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Obtain medicine registration certificate  (4) expand_more expand_less

1
Submit application for registration of medicine
(last modified: 10/10/2020)

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

MEDICINES AND MEDICAL DEVICES REGISTRATION CUSTOMER WINDOW.

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

PROSPER MWANDEPA

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

Expected results

TMDA proforma invoice

Requirements

1. Medicine registration application form
Medicine registration application form (2 original )
One hard copy and one soft copy in flash disk in PDF format, bookman old style font 12
2. 01 - Libre deuda de patente
Cover letter TMDA (original)
3. 01 - Libre deuda de patente
Sample medicine (original)
4. 01 - Libre deuda de patente
Certificate of incorporation (Simple copy)
5. 01 - Libre deuda de patente
Certificate of pharmaceutical product (original)
6. 01 - Libre deuda de patente
Tables of content (original)
A table of contents (original) listing all sections of dossier and documents and their corresponding page numbers
7. 01 - Libre deuda de patente
Medical product dossier (original)
Contains medicine specification

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

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

COMMUNICATIONS AND PUBLIC RELATIONS 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

Person in charge

GAUDENSIA SIMWANZA

Manager, Communication and public Education
Tel: +255 713616 263
Email: info@tmda.go.tz, gaudencia.simwanza@tfda.go.tz
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