Table Of Contents (TOC) for TANZANIA

TANZANIA is now doing as per WHO

Authority

TANZANIA FOOD AND DRUGS AUTHORITY

website

http://www.ministeres.tn/html/ministeres/sante.html

if any

DOSSIER REQUIRMENTS

Table of Contents

Page No.

SECTION 2:

Summary of Product Characteristics ----------------------------------

SECTION 3:

Active Pharmaceutical Ingredient(s) [API(s)] -----------------------

3.1

Nomenclature -----------------------------------------------------------

3.2

Properties of API(s) -----------------------------------------------------

3.3

Site(s) of manufacture ---------------------------------------------------

3.4

Route(s) of synthesis ----------------------------------------------------

3.5

 Specifications -----------------------------------------------------------

3.6

Container closure system ----------------------------------------------

3.7

Stability testing ----------------------------------------------------------

SECTION 4:

Finished Pharmaceutical Product(s) [FPP(s)] -----------------------

4.1

Manufacturing and Marketing authorization -------------------------

4.2

Pharmaceutical Development ------------------------------------------

4.3

Formulation  -------------------------------------------------------------

4.4

Sites of manufacture ----------------------------------------------------

4.5

Manufacturing process---------------------------------------------------

4.6

Manufacturing Process Controls of Critical Steps and Intermediates

4.7

Process Validation and Evaluation ----------------------------------------

4.8

Specifications for excipients ----------------------------------------------

4.9

Control of the FPP -----------------------------------------------------------

4.10

Container/closure system(s) and other packaging ----------------------

4.11

Stability testing --------------------------------------------------------------

4.12

Container labeling -----------------------------------------------------------

4.13

Patient information and package leaflet ----------------------------------

SECTION 5:

Interchangeability -----------------------------------------------------------

SECTION 6:

Pharmacology, Toxicology and Efficacy of new Products ------------

SECTION 7:

Fixed Dose Combination Medicinal Products ---------------------------