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Steps (33) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for wholesale medicine  (6) expand_more expand_less
Obtain medicine registration certificate  (6) expand_more expand_less
Obtain medicine export permit  (3) expand_more expand_less
Obtain EAC certificate of origin  (5) expand_more expand_less
Pre-clearance documentation  (2) expand_more expand_less
Custom declaration  (2) expand_more expand_less
Consignment inspection  (2) expand_more expand_less
Obtain release order  (2) expand_more expand_less
Port clearance  (5) expand_more expand_less

certification bar

10
Submit application documents
(last modified: 11/05/2020)

Timeframe ( see details )

Wait until next step

25 mn  -  55 mn
20 days  -  30 days

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

Unit in charge

Medicines, cosmetics 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. Application form for medicine registration
Application form for medicine registration (original)
2. 01 - Libre deuda de patente
TMDA receipt (original)
3. 01 - Libre deuda de patente
Cover letter (original)
4. 01 - Libre deuda de patente
Certificate of incorporation (Simple copy)
For companies incorporated in Tanzania
or 01 - Libre deuda de patente
Certificate of compliance (Simple copy)
For foreign companies (companies are incorporated outside Tanzania mainland and they come in the country as branches of such foreign companies.)
or 01 - Libre deuda de patente
Business registration certificate (Simple copy)
For registered business
5. 01 - Libre deuda de patente
A table of contents (original)
Listing all sections of dossier and documents and their corresponding page numbers
6. 01 - Libre deuda de patente
Medicinal product dossier (Simple copy)
Contains medicine specification
7. 01 - Libre deuda de patente
Certificate of pharmaceutical product (Simple copy)
The certificate should be in WHO Format on official papers of the issuing competent authority;
8. 01 - Libre deuda de patente
A site master file (Simple copy)
9. 01 - Libre deuda de patente
Medicine samples

Time frame

Waiting time in queue: Min.   5mn - Max.  10mn
Attention at counter: Min.   20mn - Max.   45mn
Waiting time until next step: Min.   20 days - Max.   30 days

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
Section 52

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

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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