Table Of Contents (TOC) for TRINIDAD AND TOBAGO

TRINIDAD AND TOBAGO MINISTRY OF HEALTH CHEMISTRY/FOOD AND DRUGS DIVISION

Authority

Beuro of standards

website

http://www.ttbs.org.tt/

if any

DOSSIER REQUIRMENTS

S.NO.

PARTICULARS

PAGE #

1

Certificate in respect of Imported Drugs

1.1

Free Sale Certificate – Original or

Certificate of Pharmaceutical Product-Original----------------------------

2

Chemical Documentation

2.1

Finished Product ---------------------------------------------------------------

2.1.1

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

2.1.2

Method of Analysis ---------------------------------------------------

2.1.3

Certificate of Analysis – Original -----------------------------------

2.1.4

Stability Data ----------------------------------------------------------

2.1.5

Three Samples ---------------------------------------------------------

2.2

Active Ingredients --------------------------------------------------------------

2.2.1

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

2.2.2

Method of Analysis ---------------------------------------------------

2.2.3

Certificate of Analysis (each ingredient) – Original --------------

2.2.4

One (1) gram of each -------------------------------------------------

3

Pharmaceutical Documentation

3.1

Pharmacodynamic data --------------------------------------------------------

3.1.1

General Pharmacology -----------------------------------------------

3.1.2

Tests supporting efficacy ---------------------------------------------

3.2

Pharmacokinetic data ----------------------------------------------------------

3.2.1

Distribution ------------------------------------------------------------

3.2.2

Biotransformation / Metabolism ------------------------------------

3.2.3

Excretion ---------------------------------------------------------------

3.2.4

Biological equivalence -----------------------------------------------

3.3

Pharmacotherapeutic data  ----------------------------------------------------

3.3.1

Therapeutic uses -------------------------------------------------------

3.3.2

Clinical trials -----------------------------------------------------------

3.3.3

Therapeutic equivalence ---------------------------------------------

3.4

Toxicity data – All types ------------------------------------------------------

4

Manufacturing details

4.1

Manufacturing/Unit composition Formula ---------------------------------

4.2

Brief Manufacturing Direction/Procedure ----------------------------------

4.3

Brief Manufacturing controls-------------------------------------------------

4.4

Sampling and testing procedures ---------------------------------------------

4.5

GMP Certificate ----------------------------------------------------------------

5

Packaging Materials (Containers and Closures)

5.1

Description ----------------------------------------------------------------------

5.2

Composition --------------------------------------------------------------------

5.3

Size and dimension requirements (guage, thickness, etc)

with target value and acceptable tolerances---------------------------------

5.4

Colour ----------------------------------------------------------------------------

5.5

Processes necessary to make the article acceptable to pharmaceutical production (e.g. coating, washing, sterility of surfaces, etc.) ------------

5.6

Samples --------------------------------------------------------------------------

6

Ink and Printing

6.1

Colour of Ink --------------------------------------------------------------------

6.2

Chemical Composition of Ink ------------------------------------------------

6.3

Description of Ink

(colourfast, light resistant, rub resistant, reflectance, etc.) ---------------

6.4

Other characteristics of ink (odour, distribution, etc.)

6.5

Printing-capacity t smear, smudge, scoff or

be removed during normal handling of the package ----------------------

7

Package Insert

7.1

Where applicable (Prescription Drugs) -------------------------------------

7.2

Standard Requirements. -------------------------------------------------------