap 219 of 2019

Additional information

Applications for any of TMDA services can also be forwarded to TMDA zonal offices across the country

Recourse: Tanzania Medicines and Medical Devices Authority (TMDA) HQ

Entity in charge

Tanzania Medicines and Medical Devices Authority (TMDA) HQ

Off Mandela Road, Mabibo - External, Dar es Salaam P.o.Box: 77150
Tel: +255 22 2450512 / +255 22 2450751
Tel. 1: +255 22 2450793
Email: info@tmda.go.tz
Website: www.tfda.or.tz

Unit in charge

TMDA Customer Service

Mon: 08:30 - 01:00, 02:30 - 00:00
Tue: 08:30 - 01:00, 02:30 - 00:00
Wed: 08:30 - 01:00, 02:30 - 00:00
Thu: 08:30 - 01:00, 02:30 - 00:00
Fri: 08:30 - 01:00, 02:30 - 00:00

Person in charge

Roberta Feruzi

Customer Care Officer
Tel: +255 753649019
Email: mis@tfda.or.tz
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