THE FOOD AND DRUGS AMENDMENT

TRINIDAD & TOBAGO

BASIC REQUIREMENTS FOR REGISTRATION OF DRUGS
PRODUCT DOSSIERS MUST BE SUBMITTED ON HARD COPY, ORIGINAL &
DUPLICATE. (duplicate can be soft copy)
EACH PRODUCT DOSSIER MUST BE PRESENTED IN FOUR SEPARATE SECTIONS
AND CLEARLY LABELLED USING THE FOLLOWING FORMAT:

MODULE (1) ADMINISTRATIVE DATA

(1) Table of Contents
(2) Completed F.D.A. Forms. (1, 2 & 3)
(3) Certificate in respect of Imported Drug:
Original, Apostille & Attested Country Specific C.P.P. endorsed by the Trinidad &
Tobago Embassy (must be valid at least one year from date of registration).

MODULE (2) CHEMICAL DOCUMENTATION

(1) Table of Contents
(2) Chemical Documentation
i.

Finished Product
Specifications
Method of Analysis
Stability Data (3 batches of accelerated & real time)
5 Finished Product Samples
Original Certificate of Analysis (must be stamped and signed)

ii.

Active Ingredient(s)
Specifications
Method of Analysis
One (1) gram of each
Original Certificate of Analysis (must be stamped and signed)

MODULE (3) PHARMACEUTICAL DOCUMENTATION

(1) Table of Contents

(2) Pharmaceutical Documentation
i.
Pharmacodynamic Data
General Pharmacology
Tests supporting efficacy
ii.

Pharmacokinetic Data
Distribution
Biotransformation/Metabolism
Excretion
Biological Equivalence

iii.

Pharmacotherapeutic Data
Therapeutic Uses
Clinical Trials
Therapeutic Equivalence

iv.

Toxicity Data
All types
N.B. Data:-Published and In-House

(3) Bioequivalence Studies for TABLETS and CAPSULES

a. Studies must have no less than 24 completed subjects
b. Studies must be done by the manufacturer with the international reference product, showing
proof where the reference product is listed e.g. Martindale, Pharmacopoeia
c. Include in the study the location of the manufacturer of the innovator product e.g. U.S, Brazil
etc.
(4) Detailed Published Clinical trials (can be taken from the internet)
(5) Detailed reports of animal tests
(6) Comparative Data with Innovator Drug (for injections/solutions/creams/ointments/
ophthalmic/optic solutions/inhalers) (same info. as b & c above) AND/OR
(7) Detailed In-House Clinical trials to establish the safety and efficacy of the drug (For
injections/solutions/creams/ointments/ophthalmic/optic solutions.

MODULE (4) OTHER DOCUMENTATION

(1) Manufacturing Details

Manufacturing /Unit Composition Formula

Brief Manufacturing Direction/Procedure
Brief Manufacturing Controls
Sampling and Testing Procedures
Valid GMP Certificate

(2) Packaging Materials (Containers and Closures)

Description
Composition
Size and dimension requirements (gauge, thickness, etc.) with
target value and acceptable tolerances
Colour
Processes necessary to make the article acceptable to
pharmaceutical production (e.g. coating, washing, sterility of
surfaces, etc.)
Samples
(3) Ink and Printing
Colour of Ink
Chemical Composition of Ink
Description of Ink (colourfast, light resistant, rub resistant,
reflectance, etc.)
Other Characteristics of Ink (odour, distribution, etc.)
Printing-capacity to smear, smudge, scoff or be removed during
normal handling of the package
(4) Package Insert
Where applicable (Prescription Drugs)
Standard Requirements